Shri. Yashwantrao Bhonsale Education Society’s

YASHWANTRAO BHONSALE COLLEGE OF PHARMACY

Bldg. No. 02, BKC, A/ P: Charathe - Vazarwadi, Tal: Sawantwadi, Dist.: Sindhudurg, Maharashtra- 416 510

Approved by AICTE, PCI, New Delhi, Govt. of Maharashtra, DTE. Affiliated to Mumbai University (B. Pharm, M. Pharm)

and MSBTE (D. Pharm) DTE Code: 3480; University Code: 1027; MSBTE Code: 1878

www.sybespharmacy.com +912363-272233/272299 Email:ybpharmacy@gmail.com

Mr. Achyut K. Sawantbhonsale Dr. Vijay A. Jagtap

Executive Chairman Principal

CBSGS Syllabus Copy

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AC 06/06/2012 Item No. 4.102

UNIVERSITY OF MUMBAI

Manual on CREDIT and GRADING SYSTEM

for

B. Pharm. Programme under

FACULTY OF TECHNOLOGY

(with effect from the academic year 2012–2013)

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1 INTRODUCTION 1.1 Recommendations of National Regulatory Authorities

The University Grants Commission (UGC), the National Assessment and Accreditation

Council (NAAC), the Distance Education Council (DEC) and even the National Knowledge

Commission (NKC) have time and again come out with recommendations for improving the

quality and effectiveness of Higher education provisions in the country. The ministry of Human

Resource Development at the Central level and the Ministry of Higher & Technical Education,

Govt. of Maharashtra have also repeatedly stressed on the need for universities to pay prompt

attention to improve the quality of education.

An important concern voiced more strongly in recent times, is the need to develop a Choice-

Based Credit System (CBCS) in tune with global trends and the adoption of a sound grading

system for reflecting learner performance. To quote Shri S. K. Tripathi, former Secretary, Dept.

of Secondary and Higher Education, Ministry of Human Resource Development, Govt. of India,

“...... The demand for socially relevant, economically productive, globally competitive, culturally

sustaining and individually satisfying programmes that cater to the needs of the present times is

fast growing. The constraints of pursuing programmes and participation in pre-determined

combination of Courses pose rigidities not in keeping with the demands of the changing

times…”. There is a need for a fully convertible credit-based system acceptable to other

universities.

Recommendation of the UGC in its Action Plan for Academic and Administrative Reforms

(Ref. UGC letters January 2008; March 2009) “……. Curricular flexibility and learners’

mobility is an issue that warrants our urgent attention. These can be addressed by introducing

credit based courses and credit accumulation. In order to provide with some degree of flexibility

to learners, we need to provide flexibility in course selection and also a minimum as well as a

maximum permissible span of time in which a course can be completed by a learner… The

Choice-Based Credit System (CBCS) imminently fits into the emerging socioeconomic milieu,

and could effectively respond to the educational and occupational aspirations of the upcoming

generations. In view of this, institutions of higher education in India would do well to invest

thought and resources into introducing CBCS. Aided by modern communication and information

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technology, CBCS has a high probability to be operationalised efficiently and effectively —

elevating learners, institutions and higher education system in the country to newer heights…”.

The National Knowledge Commission (NKC) under the chairmanship of Mr. Sam Pitroda, in

its report to the Prime Minister on 29th November 2006) has also reiterated the importance of

higher education and the contribution it has made to economic development, social progress and

political democracy in independent India. However, the Commission has also pointed out to a

“serious cause for concern” at this juncture. According to Mr. Pitroda, “ …. it is important for us

to recognize that there is a quiet crisis in higher education in India which runs deep. And the

time has come to address this crisis in a systematic, forthright manner. …. There is a need for a

transition to a course credit system where degrees are granted on the basis of completing a

requisite number of credits from different courses, which provides learners with choices”.

1.2 Rationale for introduction of Credit and Grading System The UGC while outlining the several unique features of the Choice-Based Credit System (CBCS) has, in fact, given in a nutshell, the rationale for its introduction. Among the features highlighted by the UGC are: Enhanced learning opportunities, ability to match learners’ scholastic needs and aspirations, inter-institution transferability of learners (following the completion of a semester), part-completion of an academic program in the institution of enrolment and part-completion in a specialized (and recognized) institution, improvement in educational quality and excellence, flexibility for working learners to complete the program over an extended period of time, standardization and comparability of educational programs across the country, etc. This credit and grading based system enables a much-required shift in focus from teacher-centric

to learner-centric education since the workload estimated is based on the investment of time in

learning, not in teaching. It also focuses on continuous evaluation which will enhance the

quality of education. It can be concluded from the above discussion that it is very much essential

to implement the credit and grading based higher education in India and University of Mumbai

has taken a lead in implementing the system at University level through its many affiliated

Institutes. In this regard it is very much essential to train and educate the faculty and staff in the

new approach of education system for successful implementation of credit and Grading based

education. The easily accessible information is essential and same will be provided through the

credit and grading manual. In this manual focus is mainly on two aspects, one is course credit

structure and another is examination/assessment and grading as discussed in the next chapters.

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2. ADMISSION 2.1 Admission Criteria

Admission to the B. Pharm. program of Mumbai University is governed by the rules and

regulations of Mumbai University and is as per norms of the Govt. of Maharashtra through the

Directorate of Technical Education (DTE) and the All India Council for Technical Education

(AICTE, New Delhi).

Learner should have passed the HSC (Std.XII) examination of Maharashtra State Board of

Secondary and Higher Secondary Education or its equivalent examination with subjects English,

Physics, Chemistry and Biology/Mathematics AND Secured minimum 45% marks (minimum

40% marks in case of candidates of Backward class categories and Physically Handicapped

belonging only to Maharashtra State) in the subjects Physics, Chemistry and

Biology/Mathematics added together (Maximum of marks obtained in Biology/Mathematics

shall be considered for the purpose of addition)

Minimum qualification for admission into Bachelor of Pharmacy program would be according to

the rules and regulations of AICTE, DTE and Mumbai University in force at the time of

admission.

2.2 Minimum qualification for admission into Semester III of Bachelor of Pharmacy

(Lateral Entry to Second Year B. Pharm.)

A learner with an aggregate of 50% marks at the Diploma of Pharmacy (ER 91) Examinations,

conducted by any Pharmacy college established in India by law and duly approved by PCI u/s 12

of the Pharmacy Act 1948, is eligible for admission to Semester III of Second Year B. Pharm.

The rules/regulations and qualifications for admission will be those in effect at the day and time

of admission. However, such a learner with Diploma in Pharmacy must keep terms for the

following subject heads (only theory papers) of ‘Physical Pharmacy I of Semester I and Physical

Pharmacy II of Semester II, henceforth referred to as ‘Remedial Subjects’. They will be assessed

both by Internal Assessment and by the End Semester Examination in the Remedial Subjects.

Learners would attend classes for Physical Pharmacy - I and would normally be evaluated (both

Continuous evaluation and End Semester Evaluation- refer infra) while studying in Semester III

of the B. Pharm. program and they would attend classes for Physical Pharmacy – II and would

normally be evaluated (both Continuous Evaluation and End Semester Evaluation) while

studying in Semester IV of the B. Pharm. program.

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3. COURSE CREDIT STRUCTURE

As the requirements for a particular degree (undergraduate or postgraduate), a certain quantum of

academic work measured in terms of credits is laid down in general. Every semester by

satisfactorily clearing courses/other academic activities a learner earns credits. The amount of

credit associated with a course is dependent upon the number of hours of instruction per week in

that course. Similarly the credit associated with any of the other activities is dependent upon the

quantum of work expected to be put in for each of the other activity per week.

3.1 Credit Assignment

3.1.1 Theory and Laboratory Courses:

Courses are broadly classified as Theory Courses and Practicals. Theory courses consist of

lecture (L) and /or tutorial (T) hours, and Practicals (P) are hours spent in the laboratory. Credits

(C) for a course is dependent on the number of hours of instruction per week in that course, and

is obtained by using a multiplier of one (1) for lecture and tutorial hours, and a multiplier of half

(1/2) for practical (laboratory) hours. Thus, for example, a theory course having four lectures

per week throughout the semester carries a credit of 4. Similarly, a practical having four

laboratory hours per week throughout semester carries a credit of 2.

3.2 Minimum Credit Requirements

The minimum credit required for award of a B. Pharm. degree is 206. This is normally divided

into Theory courses and Practicals over the duration of eight semesters. The credits are

distributed semester-wise as shown in the syllabus manual. Courses generally progress in

sequences, building competencies and their positioning indicates certain academic maturity on

the part of the learners. Learners are expected to follow the semester-wise schedule of courses

given in the syllabus manual of the respective programmes.

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4. EXAMINATION / ASSESSMENT AND GRADING Semester wise performance assessment of every registered learner is to be carried out through

various modes of examinations. These include Internal Assessment and End Semester

Examination. Normally weighting of Internal Assessment and End Semester Examination is 30

and 70 percentage, respectively, in both Theory Courses and Practicals. Internal Assessment

includes Mid-Term assessments i.e., Periodic Tests and Continuous mode of evaluation as given

in Tables 1 and 2 for Theory Courses and Practicals.

Table 1: Scheme of assessment for Theory Courses of the B. Pharm. program.

Internal assessment End Semester examination

Total for each Theory Course

Continuous mode Mid-Semester Exam (Periodic Test)

15 marks 15 marks 70 marks 100 marks

Table 2. Scheme of assessment for Practicals in the B.Pharm. program

Internal assessment End Semester Examination

Total for each Practical

Continuous mode of evaluation

Mid-Semester Exam (Periodic test)

7 marks 8 marks 35 marks 50 marks

4.1 Conduct of End Semester Examinations

The End Semester Examinations in Semesters I, II, III, IV, V and VI of the B. Pharm. Degree

course will be conducted by the respective institutions/colleges where the learner has been

admitted following rules and regulations. The examinations in Semesters VII and VIII will be

conducted by the university.

4.1.1. A common time-table and common question papers for all the theory examinations of

different semesters will be prepared/set by the university as per the procedure.

4.1.2. The question papers for the Theory courses in Semesters I, II, III, IV, V, VI, VII, VIII

will be set by examiners and paper-setters appointed by the University.

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4.1.3. The assessment and moderation of the answer booklets for the examinations in Theory

courses in Semesters I to VI will be carried out by respective institutions/colleges by the

examiners and moderators appointed by the principals of the institutions/colleges for each

paper from the panel approved by the ad-hoc Board of Studies in Pharmacy.

4.1.4. Principals of the respective institutions/colleges are authorized to appoint examiners in

the Practical examinations at Semesters I to VI on behalf of the university, only from the

panel of suitable persons for appointment as examiners prepared by the competent

authority as per the procedure laid down by the university.

4.1.5. The assessment and moderation of the answer booklets of the Theory courses in

Semesters VII and VIII will be conducted by the University through Central Assessment

Programme (CAP).

4.1.6. Non University Exam System (NUES) subjects

The question papers for NUES courses will be set by examiners and paper-setters

appointed by principals of the institutions/colleges and will be evaluated at the

institutional level following the same pattern as that for other theory subjects and marks

and grade will be forwarded to the university.

4.2 Modes of Assessment/Evaluation

4.2.1 Modes of Evaluation for Theory Courses

Of the 15 marks reserved for Continuous mode of Internal Assessment (Table 1), 5 marks are to

be reserved for attendance, 5 marks for 5 quizzes to be taken randomly over the semester without

prior notice to learners and 5 marks for learner-teacher interaction during lecture hours.

For attendance the allotment of marks are as follows: For 90% or more attendance the complete

5 marks may be given, for 85-89% attendance 4 marks, for 80-84% 3 marks and 75-79% 2 marks

and below 75% zero mark.

Learners will not be given a second chance to reappear for any quiz for which they have been

absent.

Marks for learner-teacher interaction may be given based on the learner’s drive to ask questions

in class, be ready to be part of discussions raised in class, actively participating in class projects

and other activities that are part of the lecture class.

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For the theory subjects, there will be one mid-semester test (Periodic Test) which will be held as

per the schedule fixed in the Academic Calendar of the institutions. The Periodic Test will be of

1 hour duration.

Details of the internal assessment of all learners (which is a combination of both continuous

mode of evaluation and mid semester (periodic test)) should be sent to the academic office of the

University by the Principal/Director of the college/institution at least 15 days before the End

Semester examination

The End Semester Examination will be held as per the university schedule and would be of 70

marks. The paper will be of 3 hours duration and will cover the full syllabus of the course. The

End Semester Examination is mandatory. The grade for courses can be awarded only after

successful completion of both Internal Assessment and End Semester Examination of the

respective course.

4.2.2 Modes of Evaluation for Practicals

For the Practicals, continuous assessment should be carried out and appropriate weighting should

be given to each practical/assignment/course project and proper record of the same to be

preserved by the concerned faculty for the purpose of inspection as and when required. The

assessment in Practicals will be based on regular supervision of the learner’s work during the

practicals, her/his performance in viva-voce examinations, and the quality of their work as

prescribed through laboratory journals and an End Semester Examination. It is obligatory to

maintain a laboratory journal as prescribed by the course instructor.

Of the 15 marks reserved for internal assessment (Table 2), the 7 marks for Continuous

evaluation would be given to the leaner’s work/performance at the practical classes, and a mid-

semester periodic test would be conducted for 8 marks.

The End Semester Examination for Practicals for Semesters I to VI would be done at the

institutional level by a pair of examiners appointed by the institution.

For Semesters VII and VIII, the University would appoint two examiners for each Practical

prescribed in Semesters VII and VIII. Evaluation would be done by the examiners appointed by

the University at the place and time announced by the University. The examination in each

Practical would be of 4 hours duration and would be for a total of 35 marks.

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4.3. Attendance

Attendance for all Theory courses and Practicals is compulsory. As per the University

Ordinance 119, 75% attendance is compulsory for keeping the term.

4.4. Heads of Passing

The End Semester Examination (ESE) and the Combined End Semester and Internal

Assessment for both Theory and Practicals are defined as the Heads of Passing.

4.5. Promotion of Learner and Award of Grades

A learner will be declared PASS and eligible for grade in a particular course of undergraduate

programme if a learner secures at least 40% marks in each head of passing mentioned above.

In simple words, to pass, the learner has to secure a minimum of 28 marks out of 70 marks in the

End Semester Exam in each Theory course and a minimum of 14 marks out of 35 marks in the

End Semester Exam in each Practical and further, a minimum of 40 marks out of 100 in the

Combined End Semester Exam and Internal Assessment in each Theory Course and a minimum

of 20 marks out of 50 in the combined End Semester Exam and Internal Assessment in each

Practical.

4.6. Carry Forward of Marks

In case a learner FAILS in the End Semester Examination or fails to secure the minimum 40%

in Theory and Practicals as specified in Section 4.4, then s/he shall reappear for the End

Semester Examination of that course. However his/her marks of the Internal Assessment shall

be carried over and he/she shall be entitled for grade obtained by him/her on passing.

4.7. Reexamination of Internal Assessment

A learner will have the opportunity to improve his/her performance only once in the Periodic

Test component of the Internal Assessment. The marks obtained by the learner for attendance

and quizzes/learner-teacher interaction will be carried over. The re-conduct of the periodic test

should be completed before the commencement of next semester theory examination.

Reexamination of End Semester Examination will be conducted as per the schedule planned

by University of Mumbai

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4.8 Allowed to Keep Terms (ATKT):

No learner will be admitted to any examination unless he/she keeps term at the institution/college

affiliated to the University.

ATKT rules are applicable only to those learners who have appeared for the examination in all

the subject heads.

4.8.1 A learner who is admitted to the Odd Semesters i.e. Semester I / III / V / VII shall be

eligible to the next even Semester i.e. Semester II / IV / VI / VIII even if the learner fails

in all the courses at the Odd Semester.

4.8.2. A learner failing in not more than two Theory courses and one practical of Semester I and

II taken together shall be promoted to Semester III. However, if he/she fails in more than

two Theory courses and one Practical of Semesters I and II taken together he/she will not

be promoted to Semester III, until the number of failure subject heads is less than two

Theory courses and one Practical in Semesters I and II taken together.

4.8.3. A learner failing in not more than two Theory courses and one Practical of Semester III

and IV taken together shall be promoted to Semester V provided he/she has cleared all

the subjects (Theory courses and Practicals) of Semesters I and II. However, if he/she

fails in more than two Theory courses and one Practical of Semesters III and IV taken

together, he/she will not be promoted to Semester V, until the number of failure subject

heads is less than two Theory courses and one Practical in Semesters III and IV taken

together

4.8.4. A learner failing in not more than two Theory courses and one Practical of Semesters V

and VI taken together shall be promoted to Semester VII provided he/she has cleared all

the subjects of Semesters I to IV

4.8.5. A lateral entry learner will be allowed for the Third Year B. Pharm. Semesters V and VI

provided he/she should have passed Semester III and Semester IV or passed Semester III

and ATKT for Semester IV or ATKT for Semester III and passed Semester IV or ATKT

for Semester III and Semester IV and passed/failed in the Remedial Subjects for

Semesters I and II.

4.8.6. A lateral entry learner failing in the Remedial Subjects of Semesters I and II shall be

allowed to keep terms to the higher semester upto Semester VI irrespective of the number

of subject heads failed in Semester I and II.

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However, for admission for Semester VII of the course, the learner must pass the

specified Remedial subject heads of Semesters I and II.

Note: Grade ABS should be considered as failed and treated as one head for deciding ATKT.

5. GRADING OF PERFORMANCE

5.1 Letter Grade and Grade Point Allocation

The credit and grading system will be effective from the academic year 2012-2013 for Faculty of

Technology of University of Mumbai. In every course, based on the combined performance in

all assessments in a particular semester as per the curriculum/syllabus, the learner is awarded a

letter grade. These letter grades not only indicate a qualitative assessment of the learner’s

performance but also carry a quantitative (numeric) equivalent called the Grade Point. The letter

grades and their equivalent grade point applicable for undergraduate program are given below:

Percentage of Marks Obtained Letter Grade Grade Points Performance

90.00 to 100.00 O+ 10 Brilliant

80.00 – 89.99 O 9 Outstanding

70.00 – 79.99 A 8 Excellent

60.00 – 69.99 B 7 Good

50.00 – 59.99 C 6 Average

40.00 – 49.99 D 5 Pass

Less than 40.00 F 0 Fail

A learner who remains absent in any form of evaluation/examination, letter grade allocated to

him/her should be assigned a letter grade of ABS and a corresponding grade point of zero.

S/he should reappear for the said evaluation/examination in due course.

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5.2 SGPA/ CGPA Calculation

5.2.1 Semester Grade Performance Average (SGPA)

The performance of a learner in a semester is indicated by a number called Semester Grade

Performance Average (SGPA). The SGPA is the weighted average of the grade points obtained

in all the courses by the learner during the semester. For example, if a learner takes five courses

(Theory/Practicals) in a semester with credits C1, C2, C3, C4 and C5 and the learner’s grade points

in these courses are G1, G2, G3, G4 and G5, respectively, then learners’ SGPA is equal to:

The SGPA is calculated to two decimal places.

It should be noted that, the SGPA for any semester will take into consideration the F and ABS

grade awarded in that semester. For example if a learner has a F or ABS grade in course 4, the

SGPA will then be computed as:

5.2.2 Cumulative Grade Performance Average (CGPA)

The CGPA is calculated for Semesters VII and VIII to two decimal places and is indicated in

final grade report card and is the weighted average of the grade points obtained in all the courses

by the learner during Semesters VII and VIII.

The CGPA will reflect the failed status in case of F grade(s), till the course(s) is/are passed.

When the course(s) is/are passed by obtaining a pass grade on subsequent examination(s) the

CGPA will only reflect the new grade and not the fail grades earned earlier.

The CGPA is calculated as:

… ……

where Ci is the Credits for course i and Gi is the grade for course i. Even if a learner has failed

in a course more than once, the course will figure only once in the numerator as well as the

denominator. At the end of semester VIII s/he has appeared for examination for n number of

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courses including the backlog course i and has cleared all the courses including the backlog

course, the CGPA at the end of semester VIII is calculated as,

… ……

5.3 Semester Grade Report

At the end of each semester, the current semester grade report, which reflects the performance of

the learner in that semester, is prepared and issued to the learner.

The Grade Card will reflect the letter grade obtained by the learner, credit points of the

individual courses of a particular semester, calculation of SGPA for each semester. The CGPA

will be calculated for all the successfully completed courses of B. Pharm. Programme.

This report includes the fail grades as awarded. SGPA will be calculated and reflected in the

current semester grade report only if the learner has passed in all heads. SGPA will not be

calculated and reflected in the current semester grade report if the learner does not pass in all

heads of passing. When the learner obtains a grade of D or higher on subsequent attempts a new

semester grade report will be issued to the learner. The existing system of displaying the carried

forward marks/grades and the marks/grades obtained in the current attempt must be used. The

abbreviations for the same shall be displayed in the Grade Card as a footnote. (Refer to circular

no. UG/181 of 2002 dated 24.04.2002).

The Grade Card for Lateral entry learners of the Second Year (Semesters III and IV) B. Pharm.

Course must indicate the results of the Remedial subjects of F. Y. B. Pharm. Semesters I and II

respectively i.e. the Grade Card for Semester III will indicate the result for Physical Pharmacy I

(subject in Sem. I) and the Grade Card for Semester IV will indicate the result for Physical

Pharmacy II (subject in Sem. II)

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AC 6/6/12 4.105

No Semester‐ I Credits Contact hrs/week

Weightage Marks

Subject

Continuous internal

assessment

End Semester

Examination

1 Physical Organic Chemistry 4 4 30 70 100

2 Physical Pharmacy‐I 4 4 30 70 100

3 Anatomy, Physiology and Pathophysiology I 4 4 30 70 100

4 Environmental Science 3 3 30 70 100

5 Communication Skills (NUES) 3 3 30 70 100

Total 18 18 150 350 500 Practicals

6 Physical Pharmacy Lab‐ I 2 4 15 35 50

7 Anatomy, Physiology and Pathophysiology Lab

2 4 15 35 50

8 Computer Lab 2 4 15 35 50

Total 6 12 45 105 150 Total Teaching Hrs. 30 Total Credits 24 Total Marks 650

No. Semester‐ II

1 Pharmaceutical Chemistry‐I 3 3 30 70 100

2 Biochemistry‐ I 4 4 30 70 100

3 Pharmaceutics‐ I 4 4 30 70 100

4 Physical Pharmacy‐ II 3 3 30 70 100

5 Anatomy, Physiology and Pathophysiology‐II

4 4 30 70 100

Total 18 18 150 350 500 Practicals 6 Pharmaceutical Chemistry Lab‐ I 2 4 15 35 50

7 Pharmaceutics Lab‐ I 2 4 15 35 50

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8 Physical Pharmacy Lab‐ II 2 4 15 35 50

Total 6 12 45 105 150 Total Teaching Hrs. 30 Total Credits 24 Total Marks 650

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DETAILED SYLLABUS CONTENT FOR AC 6/6/12 4.103

F.Y. B.Pharm

SEMESTER-I

Physical Organic Chemistry 4 hours / week

Sr. No. Topic Hours 1. Introduction to structure and models of bonding

Review of basic bonding concepts – quantum numbers, atomic orbitals, electron configuration, electronic diagrams, Lewis structures, formal charge, VSEPR, hybridization involving s, p and d orbitals, polar covalent bonds, electronegativity, different scales of electronegativity, electrostatic potential surfaces, inductive effects, group electronegativities, hybridization effects, bond dipoles, molecular dipoles, and quadrupoles with examples, resonance, polarizability The teacher could try to relate some of these concepts to drug effects on macromolecular targets

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2 2.1

2.2 2.3

2.4 2.5

2.6

2.7

Modern Theory of Organic Bonding Molecular Orbital Theory, Strengths and drawbacks Concept of Group orbitals Qualitative Molecular Orbital Theory (QMOT), Rules of QMOT Symmetry and Symmetry Operations, e.g. MH3 and MH3Y systems M.Os of planar methyl, Walsh diagram – pyramidal methyl, bonding in planar and pyramidal forms of methyl Consideration of NH3 and BH3 The orbitals of CH2 group, M.Os of MH2 group, molecular orbitals of H2O Building larger molecules e.g. ethane, ethylene, formaldehyde, methyl chloride, allyl system, boranes Orbitals of reactive intermediates – carbocations, carbenium ions, carbanions, radicals and carbene Bonding in organometallics

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2 2.1

2.2

2.3

2.4 2.5

Kinetics and Reaction Mechanisms. Energy surfaces, reaction coordinate diagrams, activated complex/transition state rate and rate constants, reaction order and rate laws Transition state theory and its relationship to Arrhenius Rate law, Boltzmann distributions and dependence on temperature, methods of determination of activation parameters and Arrhenius parameters with some examples Principles of Kinetic Analysis Kinetic Experiments, First order kinetics, second order kinetics, pseudo-first order kinetics, equilibrium kinetics and initial-rate kinetics, some ideas about methods for following kinetics Temperature dependence on Reaction rates, kinetic isotope effects Hammond Postulate, reactivity vs selectivity, Curtin-Hammett Principle, microscopic reversibility, kinetic vs thermodynamic control

12

3 Acid-Base Catalysis General principles of catalysis, Forms of catalysis – electrophilic catalysis, acid-base catalysis, nucleophilic catalysis, covalent catalysis, phase transfer catalysis, Brønsted Acid-base catalysis, correlation of reaction rates with acidity functions.

7

4 Charge transfer complexes and reactions Definition of complex, charge-transfer transition, donors and acceptors, ground state charge-transfer contribution The teacher could try to relate these concepts to drugs effects on macromolecular targets

4

Total 45

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In ALL subjects the teacher should adopt the latest edition of the books, hence the specific edition and year of publication have been omitted

Books

1. Eric V Ansyln and Dennis A Dougherty, Modern Physical Organic Chemistry, John Wiley. (Main Book to be adopted for teaching this course).

2. Neil Isaacs, Physical Organic Chemistry, Pearson Education.

3. Louis P Hammett, Physical Organic Chemistry, McGraw Hill Education.

4. Edward M Kosower, An Introduction to Physical Organic Chemistry, John Wiley and Sons, Inc

5. Atkins’ Physical Chemistry, Peter Atkins and Julio De Paula, International Student Edition, Oxford University Press.

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Physical Pharmacy I 4 hrs/week

Sr. No TOPICS HOURS 1. States of matter:

The Gaseous state: Ideal and Real gases, The Ideal gas Law, Kinetic Molecular Theory, The van der Waals equation for real gases, Critical phenomenon, critical constants and their determination (Problems)

The Liquid state: Liquefaction of gases and methods (Linde’s, Claude’ s and Faraday’s method), application of liquefaction in aerosols – introduction to the concept, vapour pressure of liquids, Clausius – Clapeyron equation (No derivation)

The Solid State: Crystalline solids, Polymorphism, Solvates, Amorphous solids, melting point and heat of fusion, melting point and intermolecular forces

The Liquid Crystalline state: Structure, properties and significance of liquid crystals

The Supercritical fluid state

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2. Physical properties of Drug Molecules Additive, constitutive and colligative properties with examples Dipole moment, Dielectric constant and significance to pharmacy, concept

of polarizability, molar polarization Refractive index and molar refraction, Principle and working of Abbe’s

refractometer, Application of molar refraction to determine structures Optical rotation, Specific rotation and its applications

6

3. Solutions of Non-electrolytes Units for expressing concentration Ideal and real solutions, Raoult’s law, deviation from Raoult’s law

Methods to measure vapour pressure lowering and its application (problems)

Distillation of binary mixtures and azeotropic distillation. Concept of steam distillation

Elevation of boiling point and determination of molecular weight (problems). Depression of freezing point and determination of molecular weight (problems)

Osmotic pressure: Concept, methods to determine osmotic pressure, molecular weight determination from osmotic pressure.

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4. Thermodynamics Definition, Applications and Limitations Homogenous and Heterogenous systems, Types of systems – Open,

Closed, Adiabatic, Isothermal Types of properties – Intensive and Extensive property Equilibrium and Non-equilibrium states, Types of processes - Isothermal, Adiabatic, Isobaric, Isochoric, Cyclic

process, Reversible and irreversible process First law of thermodynamics Enthalpy, heat capacity, Cp – Cv = R (Derivation) Work of expansion against constant pressure, Isothermal work of expansion against variable pressure Thermochemistry: Heat of reaction, Heat of formation, Heat of combustion, Heat of solution-

Differential and Integral heat of solution, Bond energy – Calculation of Heat of reaction from bond energy data,

Kirchoff’s equation, Hess’s law of constant heat summation Second law of thermodynamics

12

21

Carnot theorem, Efficiency of heat engine, Entropy Third law of thermodynamics Free energy and its applications: Pressure and Temperature coefficients of

free energy, Maximum net work, Criteria for equilibrium, Chemical potential (only definition), Gibbs Helmholtz equation, Clausius Clapeyeron equation (No derivation), van’t Hoff equation (No derivation) Problems

5. Properties of solutions of Electrolytes Electrolysis Faradays laws of electrolysis Electrolytic conductance, Specific conductance, Equivalent conductance,

Molecular conductance Transport number Measurement of conductance Variation of equivalent conductance with dilution Arrhenius theory of electrolytic dissociation- colligative properties

activity coefficient, coefficient expressing colligative properties Theory of strong electrolytes Degree of dissociation Kohlrausch’s law of independent migration of ions Applications of conductivity measurements - Conductometric titrations

and solubility of a sparingly soluble salt Equivalent conductance of a weak electrolyte at infinite dilution Degree of dissociation of a weak electrolyte Problems

6

Total 48 Books

1. P. J. Sinko, ‘Martin’s Physical Pharmacy and Pharmaceutical Sciences’ Fifth edition, Lippincott Williams and Wilkins, Indian Edition distributed by B.I.Publications Pvt Ltd, 2006.

2. Bahl and Tuli, ‘Essentials of Physical Chemistry’ S.Chand and Company Ltd. Ramnagar, New Delhi-110055.

3. U. B.Hadkar,’ A Textbook of Physical Pharmacy’, 9th Edition, Nirali Prakashan, Pune 2008. 4. U. B.Hadkar, T.N.Vasudevan and K.S. Laddha, ‘Practical Physical Pharmacy’, Yucca Publishing

House, Dombivali, 1994 5. Findlay, ‘Practical Physical Pharmacy’ revised and edited by J.A. Kitchener, 8th Ed. Longmans,

Green and company Ltd. 1967.

22

Anatomy, Physiology and Pathophysiology – I 4 hrs/Week

Sr.no. Details Hours 1. Brief introduction to human body and organization of human body 1 2. Structural and functional characteristics of following tissues

1) Epithelial 2) Connective 3) Nervous 4) Muscle

2

3. Detailed structure of cell membrane and trans-membrane movement of substances 2 4. Components and functions of lymphatic system

• Lymphatic organs and tissues • Organization of lymph vessels • Formation and flow of lymph

3

6. Pathophysiology of following diseases • AIDS • Autoimmune diseases (Rheumatoid arthritis, Grave’s disease, Myasthenia

Gravis, Rheumatic fever) • Hypersensitivity and types of hypersensitivity reactions.

2

7. Haematology • Composition of blood • Functions of blood elements • Erythropoiesis and life cycle of RBC. • Synthesis of Haemoglobin • Leucopoiesis • Immunity: Basics and Types • Coagulation of blood • Blood groups

8

8. Pathophysiology of following diseases • Anaemias – Types of anaemias • Polycythemia : Physiological and polycythemia vera • Leucopenia • Leukocytosis • Thrombocytopenia • Leukemia

3

9. Basic mechanism involved in the process of inflammation and repair. • Alteration in vascular permeability and blood flow. • Migration of WBC • Acute and chronic inflammation • Brief outline of the process of repair.

5

9. Structure and properties of following muscles • Cardiac muscles • Smooth muscles • Skeletal muscles • Neuromuscular transmission and contraction of skeletal muscle • Energy metabolism in the muscle • Types of muscle contractions • Muscle tone

9

Total 35

23

REFERENCES FOR ANATOMY, PHYSIOLOGY & PATHOPHYSIOLOGY

Latest editions of the following books can be referred

1. Ross & Wilson, Anatomy & Physiology in Health & Illness by Anne Waugh and Allison Grant,

Published by Churchill Livingstone

2. Gerard J. Tortora & Bryan Derrickson, Principals of Anatomy & Physiology, Published by John Wiley

and Sons, Inc.

3. A. C. Guyton & J. E. Hall, Textbook of Medical Physiology, Published in India by Prism Books Ltd. on

arrangement with W. B. Saunders Company, USA.

4. McNaught & Callander, Illustrated Physiology by B. R. Mackenna & R. Callander

Published by Churchill Livingstone

5. Kaplan, Jack, Opheim, Toivola, Lyon, Clinical Chemistry: Interpretation & Techniques

6. Praful B. Godkar, Textbook of Medical Laboratory Technology, Published by Bhalani Publishing

House, Mumbai, India

8. Harsh Mohan, Text book of Pathology, Published by Jaypee Brothers Medical Publishers Pvt. Ltd., New

Delhi

24

Environmental Science 3 hrs/week

Objectives

1 To study the importance of environmental science and environmental studies 2 To know the importance of key to the future of mankind. 3 To study continuing problems of pollution, loss of forget, solid waste disposal, degradation of environment,

issues like economic productivity and national security 4 Study of Global warming, the depletion of ozone layer and loss of biodiversity have made everyone aware of

environmental issues.

Sr. No. Details Hrs

1 Multidisciplinary Nature of Environmental Studies: • Scope and Importance • Need for Public Awareness • Depleting Nature of Environmental resources such as Soil, Water, Minerals,

and Forests. • Global Environmental Crisis related to Population, Water, Sanitation and Land. • Ecosystem: Concept, Classification, Structure of Ecosystem, overview of Food

chain, Food web and Ecological Pyramid

5

2 Sustainable Development • Concept of sustainable development • Social, Economical and Environmental aspect of sustainable development. • Control Measures: 3R (Reuse, Recovery, Recycle), Appropriate Technology,

Environmental education, Resource utilization as per the carrying capacity.

5

3 Environmental Pollution: • Air Pollution: Sources, Effects of air pollution with respect to Global Warming,

Ozone layer Depletion, Acid Rain, Photochemical smog, Two Control Measures, Bag house Filter, Venturi scrubber. Case Study: Bhopal Gas Tragedy

• Water Pollution: Sources and Treatment, Concept of waste waters - Domestic &Industrial and treatment. Case Study: Minamata Disease.

• Land Pollution: Solid waste, Solid waste Management by Land filling, Composting.

• Noise Pollution; Sources and Effects • E-Pollution: Sources and Effects.

10

4 Environmental Legislation: • Overview • Ministry of Environment and Forests (MoE&F). Organizational structure of

MoE&F. • Functions and powers of Central Control Pollution Board. • Functions and powers of State Control Pollution Board. • Environmental Clearance, Consent and Authorization Mechanism. • Environmental Protection Act • Any two case studies pertaining to Environmental Legislation.

5

5 Renewable sources of Energy: • Limitations of conventional sources of Energy. • Various renewable energy sources. • Solar Energy: Principle, Working of Flat plate collector & Photovoltaic cell.

5

25

Books

1. Hazardous Waste Incineration, Brunner R.C., McGraw Hill Inc 2. Global Biodiversity Assessment, Heywood V.H and Waston R.T., Cambridge Univ. Press 3. Environmental Science systems & Solutions, Mckinney M.L. and School R.M., Web enhanced

edition. 4. Fundamentals of Ecology, Odum E.P., W.B. Saunders Co. USA. 5. Textbook of Environmental studies by Erach Bharucha, University Press. 6. Environmental Studies by R. Rajagopalan, Oxford University Press. 7. Essentials of Environmental Studies by Kurian Joseph & Nagendran, Pearson Education 8. Renewable Energy by Godfrey Boyle, Oxford Publications. 9. Perspective Of Environmental Studies, by Kaushik and Kaushik, New Age International 10. Environmental Studies by. Anandita Basak, Pearson Education 11. Textbook of Environmental Studies by Dave and Katewa, Cengage Learning 12. Environmental Studies by Benny Joseph, Tata McGraw Hill

• Wind Energy: Principle, Wind Turbines. • Hydel Energy: Principle, Hydropower generation. • Geothermal Energy: Introduction, Steam Power Plant

6 Environment and Technology • Role of Technology in Environment and health • Concept of Green Buildings, Indoor air pollution • Carbon Credit: Introduction, General concept. • Disaster Management: Two Events: Tsunami, Earthquakes, Techniques of

Disaster Management • Case Study: Earthquake in Japan

5

Total 35

26

Communication Skills 3 hrs/week

S.No. (Topic) Hours

1.0 Remedial study of grammar, Review of grammar and vocabulary. Effective use of dictionary, Phonetics

10

1.1 Conditionals/Tenses, relative clauses, subject–verb agreement, passive voice

2.0 Written Communication 7

2.1 Discuss a topic of general interest, but related to science in about 300 words. (Analyze, comment, argue, reflect, persuade, etc.) (can also be used for oral presentations by the students, followed by discussion).

3.0 Oral Communication 5

3.1 Consulting a dictionary for correct pronunciation (familiarity with phonetics symbols and stress-marks only)

3.2 (ii) Dialogue

4.0 Scientific Writing 8

4.1 Writing a Scientific Report on a project undertaken or an experiment conducted (theory + practice)

5.0 Soft Skills

5.1 Gestures/ postures – Body language, gesture, posture. 2

5.2 Group discussion – Giving up of PREP, REP Technique, how body language during group discussion.

2

5.3 Presentation skills: (i) How to make a Power Point presentation (ii) Body language during presentation; Resume writing: Cover letter, Career objectives, Resume writing (tailor made)

4

5.4 Mock Interview: Each student to face an interview and to demonstrate the above taught skills.

2

Total 40

Books

1. English Grammar, Beaumont Digty and Colin Granger, An International reference practice book, London, Heinmann.

2. The right word at the right time A guide to the English language and how to use it, Elison John, The Reader’s Digest

3. Study writing, Hamplyons Liz & Ben Heasley, Cambridge University Press. 4. Basic Business Communication, Lesiker Raymond.V and Maire E Hatley, New York, Tata

McGraw Hill

27

Physical Pharmacy Laboratory - I 4 hrs/week

1. Determination of refractive index, molar refraction. Using water as a reference standard, to

determine refractive index of two organic solvents and their mixtures and to determine

composition of unknown. To determine RI of a solid (KCl) from two concentrations of solid

solutions.

2. Viscosity: To determine the composition of the unknown binary mixture.

3. Polarimetry: Different concentrations of sugar, determination of unknown concentration and

specific rotation.

4. Determination of molecular weight by Rast camphor method.

5. Determination of heat of solution of benzoic acid.

6. Partition coefficient of benzoic acid between benzene and water.

Demonstration Landsberger method.

Books U.B. Hadkar, T.N.Vasudevan, K.S.Laddha, ‘Practical Physical Pharmacy’, Yucca Publishing House, Dombivali

28

Anatomy, Physiology and Pathophysiology – Lab.I (4 hr./week)

Sr.no. Details Hours 1. Hematology

1. Red Blood Cell (RBC) Count 2. Total Leukocyte Count 3. Differential Leukocyte (WBC) Count 4. Hemoglobin content of blood 5. Bleeding / Clotting Time 6. Blood groups 7.Erythrocyte Sedimentation Rate (ESR) / Hematocrit (Demonstration)

2. Study of human skeleton 3. Microscopic study of permanent slides

Tissues : - Columnar, Cuboidal, Squmaous, Ciliated Epithelium - Cardiac / Skeletal / Smooth muscle - Ovary, Testis, Liver, Pancreas, Thyroid, Tongue, Stomach, Intestine, Kidney, Lung, Spinal Cord, Cerebrum, Artery, Vein

4. Measurement of blood pressure 5. Tutorial / Discussion on some common investigational procedures used in diagnosis

of diseases with the help of charts / slides Name and Importance of following tests : 1. Electroencephalogram (EEG) in diagnosis of Epilepsy 2. Use of Positron emission tomography (PET) Computed tomography scan

(CT Scan), Single photon emission computed tomography (SPECT) in diagnosis.

3. Use of flow cytometry as a diagnostic tool. 4. Electrocardiogram (ECG) in diagnosis of cardiac arrhythmia 5. Liver Function Tests –

- Serum Bilirubin, - serum glutamate oxaloacetate transaminase (SGOT) - serum glutamate pyruvate transaminese (SGPT) - Urine Bilirubin,

- Urine Urobilinogen, 6. Kidney Function Tests

– Serum Creatinine, – Serum Urea, Uric Acid – Blood Urea Nitrogen (BUN)

7. Blood Glucose 8. Serum Cholesterol / Triglycerides 9. Serum Alkaline phosphatase (ALT) 10. Serum Acid phosphatase (APT) 11. Serum Lipase 12.Serum Amylase 13. Serum Calcium 14. Serum lactate dehydrogenase (LDH) 15. Thyroid Function Tests – T3, T4 16. Prothrombin time (PT) 17. Partial thromboplastin time (PTT) 18. Activated partial thromboplastin time (APTT) 19. Diagnostic tests for infectious diseases like

- Malaria - Tuberculosis - Dengue - H1N1 swine flu -Typhoid

29

Books

1. McNaught & Callander, Illustrated Physiology by B. R. Mackenna & R. Callander, Published by by

Churchill Livingstone

2. Kaplan, Jack, Opheim, Toivola, Lyon, Clinical Chemistry: Interpretation & Techniques, Published by

Elseviers Publications

3. Praful B. Godkar, Textbook of Medical Laboratory Technology, Published by Bhalani Publishing

House, Mumbai, India

4. C. L. Ghai, Text book of Practical Physiology, Published by Jaypee Brothers Medical Publishers Pvt.

Ltd., New Delhi

30

Computer Lab 4 hrs/week

Sr. No. Topic Hours

per week 1 Introduction to Computers. 2 2 History of Computer development and respective generation: Abacus, Napier's Bones,

Slide rule, Pascal's Calculator. General use of computers in everyday life. Computer Classification: Mainframe, Mini and Micro Computers, comparison of Analog & Digital Computers, Hardware and Software. Calculator and Computer

3

3.1

3.2

Operating Systems: Introduction to types of operating systems, UNIX, MS-DOS, etc. RAM, ROM, Virtual Memory etc Students should learn on Windows and Linux OS based systems use of basic Windows and Linux commands

3 3

4.1

4.2

Type of Languages: Conventional languages; their advantages, limitations; C, Pascal, FORTRAN, Programming of these languages Students should be taught some programming in BASIC and C

4 4

5.1 5.2

Introduction to Computer Networks: Architecture of seven layers of communications Students should be taken to a computer lab with has a network and shown the basic connections and operation of different types of networks.

3 2

6.1

6.2

Introduction to Data Structure: Like Queues, list, trees, Binary trees algorithms, Flow chart, Structured Systems, Analysis and development, Ingress-SQL, Gateways etc. Statistics, methodologies. Basic Language: Constants and Variables: Character set, constants, variables, Naming the variables getting data into memory, LET, INPUT, READ. DATA, Print Statement Expressions: Arithmetic expression, Hierarchy of operations, Rules of Arithmetic, Evaluation of expressions, Relational expressions, Logical operations, Library functions Printer Control: Comma and semicolon control, the TAB function, PRINT, LPRINT Functions and Subroutines: User defined functions, subroutines, subscripted variables The above concepts should be introduced practically to students with examples, while working on a computer system.

9

7 Computer Graphics: 2 8 Computer applications in pharmaceutical area and in clinical studies 3

Books

1. Basic Electronics and Computer Applications, Rajiv Khanna, New Age International Publishers

2. Fundamentals of Computers, V. Rajaraman, Prentice Hall of India Pvt. Ltd.

3. Schaums Outline Series, Theory and Problems of Introduction to Computer Science, Francis Scheid, McGraw Hill Book Co.

31

Detailed Syllabus for

SEMESTER-II

Pharmaceutical Chemistry I 3 hours / week

An outline of methods of preparation, uses, sources of impurities, tests for purity and identity, including limit tests for iron, arsenic, lead, heavy metals, chloride, sulphate and special tests if any, of the following classes of inorganic pharmaceuticals included in Indian Pharmacopoeia.

Sr. No. Topic

Hours per

week

1 Acids and Bases: Buffers, Water 3

2 Gastrointestinal Agents : Acidifying agents, Antacids, Protectives and Adsorbents, Cathartics 4

3 Major Intra-and Extra-cellular Electrolytes: Physiological ions. Electrolytes used for replacement therapy, acid-base balance and combination therapy 4

4 Essential and Trace Elements: Transition elements and their compounds of pharmaceutical importance : Iron and haematinics, mineral supplements 4

5 Cationic and anionic components of inorganic drugs useful for systemic effects 3

6 Topical Agents: Protectives, Astringents and Anti-infectives 4

7 Gases and Vapours : Oxygen, Anesthetics and Respiratory stimulants 3

8 Dental Products: Dentifrice, Anti-caries agents 3

9 Complexing and chelating agents used in therapy 3

10

Miscellaneous Agents: Sclerosing agents, expectorants, emetics, poisons and antidotes, sedatives etc. Pharmaceutical Aids Used in Pharmaceutical Industry. Anti-oxidants, preservatives, filter aids, adsorbents, diluents, excipients, suspending agents, colorants etc.

5

11 Inorganic Radio Pharmaceuticals: Nuclear radio pharmaceuticals, Reactions, Nomenclature, Methods of obtaining their standards and units of activity, measurement of activity, clinical applications and dosage, hazards and precautions.

5

Total 41

Books

1. Inorganic medicinal and pharmaceutical chemistry, J. H. Block, E. B. Roche, T. O. Soine, and C. O.

Wilson. Lea & Febiger, Philadelphia, PA.

2. Modern Inorganic Pharmaceutical Chemistry, Clarence A. Discher. Wiley, New York.

3. Remington: the science and practice of pharmacy, Beringer, P. Lippincott Williams & Wilkins.

4. Inorganic Pharmaceutical Chemistry, Bothara, K. G., Nirali Prakashan.

5. Inorganic Pharmaceutical Chemistry, A. S. Dhake, H. P. Tipnis, Career Publication.

32

Biochemistry I 4 hrs/week

S. No. Topic Hrs/Week 1 Introduction to carbohydrates, proteins, lipids

Introduction to common monosaccharides ranging from trioses to hexoses Introduction to common disccharides sucrose, cellobiose, maltose, lactose Introduction to common polysaccaharides starch and glycogen Introduction to amino acids, their classification, three letter and one letter codes Introduction to hierarchy of protein structures Introduction to common saturated and unsaturated fatty acids Intoduction to triacyl glycerol, phospholipids, sphingolipids Introduction to the concept of glycoproteins, proteoglycans, lipopolysaccharides, glycolipids, lipoproteins, proteolipids with examples.

18

2 Enzyme Kinetics Introduction to the factors affecting enzyme activity, concept of initial velocity, derivation of enzyme kinetic equation based on steady state assumptions, direct, Lineweaver Burk and Eadie Hofstee plots of enzyme kinetic data. Modulation of enzyme activity by reversible and irreversible inhibitors. Effects of these inhibitors on enzyme kinetic parameters and the detection of type of inhibitors through Lineweaver Burke and Eadie Hofstee plots. Introduction to the nomenclature of enzymes and names of enzymes that are important drug targets/have diagnostic value and the reactions they catalyze (structures included) (Thymidylate synthase, DHFR, ACE, Renin, HMGCoA reductase, cyclcooxygenase, MAO, COMT, 14-alpha demethylase, aromatase, squalene epoxidase, DNA polymerase, Reverse transcriptase, protease, carbonic anhydrase, proton pump ATPase, acetylcholinesterase, telomerase, SGOT, SGPT, LDH, HIV protease, HIV reverse transcriptase, DNA polymerase, cell wall synthesis enzymes.). Examples of drugs modulating enzyme activity (inhibitors) that are used as drugs with emphasis on the inhibition mechanism. Endogenous regulation of enzyme activity (compartmentalization, positive and negative feedback, cascade systems (phospholipase based cascade as an example), repression/induction through repressor/promoter elements (the lac operon), post-translation modification to control enzyme activity (protein kinases).

14

3 Vitamins Vitamins as co-enzymes and their significance. Metals as co-enzymes and their significance. Biochemical roles of all the vitamins with details of the mechanisms of their functions. (riboflavin, thiamine, pyridoxal, nicotinamide, biotin, folic acid, ascorbic acid, pantothenic acid, cyanocobolamine, inositol, vitamins A, D, E, K)

14

4 Biochemical Energetics Introduction to the concept of free energy, standard free energy, transformed free energy. Thermodynamically favorable or unfavorable reactions. Spontaneous versus thermodynamically favorable reactions. Oxidations as a source of energy in biological systems. ATP, NADH and FADH2 as energy carriers. Introduction

6

33

to the concepts of anabolism and catabolism. Convergence of metabolic pathways and divergence of anabolic pathways

5 Digestion Digestion of food and absorption of food (carbohydrates, lipids and carbohydrates). Fate of absorbed nutrients and relationship with regard to immediate use, storage, release and interconversion. Role of liver, kidney, muscle, adipose tissue, brain and special features of rbcs.

3

Total 55

Books

1. Lehninger, Principles of Biochemistry, Replika Press.

2. Stryer L, Biochemistry, W. H. Freeman & Co.

3. Harper’s Biochemistry, Appleton and Lange, USA.

4. Conn E, Stumpf PK, Brueing G and Doi Roy H, Outlines of Biochemistry, Wiley Liss, USA.

5. Wilson and Gisvolds Textbook of Organic Medicinal and Pharmaceutical Chemistry, Lippincott Willliams and Wilkins, USA

6. Foye’s Principles of Medicinal Chemistry, Lippincott Williams and Wilkins, USA.

34

Pharmaceutics I 4 hrs/week

Sr. No.

Topic Hours

1 a) Historical back ground of the Profession of Pharmacy in India in brief b) Brief overview of status of Pharmaceutical Industry in India

1

2 Introduction to Pharmacopoeias: Development of Indian Pharmacopoeia and other compendia including B.P,U.S.P-NF, Ph. Eur, International Pharmacopoeia

2

3 a) Definition of drug and concept of dosage form & formulation-Scope of Pharmaceutics.

b) Introduction to route of administration and physiological considerations c) Classification of dosage form and their applications

4

4 Drug Administration: Introduction to absorption, distribution and fate of drug. Introduction to Bioavailability and Biopharmaceutics. Concept of drug efficiency and dose response.

3

5 Pharmaceutical calculations: Reduction and enlargement of formulae, formula by weight(w/v, w/w, v/v), in parts

2

6 Introduction to Good Manufacturing Practices and Quality Assurance 2

7 Introduction to alternate systems of medicine: Ayurveda, Homeopathy, Unnani and Siddha

1

8 Rheology: definition and concept, types of flow, and measurement of flow properties 3

9 Concept of Monophasic liquid dosage forms:-Preformulation and Formulation Aspects:

a) Organoleptic properties, Purity, Solubility and solubilisation technique, Dissociation and Partition coefficient, Polymorphism, Stability and Interaction with excipients.

b) General consideration of liquid dosage form design & manufacture: Selection of vehicle, stabilizing and organoleptic additives, large scale manufacturing including unit operations like liquid mixing, filtration and clarification-concept and equipments, filling operations, packaging and quality control tests.

c) Brief coverage of various monophasic liquid dosage forms: Solutions, Aromatic waters, Syrups, Elixirs, Linctuses, Nasal and Ear drops, Paints, Sprays, Lotions & Liniments.

d) Packaging of Pharmaceuticals-General concepts: Package and its components, containers and types of containers, closures and types of closures, packaging material- glass, plastic, metal, rubber and paper, quality control tests.

15

10 Micromeritics & Powder Technology a) Fundamental and derived properties of powders and their measurement b) Size Reduction c) Size separation d) Formulation, Large scale manufacturing (including powder mixing),

Packaging and Quality Control of powders. e) Brief coverage of following powders : Dusting powders, Oral Rehydration

10

35

powders, Dry Syrup formulations 11 Complexation :

Classification of complexes, Pharmaceutical applications of complexation and Analysis of Complexes

2

12 Diffusion & Dissolution a) Fick’s laws and steady state diffusion, measurement of diffusion b) Dissolution rate, Noyes – Whitney equation, Factors affecting dissolution,

Intrinsic Dissolution Rate, Hixson – Crowell Law

3

TOTAL 48

Books

2. Lachman Leon, Lieberman Herbert A, Kanig Joseph L., “The Theory and Practice of Industrial Pharmacy, Varghese Publishing House, Mumbai.

3. Lieberman Herbert A., Rieger, “Pharmaceutical Dosage Forms – Dispersed Systems”, Volume 1/2/3, Marcel Dekker Inc, New York.

4. Remington, The Science and Practice of Pharmacy, Vol I & II, B.L. Publications Pvt. Ltd. 5. Martin A., Physical Pharmacy, 4th Edition, Lea &Febiger, Philadelphia, London. 6. M.E. Aulton, Ed, Pharmaceutics-The Science of Dosage Form Design, Churchill Livingstone

Medical Divn. Of Longman Group, UK Ltd. 7. Rawlings, Bentley's Text Book of Pharmaceutics, Bailliere Tindall, London. 8. Atmaram Pawar, "Introduction to Pharmaceutics”, Career Publications, Nashik.

36

Physical Pharmacy – II 3 hrs/week

Sr. No TOPICS HOURS

1. Ionic equilibria and buffers Arrhenius Theory, Bronsted – Lowry Theory, Lewis Electronic Theory Sorensens pH scale, calculation of pH, effect of pH on ionization of weak

acids and bases, calculation of fraction unionized Buffers in pharmaceutical and biological systems, concept of tonicity,

isotonic buffer solutions, application of buffers and concept of tonicity in pharmacy

Problems

5

2. Solubility and distribution phenomenon Solvent – solute interactions Solubility of gases in liquids, Henry’s law and applications Solubility of liquids in liquids, miscible and partially miscible liquids Phase equilibria and Phase rule (one, two and three component systems) Solubility of solids in liquids, ideal and non ideal solutions, solubility

parameters and prediction of solubility in regular solutions Partition phenomenon and partitioning of weak electrolytes and

applications

6

3. Chemical kinetics Molecularity, order of a reaction and specific rate constant Zero order, First order and Second order reaction (problems) Methods to determine order of a reaction Energy of activation, Arrhenius equation and application Collision theory and transition state theory Accelerated stability studies – concepts and application Problems

8

4. Interfacial phenomena Surface tension, Interfacial tension, Surface free energy, Pressure

differences across curved interfaces, Measurement of surface and interfacial tension-capillary rise method

Drop weight method, Du Nuoytensiometer method, Spreading of liquids, Spreading coefficient, Hydrophilic-Lipophilic balance

Types of monolayers at liquid interfaces, Soluble monolayers, Gibbs adsorption equation (No derivation), Insoluble monolayers and film balance, Adsorption at solid interfaces, Adsorption isotherms, Freundlich adsorption isotherm, Langmuir adsorption isotherm, Wetting angle and contact angle

Problems

8

5. Electromotive force Electrochemical cell Types of electrodes Nernst equation and cell emf pH meter and measurement of pH Ion sensitive electrodes Oxidation reduction indicators Concentration cells

4

6. Colloids Classification, Preparation, colloid properties such as optical, kinetic and electrical Gold number Protective colloid Schultz Hardy rule

5

37

TOTAL 36 Books

1. P. J. Sinko, ‘Martin’s Physical Pharmacy and Pharmaceutical Sciences’, Lippincott Williams and

Wilkins, Indian Edition distributed by B. I. Publications Pvt. Ltd.

2. Bahl and Tuli, ‘Essentials of Physical Chemistry’ S. Chand and Company Ltd. Ramnagar, New

Delhi.

3. U. B .Hadkar,’ A Textbook of Physical Pharmacy’, Nirali Prakashan, Pune.

4. U. B. Hadkar, T. N. Vasudevan and K. S. Laddha, ‘Practical Physical Pharmacy’, Yucca

Publishing House, Dombivali.

5. A. Findlay, ‘Practical Physical Pharmacy’ revised and edited by J.A. Kitchener, Longmans, Green

and company Ltd.

38

Anatomy, Physiology and Pathophysiology – II 4 hrs/week

Sr.no. Details Hours 1. Principles of cell injury and adaptation

• Causes of cell injury • Pathogenesis and morphology of cell injury. • Cellular adaptation • Cellular atrophy and hypertrophy.

3

2. Disturbances of growth of cells • Differences between benign and malignant tumor • Classification of malignant tumors • Etiology and pathogenesis of cancer- Invasion, metastasis and patterns of

spread of cancer.

3

3. Biological effects of radiation • Nuclear radiation • U.V. radiation. • X-ray and other radiations.

2

4. Anatomy and Physiology of Respiratory System • Exchange of gases • External and internal respiration • Mechanism and regulation of respiration • Lung volumes and lung capacities

4

5. Pathophysiology of following diseases • Asthma • Pneumonia • Bronchitis • Emphysema • Respiratory Acidosis and Alkosis

2

6. Endocrine System Anatomy and physiology of following endocrine glands : • Pituitary • Thyroid & Parathyroid • Adrenal • Pancreas

9

7. Pathophysiology of hypo and hyper secretion of above endocrine glands and related diseases

4

8. Nervous System Neurons, Neurotransmitter and neurotransmission Anatomy and physiology of :

• Central Nervous System (CNS) - Autonomic Nervous System (ANS)

- Cranial and spinal nerves - Sensory and Motor pathways

9

9. Pathophysiology of following diseases • Epilepsy • Parkinsonism • Alzheimer’s Disease • Cerebral Hypoxia • Stroke (Cerebrovascular disease) • Anxiety & Depression • Mania and Schizophrenia

3

39

10. Structure and Function of following sensory organs • Eye • Ear • Tongue • Nose • Skin

6

Total 45 Books

Latest editions of the following books can be referred

1. Ross & Wilson, Anatomy & Physiology in Health & Illness by Anne Waugh and Allison Grant,

Published by Churchill Livingstone

2. Gerard J. Tortora & Bryan Derrickson, Principals of Anatomy & Physiology, Published by John Wiley

and Sons, Inc.

3. A. C. Guyton & J. E. Hall, Textbook of Medical Physiology, Published in India by Prism Books Ltd. on

arrangement with W. B. Saunders Company, USA.

4. McNaught & Callander, Illustrated Physiology by B. R. Mackenna & R. Callander, Published by

Churchill Livingstone

5. Kaplan, Jack, Opheim, Toivola, Lyon, Clinical Chemistry: Interpretation & Techniques

6. Praful B. Godkar, Textbook of Medical Laboratory Technology, Published by Bhalani Publishing

House, Mumbai, India

8. Harsh Mohan, Text book of Pathology, Published by Jaypee Brothers Medical Publishers Pvt. Ltd., New

Delhi

40

Pharmaceutical Chemistry Lab. I 4 hours / week

1. The background and systematic qualitative analysis of inorganic mixtures of up to four radicals. 2. Six mixtures to be analyzed, preferably by semi-micro methods. 3. Identification tests for pharmacopoeial inorganic pharmaceuticals and qualitative tests for cations

and anions should be covered.

41

Pharmaceutics Lab. - I 4 hrs./week

List of experiments Aromatic waters Chloroform water I.P.’66. Concentrated Dill water I.P.’66. Concentrated Anise water B.P.C. ’73. Gripe water. Syrups Syrup I.P.’66 Artificial syrup Cough syrup-Codeine phosphate syrup B.P.C. Linctus Simple linctus B.P.C. Elixirs Piperazine citrate elixir B.P.C. Ear drops Chloramphenicol ear drops B.P.C. Nasal drops Ephedrine sulphate nasal drops B.P.C. Glycerites Glycerine of starch I.P.’55 Glycerine of boric acid I.P.’55 Glycerine of tannic acid I.P.’66 Solutions Aqueous iodine solution I.P.’66 Paracetamol solubilised paediatric drops Cresol with soap solution I.P. Magnesium citrate oral solution NF XIV. Chlorinated soda solution, surgical B.P.C. Iodine paint compound B.P. C.’68. Powders Oral rehydration salt (ORS) Evaluation of a)liquids for specific gravity and viscosity and b) powders for bulk density, flow rate and angle of repose

42

Physical Pharmacy Laboratory. II 4 hrs/week Kinetics: 1. Relative strength: Hydrochloric acid/Sulphuric acid 2. Second order reaction (saponification) 3. Determination of order by equal fraction method (first order reaction) 4. Ostwald’s isolation method to determine order Non-kinetics 1. Surface tension – 1. Determination of surface tension of water, toluene, n – hexane, parachor and

critical solution temperature determination. 2. Determination of CMC 2. Phenol water – Critical solution temperature and composition 3. Determination of molecular weight of a polymer from solution viscosity 4. Adsorption – Surface area determination Demonstrations 1. HLB of a surfactant 2. Potentiometry – Titration and Determination of buffer capacity Books

1. U.B. Hadkar, T. N. Vasudevan, K S. Laddha, ‘Practical Physical Pharmacy’, Yucca Publishing

House, Dombivali.

43

AC 27/2/2013 Item no 4.86

UNIVERSITY OF MUMBAI

Revised Syllabus

Program: B.Pharm

Semester III & IV

(Credit Based Semester and Grading System with effect from the academic year 2013–2014)

44

S. Y. B. Pharm.

Syllabus Framework

No Semester‐ III Credits Contact hrs/week

Weightage Marks

Subject

Continuous internal

assessment

End Semester

Examination

1 Organic Chemistry ‐ I 4 4 30 70 100

2 Biochemistry‐II 4 4 30 70 100

3 Dispensing Pharmacy 3 3 30 70 100

4 Pharmaceutical Engineering 3 3 30 70 100

5 Anatomy, Physiology and Pathophysiology‐ III

3 3 30 70 100

6 Mathematics 3 3 30 70 100

Total 20 20 180 420 600

Practicals

7 Organic Chemistry Lab ‐ I 2 4 15 35 50

8 Biochemistry Lab 2 4 15 35 50

9 Dispensing Lab 2 4 15 35 50

Total 6 12 45 105 150

Total Teaching Hrs. 32

Total Credits 26

Total Marks 225 525 750

45

No. Semester IV

1 Organic Chemistry‐II 3 3 30 70 100

2 Pharmaceutical Analysis‐ I 3 3 30 70 100

3 Pharmaceutics ‐II 3 3 30 70 100 4 Microbiology 3 3 30 70 100

5 Pharmacology ‐ I 3 3 30 70 100

6 Mathematics and Statistics 3 3 30 70 100

Total 18 18 180 420 600

Practicals

7 Pharmaceutical Analysis Lab‐ I 2 4 15 35 50

8 Pharmaceutics Lab‐ II 2 4 15 35 50

9 Pharmacology Lab‐ I 2 4 15 35 50

10 Microbiology Lab 2 4 15 35 50

Total 8 16 60 140 200

Total Teaching Hrs. 34

Total Credits 26

Total Marks 240 560 800

46

S. Y. B. Pharm.

Scheme of Examination

No

Semester‐ III No of papers

End Semester Examination Internal Assessment Maximum marks

Minimum marks for passing the

subject

Periodic Test Continuous Evaluation

Subject ‐ Theory Duration (hrs)

Maximum marks

Minimum for passing

Duration (hrs)

Maximum marks

Maximum marks

1 Organic Chemistry ‐ I 1 3 70 28 1 15 15 100 40

2 Biochemistry ‐ II 1 3 70 28 1 15 15 100 40

3 Dispensing Pharmacy 1 3 70 28 1 15 15 100 40

4 Pharmaceutical Engineering 1 3 70 28 1 15 15 100 40

5 Anatomy, Physiology and Pathophysiology ‐ III

1 3 70 28 1 15 15 100 40

6 Mathematics 1 3 70 28 1 15 15 100 40

Practicals

7 Organic Chemistry Lab ‐ I 1 4 35 14 4 8 7 50 20

8 Biochemistry Lab 1 4 35 14 4 8 7 50 20

9 Dispensing Lab 1 4 35 14 4 8 7 50 20

47

No Semester‐ IV No of papers

End Semester Examination Internal Assessment Maximum marks

Minimum marks for passing the

subject

Periodic Test Continuous Evaluation

Subject ‐ Theory Duration (hrs)

Maximum marks

Minimum for passing

Duration (hrs)

Maximum marks

Maximum marks

1 Organic Chemistry‐II 1 3 70 28 1 15 15 100 40

2 Pharmaceutical Analysis ‐ I 1 3 70 28 1 15 15 100 40

3 Pharmaceutics ‐ II 1 3 70 28 1 15 15 100 40 4 Microbiology 1 3 70 28 1 15 15 100 40

5 Pharmacology ‐ I 1 3 70 28 1 15 15 100 40

6 Mathematics and Statistics 1 3 70 28 1 15 15 100 40

Practicals

7 Pharmaceutical Analysis Lab ‐ I

1 4 35 14 4 8 7 50 20

8 Pharmaceutics Lab ‐ II 1 4 35 14 4 8 7 50 20

9 Pharmacology Lab ‐ I 1 4 35 14 4 8 7 50 20

10 Microbiology Lab 1 4 35 14 4 8 7 50 20

48

S. Y. B. Pharm.

Syllabus

Semester III

Organic Chemistry – I 4 hrs/week

Unit Topics Hours1. Basic concepts 111.1 Electronegativity, Inductive effect, Dipole moment, Polarizability 11.2 Resonance in aliphatic and aromatic systems: Rules of resonance, Stability of the

resonating structures 2

1.3 Tautomerism (including types of tautomerism), Hyperconjugation 21.4 Reactive Intermediates in Organic Chemistry: Electrophiles and Nucleophiles (including

charged and neutral species), Carbocations, Carbanions, Carbenes and Carbon radicals: Geometry, stability and properties. Concept of leaving groups, alkyl shift, migratory aptitude.

3

1.5 Acidity and Basicity (Excluding discussion of acidity and basicity of heterocyclic compounds).

3

1.6 Basics of mechanism writing using curved arrows‐Homolytic, Heterolytic, Homogenic, Heterogenic.

2. Nomenclature of multifunctional organic compounds. 62.1 Writing common names of some common compounds.2.2 Writing IUPAC nomenclature of compounds containing multiple functional groups, use of

priority charts. 2.3 Writing structures of compounds containing multiple functional groups given the

Nomenclature. 2.4 Nomenclature of stereo isomers including cis/trans, D/L, E/Z and R/S designations. 3. Stereochemistry‐I 93.1 Concept of configuration and chirality, axis of symmetry, plane of symmetry, centre of

symmetry, representation of molecules by the use of projection formulae: Fischer, Wedge, Sawhorse and Newman.

2

3.2 Geometric isomerism: Methods of determination of configuration of geometric isomers, Optical isomerism: Enantiomers and diastereoisomers, Resolution of a racemic mixture, Atropisomerism in biphenyls.

2

3.3 Stereospecificity and stereoselectivity in organic reactions: SN1, SN2, E1, E2 and E1cb reactions, syn and anti additions of H2 to alkynes, addition of halogens (X2),Halogens in water (X2 and H2O), KMnO4, OsO4 and alkaline H2O2 to alkenes, Hydroboration‐Oxidation, Oxymercuration‐Demercuration of alkenes.

5

4. Benzene and aromaticity 64.1 Concept of aromaticity: Huckel's rule for aromaticity, identification of aromatic, non‐

aromatic and anti aromatic systems based on planarity, conjugation and Huckel's rule. 1

4.2 Electrophilic Aromatic Substitution: Reactions of benzene (with mechanism and structures of intermediate/s involved) like nitration, sulphonation, protonation, halogenation, Friedel‐Crafts alkylation and acylation. Classification and influence of substituent groups on orientation and reactivity, orientation in disubstituted benzenes.

3

4.3 Nucleophilic Aromatic Substitution: Bimolecular displacement mechanism with evidence, reactivity and orientation in nucleophilic aromatic substitution, Elimination‐Addition mechanism.

2

5. Functional group Chemistry 16 Discussion of the following classes of compounds in brief, with regard to sources, methods

49

of preparation, general reactions with mechanism.5.1 Alkanes: Physical properties, Preparation of alkanes: Hydrolysis of Grignard reagent,

reduction of alkyl halides by metal and acid, Corey House reaction, Wurtz reaction; Reactions: halogenation of alkanes (Mechanism and orientation)

2

5.2 Alkenes: Physical properties, Preparation of Alkenes: Dehydrohalogenation of Alkyl halides (Mechanism and orientation of E1 and E2), dehydration of alcohols, dehalogenation of vicinal dihalides, conversion of aldehydes and ketones to alkenes (Wittig reaction, Peterson reaction, Shapiro reaction). Reactions: Addition of H2, HX (Markovnikov and Anti‐Markovnikov), H2SO4, H2O, free radicals, alkenes (dimerization), alkanes (Alkylation), ozonolysis, Michael addition, Simmons‐Smith reaction, epoxidation, halogenation by allylic substitution.

6

5.3 Dienes: Resonance in conjugated dienes, electrophilic addition to conjugated dienes: 1, 2 and 1, 4 additions.

1

5.4 Alkynes: Physical properties, Preparation of alkynes: dehydrohalogenation of alkyl dihalides, reaction of metal acetylides with primary alkyl halides; Addition reactions: Addition of X2, addition of HX, addition of H2O (Hydration), formation of metal acetylides.

2

5.5 Alkyl halides: Physical Properties, Preparation: Hunsdieker reaction (other methods are covered under reactions of other functional groups). Reactions: Nucleophilic Aliphatic Substitution reaction (Mechanism, Factors affecting SN1 and SN2 reactions to be discussed in detail), SNi reaction.

5

Conversions to be discussed Total 48

Books (Latest Editions to be adopted) 1. Organic Chemistry by R.T. Morrison and R.N.Boyd, 6th edition,Prentice Hall Publications 2. Organic Chemistry by Pine, Stanley H.; Hendrickson, James B.; Cram, Donald J.; Hammond, George S., 4th edition. The Macgraw hill publications 3. Organic Chemistry by I.L. Finar, Vol 1& 2, 6th edition, Pearson education 4. Advanced Organic Chemistry: Reactions, Mechanisms, Structures by Jerry March, John Wiley and sons 5. Organic Chemistry, Part A: Structures and Mechanism, Part B: Reactions and Synthesis, Francis and Carry, Richard J Sundberg. Springer publications 6. A Guidebook to Mechanism in Organic Chemistry, 6th edition, Peter Sykes, Pearson Education 7. Peter Sykes, Essentials of Organic chemistry by Paul M Dewick, Wiley, Pine 8. Essentials of Organic chemistry by Paul M Dewick, Wiley 9. Eliel, Kalsi, Organic Chemistry by L.G.Wade, Jr., Maya Shankar Singh, Pearson Education, 6th Ed, Organic Chemistry, 2nd Ed., Thomas Sorrell, University Science Books 10. Stereochemistry: Conformation and Mechanism, b) Organic Reactions And Their Mechanisms. By P. S. Kalsi. New age International 11. Organic Chemistry through Solved Problems, Goutam Brahmachari. Edition, Morgan & Claypool 12. Organic Name Reactions: A Unified Approach. Goutam Brahmachari. Alpha Science publications

50

Biochemistry II 4 hrs/week

Unit Topics Hours 1 Carbohydrate metabolism discussed with respect to the structures of

intermediates, enzymes and cofactors, energy yield/requirements and regulation. Examples of drugs modulating carbohydrate metabolism.

12

1.1 Glycolysis (Embden Meyerhoff Pathway), TCA cycle (Kreb’s Cycle, Citric acid Cycle) and glyoxalate shunt. Entry of sugars other than glucose into glycolytic pathway. Discussion of shuttle systems to transfer NADH to the mitochondria.

04

1.2 Electron Transport Chain discussed with respect to the components of the ETC, explanation of oxidative phosphorylation vs substrate level phosphorylation. Discussion of proton motive force and generation of ATP using proton gradients. Discussion of uncouplers of oxidative phosphorylation.

04

1.3 Discussion of pentose phosphate pathway, glycogenesis, glycogenoysis, gluconeogenesis and other systems involved in carbohydrate metabolism

04

2.0 Lipid metabolism discussed with respect to the structures of intermediates, enzymes and cofactors involved, energy yield/requirements and regulation.

08

2.1 Beta oxidation pathway for catabolism of saturated and unsaturated even number fatty acids, catabolism of odd number carbon containing fatty acids, formation of ketone bodies,

03

2.2 Acetate mevalonate pathway to cholesterol biosynthesis, 02 2.3 Biosynthesis of fatty acids and phospholipids. 02 2.4 Examples of drugs modulating lipid/cholesterol metabolism. 01 3 Nucleic Acid Metabolism discussed with respect to the structures of

intermediates, enzymes and cofactors, energy yield/requirements and regulation

08

3.1 Discussion of biosynthesis of purines. 03 3.2 Discussion of biosynthesis of pyrimidines. 02 3.3 Salvage pathways for nucleic acid metabolism. Examples of drugs modulating

purine/pyrimidine biosynthesis. 03

4 DNA replication 08 4.1 Details of DNA replication, differences between prokaryotes/eukaryotes. Brief

description of telomeres and telomerase activity. DNA polymorphisms and SNPs. Examples of drugs modulating these pathways (polymerase inhibitors, telomerase inhibitors, topoisomerase inhibitors) and polymorphisms involved in disease states.

04

4.2 Discussion of solid phase DNA synthesis, DNA synthesizers and comparison between biosynthesis and chemical synthesis.

02

4.3 Discussion of DNA sequencing (Sanger dideoxy method) 02 5 Protein biosynthesis 10 5.1 Details of DNA transcription and RNA translation. Transcriptional and

translational differences in prokaryotes and eukaryotes especially with respect to post‐transcriptional and post‐translational modifications. Examples of drugs modulating these pathways with emphasis on protein synthesis inhibitors used as drugs.

06

5.2 Discussion of solid phase peptide synthesis, peptide synthesizers and comparison between biosynthesis and chemical synthesis.

02

5.3 Discussion of peptide sequencing (Edman method and its automation). Utility of peptidases and chemical agents to cleave proteins in preparation for sequencing.

02

Total 48

51

Books 1. Lehninger, Principles of Biochemistry, Replika Press. 2. Stryer L, Biochemistry, W. H. Freeman & Co. 3. Harper’s Biochemistry, Appleton and Lange, USA. 4. Conn E, Stumpf PK, Brueing G and Doi Roy H, Outlines of Biochemistry, Wiley Liss, USA. 5. Wilson and Gisvolds Textbook of Organic Medicinal and Pharmaceutical Chemistry, Lippincott Willliams and Wilkins, USA 6. Foye’s Principles of Medicinal Chemistry, Lippincott Williams and Wilkins, USA.

52

Dispensing Pharmacy 3 hrs/week

Unit Topics Hours 1. 1.1 1.2 1.3 1.4 1.5 1.6

Introduction. Introduction to compounding and dispensing. Prescription and its parts. Types of prescriptions. Pricing and recording of prescriptions. Types of dispensed preparations. Weights and measures including imperial weights (Apothecary system).

6

2. 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8

General dispensing. Fundamentals of compounding and dispensing including good practices. Formulation of dispensed products. Containers and closures/packaging for dispensed products. Storage and stability of dispensed products. Labeling of dispensed preparations. Latin Terms and abbreviations. Preparation of stock solutions. Dispensing of proprietary medicines.

6

3. 3.1 3.2 3.3 3.4

Calculations. Calculations based on expressions of concentration and dilution (percentage, parts, alligation) ,proof strength. Calculations based on Isotonicity. HLB calculations. Posology.

4

4. 4.1 4.2 4.3

Solutions. Solutions taken orally. Solutions used in body cavities. Solutions for external use.

2

5. 5.1 5.2 5.3 5.4 5.5 5.6

Suspensions. Suspensions containing diffusible solids. Suspensions containing indiffusible solids. Suspensions containing poorly wettable solids. Suspensions containing precipitate forming liquids. Dispersion of oil in inhalation. Suspensions produced by chemical reaction.

3

6. 6.1 6.2 6.3 6.4

Emulsions Types of Emulsions. Emulsifying agents. Compounding and preservation of Emulsions. Emulsions for external use (Creams).

3

7. 7.1 7.2 7.3 7.4

Ointments, Pastes and Gels. Types of Ointment bases. Preparation Of Ointments. Pastes and Poultices. Gels.

3

8. 8.1 8.2 8.3 8.4 8.5

Dispensed Oral Solid Dosage forms.Powders. Granules. Tablet Triturates. Pills. Lozenges and Pastilles.

4

53

8.6 Capsules. 9. 9.1 9.2

Suppositories and Pessaries. Types of Suppository base. Compounding of Suppositories.

2

10. 10.1 10.2

Incompatibilities. Physical Incompatibilities. Chemical Incompatibilities.

3

Total 36 Comment on Prescriptions to be covered for all types of formulations listed in the syllabus.

Books

1. Cooper and Gunns Dispensing for Pharmaceutical Students, Edns. 11 and 12; Edited by S.J.Carter, Indian Edition, CBS Publishers, Delhi.

2. Pharmaceutical Practice; Edited by D.M.Collet and M.E.Aulton; Churchill Livingstone, ELBS Edition, 1991. 3. Pharmaceutical Practice Edited by A.J.Winfield and R.M.E. Richards, Second Edition, Churchill Livingstone,

1998. 4. Pharmaceutical Practice; Edited by A.J. Winfild and R.M.E. Richards, Third Edition, Churchill Livingstone,

2004. 5. Husa’s Pharmaceutical Dispensing, Edited by Eric Martin, Sixth Edition, Mack Publishing Company, 1996. 6. Pharmaceutical Calculations, A.C. Ansel and M.J.Stoklosa, Lippincott Williams and Wilkins, 2006. 7 Pharmaceutical Calculations – Bradley, Gustafson and Stoklosa, Third Edition, Lea and Febiger, 1957.

54

Pharmaceutical Engineering 3 hrs/week

Coverage: Only theory, principles, equipments and pharmaceutical applications to be covered. Mathematical derivations and numerical problems are not within the scope. Unit Topics Hours1 1.1

Fluid flow Mention fluid properties such as viscosity, compressibility and surface tension of fluids. Hydrostatics influencing fluid flow. Fluid dynamics‐ Bernoulli’s theorem, flow of fluids in pipes, laminar and turbulent flow.

3

2 2.1

2.2

Fluid and pressure measurements• Measurement of flow‐ Classification of flow meters, venturimeter,

orificemeter, pitot tube, rotameter and current flow meters. • Pressure measurement‐ Classification of manometers, simple manometer,

U tube manometer and modifications, Bourdon gauge.

4 2 2

3 3.1 3.2

Pumps: • Positive displacement pumps‐reciprocating pumps, rotary pumps. • Centrifugal pumps

2 1 1

4 4.1

4.2

Heat and Mass transfer • Modes of heat transfer‐ conduction, convection and radiation, Heat

exchangers‐tubular and plate, Temperature measurement‐basic principles and devices Mass transfer in turbulent and laminar flow

• Concept of interfacial mass transfer

4 3 1

5 Conveying of solids • Belt conveyor, Bucket conveyor, Screw conveyor and Pneumatic conveyor.

1

6 6.1

6.2

6.3

Crystallization • Crystal forms and crystal habits, Theory of crystallization‐Supersaturation‐

Mier’s theory of supersaturation, Nucleation, Crystal growth. • Crystallizers‐ Classification, Tank crystallizers, Agitated tank crystallizers,

Swenson Walker crystallizer, Vacuum crystallizer and its modifications, Krystal or Oslo crystallizer.

• Factors affecting crystallization and Caking of crystals

6 2 3 1

7 7.1

7.2

Evaporation: • Introduction, factors influencing rate of evaporation, including scale

formation, Evaporators classification‐ Pan evaporators, Tubular evaporators (Horizontal tube evaporator, Vertical tube evaporators‐ short tube vertical evaporator, Multiple effect evaporator, Long tube evaporators ‐Climbing film evaporator, Falling film evaporator, Forced circulation evaporator, ) Wiped film evaporator , Centrifugal rotary evaporator.

• Evaporator accessories‐ condensers, vacuum pumps, expansion and bucket traps, entrainment separators

4 2 2

8 8.1

8.2

8.3

Distillation: • Revision of Vapour‐liquid equilibrium,Distillation methods‐ Equilibrium

distillation, Simple distillation • Fractional distillation‐ Theory of batch fractionation, Columns (only

construction and working) Bubble cap, sieve plate columns, packed columns. Concept of plate efficiency and HETP (no detailed theories and derivations).

• Distillation under reduced pressure‐ Theory of molecular distillation and

6 1 3 2

55

equipments. Falling film and centrifugal molecular distillation still, applications. Azeotropic and Extractive distillation‐ Theory and applications. Steam distillation‐ Theory and applications

9 Refrigeration: • Refrigeration –equipment and concept of refrigeration load, concepts of

brine systems and absorption systems.

1

10 10.1

10.2

Materials of construction and Corrosion:• Classification into metals and non‐metals. Ferrous and its alloys‐cast iron,

mild steel and stainless steel. Copper and its alloys. Nickel and its alloys. Aluminium and its alloys. Plastics‐ Classification into thermoplastics and thermosetting plastics, properties and applicationsof polyvinyl chloride, polyethylene, polyporopylene, polystyrene, polyester, ABS, phenolic and epoxy plastics, fluorocarbon plastics, chlorinated plastics and polycarbonated plastics.

Corrosion: • Mechanism and types of corrosion. Factors influencing rate of corrosion.

Methods of combating corrosion.

5 2 3

11 Industrial Hazards and safety regulations:• Mechanical hazards and prevention. • Electrical hazards and prevention • Chemical hazards and prevention • Fire hazards and extinguishers

2

Total 38

BOOKS (Latest editions of all books to be referred) 1. K. Sambamurthy, Pharmaceutical Engineering, New age international (P) Limited Publishers, 1998. 2. Dr. A. R. Paradkar, Introduction to Pharmaceutical Engineering, 10th Edition, Nirali Parakashan, 2007. 3. James Swarbrick & James C. Boylon, Encyclopedia of Pharmaceutical Technology, Marcel Dekker, INC, New York, 1994.

4. Walter I. Badger & Julius T. Bancher, Introduction to Chemical Engineering, Mc Graw Hill Inc, 1995. 5. M. E. Aulton, Ed, Pharmaceutics‐The Science of Dosage Form Design, Churchill Livingstone Medical Division Of Longman Group UK Ltd, 2002.

6. S. J. Carter, Cooper and Gunn’s Tutorial Pharmacy, 6th Edition, CBS Publishers & Distributors, New Delhi, 2005. 7.Robert H. Perry, Don W. Green, Perry’s Chemical Engineers Handbook,7th Edition, Don W. Green, James O. Maloney, McGraw Hill,1997.

8. G. K. Jani, Pharmaceutical Engineering, Vallabh Prakashan.

56

Anatomy, Physiology and Pathophysiology‐ III 3 hrs/week

Unit Topics Hours1. Reproductive system

- Anatomical and Physiological considerations of male and female reproductive system

- Reproductive and endocrine functions of testes and ovaries - Menstrual cycle

4

2. Pathophysiology of following diseases - Infertility - Sexually transmitted diseases (STD) - Dysmenorrhea

2

3. Cardiovascular System ‐ Functional anatomy of heart ‐ conducting system of heart ‐ cardiac cycle, Electrocardiogram (ECG) ‐Physiology of blood circulation ‐ Functional anatomy of blood vessels ‐ Blood pressure and factors regulating blood pressure ‐ Baroreceptors, chemoreceptors, vasomotor center ‐ Humoral and neuronal control of blood pressure and circulation

8

4. Pathophysiology of following diseases- Hypertension - Congestive Cardiac Failure - Cardiac Arrhythmia - Angina Pectoris - Ischemic Heart Disease - Arteriosclerosis/Atherosclerosis

4

5. Urinary system ‐ Anatomy and Physiology of Urinary System ‐ Formation of urine ‐ water balance, electrolyte balance & acid – base balance

5

6. Formation of body fluids and fluid compartments. 3 7. Pathophysiology of following diseases

- Renal failure - Glomerulonephritis - Renal calculi / kidney stones - Urinary Tract Infections (UTI)

3

8. Digestive System ‐ Anatomy and physiology of digestive system ‐ Digestion and absorption of carbohydrates, proteins and fats

6

9. Pathophysiology of following diseases ‐ Peptic ulceration ‐ Zollinger – Ellison’s Syndrome ‐Inflammatory Bowel Disease (Ulcerative colitis, Crohn’s disease) ‐ Cholecystitis & Cholelithiasis ‐ Jaundice ‐ Hepatitis ‐ Pancreatitis ‐ Achalasia ‐ Reflux esophagitis

3

Total 38

57

Books Latest editions of the following books to be referred 1. Ross & Wilson Anatomy & Physiology in Health & Illness by Anne Waugh and Allison Grant, Published by Churchill Livingstone 2. Gerard J. Tortora & Bryan Derrickson, Principals of Anatomy & Physiology, Published by John Wiley and Sons, Inc.

3. A. C. Guyton & J. E. Hall, Textbook of Medical Physiology, Published in India by Prism Books Ltd. on arrangement with W. B. Saunders Company, USA.

4. McNaught & Callander, Illustrated Physiology by B. R. Mackenna & R. Callander, Published by by Churchill Livingstone

5. Kaplan, Jack, Opheim, Toivola, Lyon, Clinical Chemistry: Interpretation & Techniques 6. Praful B. Godkar, Textbook of Medical Laboratory Technology, Published by Bhalani Publishing House, Mumbai, India

8. Harsh Mohan, Text book of Pathology, Published by Jaypee Brothers Medical Publishers Pvt. Ltd., New Delhi

58

Mathematics 3 hrs/week

Unit Topics Hours 1 Differential Calculus 05 1.1 Successive Derivatives 1.2 Lebnitz’s Rule fourth derivative

1.3 Lagrange’s and Rolle’s Mean Value Theorems (Statements only) 1.4 Taylors and Maclaurins Series (No proof) with application 2 Partial Differentiation 05 2.1 Functions of two or three variables 2.2 Change of variables 2.3 Application to errors, maxima and minima

3 Integral Calculus 07 3.1 Integration by parts 3.2 Properties of definite integrals and reduction formulae 3.3 Determination of the length of the curve, are and volume 4 Differential Equations 07 4.1 Formation of differential equations 4.2 Solution of first‐order and first‐degree equations 4.3 Linear differential equations of higher order with constant coefficients 4.4 Simple applications to chemical reactions and biopharmaceutics 5 Determinants and Matrices 07 5.1 Properties of determinants and applications 5.2 Solution of simultaneous equations with three variables by Cramers method 5.3 Types of matrices, inverse of matrix, rank of a matrix, eigen value and eigen

vectors

5.4 Caley Hamilton Theorem 6.0 Numerical Methods 06 6.1 Finite difference operators (delta and E) 6.2 Interpolation of equal and unequal intervals – Newtons method and Lagrange

method

6.3 Numerical integration – Trapezoidal rule, Simpsons 1/3rd and 3/8th rules TOTAL 37

Books – Latest Editions to be adopted 1. Mathematics for Pharmacy Students (Vol. 1), Gujar, K. N., Bhavale Ashok, Career Publications. 2. Differential Calculaus; Nareyan, S., S. Chand Publication 3. Applied Mathematics – I, Baphana R. M., Techmax Publication. 4. Textbook of Applied Mathematics, Vols. I and II, Wartikar, P. N. Pune Vidyarthi Griha Prakashan. 5. Integral Calculus, Shanti Narayan, S. Chand Publication. 6. A Textbook of Matrices, Shantinarayan, S. Chand Publication.

59

Practicals

Organic Chemistry Lab. – I 4 hrs/week

1) Laboratory safety measures to be taken for: a. Fire and burns b. Spillage c. Inhalation of toxic fumes d. Dress code in a laboratory e. First aid measures to be taken in cases of accidents f. Use of fume hood, eye shower, body shower.

2) Organic spotting: Minimum eight samples of mono‐functional groups and two samples of bifunctional groups to be taken.

3) Theoretical aspects of physical constant determination, and detection of functional groups.

Books 1. A laboratory hand book of Organic qualitative analysis and separations, V.S. Kulkarni, S.P.Pathak, D.

Ramchandra & Co., Pune 2. Text book of organic practical chemistry, V.S. Kulkarni, S.P.Pathak, D. Ramchandra & Co., Pune. 3. R. L. Shriner, R. C. Fuson and D. Y. Curtin, The systematic Identification of Organic compounds, 6th Ed., Wiley,

New York, 1980 4. A. I. Vogel, A textbook of practical organic chemistry, 4th edition, Wiely New York, 1978 5. Comprehensive Practical Organic Chemistry: Qualitative Analysis, V.K. Ahluwalia, S. Dhingra, Universities Press

(India) Limited, 2000 6. Comprehensive Practical Organic Chemistry: Preparation and Quantitative analysis, V.K. Ahluwalia, Renu

Aggarwal, Universitites Press (India) Limited, 2000

60

Biochemistry Lab. 4 hrs/week

1. Qualitative tests for carbohydrates and confirmatory tests by ozasone formation 2. Qualitative test and simple color reactions for amino acids and proteins. Precipitation reactions of

proteins. 3. Chromatographic separation of amino acids. 4. Quantitative estimation of glucose (Willstaters and Lane & Eynon’s methods). Estimation of sucrose.

Colorimetric estimation of glucose. 5. Quantitative estimation of proteins by Biuret method and Folin method (one titrimetry and one by

colorimetry) 6. Estimation of enzyme activity – ptyline (amylase) in saliva and alkaline phosphatase (including plotting of

data to determine Km and Vmax for any one of these enzymes) 7. Quantitative estimation of properties of lipids – acid value, iodine value, saponification value. 8. Quantitative estimation of RNA and DNA. 9. Demonstrations of estimation of blood glucose, SGOT or SGPT using commercial kits (suggest that

students should volunteer for fasting and post prandial glucose determinations) 10. Demonstration of isolation of DNA.

Books 1. An Introduction to Practical Biochemistry – Plummer D.T., Tata Mcgraw Hill, N Delhi, India 2. Laboratory Manual In Biochemisty, Jayaraman J, Wiley Easter, N Delhi. India

61

Dispensing Lab 4 hrs/week

Dosage form Representative preparations1. Solutions 1. Potassium Permanganate Solution

2. Zinc Chloride and Zinc sulphate Mouthwash BPC 1973 3. Sodium Bicarbonate Ear Drops BP 4. Paediatric Ferrous Sulphate Oral Solution BP 1988

2. Suspensions 1. Menthol and Eucalyptus oil inhalation2. Paediatric Chalk Mixture BP 1988 3. Kaolin Mixture BP 1988

3. Emulsions And Creams

1. Arachis Oil Emulsion2. Calciferol Emulsion 3. Aqueous Calamine cream IP 2010 4. Medicated cream 5. Buffered Cream BP 1988

4. Ointment 1. Zinc and Castor Oil Ointment BP 1988 / Calamine Ointment IP 20105. Gel 1. Lubricating Jelly6. Paste 1. Compound Zinc Paste BP 1988/ Zinc and Salicylic Acid paste BP 1988

2. Kaolin Poultice BP 1988 7. Powder 1. Bulk Powder : Compound Magnesium trisilicate Oral Powder BP 1988 /

Zinc, Starch and Talc Dusting Powder BPC 1973 2. Divided Powder : Hyoscine Hydrobromide Powder 3. Siedlitz Powder

8. Granules 1. Isapguhl Granules2. Effervescent Granules

9. Tablet triturate 1. Boric acid / Riboflavin tablet triturate10. Capsule 1. Chlordiazepoxide capsules BP11. Pills 1. Compound Rhubarb Pills BPC 1960 / Potassium Permanganate Pills12. Pastilles 1. Medicated Pastille13. Lozenge 1. Brompton Cough Lozenge BPC 1973 / Compound Bismuth Carbonate

Lozenge BPC 1973 14. Suppository 1. Compound Bismuth Subgallate Suppositories BP 1980 15. Incompatability 1. Eutectic Mixture

Books

1. Relevant editions of IP, BP, BPC 2. Cooper and Gunns Dispensing for Pharmaceutical Students, Edns. 11 and 12; Edited by S.J.Carter, Indian

Edition, CBS Publishers, Delhi. 3. Pharmaceutical Practice; Edited by D.M.Collet and M.E.Aulton; Churchill Livingstone, ELBS Edition, 1991. 4. Pharmaceutical Practice Edited by A.J.Winfield and R.M.E. Richards, Second Edition (1998), Third Edition

(2004) Churchill Livingstone.

62

Semester IV Organic Chemistry – II 3 hrs/week

Unit Topics Hours

1. Functional Group Chemistry and Molecular Rearrangements 1.1 Aldehydes and Ketones

Methods of preparation :Dry distillation of anhydrides, Oxidation of primary and secondary alcohol, Oxidation of methylbenzene, Reduction of acid chlorides, from Reaction of acid chloride with organocopper. Oxidation with Ag(NH3)2, KMnO4, K2Cr2O7, NaOH/I2, Reduction with H2/Pt or Ni or Pd, LiAlH4, NaBH4, Clemmesons & Wolf Kishner Reduction, reduction. Nucleophilic additions like Cyanohydrin, Acetal formation, Grignard, Derivatives of ammonia, NaHSO3, organolithium compounds. Condensations with discussion of mechanism of aldol (Acid and Base catalyzed), Mixed aldol, crossed aldol, nitroaldol, retroaldol, Claisen‐Schmidt, Halogenation of ketones, Perkin, Knovengeal, Dobener‐Knovengeal, Reformatsky, Micheal, Benzillic acid alkylations, Dakin oxidation, Benzoin Condensation, Wittig with Ph3P, Wolff, Bayer‐Villiger Oxidation, Diazomethane reaction, Stobbes, Willgerodt, Favorskii, Cannizzaro reduction. Problems related to above reactions.

7

1.2 Amines Methods of preparation : From alkyl halides, Reduction of nitro compounds with Metal/HCl and Na2S2/NH4S6, Reduction of amides, Reduction of cyanides, Reduction of oximes, Reductive amination, Leukart method, Gabriel‐pthalimide method, discussion and Mechanism of Curtius, Lossen, Scmidt rearrangement. Discussion on physical properties Reactions of amines : With acid, with alkyl halides, conversion to amides, Schotten‐Baumann technique, ring substitution in aromatic amines, Hoffman elimination from alkylation ammonium, salts. Mechanism of Steven & Sommelet alkylations, Diazotization with mechanism and its application including Sandmeyer reaction mechanism and Gomberg reaction mechanism Problems related to above reactions.

6

1.3 Carboxylic acids Methods of alkylation: Oxidation of alcohols, Oxidation of alkylbenzene, from alkylation reagent, hydrolysis of nitriles, malonic ester synthesis of carboxylic acid with alkylation Reactions with Base, with SOCl2, PCl3.PCl5 SO2Cl2, with alcohol, Conversions to amides, Reduction, Hell‐Volhard‐Zelinsky reaction Condensation reactions like Dieckmann condensation with mechanism. Problems related to all reactions

3

1.4 Amides Methods of preparation of amides, imides Reactions of amides: Hoffmann and Beckmann alkylations and its mechanism including transformations. Identification test like diazotization after acidic hydrolysis

2

1.5 Esters Methods of preparation Reactions: Basic and acidic hydrolysis of esters with mechanism, conversions to amides, transesterification, reaction with Grignard & organolithium, catalytic hydrogenation of esters, reduction with LiAlH4, Claisen condensation, mixed Claisen, crossed Claisen Problems related to above reactions.

2

1.6 Alcohols 2

63

Books (Latest Editions to be adopted) 1. Organic Chemistry by R.T. Morrison and R.N.Boyd, 6th edition,Prentice Hall Publications 2. Organic Chemistry by Pine, Stanley H.; Hendrickson, James B.; Cram, Donald J.; Hammond, George S., 4th edition. The Macgraw hill publications 3. Organic Chemistry by I.L. Finar, Vol 1& 2, 6th edition, Pearson Education 4. Advanced Organic Chemistry: Reactions, Mechanisms, Structures by Jerry March, John Wiley and sons 5. Organic Chemistry, Part A: Structures and Mechanism, Part B: Reactions and Synthesis, Francis and Carry, Richard J Sundberg. Springer publications 6. A Guidebook to Mechanism in Organic Chemistry, 6th edition, Peter Sykes, Pearson Education 7. Name Reactions: A Collection of Detailed Reaction Mechanisms. Jie Jack LiJi Jack Lee, Springer publications 8. Organic Chemistry, 9th Ed, T. W. Graham Solomons, Craig Fryhle. John Wiley & Sons 9. a) Stereochemistry: Conformation and Mechanism, b) Organic Reactions And Their Mechanisms. By P. S. Kalsi. New age International 10. Organic Chemistry through Solved Problems, Goutam Brahmachari. Edition, Morgan & Claypool 11. Organic Name Reactions: A Unified Approach. Goutam Brahmachari. Alpha Science publications

Physical Properties, Preparation of alcohols using Grignard synthesis, Aldol Condensation, Reduction of acids, esters carbonyl compounds. Reactions: HX, PX3, with metal, esterification, oxidation, Pinacol‐Pinacolone rearrangement. Problems related to above reactions.

1.7 Phenols Physical Properties. Preparation of Phenols: Hydrolysis of diazonium salts, from aryl sulphonates. Reactions: Ester formation, Electrophilic substitution reaction‐Nitration, sulponation, alkylations, Freidel‐crafts alkylation, nitrosation, Fries rearrangement, Kolbe‐Schimdt reaction, Reimmer‐Tiemman reaction, Schotten‐ Baumann reaction

2

1.8 Ethers Physical Properties, Preparation Willimason’s synthesis, alkoxymercuration‐demercuration, Industrial sources of ethers. Reaction with HX and Wittig reaction

1

2. Polycyclic aromatic compounds: naphthalene,anthracene and phenanthrene: preparations and reactions (Reactions of derivatives not included) Methods of preparation of polycyclic aromatic compounds‐ : Fittig reaction, Friedel‐Crafts reaction, Elbs reaction, Pschorr synthesis, Haworth synthesis for naphthalene and phenanthrene, Stobbe condensation, Bardhan‐Sengupta synthesis, Bogert‐Cook synthesis, resonance and nomenclature, Reactions of naphthalene‐ oxidation

3

3. StereochemistryConformation of ethane, Butane, Cyclohexane Types of strains: Angle strain, Transannular strain, Bayer strain, Pitzer strain stability, optical activity and conformational analysis of mono and disubstituted cyclohexanes (1,2/1,3/1,4 disubstituted with –OH, ‐X, t‐butyl, ‐COOH like groups)

6

4. Redox ReactionsReagents used in Oxidation : perbenzoic acid, CF3CO3H, V2O5, lead tetracetate, Al‐isopropoxide and reactions using these reagents. Reagents used in Reduction : NaBH4, LiAlH4, SnCl2, Na/alcohol, Na/Liq. NH3, Raney Ni, Na dithionate and reactions using these reagents, Birch reduction

4

Total 38

64

Pharmaceutical Analysis – I 3 hrs/week

Unit Topics Hours1 Introduction to Pharmaceutical Analysis 41.1 • Scope of Pharmaceutical Analysis, Classification of Quantitative Analytical techniques

(Instrumental and Non‐Instrumental). • Introduction to pharmacopoeial monograph ‐ Drug and formulation (As API‐Aspirin,

Calcium gluconate and Dried aluminium hydroxide gel. formulation‐Soluble Aspirin tablets and Calcium gluconate injection).

2

1.2 • Types Of Errors – Determinate and indeterminate: Causes of errors and ways to minimize them.

• Concept and numerical of –Mean, Median, Standard deviation, relative standard deviation, Absolute and relative errors, precision, accuracy, significant figures.

2

2 Aqueous acid‐base titrations. 72.1 • Theoretical terms: Titrimetric analysis, Titrant, Titrand, Theoretical end point or

equivalence point, end point of titration, Titration error, Conditions for titrimetric analysis, Classification of reactions for titrimetric analysis, Expression of concentration of Standard solutions‐Molarity‐(Analytical and equilibrium molarity), Molality, percent concentration, ppm, ppb, Normality, Primary and Secondary standards.

• Law Of Mass Action, Equilibrium Constant, Application Of Law of Mass Action to solutions Of Weak Electrolytes, pH, pKa, pKb, hydrolysis of salts (weak base‐strong acid, weak acid‐strong base, weak acid, weak base), Buffer solutions, Buffer Capacity.

2

2.2 • Neutralisation curves‐(strong acid by strong base, weak acid by strong base, weak base by strong acid, and weak acid by weak base).

• Neutralisation indicators‐different theories (Ostwald’s theory, Resonance theory), Mixed indicators, concept of range of indicators, Choice of indicators.

2

2.3 • Methods of titration –Direct titration, back titration and need, blank determination use, significance (One Example for each type) and concepts of factor calculation for assay.

• Problems related to calculation of‐ pH and its numericals with respect to neutralisation curve, Strength of Electrolytes (molarity, normality, and milliequivalence), and assay.

• Applications.

3

3 Non‐aqueous titrations 23.0 • Theoretical considerations‐Need, Types of non‐aqueous solvents (aprotic,

protophilic, protogenic, amphiprotic), Characteristics of solvents for non‐aqueous titrations (acid‐base character, dielectric constant, leveling and differentiating effect), Indicators for non‐aqueous titrations, Determination of Bases and Acids (solvent, titrants and indicator used).

• Applications.

2

4 Complexometric titrations 3

65

• Terms‐Complex, complexing agents (Complexones), Chelate, Ligand, Dentate and types, Co‐ordination number, Chelating agent, Sequestering agent, Metal – Ligand complex.

• Aspects in complex formation with respect to Disodium Edetate‐ Dissociation constant, pH, Stability, colouration, titrability of polyvalent metal ions, pM indicators, presence of auxiliary complexing agent, and general structure of complexes formed with di‐, tri‐, and tetravalent metal ions.

• Complexometric titrations: Direct method, back titration, Replacement titration, Titration of mixture of metal ions, masking agent (auxiliary ligand) and demasking agents, and Titration curve w. r. t Disodium Edetate.

• Applications: Determination of individual cations (aluminium by back titration, nickel by direct titration), determination of mixture of lead, zinc and magnesium in a sample, and assay of calcium gluconate injection.

3

5 Oxidation – Reduction Titrations 6

5.1 • Terms: Oxidation –Reduction, Oxidising and reducing Agents, Standard Reduction Potential, Nernst Equation, redox titration curve and Equivalence point potential.

1

5.2 • Theory, indicators, and titrants for : Permaganatometry and Cerrimetry,

• Applications‐ Assay of hydrogen peroxide solution (Permaganometry), Assay of Ascorbic acid tablets/ Dried Ferrous sulphate, Paracetamol (Cerrimetry).

2

5.3 • Theory, indicators, and titrants for : Iodometry, Iodimetry, Potassium dichromate, potassium iodate titrations, and Potassium bromate titrations. Applications‐Assay of hydrogen peroxide solution, Assay of Ascorbic acid API (Iodimetry), Assay of KMnO4 (Back Iodometry), Assay of Potassium iodide (Iodate titration).

2

5.4 • Balancing Of Redox Equation‐half cell reaction and net reaction. 1

6 Precipitation Titration 3

6.1 • Theoretical considerations‐Common Ion Effect, Solubilty Product, Factors affecting solubility of precipitates, Fractional precipitation.

1

6.2 • Types Of Precipitation Titration (Argentometric, Non– Argentometric), Argentometric Titration methods ‐Mohr’s method, Volhard’s Method and Adsorption Indicator Method.

• Applications: Standardisation of silver nitrate, Assay of NaCl and KCl.

2

7 Gravimetry 37.1 • Theory mass as measurement signal and precipitation equilibria, Unit operations in

gravimetric analysis, Organic and inorganic precipitants, precipitation from homogeneous solution.

• Problems associated with gravimetric analysis and methods to overcome (co‐precipitation and reprecipitation, Ostwald’s ripening, degree of supersaturation or von Weimarn ratio, solubility of precipitate, peptisation).

2

7.2 • Applications‐Assay of Nickel by dimethylglyoxime, Assay of aluminium by oxine reagent, Assay of Ba+2 as BaSO4.

• Numerical related to gravimetric factor.

1

8 Miscellaneous methods 2

66

8.0 • Oxygen flask combustion method‐technique, apparatus, principle and determination of organically bound halogens, sulphur and phosphorus, Application‐ Diloxanide furoate.

• Nitrite titrations‐ Concept of external indicator and application‐ Assay of Sulphacetamide sodium

• Determination of nitrogen (Kjeldahl method)‐Technique (direct and indirect method), reagents & apparatus used, reaction & factor calculation and numerical for estimation of nitrogen. Application‐Assay of Urea (API)

9 Electro Analytical Techniques: 6

9.1 Polarography‐ • Apparatus‐Construction and working of Dropping mercury electrode (DME),

advantages and disadvantages of DME. • Theory‐Current‐Voltage curve (Polarogram), supporting electrolyte, Oxygen wave,

polarographic maxima, Ilkovic equation, factors affecting limiting current, half wave potential.

• Applications‐In brief. • Pulse polarography‐Normal pulse polarography and Differential pulse polarography

and square wave polarography).

2

9.2 • Amperometry‐DME cell, four types of end points in amperometric titrations, advantages, general applications and Biamperometric titrations.

• Aquametry by Karl Fischer titration: principle, composition and stability of KFR, standardization of KFR as per I.P, determination of water in a sample‐e.g.Amoxycillin trihydrate.

2

9.3 • Coulometry and High Frequency Titration‐Faraday’s first law of electrolysis, Current vs Time plot, Cells for coulometric titration and generation of titrant, Types of coulometric methods (potentiostatic and amperostatic), primary and secondary coulometric titrations, advantages of coulometric titrations, and applications in brief.

1

9.4 • Electrogravimetry‐ Theory of electrolysis – constant current electrolysis and constant potential electrolysis, theory of electrogravimetry‐ Ohm’s Law, Faraday’s second law of electrolysis, Terminology: polarization, overvoltage, current density, current efficiency, decomposition potential, polarized electrode, types of polarization‐ concentration and kinetic, apparatus for electrogravimetric determinations, characteristics of the deposit, factors affecting physical properties of the deposit, applications in brief.

1

10 Liquid‐Liquid Extraction 210.0 • Terms: Nernst Distribution law and partition coefficient, Distribution coefficient,

Distribution Ratio, Percent extraction or extraction efficiency, Separability factor. • Types‐Single extraction (Batch), Multiple extractions, Countercurrent Distribution

and Continuous. • Factors influencing solvent extraction, Emulsion formation problem in extraction and

ways to minimise. • Applications.

2

10.1 • Problems based on distribution coefficient. Total 38

Reference books and textbooks (Please refer latest editions if available)

1 Practical Pharmaceutical Chemistry by Beckett, A H & Stenlake, J B , 2005, 4th edition, Part I and II, CBS Publishers and Distributors, India.

2 A Textbook of Pharmaceutical Analysis by Kenneth A Connors, 2002, 3rd edition, John Wiley and Sons, Canada.

67

3 Principles of Instrumental Analysis by Douglas A. Skoog, F.James Holler, 1992, 5th edition, Saunders College Publishing, USA.

4 Fundamentals of Analytical Chemistry by Douglas A. Skoog, Donald M. West, F. James Holler, 1991, 7th

edition, Saunders College Publishing, USA. 5 Analytical Chemistry by Gary D. Christian, 6th edition, John Wiley & Sons, Singapore. 6 Vogel’s textbook of quantitative chemical analysis by Mendham J, R.C. Denney, J.D. Barnes, M.Thomas, 2002,

6th edition, Pearson Education Ltd. 7 Pharmaceutical Drug Analysis by Ashutosh Kar, 2005, 2nd edition, New Age International (P) Ltd Publishers,

India. 8 Instrumental Methods of Analysis by Dr. Supriya S. Mahajan, 2010, 1st edition, Popular Prakashan Pvt Ltd,

India. 9 Instrumental methods of chemical analysis (Analytical Chemistry) by Gurudeep R. Chatwal and

Sham.K.Anand, 2008, 5th revised and enlarged edition, Himalaya Publishing House Pvt Ltd. 10 Indian Pharmacopoeia. 11 Instrumental Method of Analysis by Willard H.H.L. L. Merrit & John A. Dean, 1986, 6th edition, CBS Publishers

& Distributors, New Delhi. 12 Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists by David G

Watson, second edition, Pub: Elsevier, Churchill Livingstone 13 Undergraduate instrumental analysis by J.W. Robinson, E.M. Skelly Frame and G.M. Frame II, Pub. Marcel

Deker, 2009 14 Analytical Chemistry, A modern approach to analytical science, second edition, R. Kellnar, J.M.Mermet,

M.Otto, M. Valcarcel, H.M.Widner, Pub: WILEY‐VCH

15 Analytical chemistry by Open learning Pub: John Wiley and sonsClassical methods Vol. 1 by and Chris Doran Classical methods Vol.2 by John Mendham and Derek Cooper Principles of electroanalytical methods by Tom Riley and Colin Tomlinson Polarography and other voltammetric methods by Tom Riley and Arthur Watson

68

Pharmaceutics – II 3 hrs/week

Unit Topics Hours 1 1.1

Disperse Systems: Suspensions and EmulsionsIntroduction and Physicochemical principles, (Revision) surface & interfacial tension, surface free energy, Gibb’s equation , concepts of thermodynamic & kinetic stability of disperse systems and challenges to formulator, Classification of disperse systems

15 1

1.2 A)Suspensions:‐ Definition, advantages and disadvantages, desirable features and pharmaceutical applications B) Emulsions:‐ Definition, advantages and disadvantages, pharmaceutical applications

1

1.3 Theoretical aspects of Suspensions:‐Wetting phenomenon, particle‐particle interactions, DLVO theory, flocculated and deflocculated systems, Schulze Hardy rule, Sedimentation in suspensions, Ostwald ripening and crystal factors, rheology

3

1.4 Theoretical aspects of Emulsions:‐Need for emulsifier Emulsifiers‐mechanisms, droplet stabilization, classification, Selection of emulsifiers‐HLB method, Davies method, PIT method, Cloud point method

3

1.5 Preparation of suspensions:‐ Precipitation methods and dispersion method. Formulation additives

2

1.6 Preparation of Emulsions‐Other formulation additives, rheological aspects, physical stability of emulsions, symptoms of instability.

2

1.7 Large scale manufacture of emulsions & suspensions.with layout of manufacturing area and equipments for each step Quality control tests for emulsions & suspensions‐ including stress testing Examples of official formulations.

3

2 2.1

Factors influencing skin penetration‐physiological and physicochemical factors, vehicles and penetration enhancers, methods to evaluate skin penetration.

6 2

2.2 Raw materials for semisolids, types of vehicles, ointment bases, pastes, gels, poultice, Formulation additives.

2

2.3 Large scale manufacture with equipments involved in each step and layout, Quality control tests, Examples of official formulations.

2

3 3.1

Suppositories: Introduction, definition, advantages and disadvantages, desirable features of suppositories, factors affecting rectal absorption.

7 2

3.2 Suppository bases‐ specifications and desired features, classification and selection of suppository bases, special bases.

2

3.3 Formulation and specific problems involved in formulating suppositories, large scale manufacture with equipments involved in each step, packaging.

2

3.4 Quality control tests, Examples of official formulations. 1 4 4.1

Blood products: Need, problems/hazards, blood banking procedures

6 1

4.2 Whole human blood, Red cell concentrate, Platelet concentrate, Plasmapheresis, plasma, serum. Fractionation of plasma, study of some fractions‐clotting factors like fibrinogen, AHF, factor IX complex, prothrombin, albumin preparations, γ globulin preparations. Quality control aspects of blood products

3

69

4.3 Plasma substitutes (plasma volume expanders)‐ need, desired properties, examples‐ hydrolyzed gelatin based products, HETA starch, Dextran (in detail – source, preparation, official injections )

2

5 5.1

Sutures/ligatures: Definition, classification, cat gut manufacturing and processing, other absorbable sutures‐natural & synthetic

4 2

5.2 Nonabsorbable sutures‐ silk, linen, polyamides, polyesters, polyolefins, and metallic wires.

2

5.3 Quality control tests for sutures/ligatures 1 Total 38

Books (Latest editions should be referred)

1. Lachman Leon, Liberman Herbert A., kaing Joseph L., “Theory and practice of Industrial Pharmacy” 3rd edition,1987, Varghese Publishing house,Mumbai.

2. Liberman Herbert A., rieger, “Pharmaceutical dosage Forms‐Disperse Systems”, vol 1/2/3, 2nd edition,2005, Marcel Dekker Inc., New York.

3. Allen, Loyd v V.Jr, “Remingtons‐ the Science and Practice of Pharmacy, Vol 1 / 2, 22nd edition, Pharmaceutical Press

4. Patrik Sinko Ed.”Martin’s Physical Pharmacy and Pharmaceutical Sciences”, 6th edition, 2010, Lippincott Williams and Wilkins.

5. M.E. Aulton Ed.,”Pharmaceutics‐The Science of Dosage Form Design”3rd edition,2007, Churchill livingstone Elsevier Ltd., UK.

6. E.A. Rawlins Ed.,”Bentley’s Textbook of Pharmaceutics”, 2010, Elsevier Publications. 7. S.J.Carter Ed.,”Tutorial Pharmacy‐Cooper & Gunn”, 6th edition,1986, CBS Publishers & distributors, India. 8. Pharmacopeias‐IP, BP, USP‐latest editions

70

Microbiology 3 hrs/week

Unit Topics Hours

1 1.1

Introduction to MicrobiologyBrief history, Scope of Microbiology‐Basic & Applied, Relevance and Applications in Pharmaceutical Industry

2 1

1.2 Classification of Microorganisms, Procaryotic and eukaryotic microorganisms, Microbes and the environment.

1

2 2.1

Microscopy Simple microscope, Compound microscope, resolving power, magnification, angular aperture, numerical aperture, oil immersion objective.

3 1

2.2 Dark field microscopy, phase contrast microscopy, fluorescent microscopy, electron microscopy.

2

3 3.1

Techniques to study and characterize microorganismsStaining of microorganisms‐Monochrome stain; Negative staining; Differential staining (Gram staining & Acid fast staining), Capsule, Flagella, Cell wall, Spore staining; Study of motility by hanging drop technique

2 1

3.2 Information used to characterize and identify microorganisms (in brief) ‐ morphological, cultural, metabolic, antigenic, pathogenic, genetic.

1

4 4.1

Bacteria Morphology, Cell characteristics, Habitat, Nutritional requirements, Cultivation of bacteria, Culture media‐ Cultivation & Storage media, Enrichment media, Differential media, Assay media, Cultivation of aerobes and anaerobes.

9 5

4.2 Pure culture, Methods to isolate pure cultures, Preservation of cultures. 1

4.3 Reproduction of bacteria, Growth phases, Measurement of growth, factors affecting growth, continuous cultivation, enumeration of bacteria.

1

4.5 Overview of bacterial diseases and the pathogens causing them‐Mycobacterium sp., Salmonella sp., Shigella sp., Staphylococci sp., Pseudomonas sp., Klebsiella sp., Clostridium sp

2

5 5.1

Viruses & related microorganisms Morphological characteristics, Nutritional aspects, Cultivation and reproduction, HIV and Oncogenic viruses.

3 2

5.2 Rickettsiae and Chlamydiae‐Morphological characteristics, Cultivation, Rickettsial & Chlamydial diseases.

2

6 6.1

Major groups of Eucaryotic microorganismsFungi‐Morphological characteristics, Classification, Reproduction of fungi, Cultivation of fungi, Culture media

7 2

6.2. Study of some important fungi‐Penicillium, Aspergillus, Candida, Saccharomyces. Fungal infections‐Mycoses

1

6.3 Algae ‐ Classification, Morphological characteristics, reproduction, economic significance of algae.

2

6.4 Protozoa‐ Morphological characteristics and classification, reproduction, pathogenic protozoa like Amoeba, Paramecium, Trichomonas, Plasmodium

2

9 9.1

Control of Micro‐organisms Fundamentals of Microbial Control ‐ Pattern of Death in a Microbial population, Conditions affecting Antimicrobial activity, Mechanisms of microbial cell damage, Survivor curves and concepts of D ‐ value and Z‐ value.

10 1

71

Sterility assurance and Inactivation factor.9.2 Sterilization methods & Equipments‐ Heat Sterilization methods (Moist heat,

dry heat, low temperature sterilization methods), Radiation Sterilization (Ionizing and non‐ionizing radiations), Filtration Sterilization, Gaseous Sterilization

4

9.3 Chemical agents used for control of microorganisms‐ Terminology of Chemical agents, Ideal properties, Major groups of disinfectants and antiseptics (with mechanisms and applications), Chemical sterilants, Evaluation of potency‐Tube dilution & Agar plate methods, Phenol Coefficient technique

2

9.4 Introduction to Aseptic techniques (no equipments), Sterilization control and sterility assurance‐ Various types of sterilization indicators, Test for sterility

2

Total 36

Books: (Latest editions should be referred)

1. M.J. Pelzer Jr., E.C.S. Chan and N.R. Krieg “Microbiology Concepts and Applications” McGraw ill, Inc., USA, 1993.

2. M.Frobisher, R.D. Hinsdill, K.T. Crabtree and C.R. Goodheart “Fundamentals of microbiology”, 9th Edn. Saunders College Publishing, Philadelphia 1968.

3. W. B. Hugo and A. D. Russel “Pharmaceutical Microbiology” 6th Edn. Blackwell science Ltd. UK, 2003. 4. R. Ananthianarayan and Ck. J. Paniker “Text Book of Microbiology”, 7th edn. Orierit Longman Pvt. Ltd.

Hydrabad, 2005.

72

Pharmacology – I 3 hrs/week

Unit Topics Hours1. General Principles of Pharmacology

• Introduction to Pharmacology • Routes of drug administration with special reference to their advantages and

disadvantages. • Drug Absorption, Distribution, Metabolism & Excretion (ADME)

6

2. Mechanisms of drug action • Brief introduction to physiological receptors • Structural and functional families of receptors • Mechanisms of drug action:

‐Drug receptor interaction ‐Dose response curve (DRC) ‐Drug antagonism

4

3. Factors modifying actions of drugs 1 4. Toxic effects of drugs on different organs and systems. 2 5. Autonomic nervous system

• Autonomic neurotransmission • Parasympathomimetics • Parasympatholytics • Sympathomimetics • Sympatholytics • Drugs acting on autonomic ganglia • Skeletal muscle relaxants

12

6. Cardiovascular system • Drugs used in the treatment of: ‐ Congestive cardiac failure ‐ Hypertension ‐ Cardiac arrhythmia ‐ Angina pectoris ‐ Hyperlipoproteinemia

10

7. Diuretics 3 Total 38

Books (Latest edition of following books to be referred)

1. Goodman & Gilmans Pharmacological Basis of Therapeutics; Joel. G, Hardmon Lee, E. Limbird, Alfred Goodman Gilman; 11th Ed.; The Mcgraw‐Hill Companies, Inc; 2011.

2. Pharmacology and Pharmaco therapeutics; R.S. Satoskar, S.D. Bhandarkar, Nirmala N. Rege; 20th Ed.; Popular Prakashan; 2007.

3. Pharmacology; Rang and Dale; 7th Ed.; Churchil Livingstone; 2012. 4. Lippincott’s illustrated reviews: Pharmacology, Lippincott‐Raven; 3rd Ed.; Howland & Nycets Publishers,

N.Y.; 2006. 5. Lewis Pharmacology; Crossland; 5th Ed. Churchill Livingstone. 6. Clinical Pharmacology‐ Lawrence, D.R and Bennet‐ 9th Ed.; Elsevier, N.Y. 2006. 7. Clinical Pharmacology‐ B.G. Katzung; 11th Ed.; Appleton & Lange Publications. 2009. 8. Pharmacology; George M. Brenner, Craig W. Stevens; 2nd Ed.; Elsevier Publishers, 2006.

73

Mathematics and Statistics 3 hrs/week

Unit Topics Hours 1 Measurement of Central Tendency: Arithmetic Mean, median and mode 10 2 Measures of Dispersion 18 2.1 Range, quartile deviation, mean deviation and standard deviation

2.2 Coefficients of variation, moments, skewness and kurtosis, generating moments 2.3 Probability expectations and variance 2.4 Binomial, Poisson and Normal Distributions 2.5 Fitting of curves by the method of least squares Y = a + bX, Y = a + bX + cX2, Y =

aXb, Y = abX, Y = acbX

3 Sampling distribution for mean and proportion. 08 3.1 Test of hypothesis for specified values of mean and proportion for large

samples

3.2 Testing equality of two means and proportions 3.3 Students “t” test for single sample and paired observation, F‐test and analysis of

variance, testing of attributes, Chi‐square distribution.

Total 36

Books – Latest Editions to be adopted 1. Fundamentals of Statistics, Gupta S. C., Himalaya Publication. 2. Mathematics for Pharmacy Students (Vol. I), Gujar K. N., Bhavale Ashok, Career Publicaiton. 3. Measurement, Statistics of Computation, C Cornmich D, John Wiley and Sons. 4. Biostatistics in Pharmaceutical Industry, Buchner R. C., Marcel Decker Inc. 5. Integral Calculus, Shanti Narayan, S. Chand Publication.

74

Practicals Pharmaceutical Analysis Lab. – I 4 hrs/week

NOTE: For all the experiments, the latest edition of the Indian Pharmacopoeia 2010 has to be referred, except for gravimetric analysis.

Acid‐Base titrations: 1) Assay of Aspirin API (with special emphasis on the test for salicylic acid). 2) Assay of Aspirin tablets. 3) Estimation of Total alkalinity in a solution of Sodium Hydroxide. 4) Assay of Benzoic acid.

Redox titrations: 5) Assay of hydrogen peroxide solution (Permanganatometry). 6) Assay of Ascorbic acid API (Iodimetry) 7) Assay of Sodium metabisulphite API (Iodometry) 8) Assay of KMnO4 (Back Iodometry) 9) Assay of Ascorbic acid tablets/ Dried Ferrous sulphate/ Ferrous fumarate/ Paracetamol (Cerrimetry). 10) Assay of Potassium iodide (Iodate titration)

Complexometric titrations: 11) Assay of Calcium gluconate injection. 12) Assay of Zinc sulphate. 13) Assay of Magnesium sulphate.

Miscellaneous titrations: 14) Assay of Sulphacetamide sodium using external indicator. 15) Assay of Soluble Aspirin tablets (Solvent extraction followed by Bromometry‐iodometry).

Gravimetric analysis: (Ref. Vogels’ Textbook of Quantitative Chemical Analysis by Mendham J, Denney R C, Barnes J D, Thomas N, 2002, 6th Edition, Pearson Education Ltd.) 16) Ni2+ using Dimethyl glyoxime/ Al3+ as Al‐oxinate. 17) Ba2+ as BaSO4.

Demonstration titrations: 18) Assay of Pyridoxine hydrochloride/ Sodium benzoate using non‐aqueous titration method. 19) Assay of Sodium chloride. 20) Assay of Potassium chloride.

P. B. Standardization of all volumetric solutions has to be done

75

Pharmaceutics Lab. – II 4 hrs/week

1. SUSPENSIONS: (a) Antacid Suspension (Aluminium Hydroxide gel I.P’ 2010/ Magnesium hydroxide oral

suspension I.P’ 2010) (b) Paracetamol Suspension (c) Calamine Lotion I.P’ 2010 (d) Microscopic evaluation, rheology and sedimentation rate studies for any one of the above suspensions.

2. EMULSIONS: (a) Liquid Paraffin Emulsion I.P ’ 2010 (b) White Liniment B.P.C, 73 (c) Turpentine Liniment I.P ‘ 66 (d) Benzyl Benzoate Application I.P ‘ 2010 (e) Microscopy of any one of the above emulsion

3. OINTMENTS: (a) Simple Ointment I.P ‘ 66 (b) Sulphur ointment I.P ‘ 66 (Microscopic evaluation) (c) Emulsifying ointment I.P ‘ 66 (d) Compound Benzoic acid ointment I.P’ 2010 in emulsifying ointment base (e) Iodine ointment, Non – staining B.P.C 68 (f) Iodine ointment, Non – staining with methyl salicylate B.P.C 68

4. CREAMS: (a) Cetrimide cream I.P’ 2010 5. GELS: (a) Diclofenac sodium gel 6. PASTES: (a) Titanium dioxide paste B.P.C’ 73 7. SUPPOSITORIES: (a) Indomethacin Suppositories I.P’ 2010 Books

1. Relevant editions of Indian Pharmacopoeia, British Pharmaceutical Codex. 2. Lachman Leon, Liberman Herbert A., kaing Joseph L., “Theory and practice of Industrial Pharmacy” 3rd

edition, 1987, Varghese Publishing house, Mumbai. 3. Allen, Loyd V.Jr, “Remingtons‐ the Science and Practice of Pharmacy, Vol 1 / 2, 22nd edition,

Pharmaceutical Press.

76

Pharmacology Lab. – I 4 hrs/week

Sr. No. Experiment1. Dose response curve (DRC) of Ach using suitable isolated tissue preparation (e.g. Cock ileum)2. Demonstrations:

Effect of drugs on isolated frog heart (CDs) ‐Adrenaline, ACh ‐Atropine, propranolol ‐Effect of excess calcium and potassium on isolated heart ‐Effect of lack of calcium and potassium on isolated frog heart ‐Effect of digitalis on hypodynamic heart

3. Simulated experiments (CDs) ‐Effect of drugs on eye ‐Effect of drugs on GI motility

4. Demonstration with the help of CDs or kymograph recordings:–Effect of neostigmine on DRC of Ach –Effect of pancuronium on DRC of Ach (Give the readings to the students and ask them to plot the graphs and draw conclusions from the results eg. Identify type of antagonism existing between two drugs by studying the nature of the graphs, competitive and non competitive. Find out the potency of the drugs by studying the DRC and determining IC50 values) ‐Calculation of pA2 value of atropine using Ach as an agonist

5. Tutorials ‐Laboratory animal handling ‐Care and ethics in animal experimentation

Books: Latest editions of following books to be referred. 1. Kulkarni, S.K. Handbook of Experimental Pharmacology; 3rd Ed.; Vallabh Prakashan, New Delhi. 2005. 2. Gosh M.N. Fundamentals of Experimental Pharmacology, 3rd Ed.; Hilton & Company, Calcutta. 2005. 3. S.B. Kasture A Handbook of Experiments in Pre‐Clinical Pharmacology‐ 1st Ed.Career Publications. 2006. 4. W.I.M. Perry, Pharmacological Experiments on Isolated Preparations. 2nd Ed.; E & S Livingstone, Edinburgh &

London, 1970.

77

Microbiology Lab 4 hrs/week

1. Study of microscope and common laboratory equipments. 2. Gram Staining 3. Monochrome staining 4. Negative staining 5. Cell wall staining 6. Spore staining 7. Capsule staining 8. Motility by hanging drop technique 9. Preparation and sterilization of nutrient broth, agar slants, plates and inoculation techniques. 10. Isolation of pure culture by pour plate and streak plate methods. Colony characterization and growth

patterns in broth of cocci and bacilli. 11. Total counts by Breeds smear method 12. Growth by optical density, total plate count 13. Study of yeast, Aspergillus and Penicillum with respect to morphology 14. Observation on prepared slides of malarial parasites in blood smear, intestinal amoeba in stools.

Books 1. C. R. Kokare “Pharmaceutical Microbiology Experiments and Techniques”, Career Publication, Nashik. 2. R. S. Gaud and G. D. Gupta “Practical Microbiology”, Nirali prakashan, Pune. 3. C. H. Collins, Patricia M. Lyne, J. M. Grange “Microbiological Methods “7th Edn. Butterworth‐Heinemann Ltd Oxford, London

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Framework for the Third Year B. Pharm. (Credit Based System)

Syllabus Framework

No Semester- V Credits Contact hrs/week Weightage Marks

Subject Continuous

internal assessment

End Semester

Examination

1 Organic Chemistry - III 4 4 30 70 100 2 Cosmeticology 3 3 30 70 100 3 Pharmaceutical Biotechnology 4 4 30 70 100 4 Pharmacology-II 4 4 30 70 100 5 Pharmaceutical Management 3 3 30 70 100 Total 18 18 150 350 500 Practicals

6 Organic Chemistry Lab - II 2 4 15 35 50 7 Pharmaceutical Biotechnology

Lab 2 4 15 35 50

8 Cosmeticology Lab 2 4 15 35 50 Total 6 12 45 105 150 Total Teaching Hrs. 30 Total Credits 24 Total Marks 195 455 650

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2

No. Semester -VI 1 Pharmaceutical Chemistry-II 3 3 30 70 100 2 Pharmaceutical Analysis- II 3 3 30 70 100 3 Pharmaceutics -III 3 3 30 70 100 4 Pharmacognosy &

Phytochemistry-I 4 4 30 70 100

5 Hospital Pharmacy and Drug Store Management 3 3 30 70 100

Total 16 16 150 350 500 Practicals 6 Pharmaceutical Chemistry Lab -

II 2 4 15 35 50

7 Pharmaceutical Analysis Lab - II 2 4 15 35 50 8 Pharmaceutics Lab - III 2 4 15 35 50 9 Pharmacognosy &

Phytochemistry Lab - I 2 4 15 35 50

Total 8 16 60 140 200 Total Teaching Hrs. 32 Total Credits 24 Total Marks 210 490 700 Credits Sem V plus Sem VI 48

80

3

Scheme of Examination

No Semester- V No of papers

End Semester Examination Internal Assessment Maximum

marks

Minimum marks

for passing

the subject

Periodic Test ContinuousEvaluation

Subject - Theory Duration (hrs)

Maximum marks

Minimum for passing

Duration (hrs)

Maximum marks

Maximum marks

1 Organic Chemistry - III 1 3 70 28 1 15 15 100 40 2 Cosmeticology 1 3 70 28 1 15 15 100 40

3 Pharmaceutical Biotechnology 1 3 70 28 1 15 15 100 40 4 Pharmacology-II 1 3 70 28 1 15 15 100 40 5 Pharmaceutical Management 1 3 70 28 1 15 15 100 40

Practicals

7 Organic Chemistry Lab - II 1 4 35 14 4 8 7 50 20 8 Pharmaceutical Biotechnology

Lab 1 4 35 14 4 8 7 50 20

9 Cosmeticology Lab 1 4 35 14 4 8 7 50 20

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4

No Semester- VI No of papers

End Semester Examination Internal Assessment Maximum

marks

Minimum marks

for passing

the subject

Periodic Test Continuous Evaluation

Subject - Theory Duration (hrs)

Maximum marks

Minimum for

passing

Duration (hrs)

Maximum

marks

Maximum marks

1 Pharmaceutical Chemistry-II 1 3 70 28 1 15 15 100 40 2 Pharmaceutical Analysis- II 1 3 70 28 1 15 15 100 40

3 Pharmaceutics -III 1 3 70 28 1 15 15 100 40 4 Pharmacognosy &

Phytochemistry-I 1 3 70 28 1 15 15 100 40

5 Hospital Pharmacy and Drug Store Management

1 3 70 28 1 15 15 100 40

Practicals

6 Pharmaceutical Chemistry Lab - II

1 4 35 14 4 8 7 50 20

7 Pharmaceutical Analysis Lab - II 1 4 35 14 4 8 7 50 20 8 Pharmaceutics Lab - III 1 4 35 14 4 8 7 50 20 9 Pharmacognosy &

Phytochemistry Lab - I 1 4 35 14 4 8 7 50 20

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Detailed Syllabus Semester V

Organic Chemistry – III 4 Hrs/week Unit Topic Hours

1 Heterocyclic Chemistry 27 1.1 Nomenclature of mono, bi- and tri-cyclic hetero-aromatic, fused heterocyclic ring and

bridge head system of the drug molecules. 2

Synthesis, properties and reaction of the following heterocycles 1.2 Furan :

Synthetic methods including synthesis using carbohydrates, oxazoles, Diels-Alder Adduct, Paal-Knorr synthesis. Reactions with acids, bases, Electrophilic Aromatic Substitution (EAS), carbenes, nitrenes, oxidizing and reducing agents, Diels-Alder reaction.

9

Pyrrole : Synthetic methods including synthesis using furan, ammonium mucate, primary amines, Knorr synthesis, Paal-Knorr synthesis, Hantzsch synthesis, Piloty-Robinson synthesis. Reactions with acids, bases, alkylation, Electrophilic Aromatic Substitution (EAS), carbenes, nitrenes, oxidizing and reducing agents, Diels-Alder reaction. Thiophene : Synthetic methods including synthesis using Na- succinate, Ring closure, Paal-Knorr synthesis and Hinsberg synthesis. Reactions with acids, Electrophilic Aromatic Substitution (EAS), carbenes, nitrenes, nucleophiles, Free Radicals, aldehydes and ketones, oxidizing and reducing agents, Diels-Alder reaction.

1.3 Imidazole: Synthetic methods including synthesis from imidazolines, α-haloketones, Radiszewskii reaction. Reactions with acids, Electrophilic Aromatic Substitution (EAS), nucleophiles, oxidizing and reducing agents, imidazoles as catalysts in ester hydrolysis.

9

Pyridine : Synthetic methods including synthesis using 1,5-diketones, cyclic diketones, other ring systems, Hantzsch synthesis. Reactions with acids, Electrophilic Aromatic Substitution (EAS), alkyl and aryl halides, nucleophilic substitution, Hetaryne formation, oxidizing and reducing agents, Diels-Alder reaction, ring opening. Pyrimidine : Synthesis using malonic ester; 2,4-dichloropyridine, amidine and maleic acid Reactions with acids, Electrophilic Aromatic Substitution (EAS), nucleophiles, hydrazines, oxidizing and reducing agents.

1.4 Quinoline : Synthetic methods including Skraup synthesis, Doebner-Miller synthesis, Friedlander synthesis, Pfitzinger synthesis, Pictet synthesis, Conrad-Limpach synthesis. Reactions with acids, Electrophilic Aromatic Substitution (EAS), nucleophiles, oxidizing and reducing agents, reaction with S and Hg.

7

Isoquinoline : Synthetic methods including Bischler-Napieralski, Pictet-Gams, Pomeranz-Fritsch, Pictet-Spengler syntheses. Reactions including EAS, nucleophiles, oxidizing and reducing agents. Indole : Synthesis by Fischer indole synthesis, Mandelung synthesis, Reissert synthesis and Bischler synthesis. Reactions with acids, EAS, Metallic K, Mannich reaction, oxidizing and reducing agents.

2 Pericyclic Reactions 10 2.1 HOMO and LUMO of pi systems, molecular orbitals and pericyclic reactions, concerted

and pericyclic reactions.

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6

2.2 Electrocyclic reactions and stereochemistry, Woodward Hoffmann rule [4n and 4n+2] (conrotatory and disrotatory),Diel’s Alder, Retro Diel’s Alder.

2.3 Cycloaddition: 2π+2πand 4π+2π. 2.4 Sigmatropic rearrangement:1,5 rearrangement, 3,3-rearrangements (Cope and Claisen). 3 Synthon Approach: 6

3.1 Definition of reterosynthesis or disconnection approach, synthon, synthetic equivalent, functional group interconversion, functional group addition, functional group removal.

3.2 Strategies for disconnection approach. 3.3 Disconnection of simple alcohols, alkyl halide, ethers, olefins, esters, carboxylic acids, aryl

ketones,heterocyclics ring. 3.4 Design of retrosynthesis of drugs: Paracetamol, benzocaine, sulfadiazines, atenolol,

ibuprofen. 4 Chemistry of Steroids 7

4.1 Definition of steroids and sterols, numbering and ring letters, orientation of projection formulae, stereochemistry of ring junction and side chain attachments, stereochemistry of substituents in the side chain.

4.2 Types of steroid hormones:, androgens, estrogens, progestins, corticosteroids. Structure and synthesis of steroids, squalene, cholesterol, pregnenolone Conformation and chemical reactivity, steroid specific reactions of A and B rings, Addition-elimination, epoxide opening, relative rates of esterification, oxidation of epimeric alcohols, reduction of ketones.

5 Application of Catalysis in Organic Chemistry 10 5.1 Role of catalysis and its development -Classical and non-classical organic synthesis with

examples like hydroquinone, amino acid ester synthesis. 5.2 Catalysis by solid acid-base and its application in Friedal Craft reaction, Beckmann

rearrangement, H-USY as solid acid catalyst and hydrocalcite base catalyst, application of base catalyst in condensation reactions. Catalytic hydrogenation and application in chemoselective synthesis of saquinavir intermediate, zeolite based MPV reduction. Catalytic oxidation by stable free radical and application in progesterone synthesis, application in sigmatropic reaction e.g. citral, catalytic oxidation with H2O2 under phase transfer catalysis. Catalytic C-C bond formation and its application in lozabemide, naproxen and in synthesis of biaryl compounds by Suzuki, Negishi, Kumada coupling. Biocatalysis and its significance, applications in 6-APA, aspartame, heteroaromatic oxidation mediated by yeast, vitamin B-6. Enantioselective catalysis and application in menthol synthesis.

5.3 Application of catalysis in sustainable technology: Concept of E-factor and atom efficiency Total 60

Latest editions of following books to be adopted. 1. I. L. Finar: Organic chemistry- Volumes 1 and 2, Pearson Education, Ed:5 2. Morrison and Boyd, Organic chemistry, Prentice Hall. 3. Clayden and Greeves, Organic chemistry, Oxford University Press. 4. S. H. Pine et al, Organic chemistry, McGraw-Hill Science/Engineering/Math. 5. S. Warren, Designing organic synthesis, and the disconnection approach, Wiley India Pvt. Ltd. 6. Corey and Chelg, The logic of chemical synthesis, JOHN WILEY & SONS, New York. 7. R. P. Iyer and A. Prabhu, Synthesis of drugs : A synthon approach. 8. D. Lednicer: Steroid chemistry at a glance, Wiley. 9. I. Arends, R. Sheldon, U. Hanefeld, Green chemistry and catalysis, WILEY-VCH Verlag GmbH & Co.

KGaA, Weinheimpp 1-48. 10. J.G. Vries, A.H M. Vries, Innovations in pharmaceutical technology, Chemical Technology. 11. C. A. Busacca, D. R. Fandrick, J. J. Song, and C. H. Senanayakea, Adv. Synth. Catal. 2011, 353, 1825 –

1864 " The growing impact of catalysis in the pharmaceutical industry-Review"

84

7

85

8

Cosmeticology 3 Hrs/week

Unit Topic Hours 1. General Aspects in Cosmeticology 11 1.1 Definition of cosmetics, historical background, classification.

Structure of skin, hair, nails, teeth (self study). Regulatory aspects- Schedules to Drug and Cosmetics Rules - M II, S, Q.

1 1 1

1.2 Raw materials including colours, perfumes, antioxidants, preservatives and water, herbal products (self study).

3 2

1.3 Microbiological aspects of cosmetics. 1 1.4 Toxicology of cosmetics-irritation and sensitization reactions to cosmetics, sensitivity

testing and safety aspects. 2

2. Skin care products - raw materials, formulation, large scale manufacturing and quality control (including BIS) and functional evaluation.

7

2.1 Skin creams and lotions - Cleansing, cold, vanishing, moisturizing, hand and body products, face packs.

3

2.2 Sunscreen, suntan and anti-sunburn preparations. 2 2.3 Protective preparations-Barrier products, anti-acne, anti-wrinkle, bleach products. 2 3. Colored cosmetics products- raw materials, formulation, large scale manufacturing

and quality control (including BIS). 8

3.1 Foundation, face powders. Rouge (self study).

1 1

3.2 Eye makeup products. 1 3.3 Lipsticks. 2 3.4 Nail speciality products-cuticle softener, nail bleach, nail strengthener, nail whites. 1 3.5 Nail lacquer. 2 4. Hair care products -raw materials, formulation, large scale manufacturing and quality

control (including BIS) and functional evaluation. 7

4.1 Shampoos (including antidandruff and antilice) 2 4.2 Hair grooming, hair waving, hair straighteners and conditioners. 2 4.3 Hair colorants. 2 4.4 Depilatories. 1 5. Shaving preparations raw materials, formulation, large scale manufacturing and

quality control (including BIS) and functional evaluation. 4

5.1 Wet shaving preparations-foaming and brushless. 3 5.2 Dry shaving preparations and after shave products. 1 6. Oral and personal hygiene products - raw materials, formulation, large scale

manufacturing and quality control (including BIS) and functional evaluation. 8

6.1 Toothpaste, medicated toothpaste. Toothpowder (self study).

2 1

6.2 Self study. Mouthwashes and denture cleansers. Bath products-shower gels, body washes, bubble washes, bath salts.

3

6.3 Self study. Antiperspirants and deodorants, insect repellants. Baby toiletries - Oils, creams & lotions, shampoos, powders.

2

Total 45

Latest editions of following books to be adopted 1. Harry’s Cosmeticology Edited by J. B. Wilkinson and R. J. Moore, Longman Scientific & Technical

Publishers 2. Cosmetics Science and Technology, Edited by M. S. Balsam, E. Sagarin, S. D. Gerhon, S. J. Strianse

and M. M. Rieger, Volumes 1,2 and 3.Wiley-Interscience, Wiley India Pvt. Ltd.

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9

3. Poucher’s Perfumes, cosmetics & Soaps, Editor- Hilda Butler, Klewer Academic Publishers, Netherlands

4. Cosmetic Technology, Ed. By S. Nanda, A. Nanda and R. Khar, Birla Publications Pvt. Ltd., New Delhi

5. Handbook of Cosmetic Science and Technology, edited by M. Paye, A. O.Barel, H. I. Maibach, Informa Healthcare USA, Inc.

6. Encyclopedia of Pharmaceutical Technology, Vol. 6, Eds. James Swarbrick, James C. Boylan, Marcel Dekker Inc.

7. BIS Guidelines for different cosmetic products.

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10

Pharmaceutical Biotechnology 4 Hrs/week

Unit Topic Hours

1 1.1 1.2

Introduction to Biotechnology Definitions, scope, relevance to Pharma Industry. Microbiological limit tests – Need, standards for raw materials of natural origin (Pharmacopoeial with some examples) Microbiological assays - Diffusion bioassays, turbidometry, end point assays. Self study : Historical perspectives.

4 2 2

2 2.1 2.2

Fermentation Technology Example of products of fermentation (microbial, animal and plant), types of fermenters (mechanically stirred, air-lift, tray), design of fermenter, factors affecting fermentation (innoculum preparation, temperature, pH, media composition, aeration, agitation, antifoam agents, strain optimization, growth kinetics) and down stream process. Production of penicillin, single cell protein. Self study : Production of dextran, tetracycline, amylase.

7 4 3

3 3.1 3.2

Recombinant DNA technology Steps involved in rDNA technology, enzymes involved in DNA technology with reference to restriction endonucleases and ligase, vectors (Plasmid, Cosmid, YAC), Gene expression/Host- (Bacterial expression system, yeast expression system, animal expression system, plant expression system) Application of rDNA technology for production of pharmaceutical products e.g. Insulin. Self study : Production of human growth hormone, interferon. Preparation of a list of approved biotech derived products.

11 8 3

4 4.1 4.2

Techniques used in molecular biology Introduction to polymerase chain reaction, DNA sequencing (Sanger, Maxam and Gilbert), RFLP, DNA fingerprinting, cDNA library, gene library, Southern blotting technique, Northern blotting, Western blotting, introduction to gene therapy, transgenic animal and transgenic plants. Self study: SDS- PAGE.

9 8 1

5 5.1

Enzyme and cell immobilization. Methods for enzyme immobilization (adsorption, covalent binding, entrapment, microencapsulation) with examples and applications. Introduction to biosensor and applications e.g. glucose oxidase, penicillinase.

6 5

6 6.1 6.2 6.3

Immunology a) Host-microbe interactions, Introduction to terms-infection, infestation, pathogen, resistance, susceptibility etc. b)Factors affecting pathogenicity and infection, c) Innate defense mechanism – first line of body defense, physiological phenomena-inflammatory response, fever, cellular, mediators; soluble (humoral) mediators, phagocytosis. d)Specific defense Mechanism – Characteristics, Antigen, Cell-mediated immunity, humoral immunity. e) Antibody structure and types, pathways of immune response, clonal selection theory. Self study: organization of immune system-organs & cells involved. Serology-Precipitation , agglutination, complement fixation tests, immunofluoroscence, RIA, ELISA. Introduction to Hypersensitivity & Allergy. Immunodeficiency states- Primary & acquired, autoimmunity. Hybridoma technology – Production and application of monoclonal antibodies.

15 8 2 5

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11

7 Vaccines & Sera- Definitions and classification, outline of general method of preparation of bacterial & viral vaccines, typical examples of each type (diphtheria,TAB, polio), antisera (anti-tetanus sera) Q. C. aspects, recent trends in vaccines (recombinant vaccines) Self study: Outline of general method of preparation of BCG and rabies vaccine

4 2 2

8 Cell culture (plant and animal) Tissue culture media, primary cell culture, continuous cell culture, pharmaceutical applications of animal cell culture. Stem cell culture, cryopreservation/stem cell bank Self study: Media and media composition (typical) for plant and animal cell culture, names of commonly used animal cell lines, their tissue origin and typical applications.

4 2 2

Total 60

Latest editions of the following books to be adopted.

1. R. C. Dubey , A textbook of biotechnology 2. B. D. Singh, Biotechnology. 3. S. P. Vyas and Dixit, Pharmaceutical Biotechnology, CBS publisher & distributers. 4. S. S. Kori , Pharmaceutical Biotechnology. 5. H. D. Kumar, Biotechnology, Affiliate East-West press Pvt. Ltd New Delhi. 6. Ananthnarayan, A textbook of microbiology, Orient Longman Pvt. Ltd. 7. W. B. Hugo and A. D. Russell, Pharmaceutical Microbiology, Blackwell Science. 8. David, Nelson, Lehninger - Principle of Biochemistry, W. H. Freeman & Co. 9. Pelezar, Chan & Krieg, Microbiology-Concepts and Applications, International Edn., McGraw Hill, Inc., 10. Weir Stewart: Immunology, Churchill Livingstone. 11. Chandrakant Kakote, Pharmaceutical Biotechnology. 12. Desmond S.T. Nicholl, An introduction to genetic engineering, Panima Publishing Corporation, New

Delhi.

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12

Pharmacology – II 4 Hrs/week Unit Topic Hours 1 Chemotherapy 30 1.1 Introduction to chemotherapy including drug resistance. 2 1.2 Sulfonamides, trimethoprim, fluoroquinolones, nitrofurantoin. 3 1.3 Penicillins, cephalosporins and cephamycins. 3 1.4 Tetracyclines, chloramphenicol, macrolides, clindamycin, linezolid, streptogramins and

fusidic acid. 3

1.5 Aminoglycosides and spectinomycin. 2 1.6 Antifungal agents. 2 1.7 Antiviral agents including anti-HIV agents. 2 1.8 Chemotherapy of tuberculosis, leprosy, and malaria. 3 1.9 Chemotherapy of amoebiasis. 1 1.10 Anthelmintic drugs. 1 1.11 Chemotherapy of neoplastic diseases (Anticancer drugs). 3

1.12 1.13

SELF STUDY Rational use of antimicrobials. General principles of chemotherapy of infection.

3 2

2 Immunomodulators 9 2.1 Immunology: Regulation of immune system, signalling pathways for its activation and

inhibition. 1

2.2 Immunostimulants and immunosuppressants. 2 2.3 Immunomodulators in the treatment of HIV and Cancer. 2 2.4

SELF STUDY Physiology of immune system.

4

3 Drugs in Endocrine Disorders 11 3.1 Thyroid and anti-thyroid drugs. 2 3.2 Insulin, antidiabetic agents including DPP-IV inhibitors. 3 3.3 Agents affecting bone mineral homeostasis. 1 3.4 Oxytocics. 1 3.5 Oral contraceptives. 1 3.6

SELF STUDY Corticosteroids

3

4 Drugs in Haematological Disorders 10 4.1 Drugs used in anemia. 2 4.2 Coagulants and anti-coagulants. 3 4.3 Thrombolytics and anti-platelet agents. 2 4.4

SELF STUDY Physiology of blood coagulation.

3

Total 60

Latest editions of the following books to be adopted 1. Goodman & Gilman’s Pharmacological Basis of Therapeutics, McGraw Hill Companies Inc. 2. Satoskar R.S. Bhandarkar S.D. & Rege N. N. Pharmacology & Therapeutics, Popular Prakashan. 3. Rang & Dale Pharmacology, Churchill Livingstone. 4. Lippincott’s Illustrated Reviews: Pharmacology- Lippincott-Raven Howland & Nyeets Publishers NY. 5. Laurence D. R. & Bennett Clinical Pharmacology, Elsevier NY.

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6. Kulkarni S. K. Handbook of Experimental Pharmacology, Vallabh Prakashan, New Delhi. 7. Katzung B. G. -Basic and Clinical Pharmacology, Appleton and Lange publications. 8. Ghosh M. N. Fundamentals of Experimental Pharmacology Hilton & Company, Kolkata.

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14

Pharmaceutical Management 3 Hrs/week Unit Topic Hours 1 Understanding of health care industry 5 1.1 Different components of health care industry/ What constitutes health care industry 1

1.2 Indian pharmaceutical industry (in today’s scenario and its potential as your career option)

1

1.3 Details of therapy segment, major companies and major brands 1 1.4 Elements of pharmaceutical industry in order to understand its working uniqueness of

medical products marketing-C&F agent, stockist & retailer/chemist. 1

1.5 Different working style of acute, chronic and OTC therapy segment 1 2. Financial Management 2 2.1 Understanding basic concept of market share, growth, profitability 1 2.2 Basics of balance sheet and profit and loss account 1 3 SWOT analysis 3 31 Basic concept SWOT analysis. 1 3.2 Application of SWOT analysis considering any therapeutic class of a drug. 2 4 Brand Plan 4 4.1 Importance of brand plan. 1 4.2 Basic elements of a brand plan 3 5 Identifying Market Segments and Targets (STP) 3 5.1 Segmentation: Geographic, demographic, psychographic and behavioral

Targeting: Effective segmentation criteria, evaluation and selection of market segment 1

5.2 Positioning: Understanding the importance of positioning based on indication with live examples from pharmaceutical industry

2

6 Product Life Cycle (PLC) 4 6.1 Importance of PLC 1 6.2 How to manage product at different stages of PLC 3 7 4 P’s of Marketing Mix (Product, Price, Promotion, Place) 3 7.1 Product: Different types of pharmaceutical products (acute, chronic and OTC)

Pricing: How to determine the pricing of products, determination of NRV (Net Retail Value) and MRP (Maximum Retail Price) Place: All India, Hospitals, Govt./ Corporate purchasers, ESIS schemes, NGOs. Promotion: direct distribution, direct home delivery, dispensing, scheme, etc.

2

7.2 Packaging: importance of packaging in pharmaceutical products, types of packing and its importance.

1

8 Important Marketing models 4 8.1 BCG matrix 2 8.2 Porter’s 5 force model 2 9 Soft skills and self development 2 9.1 Human resource management: Leadership, motivation, delegation, conflict

management and communication, time management, multitasking, planning and organizing and stress management

1

9.2 Skills to excel in interview: dress code, body language and handling difficult situations, dos and donts of resume making (Self Study)

1

10 Pharmaceutical quality and legal regulatory bodies 6 10.1 DPCO- meaning and its role 1 10.2 Quality management: FDA regulations and approvals, WHO requirements, 1 10.3 General awareness of Global requirements of MHRA/ MCA/ TGA/ USFDA/ ISO up

gradation/ Six sigma concept, 2

10.4 Clinical research, patent registration and IPR 2

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11 Case Studies 5 12 Presentations 4 Total 45

Latest editions of the following books to be adopted 1. Kotler, Loshy & Jha , Marketing Management. 2. Dr. Rajan Saxena, Marketing Management. 3. Adrian Palmer, Introduction to Marketing Management. 4. Prasanna Chandra, Financial Management. 5. M. Pandey, Financial Management. 6. K. Ashwathapa, Human Resource management. 7. Subba Rao, Personnel & Human Resource Management. 8. K. Ashwathapa, Production & Operations Management. 9. S. N. Chary, Production & Operations Management. 10. S. A. Chunawala, Production & Operations Management. 11. Ronald Ballon, Business Logistics/ Supply Chain Management. 12. Robert Hanfiels, Introduction to Supply Chain Management.

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Organic Chemistry Lab. – II 4 Hrs/week

1) Separation and quantification of binary mixtures by physical and chemical methods. Identification of one component and confirmation by preparation of a suitable derivative. Minimum eight binary mixtures, covering a wide variety of types to be studied

2) Theoretical aspects of recrystallization 3) Recrystallization of organic compounds: at least two with the use of different solvents.

Latest editions of the following books to be adopted 1. A laboratory hand book of organic qualitative analysis and separation, V.S. Kulkarni, S. P. Pathak, D.

Ramchandra & Co., Pune. 2. Text book of organic practical chemistry, V.S. Kulkarni, S. P. Pathak, D. Ramchandra & Co., Pune. 3. R. L. Shriner, R. C. Fuson and D. Y. Curtin, The systematic Identification of Organic compounds, 6th

Ed., Wiley, New York, 1980. 4. A. I. Vogel, A textbook of practical organic chemistry, 4th edition, Wiley New York, 1978. 5. Comprehensive Practical Organic Chemistry: Qualitative Analysis, V. K. Ahluwalia, S. Dhingra,

Universities Press (India) Limited, 2000. 6. Comprehensive Practical Organic Chemistry: Preparation and Quantitative analysis, V.K. Ahluwalia,

Renu Aggarwal, Universities Press (India) Limited, 2000.

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Pharmaceutical Biotechnology Lab. 4 Hrs/week

1. Air microbiology by solid and liquid impingement methods. 2. Coliform count of water by MPN technique. 3. Test for sterility as per IP (Injection water/ nonabsorbent cotton/soluble powder/ear drops). 4. Microbial limit test on excipients as per I.P. – Hard gelatin, tragacanth, starch, lactose 5. Studies on selective media: McConkey Agar, Cetrimide Agar, Vogel Johnson, Salt mannitol agar. 6. Antibiotic sensitivity test by disc method. 7. Widals test tube agglutination method 8. Biochemical tests (Catalase, Oxidase, Urease, Nitratase, Protease, Amylase and IMVIC). 9. Antimicrobial assay of antibiotic, introduction to zone of inhibition and calculation. 10. Immobilization of enzymes/cells by calcium alginate/gelatin/agar. 11. Isolation of DNA. 12. Selection and isolation of bacteria by replica plating. 13. Determination of thermal death time and thermal death point. 14. Effect of Ultra-Violet exposure on growth of E coli. 15. Demonstration of electrophoresis either by PAGE or Agarose gel electrophoresis.

Latest editions of the following books to be adopted

1. Medical Laboratory Technology: A Procedure Manual for Routine Diagnostic Tests (Vols. I, II & III), Kanai L. Mukherjee (Chief Editor), Tata McGraw Hill Publishing Company Ltd., New Delhi.

2. An Introduction to GENETIC ENGINEERING, 2nd Edition, Desmond S. T. Nicholl, Cambridge University Press.

3. Biotechnology: A Textbook of Industrial Microbiology, 2nd Edition, Wulf Crueger & Anneliese Crueger, Panima Publishing Corporation, New Delhi/Bangalore.

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Cosmeticology Lab 4 Hrs/week

Formulation and evaluation of the following cosmetic products: 1. Cleansing milk/lotion 2. Cold cream 3. Vanishing cream 4. Sunscreen cream 5. Foundation makeup 6. Moisturizing Lotion 7. Anti-acne cream 8. Anti-wrinkle cream 9. Clear liquid shampoo 10. Eye shadow 11. Nail lacquer 12. Lipstick 13. Toothpaste/medicated toothpaste 14. Mouthwash 15. Lather shaving cream 16. Brushless shaving cream 17. Aftershave lotion 18. Face powder 19. Facepack

Latest editions of the following books to be adopted

1. Harry’s Cosmeticology Edited by J.B. Wilkinson and R. J. Moore, Longman Scientific & Technical Publishers

2. Cosmetics Science and Technology, Edited by M.S. Balsam, E. Sagarin, S. D. Gerhon, S. J. Strianse and M. M. Rieger, Volumes 1,2 and 3.Wiley-Interscience, Wiley India Pvt. Ltd.

3. Poucher’s Perfumes, cosmetics & Soaps, Editor- Hilda Butler, Klewer Academic Publishers, Netherlands 4. Cosmetic Technology, Ed. By S. Nanda, A. Nanda and R. Khar, Birla Publications Pvt. Ltd., New Delhi 5. Handbook of Cosmetic Science and Technology, edited by M. Paye, A. O. Barel, H. I. Maibach, Informa

Healthcare USA, Inc. 6. Encyclopedia of Pharmaceutical Technology, Vol. 6, Eds. James Swarbrick, James C. Boylan, Marcel

Dekker Inc. 7. BIS Guidelines for different cosmetic products.

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Semester –VI Pharmaceutical Chemistry – II 3 Hrs/week

Unit Topic Hours 1 Pharmacodynamics 5 1.1 Drug targets at molecular level –

Cell Structure. Lipids, carbohydrates, proteins and nucleic Acids as drug targets.

2

1.2 Intermolecular bonding forces like electrostatic, hydrogen bonding, van der Waal’s interactions, dipole-dipole and ion-dipole interactions and hydrophobic interactions.

3

2 Proteins as Drug Targets 9 2.1 Primary, secondary, tertiary and quarternary structure of proteins and post translational

modifications (Self Study). 1

2.2 Proteins as drug targets / Drugs. Monoclonal antibodies, peptides. Introduction to proteomics.

2

2.3 Enzymes as Drug targets 2.3.1 Enzyme Inhibitors – Reversible and irreversible (Self Study). 1 2.3.2 Enzyme Inhibitors against microorganisms, viruses, body’s own enzymes. 1 2.4 Receptors as Drug Targets. 2.4.1 Types of receptors and signal transduction - Ion Channels, G-protein coupled receptor

(GPCR), Kinases, nuclear receptors. 3

2.4.2 Concept of agonist, antagonist, partial agonist, inverse agonist, concept of desensitization/sensitization, tolerance, affinity, efficacy, potency (Self Study).

1

3 Nucleic Acids as Drug target 8 3.1 Primary, secondary and tertiary structure of DNA (Self Study) 1 3.2 DNA intercalation, DNA alkylation, antisense therapy 1 4 Pharmacokinetics and Physicochemical Properties of Drug Action 4.1 Solubility, partition coefficient, acidity-basicity, pKa, bioisosterism, stereochemistry

(geometrical, optical and conformational), Protein Binding 2

4.2 Drug metabolism – Phase I and Phase II Reactions 4 5 Tools of the Trade (Structure Activity Relationship – SAR)

Introduction to the concepts of SAR –A Case Study 1

Discussion on the following classes of drugs including enzyme/receptor structure, classification, chemical nomenclature, structure including stereochemistry, generic names, chemistry, SAR, metabolism, molecular mechanism of action, introduction to rational development, drug resistance, if any, of following classes of drugs 6 Antiinfective Agents 10 6.1 Antibiotics

Penicillins (natural and semisynthetic penicillins like Penicillin G, Penicillin V, ampicillin*, amoxicillin, cloxacillin*, oxacillin, naficillin, methicillin and ampicillin prodrugs like bacampicillin and hetacillin). -lactamase inhibitors like clavulinic acid, (self study – tazobactam). Cephalosporins (cephalexin, cefadroxil, cefazolin, cefamandole, cefoxitin, cefuroxime, cefotaxime, ceftriaxone, cefpodoximeproxetil) Tetracyclines (tetracycline, chlortetracycline, oxytetracycline, doxycycline, and minocycline and its prodrug – rolitetracycline); Macrolides, (erythromycin, roxithromycin, azithromycin - only highlights of structure to be discussed). Aminoglycosides (gentamicins, and neomycins, - only highlights of structure to be discussed) Carbapenems (Emepenem, meropenem). Monobactams (Aztreonam, Tigemonam). Chloramphenicol, Linezolid. Only highlights of structures of Vancomycin, Bacitracin, Polymyxin B.

7

6.2 Sulfonamides (Self study) Short, intermediate and long acting sulfonamides, sulfonamides for ophthalmic infections,

1

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ulcerative colitis and for reduction of bowel flora. Sulfamethoxazole, sulfadiazine*, sulisoxazole, sulfacetamide, sulfasalazine.

6.3 Fluoroquinolones Norfloxacin, ciprofloxacin*, sparfloxacin, gatifloxacin, levofloxacin, lomefloxacin.

2

7 Antiparasitic Agents 6 7.1 Antimalarial Agents

Natural products like cinchona alkaloids (with stereochemistry and drug action) and artemisinin and its derivatives like artether, artemether and artesunate, synthetic antimalarials such as 8- aminoquinolines e.g. primaquine*, 4- aminoquinilines e.g. chloroquine*, Quinolinemethanols e.g. mefloquine; misc like halofantrine, lumefantrine and; DHFR inhibitors like pyrimethamine* and proguanil, cycloguanil, atovaquone, sulfadoxine Combination therapy.

3

7.2 Drugs for treatment of amoebiasis, giardiasis and trichomoniasis (Self Study). Metronidazole*, tinidazole, secnidazole, diloxanide furoate*, nitazoxanide.

1

7.3 Anthelmintics Albendazole, mebendazole*, thiabendazole, diethylcarbamazine, ivermectin, praziquantel, pyrantel pamoate

1

7.4 Drugs for the treatment of pneumocystis, trypanosomiasis, leishmaniasis(Self Study) Atovaquone, pentamindine, co-trimoxazole, trimetrexate, benznidazole, eflornithine, melarsoprol, suramin, nifurtimox, sodium stibogluconate, miltefosine)

1

8 Antimycobacterial Agents Antitubercular drugs - PAS*, ethionamide, isoniazid, pyrazinamide, ethambutol*, antitubercular antibiotics (streptomycin, rifampin, rifapentine, capreomycin, cylcoserine – the first four only highlights of structure to be discussed), fluoroquinolones, bedaquiline. Antileprotic drugs.- Dapsone*, clofazimine, rifampin. Combination therapy

3

9 Antifungal Agents Natural products like griseofulvin , amphotericin B and nystatin (later two only general aspects of structure related to activity). Antifungal azoles like clotrimazole*, miconazole, ketoconazole, fluconazole, and itraconazole. Allyl amines like naftifine, butenafine and terbinafine. Flucytosine and tolnaflate.

3

Total 45 *Synthesis to be taught

Latest editions of the following books to be adopted. 1. Graham L. Patrick, An Introduction to Medicinal Chemistry, Oxford University Press. 2. Gareth Thomas, Fundamentals of Medicinal Chemistry, Wiley, New York. 3. Richard B. Silverman, The Organic Chemistry of Drug Design and Drug Action, Academic Press. 4. Thomas L. Lemke, David A Williams, Foye’s Principles of Medicinal Chemistry, Lippincott Williams &

Wilkins. 5. John M. Beale, John H. Block, Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical

Chemistry, Lippincott Williams & Wilkins. 6. Ashutosh Kar, Medicinal Chemistry, New Age International Publishers. 7. Alex Gringauz, Introduction to Medicinal Chemistry, Wiley. 8. Daniel Lednicer, Lester A. Mitscher, The Organic Chemistry of Drug Synthesis, John Wiley and Sons. 9. H. J. Roth & A. Kleemann, Pharmaceutical Chemistry, Volume 1, Organic Synthesis, Ellis Horwood

Series in Pharmaceutical Technology, Halsted Series. 10. Ruben Vardanyan and Victor Hruby, Synthesis of Essential Drugs, Elsevier. 11. Kleemann & Engel, Pharmaceutical Substances: Syntheses, Patents, Applications, Thieme Publications.

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Pharmaceutical Analysis – II 3 Hrs/week Unit TOPIC Hours

1 Basis of spectrophotometry 8 1.1 Terms-

• Electromagnetic radiation, Visible light and electromagnetic spectrum, wavelength, wave number, frequency, absorbance, transmittance (Self study-0.5h), singlet state, triplet state, fluorescence, phosphorescence and energy transitions.

• Atomic spectra, molecular spectra, atomic absorption spectroscopy, atomic emission spectroscopy, molecular absorption spectroscopy, molecular emission spectroscopy.

2

1.2 Instrumentation for: UV-Vis, Fluorescence (Self study-1 hr), FTIR spectroscopy • Sources of electromagnetic radiation • Monochromators (Filters, prisms, gratings) • Sample cells • Detectors

4

1.3 • Colorimeter & UV-Vis Spectrophotometers-Single beam and Double beam (including Block diagram & ray diagram).

• Filter fluorimeter (including Block diagram) and Spectrofluorimeter. • Interferometer in FTIR

2

2 Atomic absorption spectroscopy (AAS) and Flame emission spectroscopy (Flame photometry)

3

2.1 • Principle, partial emission spectrum of sodium • Difference between atomic absorption spectroscopy and flame emission

spectroscopy, Advantages and disadvantages (Self study-1 hr) • Instrumentation: Radiation sources (For AAS-Hollow cathode lamp, Electrode

discharge lamps; For Flame photometry-Inductively coupled plasma source, Direct current plasma source); Flame atomization (types of flames, flame structure, flame atomizers).

2

2.2 • Sample preparation • Spectral Interferences and Chemical Interferences in AAS. • Cationic, Anionic and Physical interferences in Flame photometry. • Pharmaceutical applications.

1

3 UV-Visible spectroscopy 7 3.1 Terms-chromophore, auxochrome, bathochromic shift, hypsochromic shift,

hyperchromism, hypochromism, wavelength maxima, specific absorbance, molar absorptivity, cut-off wavelength for solvents.

1

3.2 • General concepts-Types of absorbing electrons, electronic transitions, • Beer-Lambert’s law-statement, derivation of mathematical expression, limitations. • Choice of solvents (Self study-0.5 h) • Chemical derivatization.

2

3.3 • Application of Beer’s law in quantitative spectrophotometric assays-Single component assays-use of a standard absorptivity value -use of a calibration graph -single and double point standardization

• Measurement of Equilibria constant. • Measurement of rate constant.

2

3.4 Numericals based on Beer-Lambert’s law. 2 4 Fluorescence spectroscopy 3 4.1 Origin of fluorescence and phosphorescence spectra, Fundamental equation for

fluorescence intensity, factors affecting fluorescence intensity (intensity of radiation source, quantum yield, molecular structure and rigidity, temperature, solvents, pH, dissolved oxygen, quenchers & concentration).

2

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22

4.2 Chemical derivatization of non-fluorescent compound to fluorescent compound (e.g: use of Dansyl chloride, Fluoresamine, o-phthalaldehyde) (Self study-0.5 h), Choice of fluorimetry over UV-Vis spectroscopy with respect to Sensitivity and Specificity. Pharmaceutical Applications (Self study-0.5 h)

1

5 Infrared / Near IR spectroscopy 6 5.1 I.R. regions, requirements for I.R. absorption, vibrational and rotational transitions, dipole

changes, types of molecular vibrations, potential energy diagrams (harmonic oscillator and anharmonic oscillator), Vibrational frequency, factors influencing vibrational frequencies, force constants, vibrational modes (normal mode, combination bands and overtone bands), Finger print region

2

5.2 • Sample preparation for I.R spectroscopy-Solids (mulling, pelleting & thin film deposition, and in solution form), Liquids (Neat and in solution form).

• Sample handling: Attenuated Total Reflectance and Diffuse Reflectance. • Pharmaceutical applications of IR spectroscopy (including characteristic IR

absorption frequencies of some common bond types such as hydroxyl stretch, nitrile stretch and carbonyl stretch of aldehydes and ketones, aliphatic and aromatic C-H stretch) (Self study-1 hr)

• Pharmaceutical applications of Near IR spectroscopy including PAT (Process Analytical Techniques).

4

6 Raman Spectroscopy 3 6.1 • Principle of Raman scattering.

• Comparison between I.R. Spectroscopy and Raman Spectroscopy (Self study-0.5 h)

• Raman instrumentation-Sources of light, Sample illumination system (Liquid, solid and fibre optic sampling), Block diagram of Raman spectrometer.

• Applications(Self study- 0.5 h)

3

7 Thermal methods of analysis 4 7.1 • Principle, instrumentation, working and applications of thermogravimetry(TG)

• Factors affecting TG curve 2

7.2 Principle, instrumentation, working and applications of : • Differential Thermal Analysis (DTA) (Self study-1 hr) • Differential Scanning Calorimetry (DSC)

2

8 Radiochemistry and Radiopharmaceuticals 5 8.1 Fundamentals of radioactivity:

• Properties of radionuclide, Radionuclide, Radioisotope, Radioactive decay, half-life of radioactivity, specific activity, Becquerel, curie, Sievert and Gray(Self study-0.5 h)

• Relative biological effectiveness, Radionuclidic purity, Radiochemical purity, Geiger-Muller Counting, liquid Scintillation Counting

• Safety aspects of radiopharmaceutical laboratory (Self study-0.5 h)

2

8.2 Quality control of radiopharmaceuticals: Physical, Chemical (Radionuclidic purity, Radiochemical purity), and pharmaceutical properties (Self study-0.5 h-apyrogenicity, pH and absence of particulate), Isotope dilution analysis (Direct and Inverse), 99mTc generator.

3

9 X-Ray Diffraction Technique 2 9.1 • Fundamentals- Origin of X-ray, Bragg’s law & its mathematical derivation, and

Miller indices (Self study-0.5 h) • Pharmaceutical applications

2

10 Statistical data handling 4 10.1 • Normal Distribution

Numericals based on: • Confidence limits & Tests of significance (F-test, Student t-test-paired and

unpaired) • Linear regression analysis and correlation coefficient

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23

• Rejection of results (Q-test) Total 45

Latest editions of the following books to be adopted

1 D. A. Skoog, F. J. Holler and S. R. Crouch, Principles of Instrumental Analysis, Saunders College Publishing, USA.

2 K. A. Connors, A Textbook of Pharmaceutical Analysis, John Wiley and Sons, Canada. 3 A. H. Beckett and J. B. Stenlake, Practical Pharmaceutical Chemistry, Part I and II, CBS Publishers and

Distributors, India. 4 D. A. Skoog, D. M. West, F. J. Holler and S. R. Crouch, Fundamentals of Analytical Chemistry, Saunders

College Publishing, USA. 5 G. D. Christian, Analytical Chemistry, John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd. 6 H. H. Willard, L. L. Merrit and J. A. Dean, Instrumental Method of Analysis, CBS Publishers &

Distributors, New Delhi. 7 Ashutosh Kar, Pharmaceutical Drug Analysis, New Age International (P) Ltd. Publishers, India. 8 S. S. Mahajan, Instrumental Methods of Analysis, Popular Prakashan Pvt Ltd., India. 9 G.R. Chatwal and S. K. Anand, Instrumental methods of chemical analysis, Revised and enlarged,

Himalaya Publishing House Pvt. Ltd. 10 Indian Pharmacopoeia, The Indian Pharmacopeia Commission, Ghaziabad, Government of India. 11 United States Pharmacopoeia. 12 J. Mendham, R. C. Denney, J. D. Barnes, M.J. K. Thomas, Vogel’s Textbook of Quantitative Chemical

Analysis, 6th Ed., Pearson Education Ltd. 13 D.G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists,

Churchill Livingstone Elsevier. 14 J.W. Robinson, E. M. S. Frame and G. M. Frame II, Undergraduate Instrumental Analysis, Marcel

Dekker, New York, USA. 15 R. Kellnar, J. M. Mermet, M. Otto, M. Valcarceland, H. M. Widmer, Analytical Chemistry: A modern

approach to analytical science, Wiley-VCH, USA. 16 J. W. Munson, Pharmaceutical Analysis: Modern methods (in two parts), Marcel Dekker Inc., USA. 17 W. Kemp, Organic Spectroscopy, Reprinted, Palgrave Publishers Ltd., New York, USA. 18 R. M. Silverstein, F. X. Webster and D. J. Kiemle, Spectrometric identification of organic compounds,

John Wiley & Sons, Inc. (Indian edition), New Delhi. 19 D.B. Troy and P. Beringer, Remington-The Science and Practice of Pharmacy, Vol. I & II, Walters

Kluwer/ Lippincott Williams & Wilkins (Indian edition), New Delhi. 20 J.W. Robinson, E. M. S. Frame and G. M. Frame II, Undergraduate Instrumental Analysis, 6th Ed.,

Marcel Dekker, New York, USA. 21 J.R. Dyer, Applications Of Absorption Spectroscopy Of Organic Compounds, Prentice- Hall of India Pvt.

Ltd, New Delhi, India. 22 D. L. Pavia, G. M. Lampman, G.S. Kriz and J. R. Vyvyan, Introduction to Spectroscopy, Brooks / Cole

Cengage Learning, Australia. 23 S. Bolton and C. Bon, Pharmaceutical statistics: Practical and clinical applications, Drugs and

Pharmaceutical Sciences Series, Vol. 203, Informa Healthcare, USA.

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Pharmaceutics – III 3 Hrs/week Unit Topic Hours 1 TABLETS 19 1.1 Definition, advantages and limitations, preformulation aspects. 3 1.2 Tablet formulation and design, additives, excipients with examples. 3 1.3 Large scale manufacturing.

Drying as a unit operation. Equipments for mixing. Direct compression, wet Granulation, dry Granulation (Slugging and roller compaction).

5

1.4 Compression – (Single station tablet press and Rotary press), physics of tablet compression (brief).

3

1.5 Processing problems in tableting. Quality control of tablets.

3

1.6 Self Study -Types of tablets-Effervescent, succal, lozenges, chewable, sublingual, dispersible, soluble, orodispersible. layered tablets.Layout of tablet section.

2

2. CAPSULES 9 2.1 Definition, types of capsules, advantages and limitations, and raw materials including

gelatin and other materials. Self Study-Manufacture of gelatin.

1 1

2.2 Hard gelatin capsule: Manufacturing of hard gelatin capsule shells, size, size selection, sealing, storage, defects of shells.

1

2.3 Hard capsule fill formulation aspects: Large scale manufacturing. Filling of hard capsule shells, types of fills and excipients. Filling equipments: classification-volumetric, dosator type and tamping type (one example of each type of equipment). Humidity control in capsule manufacturing and filling area. Problems in capsule filling & remedies

3

2.4 Soft gelatin capsules: Properties, nature of shell and contents, Formulation aspects-concepts(minim/gm) Large scale manufacturing- Rotary Die Process

2

2.5 Self study -Quality Control of empty capsule shell and hard and soft gel capsules. Layout of capsule section.

1

3 PACKAGING 3 3.1 Blister and strip Packing, manufacturing defects, QC 2 3.2 Self study -Packing materials 1 4 AEROSOL 6 4.1 Definition, advantages & disadvantages, desirable features. Components –

Prepellants-types, selection, two phase & three phase systems 2

4.2 Containers – Tin Plate, Aluminum, Glass, Plastics, Valve, & Actuator Standard valve (detail) & specialized valves (in brief).

2

4.3 Product concentrate Different formulation systems- solution, Dispersions, Foams Powders.

1

4.4 Manufacturing and Quality Control testing. 1 5 COATING OF TABLETS 8 5.1 Need for tablet coating, types of coating, tablet core properties. 1 5.2 Sugar coating – Raw materials, Steps in detail, Sugar coating defects/problems. 2 5.3 Film coating including Enteric coating.

Raw materials, Aqueous film coating, film coating defects/problems. 2

5.4 Coating Equipments – Conventional & modified pans, coating columns (fluidized bed coating), Spray equipment & other accessories..

2

5.5 Self study –Quality control of coated tablets. 1 TOTAL 45 hrs

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Latest editions of the following books to be adopted 1. Aulton Michael E., Pharmaceutics: The Science of Dosage Form Design, Churchill Livingstone

Publishers. 2. Lachman Leon, Liberman Herbert A., Kanig Joseph I., The Theory and Practice of Industrial Pharmacy,

Varghese Publishing House, Mumbai. 3. Liberman Herbert A., Lachman Leon, Schwartz Joseph B., Pharmaceutical Dosage Forms – Tablets,

Volume 1/2/3, Marcel Dekker Inc., New York. 4. Larry L. Augsburger and Stephen W. Hoag., Pharmaceutical Dosage Forms – Tablets Volume 1/2/3,

Informa healthcare, New York, London. 5. Cole G., Pharmaceutical Coating Technology” Taylor and Francis Ltd., Bristol, PA. 6. S.J. Carter Ed., Tutorial Pharmacy, Cooper and Gunn, CBS Publishers & Distributors, India.

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Pharmacognosy and Phytochemistry – I 4 Hrs/week

Unit Topic Hours

1 Introduction to Pharmacognosy 7

1.1 Historical development, modern concept and scope of Pharmacognosy and Phytochemistry. Sources of drugs of natural origin (DONO) including plants, animals, minerals, marines and plant tissue culture products with examples of each source. Significance of pharmacognosy in various systems of medicine practised in India viz. Ayurveda, Unani, Homeopathy and Siddha. Introduction to the concept of phytomedicines. Self study: (4 or 5 examples of each of the following)

• Examples of sources of DONO • Examples of drugs used in different traditional systems of medicine.

2 2

1.2 Introduction to organized drugs, unorganized drugs (dried latex, dried juices, dried extracts, gums and mucilages, oleoresins and oleo- gum -resins), unofficial and official drugs as per the Indian Pharmacopoeia with suitable examples. Classification of DONO based on alphabetical, morphological, pharmacological, chemical, taxonomical and chemotaxonomical methods along with the significance of each method

3

2. Commercial production, Collection & Preparation of Crude Drugs 7 2.1 Overview of cultivation, collection, preparation, drying and storage (Pest control, moisture

control) of crude drugs. Self study: Commerce of crude drugs and 4-5 examples of plants from different geographical sources and climatic zones.

3 1

2.2 Factors affecting quality of crude drugs – Exogenous Factors, Environmental Factors and Endogenous factors: Mutation, Polyploidy and Hybridization. Introduction to plant tissue culture and its applications to pharmacognosy. Plant growth regulators and their application to tissue culture, propagation of plants and production of secondary metabolites.

3

3. Morphological and histological characteristics of crude drugs 12 3.1 Study of ergastic cell contents including calcium oxalate crystals, starch grains and

aleurone grains and idioblasts 2

3.2 Study of morphology and histology of monocot and dicot roots, rhizomes, stems, barks, woods, leaves, flowers, fruits and seeds. Details of mountants, clearing agents and microchemical reagents. Self study:

• Classification of roots, stems, fruits • Salient features of monocot, dicot root and stem • Different types of inflorescence

6 3

3.3 Identification and significance of morphological & microscopic differences between plants of allied species as exemplified by digitalis, brahmi, cinnamon &tinospora.

1

4 Introduction to Phytoconstituents 6

4.1 Brief introduction to Primary and secondary metabolites in plants with structures. Self Study:

• Any two examples of each class of phytoconstituents and significance of phytoconstituents for therapeutic application

2 2

4.2 Study of their biosynthetic pathways with structures (Including shikimic acid pathway and acetate hypothesis, polyketides and terpenoids)

2

5 Extraction of phytochemicals 5 5.1 Introduction to general methods of extraction of different classes of phytochemicals from

crude drugs viz.maceration , percolation, soxhlet extraction, Dien Stark assembly for moisture content determination and extraction of volatile oil. Introduction to newer

2

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techniques of extraction like microwave assisted extraction, countercurrent extraction and supercritical fluid extraction. Self Study:

• Commercial applications of recent methods of extraction techniques with any two examples.

2

5.2 General methods of extraction for following classes of phytoconstituents : alkaloids, glycosides & tannins

1

6 Evaluation & Quality Control of drugs of natural origin (DONO) 8

6.1 Introduction & significance of evaluation of DONO. Study of organoleptic, microscopic, physical, chemical and biological methods of evaluation of crude drugs with respect to pharmacopoeias. Introduction to WHO guidelines and monographs of drugs of natural origin.

4

6.2 Quantitative microscopy of crude drugs including lycopodium spore method, leaf constants, camera lucida and diagrams of microscopic objects to scale with camera lucida. Study of adulteration and substitution of crude drugs. Self Study:

• Examples of adulteration and substitution of crude drugs

2 2

7 Study of Fibres 3 7.1 Study of plant, animal & mineral fibres with respect to their classification, sources,

production, chemistry, commercial utility and significance in Pharmaceutical Industry for the following: Absorbent & nonabsorbent cotton, jute, flax, hemp, asbestos, glass wool, silk, wool, rayon, viscose

3

8 Study of carbohydrate containing drugs of natural origin 8 8.1 Detailed study of Carbohydrates with respect to chemistry, sources, preparation, evaluation

and commercial utility as Pharmaceutical Aids and Medicines for the following: Cellulose and cellulose derivatives, starches, honey, inulin, alginic acid, malt and malt extract, dextran, pectin, chitin, tamarind kernel powder (TKP).

3

8.2 Plants as sources of gums including tragacanth, acacia, sterculia, xanthan, guar gum, galactomannans. Plants as sources of mucilages including agar, Isapghol and linseed. Self Study: Study of monograph of any two carbohydrate containing drugs as per IP

3 2

9 Proteins and Enzymes 4 9.1 Study of Proteins and Enzymes with respect to sources, preparation and uses - protein

hydrolysates, gelatin, casein, thyroid hormones, proteolytic enzymes (Papain, bromelain, serratiopeptidase, urokinase, streptokinase, pepsin). Study of plant lectins with respect to sources, composition and applications for Abrin, ricin. Self study:

• Marketed formulations containing serratiopeptidase and their applications.

3 1

Total 60

Latest editions of the following books to be adopted 1. Trease D. & Evans W. C.: Text Book of Pharmacognosy: W. B. Saunders. 2. Tyler V.E., Brady L.R. & Robbers J. E.: Pharmacognosy; LeaFeibger, USA. 3. Wallis T. E.;Text Book of Pharmacognosy; CBS Publishers, Delhi. 4. Kokate C.K., Purohit A. P. & Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune. 5. Harbone J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman& Hall,

London. 6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited. 7. Vasudevan T.N. & Laddha K.S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon. 8. The Indian Pharmacopeia: The Controller of Publication; Delhi. 9. Brain K.R. & Turner T. D.: ThePractical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol. 10. Iyengar M. A. & Nayak S. G.: Anatomy of Crude Drugs: Manipal Power Press Manipal.

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11. Iyengar M. A.: Pharmacognosy of Powdered Drugs; Manipal Power Press, Manipal. 12. Kokate C. K.: Practical Pharmacognosy;Vallabh Prakashan. 13. Wagner, Bladt & Zgainski; Plant Drug Analysis; Springer Verlag. 14. Khandelwal K. R.: Practical Pharmacognosy Techniques and Experiments; Nirali Prakashan, Pune. 15. Vasudevan T. N. and Laddha K. S.:Practical Pharmacognosy; New Vrinda Publishing House, Jalgaon.

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Hospital Pharmacy and Drug Store Management 3 Hrs/week Unit Topic Hours

1. 1.1 1.2 1.3

Introduction to Hospitals and Hospital Pharmacy Definition, Classification, Organizational structure of Hospital, administration and functions of hospitals Definition, History, Development and Current status of Hospital Pharmacy Duties and Responsibilities of Hospital Pharmacist Layout, space and facilities, Concept of Pharmaceutical care. (self study)

5 2 2 1

2. 2.1 2.2 2.3

Pharmacy and Therapeutics Committee Objective, Composition and Functions of P and T Committee, Drug Utilization Review Hospital Formulary: Definition, advantages, limitations, preparation, content, with few examples, selection of drugs, publication and format 2.3. Hospital Pharmacy procedural manual (self study)

5 2 2 1

3. 3.1 3.2

Purchasing procedure in hospitals (self study) Purchasing procedure and storage Inventory control in hospitals

3 1 2

4. 4.1 4.2

Drug Distribution systems in Hospitals Dispensing to In – patients, Outpatients, Unit dose dispensing, Prepackaging Dispensing of controlled substances

4 2 2

5. 5.1 5.2 5.3

Central Sterile Supply Services Advantages, Plan, Location, Layout Sterilization of surgical dressings – methods of packing, loading and prevention of wetting of dressings. Sterilization of rubber gloves, syringes, needles, catheters, tubings, surgical instruments, mattresses, utensils and bedpans and other accessories Manufacturing and Bulk compounding of large volume parenterals, Total Parenteral Nutrition and Intravenous additives.

6 1 3 2

6. 6.1

Safe use of medication in hospitals (self study) Medication errors and ASHP Guidelines to prevent errors, Infection control in hospitals

2 2

7. 7.1

Health Accessories (self study) Wheel chairs, canes, crutches, bedpans, vapourizers, syringes, needles, clinical thermometers, first aid supplies

2 2

8. 8.1

Introduction to Pharmacy Practice Pharmacy Trade or Profession, Community Pharmacy, Code of Ethics for a pharmacist.

3 3

9. 9.1 9.2 9.3

Channels of distribution and Forms of Business Organization Wholesalers and Retailers and their professional role. Hindu undivided family, Sole Proprietorship, Partnership, Co – operative society and Company Planning of retail pharmacy and Entrepreneurship.

5 2 2 1

10. 10.1 10.2 10.3

Drug Store Management Legal aspects, Licenses and Registrations. Location analysis and layout design. Sales promotion and Window display.

5 1 2 2

11. 11.1 11.2

Purchasing and Inventory control in retail trade Purchasing procedure in retail trade Inventory control ( Want Book, Systematic Want Book, Open to Buy budgeting, ABC, VED, EOQ analysis), Use of computers for Inventory control

3 1 2

12. 12.1

Risk Management and Frauds in retail practice Risk management, Insurance policies and Frauds in retail practice

2 2

Total 45

Latest editions of the following books to be adopted

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1. Hospital Pharmacy, W. E. Hassan, Edition, Lea and Febiger, Philadelphia. 2. A text – book of Hospital Pharmacy, S.H. Merchant and Dr. J.S. Quadry, B.S. Shah Prakashan, Ahmedabad. 3. Hospital Pharmacy, Dr. H. P. Tipnis and Dr. Amrita Bajaj, Career Publication, Maharashtra. 4. Gennaro Alfonso R, Remington – The Science and Practice of Pharmacy”, Lippincott Williams and Wilkins. 5. Principles and methods of Pharmacy Management, Smith, Lea and Febiger, Philadelphia. 6. Drug store management, Nolen and Maynard. McGraw Hill. 7. Drug Store and Business Management, A. P. Battasse, Unique Publication. 8. Text book of Forensic Pharmacy, N. K. Jain, Vallabh Prakashan.

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Pharmaceutical Chemistry Lab. – II 4 Hrs/week

Traditional methods of synthesis to be followed for each of the Unit Operations in addition to specific methods as indicated.

1. Acetylation - Synthesis of aspirin using Microwave Procedure Ref: Green Chemistry V. K. Ahluwalia, pg. no. 7.3. Synthesis of Acetanilide as per Green Chemistry DST Monograph

2. Halogenation – Synthesis of p-bromoacetanilide as per Green Chemistry, DST Monograph 3. Esterification of Ibuprofen using DCC coupling. 4. Oxidation - Synthesis of benzoic by oxidation of toluene or benzyl alcohol with alkaline potassium

permanganate. 5. Hydrolysis of methyl benzoate. 6. Reduction - ketones: Synthesis of benzhydrol by reduction of benzophenone with zinc and sodium

hydroxide) or synthesis of m-nitroaniline by partial reduction of m- dinitrobenzene with sodium polysulfide. 7. Nitration: Synthesis of 5-nitrosalicylic acid as per Green Chemistry, DST Monograph. 8. Synthesis of benzimidazole.

Books 1. Vogel’s A Text book of Practical Organic Chemistry by Vogel, Longman group limited, London. 2. Practical Organic Chemistry by Mann FC & Saunders BC, Longman Group Limited, London. 3. Laboratory Techniques in Organic Chemistry, Ahluwalia V.K. I.K. Publishers. 4. Green Chemistry, V. K. Ahluwalia. 5. New Trends in Green Chemistry, V K Ahluwalia and M Kidwai, KluwerAcademic Publishers 6. Monograph on Green laboratory Experiments, Grenn Chemistry Task Force Committee, DST. 7. Practical Organic Synthesis: A Student's Guide - Reinhart Keese, Martin Brändle, Trevor Toube. 8. Advanced practical Medicinal Chemistry by Ashutosh Kar, New Age International Publications.

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Pharmaceutical Analysis Lab. – II 4 Hrs/week

1. Assay of finished products by UV spectroscopy, using A (1%, 1 cm)-minimum assay of 5 formulations to be done.

• Paracetamol tablets • Propranolol tablets • Atenolol tablets • Hydrochlorthiazide tablets • Frusemide tablets • Albendazole tablets • Rifampicin capsules

2. Assay of drugs using single point and double point standardization method by UV spectroscopy. e.g. Paracetamol

3. Colorimetric assays (Construction of calibration curve using linear regression analysis) • Assay of streptomycin injection. • Assay of salicylic acid.

4. Fluorimetric analysis • Assay of quinine sulphate. • Effect of different concentrations of iodide ions on fluorescence of quinine sulphate.

5. Potentiometric titrations using pH meter • Determination of pKa and normality of phosphoric acid (Second end-point). • Determination of normalities of individual acids in a mixture of acids. (e.g: HCl and H3PO4-

Second end point). 6. Demonstration experiments:

• Determination of Na+/ K+ by Flame photometry. • Working of FTIR and Interpretation of IR spectra of any one drug.

Latest editions of books to be adopted

1 Indian Pharmacopoeia, The Indian Pharmacopoeia Commission, Ghaziabad, Government of India. 2 G. D. Christian, Analytical Chemistry, John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd. 3 A. H. Beckett and J. B. Stenlake, Practical Pharmaceutical Chemistry, Part I and II, CBS Publishers and

Distributors, India. 4 United States Pharmacopoeia. 5 J. Mendham, R. C. Denney, J. D. Barnes, M. J. K. Thomas, Vogel’s Textbook of Quantitative Chemical

Analysis, Pearson Education Ltd. 6 D. G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists,

Churchill Livingstone Elsevier. 7 R. M. Silverstein, F. X. Webster and D. J. Kiemle, Spectrometric identification of organic compounds,

John Wiley & Sons, Inc. (Indian edition), New Delhi.

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33

Pharmaceutics Lab - III 4 Hrs/week

1. A ) Evaluation of Excipients-Bulking agents- At least one excipient in Conventional and Directly Compressible form for : Flow properties , Bulk density, Compressibility and Particle size and Discussion of Observations. 1. B ) Evaluation Of Excipients-Disintegrating Agents for their swelling Index and Discussion of Observations. 1. C) Evaluation Of Excipients of tablets-Lubricants and Glidants-Influence on flow properties of granules, Results and discussion. 2. Granulation for Soluble Aspirin Tablets IP and Evaluation. 3. Granulation, Compression and evaluation of Riboflavin Tablets IP 96. 4. Granulation, Compression and evaluation of Chewable Antacid Tablets. 5. Granulation Compression and evaluation of Paracetamol Tablets IP 96. 6. Preparation and evaluation of orodispersible tablet for low dose drug. 7. Dissolution Test of Paracetamol Tablet IP 8. Evaluation of Capsule shells, filling of Ampicillin trihydrate capsule and their evaluation. 9. Introduction to different devices for inhalation and demo of evaluation of a suitable commercial product for simple test related to spray and weight / drug content per discharge Books

All books listed in the theory syllabus as well as current editions of IP, BP and USP.

111

34

Pharmacognosy & Phytochemistry Lab. – I 4 Hrs/week

1. Quantitative microscopy (Estimation of Leaf constants i.e. Stomatal Index, Vein islet number and Vein termination number, Palisade ratio)

2. Evaluation of Cinnamon powder or Nux vomica powder by Lycopodium Spore method. 3. Determination of alcohol soluble and water soluble extractives, Total ash value and acid insoluble ash

and water soluble ash value for any one crude drug as per IP. 4. Microscopical Studies of basic tissues both monocot and dicot stem, leaves, roots, bark, seed, fruits. 5. Study of different types of starch grains, calcium oxalate crystals, Trichomes and stomata 6 Identification of Fibres and Minerals based on chemical tests as covered in theory. Tests for detection of

honey, starch, tragacanth, acacia, guar gum, agar. 7 Extraction and detection of starch/pectin from any one source. 8 Morphological identification of any twenty crude drugs and their salient morphological features:

Acacia tears, Agar strips, Sterculia lumps, Cinnamon, Cassia, Tinospora, Isapghul, Senna, Potato, Pyrethrum, Tragacanth ribbons, Bael, Tamarind, Rhubarb, Squill, Colchicum corm, Senna pod, Any one inflorescence, Hibiscus, Red sandalwood.

Latest Editions of the following books to be adopted 1. Trease D. & Evans W.C.: Text Book of Pharmacognosy:W. B. Saunders. 2. Tyler V. E., Brady L. R. & Robbers J. E.: Pharmacognosy; LeaFeibger, USA. 3. Wallis T. E.;Text Book of Pharmacognosy; CBS Publishers, Delhi. 4. Kokate C. K., PurohitA.P. & Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune. 5. Harbone J. B.: Phytochemical Methods:A guide to modern techniques Analysis: Chapman& Hall,

London. 6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited. 7. Vasudevan T. N. & Laddha K. S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon. 8. The Indian Pharmacopeia: TheController of Publication; Delhi. 9. Brain K. R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol. 10. Iyengar M. A.& Nayak S. G.: Anatomy of Crude Drugs: Manipal Power Press Manipal. 11. Iyengar M. A.: Pharmacognosy of Powdered Drugs; Manipal Power Press, Manipal. 12. Kokate C. K.: Practical Pharmacognosy; Vallabh Prakashan. 13. Wagner, Bladt & Zgainski; Plant Drug Analysis; Springer Verlag. 14. Khandelwal K. R.: Practical Pharmacognosy Techniques and Experiments; Nirali Prakashan, Pune. 15. Vasudevan T. N. and Laddha K. S.: Practical Pharmacognosy; New Vrinda Publishing House, Jalgaon.

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AC 6/6/12 4.104

No

Semester‐VII No of papers

End Semester Examination Internal Assessment Maximum marks

Minimum marks

for passing the

subject

Periodic Test Continuous

Evaluation

Subject ‐ Theory Duration (hrs)

Maximum marks

Minimum for passing

Duration (hrs)

Maximum marks

Maximum marks

1 Pharmaceutical Chemistry ‐ III

1 3 70 28 1 15 15 100

40

2 Pharmaceutical Analysis ‐ III 1 3 70 28 1 15 15

100

40

3 Pharmacology ‐ III 1 3 70 28 1 15 15 100

40

4 Pharmaceutics ‐ IV 1 3 70 28 1 15 15 100

40

5 Pharmacognosy & Phytochemistry ‐ II

1 3 70 28 1 15 15 100

40

6 Pharmaceutical Jurisprudence

1 3 70 28 1 15 15 100

40

Practicals

7 Pharmaceutical Analysis Lab ‐ III

1 4 35 14 4 8 7 50 20

8 Pharmaceutics Lab ‐ IV 1 4 35 14 4 8 7 50 20 9 Pharmacology Lab ‐II 1 4 35 14 4 8 7 50 20 10 Pharmacognosy &

Phytochemistry Lab ‐ II 1 4 35 14 4 8 7 50 20

No

Semester‐VIII No of papers

End Semester Examination Internal Assessment Maximum marks

Minimum marks

for passing the

subject

Periodic Test Continuous

Evaluation

Subject ‐ Theory Duration (hrs)

Maximum marks

Minimum for passing

Duration (hrs)

Maximum marks

Maximum marks

1 Pharmaceutical Chemistry‐IV

1 3 70 28 1 15 15 100

40

2 Pharmaceutics‐ V 1 3 70 28 1 15 15 100

40

3 Biopharmaceutics and Pharmacokinetics

1 3 70 28 1 15 15 100

40

4 Pharmacognosy & Phytochemistry ‐ III

1 3 70 28 1 15 15 100

40

5 Clinical Pharmacy 1 2 35 14 1 8 7 50 20

Practicals 6 Pharmaceutical Chemistry

Lab‐ III 1 4 35 14 4 8 7 50 20

7 Pharmaceutics Lab‐ V 1 4 35 14 4 8 7 50 20 8 Pharmacognosy &

Phytochemistry Lab‐ III 1 4 35 14 4 8 7 50 20

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SYLLABUS COPY FOR FINAL YEAR B. PHARM SEMSETER VII

PHARMACEUTICAL MEDICINAL CHEMISTRY – III 3 hrs/ week

S. No. Topic Hours Discussion of the following classes of drugs including classification, chemical nomenclature, structure including stereochemistry, generic names, chemistry, physicochemical properties, SAR, metabolism, molecular mechanism of action and synthesis, introduction to rational development if any of the class of drugs.

1. Cholinergic Drugs: (i) cholinergic agonists (methocholine, carbochol*, bethanechol,

pilocarpine) (ii) Ach esterase inhibitors (physostigmine, neostigmine*,tacrine*,

ambenonium chloride, isofluorphate, pralidoxime) (iii) Cholinergic antagonists (atropine, scopolamine, homatropine

hydrobromide, ipratropium bromide); synthetic cholinergic antagonists (cyclopentolate*, dicyclomine*, ben/otropine mesylate, procyclidine hydrochloride, isopropamide iodide, tropicamide)

(iv) Ganglion blocking agents (trimethaphan, camsylate, mecamylamine) (v) Neuromuscular blocking agents (tubocurarine, gallamine, triethiodide,

succinyl choline chloride)

9

2. Adrenergic Drugs: (i) α­adrenergic agonists (phenylephrine, naphazoline, xylometazoline,

oxymetazoline, methyldopa, clonidine*, guanabenz, guanfacine ) (ii) β­adrenergic agonists (isoproternol, terbutaline*, albuterol, salmeterol,

isoxsuprine, ritodrine) (iii) α­adrenergic antagonists (tolazine, phentolamine,

phenoxybenzamine, prazosin, doxazosin) (iv) β­adrenergic antagonists (propranolol*, atenolol, metoprolol,

acebutalol, alprenolol, timolol, labetalol*) other adrenergic agents (amphetamine, pseudophedrine, ephedrine, guanethidine*, propylhexedrine, reserpine).

9

3. CVS Drugs: (i) antianginal agents (amyl nitrite, isosorbide dinitrate, pentaerythritol

tetranitrate, verapamil, bepridil, diltiazem, nifendipine*, amlodipine, nimodipine, dipyridamole)

(ii) antiarrhythmic agents (quinidine, procainamide*, disopyramide, lidocaine, tocainide, mexilitine, encainide, amiodarone, pro[afenone, verapamil, diltiazen, propranolol, sotalol*).

(iii) Antihypertensive agents (a) review of adrenergic agents (b) review of Ca channel blockers (c) ACE inhibitors (captopril*, enalapril, benzepril, ramipril) (d) angiotensin II receptor antagonists (losartan, valsartan*, candersartan)

(iv) Vasodilators and K­channel agonists (diazoxide, minoxidil) (v) Antihyperlipidemic agents (clofibrate*, gemfibrozil, niacin, lovastatin,

4

4

6

1

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atorvastatin) 3 * Indicates synthesis to be discussed

Reference Books:

1. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry, 11 th Ed. Eds. John H. Block and John M. Beale, Lippincott Williams & Wilkins, 2004

2. Foye’s Principals of Medicinal Chemistry, Eds. T. L. Lemke and D. A. Williams. Williams & Wilkins, Baltimore, 2002.

3. Medicinal Chemistry, Ashutosh Kar, 4 th Edition, New Age International Publishers, 2007.

4. The Art of Drug Synthesis, Eds. Douglas S. Johnson and Jie Jack Li, Wiley Interscience, 2007.

5. Pharmaceutical Chemistry, Vol. EDrug Synthesis Eds. H. J. Roth, A. Kleeman and T. Beissewenger, Ellis Horwood Ltd. 1988.

6. The Organic Chemistry of Drug Synthesis, Daniel Lednicer, Vols 1 to 7, Wiley.

PHARMACEUTICAL ANALYSIS IV 3 hrs/ week

S. No. Topic Hours 1. Chromatography

Principal’s, terminology­stationery phase, mobile phase, classification of chromatography methods, migration rate of species (partition coefficient, retention time, adjusted retention time), Rate of solute migration (capacity factor, selectivity factor), Column efficiency and band broadening (shape of peak­Gausssian, plate height, number of theoretical plates, van Deemeter equation), Optimisation of column performance (Column resolution, capacity factor, selective factor, tailing factor, peak width), Qualitative analysis, Quantitative analysis (Peak height, peak areas, calibration and internal standard, external standard, area normalization).

3

2. Gas chromatography (GSC &GLC) Introduction, Principal, Instrumentation­carrier, columns, injection system, detectors (advantage, disadvantage, applications of Thermal conductivity, electron capture, thermionic, flame ionization, nitrogen phosphorus, photoionisation), head space analysis, applications.

5

3. HPLC Introduction, Principal, Instrumentation­mobile phase reservoir, pumps (reciprocating, displacement, pneumatic, isocratic elution, gradient elution), solvent treatment system, Injection systems (Rheodyne injector in detail, direct sample introduction, sampling loops), columns and fittings (for reverse and normal phase, analytical and guard columns. Thermostats, column packing), detectors advantages, disadvantages, (UV­single wavelength, variable wavelength, phtotodiode array), fluorescence, refractive index, electrochemical.

4. Ion exchange chromatography Principal, ion exchange resins, mobile phases, applications.

2

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5. Ion pair chromatography Principal, applications

1

6. Size exclusion chromatography Principal for gel permeation and gel filtration method, support media, mobile phases, applications

1

7. Paper chromatography Introduction, choice of filter papers, solvents, chromatographic chambers, development techniques (descending, ascending, radial multiple chromatography, two­dimensional chromatography), qualitative analysis­ location of spots, Quantitative analysis (direct and elution method), factors affecting retention factor, applications.

3

8. Thin layer chromatography Introduction, Principal, different absorbents different methods for preparation of plates, solvents, development techniques cascending, descending, horizontal, multiple development two dimensional development, preparative TLC, Qualitative evaluation visualization of spots, Quantitative evaluation (Area, weight, densitometry elution factors affecting RF, applications)

3

9. High performance thin layer chromatography Introduction, Principal, preparation of plates, development techniques Qualitative evaluation, Quantitative evaluation Instrumentation (adsorbents, solvents, sample application, scanning and documentation), applications.

10. Validation of analytical methods as per U.S.P. 1 11. Statistics & Statistical Quality control

Normal distribution, t­test, F­test, linear regression correlation coefficient, confidence limits.

3

12. Sampling procedures Objectives, different kinds of samples, sampling plan, sampling schemes, sampling equipments, methods of statistical analysts as applied to sampling and interpretation of results.

3

13. Thermal methods of analysis Theory, introduction, instrumentation, factors affecting analysis, pharmaceutical applications of: Thermogravimetry (TG), Differential thermal analysis (DTA), Differential Scanning Calorimetry (DSC).

5

Reference Books:

1. Skoogh­Principals of Instrumental Analysis, 4 th edition, Saunders College Publishing, 1992, USA.

2. Browning Chromatography, 1969, Mc Graw Hill, London. 3. Willard H. H., L. L. Merrit & John A. Dean­Instrumental Method of Analysis 6 th edition,

1986, CBS Publishers & Distributors, New Delhi. 4. Beckett & Stenlake­Practical Pharmaceutical Chemistry, 4 th edition, 1988, CBS

Publishers & Distributors, India. 5. I.P., U.S.P., B.P. European Pharmacopeia.

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6. James W. Munson­Pharmaceutical Analysis, Modern methods, Marcel Dekker Inc. 1981, USA.

PHARMACOGNOSY III 3 hrs/week

Drug mentioned in bold are or detailed study

S. No. Topic Hours 1. Alkaloids: Chemistry, Classification and occurrence of alkaloid in general.

Detailed study of the following plants containing alkaloids Ephedra, Colchicum, cocoa, & tea, coffee, lobelia, tobacco, belladonna, datura stramonium, hyoscyamus, cinchona, opium, ashwagandha, ipecac, rauwolfia, vinca, nux vomica, vasaka, aconite, kurchi, pilocarpus, cola, coca, pepper, curare, alkaloids, ergot.

Biosynthesis of lysergic acid, opium alkaloids, tropane, alkaloids, colchicines, emethine, quinine.

12

2. Occurrence structure and applications of following Glycosides a) Anthroquinone­ Rubia, cochineal, aloes, hyperieum, cascara,

andira, senna, rhubiarb. b) Isothiocyanate­ Brassica c) Cyanogenetic­ Almonds, wild cherry d) Napthoquinone­ Plumbago, alkanna, henna, walnut

Biosynthesis of aloe emodin, amygdaline, juglone.

6

2 3. Brief introduction to Plant allergens

Definition, classification (inhalant, injectant, infestants etc.) with example. Plants causing hay fever & dermatitis, mould causing allergy.

2

4. Sources, preparation and uses of following enzymes: Papain, bromelain, malt extract, serratiopeptidase, urokinase, streptokinase, pepsin. Study of lectins and snake venom, Preparation of polyvalent antivenins

3

5. Study of following herbs as health food (Neutraceuticals): Alfaalfa, arnica, apricot, pits, bran, chamomic, chicory, cucumber, fenugreek, onion, garlic, gentian, hydrocotyle, hibiscus, hops, honey, marigold, amla. Ginseng, ashwagandha, ginko biloba, spirulina, gymnema, momordica, tinospora.

3

6. Occurrence, composition, preparation and uses of following drugs of mineral origin: Diatomic, chalk, bentonite, talc. Study of sulphur containing naturally occurring compounds (sulphide, thiophenes).

2

Reference Books:

1. Trease D. & Evans W.C; Textbook of Pharmacognosy; W. B. Saunders. 2. Tyler V. E. Brady L. R. & Robbers J. E.; Pharmcognosy; Lea Feibger, USA.

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3. Wallis I. E. Textbook of Pharmacognosy; CBS Publishers, Delhi. 4. Kokate C. K. Purohit A. P. & Gokhale S. B. Pharmacognosy: Nirali Publications,

Pune. 5. Harbone J. B. Phytochemical Methods: A guide to modern techniques of

Plant Analysis Chapmann & Hall, London. 6. Bruncton J. Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited. 7. Vasudevan I. N. & Buddha K. S. A textbook of Pharmacognosy, Vrinda Publication

House, Jalgaon. 8. The Indian Pharmacopeia. The Controller of Publication Delhi. 9. Brain K. R. & Furner L. D. The Practical Evaluation of Phytopharmaceuticals Wright

Sceintica, Bristol. 10. Lyenger M. A. & Nayak S. G. Anatomy of Crude Drugs: Manipal Power Press,

Manipal. 11. Lyenger M. A. Pharmacognosy of Powdered Drugs: Manipal Power Press, Manipal. 12. Kokate C. K. Practical Pharmacognosy, Vallabh Prakashan. 13. Wagner, Bladi & zagainskit: Plant Drug Analysis: Springer Verlag. 14. Khandelwal K. R.: Practical Pharmacognosy Techniques and Experiments: Nirali

Prakashan, Pune. 15. Vasudevan L. N. Laddha K. S.: Practical Pharmacognosy: New Vrinda Publishing

House, Jalgaon.

PHARMACEUTICS VI 3 hrs/ week

S. No. Topic Hours 1. Introduction to sterile dosage forms

Parental products • Various routes of parental administration, pyogens, vehicle,­ WFI

preparation, purity, storage and distribution, vehicles other than WFI, additives in parental products, types of formulations, freeze drying , containers­ glass and plastics­ types and evaluation, concept of FFS, rubber closures and testing, personnel, facilities­ layout, environmental control cleanliness classes, air handling (HVAC systems), HEPA filters, laminar flow, production procedures, QA & QC­ sterility test, pyrogen/ endotoxin test, particulate evaluation, leaker test.

12

2. Ophthalmic products • Anatomy and physiology of eye – lachrymal system, tears,

precorneal tear film, cornea, ocular bioavailability, types of ophthalmic products­ solutions, suspension, ophthalmic ointments and gels, preservatives and efficacy test, additives, QA and QC sterility test, clarity, particle size for suspension, tests on ointments and collapsible tubes, packaging.

• Contact lens solutions: types of lenses­cleaning solution, disinfection solution, lubricants, multipurpose solutions and packages.

8

3. Oral sustained and controlled release systems • Advantages of SR systems, biopharmaceutical consideration and

8

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dose calculation of drug, properties of drug with reference to the design of oral SR systems, matrix and reservoir type of systems, dissolution controlled systems, diffusion controlled systems, ion exchange controlled systems.

4. Stability studies • Kinetic principles, Arrhenius equation and derivation of shelf life

based on Arrhenius equation, limitations and advantages equation, degradation pathways­ hydrolysis, oxidation , photolytic degradation, methods to enhance stability studies, introduction to ICH guidelines.

8

Reference Books:

1. Pharmaceutical dosage forms: Parental medications, Vol. I, II, III, ed. by Kenneth A. Avis, Leon Lachman and H. A. Liberman, Marcel Dekker Inc., 1986.

2. Pharmaceutics The Science of dosage form design ed. by M. E. Aulton, 2 nd ed., Churchill Livingstone, 2002.

3. Modern Pharmaceutics, 4 th ed. Revised and Expanded ed. by Gilbert S. Banker and Christopher T. Rhodes, Marcel Dekker INC., 2002.

4. The theory and practice of industrial pharmacy, ed. by Leon Lachman, H. A. Liberman, J. I. Kanig, 3 rd ed., Verghese Publishing house, 1987.

5. Remington, The science and practice of Pharmacy, 21 st ed., Vol. I and II, B. L. Publications Pvt. Ltd., 2005.

6. Ophthalmic drug delivery, ed. by Ashim K. Mitra, 1993, Marcel Dekker INC. 7. Turco and Kings, Sterile Dosage forms, 3 rd Edn., Lea & Febiger, Philadelphia, 1985. 8. Michael J. Akers, Quality Control of Parenterals, Marcel Dekker 9. “Controlled drug delivery – Fundamentals and Applications”, Robinson Joseph R.,

Lee Vincent H., Vol. 29, Marcel Dekker Inc.

BIOPHARMACEUTICS AND PHARMACOKINETICS 3 hrs/ week

Topic Hours Introduction to the subject of biopharmaceutics and Pharmacokinetics. Emphasis on the importance in drug discovery, development and clinical pharmacy.

1

Definitions, different mechanisms of drug transport, physiology of cell membrane and passage of drugs across cell membrane.

2

Modified pH partition theory and its limitations. Zero v/s first order transport. 2 Rate limiting steps in drug absorption, Theories of dissolution, Physicochemical factors affecting the bioavailability of drugs.

2

Physiology of GH and oral bioavailability Formulation, dosage form related factors and physiological factors affecting oral bioavailability

2

Different routes of drug administration as alternative to oral route Factors affecting bioavailability of drugs from parental routes e.g. insulin zinc suspension

2

Dissolution rate and methods of enhancing dissolution rate. Official and unofficial methods of dissolution. Application to different dosage forms

2

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In vitro in view correction and its significance 1 Distribution Definition relationship of drug transport to distribution process, perfusion limitation permeability limitation. Plasma protein and tissue protein binding, introduction to the concept of volume of distribution and factors affecting distribution.

3

Elimination, Definition, introduction to elimination via metabolism and excretion Hepatic clearance drugs, first pass effect and dependence of hepatic extraction ratio. Introduction to renal clearance and factors affecting renal clearance.

3

Pharmacokinetics: Introduction to compartmental and physiological models. Introduction to the compartmental open model and its assumptions.

1

Mathematical treatment of Pharmacokinetics upon IV bolus dosing and extravascular dosing. Importance of volume of distribution. Clearance, elimination rate constant, half life, absorption rate constant, bioavailability. Introduction of the concept of area under the curve, the trapezoidal rule and the method residuals Introduction to the rate method and sigma minus method for urine analysis for IV.

9

Introduction to method for estimating bioavailability and bioequivalence. 2 Discussion of linear and nonlinear kinetics and description of factors resulting in non linear kinetics.

2

Application of PK principles through simple problems. 2

Reference Books:

1. Brahmankar, D. M. Jaiswal, Sunil B., “Biopharmaceutics and Pharmacokinetics: a treatise”, 1 st Edition, 1995, Vallabh Prakashan, Delhi.

2. Banakar, Umesh, “Pharmaceutical Dissolution Testing”, Volume 49, Marcel Dekker Inc., New York, 1992.

3. Malcom Rowland, Thomas Tozer, “Clinical Pharmacokinetics: Concept and Application”, 3 rd Edition, 1996. A Lea­Febiger book, B. L. Baverly Books Pvt. Ltd. USA.

4. Robert E. Notari, “Biopharmaceutics and Pharmacokinetics An Introduction”, 1971, 4 th

Edition, Marcel Dekker Inc., New York. 5. Leon Shargel, Susanna Wu­Pong, Andrew B. C. Yu. “Applied Biopharmaceutics &

Pharmacokinetics” 5 th Edition, 2005, Singapore. 6. Milo Gibaldi, “Biopharmaceutics Clinical Pharmacokinetics” 4 th Edition, 1991, USA.

PHARMACOLOGY IV 3 hrs/ week

S. No. Topic Hours 1. Drugs acting on central nervous system

• Aliphatic alcohols • General anaesthetics • Local anaesthetics • Sedative­hypnotics & anxiolytic agents • Antidepressants • Antipsychotics

18

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• Drugs used in Neurodegenerative disorders ­ Antiparkinsons ­ Drugs used in Alzheimer’s disease

• Analgesics, antipyretic and anti­inflammatory drugs • CNS stimulants & Psychotomimetic drugs

(Convulsions and respiratory stimulants, Psychomotor stimulants and Psychotomimetic drugs)

2. Autocoids ­ Histamine, Antithistaminics ­ 5 HT and Antagonists ­ Kinins, Ecosonides, Cytokines, PAF

6

3. Pharmacotherapy of Bronchial asthma 2 4. Immunology – Regulation of Immune system physiological and

pathological states, Signaling Pathways for activation and inhibition, Immunology of diseases like HIV and Cancer and their modulation & Immunomodulators.

6

5. Principals of toxicology ­ Heavy metal poisoning and its treatment ­ Pesticide poisoning and its treatment ­ Opium alkaloid poisoning and its treatment

4

Reference Books:

1. Goodman & Gilman’s Pharmacological Basis of Therapeutics – Joel G. Hardman, Lee E, Limbird, Alfred Goodman Gillman 11 th Edition, The McGraw Hill Companies Inc., 2001.

2. Satoskar, R. S. Bhandarkar S. D. & Rege N. N. Pharmacology & Therapeutics 20 th

Edition, Popular Prakashan, 2007. 3. Rang & Dale Pharmacology – 5 th Edition, Churchill Livingstone, 2003. 4. Lippincott’s Illustrated Reviews: Pharmacology – Lippincott Raven 3 rd Edition

Howland & Nycets Publishers N Y, 2006. 5. Lewis Pharmacology – By Crossland – 5 th Edition, Churchill Livingstone. 6. Laurence D. R. & Bennet Clinical Pharmacology – 9 th Edition, Elsevier, N Y, 2006. 7. Kulkarni, S. K. Handbook of Experimental Pharmacology, 3 rd Edition, Vallabh

Prakashan, New Delhi, 2005. 8. B. G. Katzung ­ Basic and Clinical Pharmacology 9 th Edition Appleton and Lange

publication, 2004. 9. Gosh M. N. – Fundamentals of Experimental Pharmacology, 3 rd Edition, Hilton &

Company, Calcutta, 2005.

PHARMACOLOGY LABORATORY II 4 hrs/ week

S. No. Topic 1. Experiments

Bioassay of ­ Acetylchoine

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­ Histamine 2. Demonstration

­ bioassay of oxytocin ­ bioassay of pancuronium (With Graph or Actual)

3. Demonstration/ Simulated CD’s ­ To study the CNS depressant activity of chlorpromazine on locomotor

activity of mice using actophotometer ­ To study the effect of diazepam on the muscle grip strength of mice

using rota­rod apparatus. ­ Analgesic effect of asprin using analgesiometer ­ To study phenothiazine induced catatonia in rats and to study

anticatatonic (antiparkinsons) effect of scopolamine ­ To study the anticonvulsant property of diazepam on pentylene tetrazole

induced convulsions in mice or anticonvulsant effect of phenytoin against maximal electroshock induced convulsion in mice

4. Toxicity studies (CPCSEA, OCED guideline) ­ brief introduction to acute, subacute and chronic toxicity studies.

Reference Books:

1. Kulkarni, S. K. Handbook of Experimental Pharmacology – 3 rd Edition Vallabh Prakashan New Delhi, 2005.

2. Gosh M. N. Fundamentals of Experimental Pharmacology, 3 rd Edition, Hilton & Company, Calcutta, 2005.

3. S. B. Kasture. A Handbook of Experiments in Pre­Clinical Pharmacology­ 1 st Edition, Career Publications, 2006.

4. W. L. M. Perry, Pharmacological Experiments On Isolated Preparations, 2bnd Edition, E & S Livingstone, Edinburgh & London, 1970.

5. Websites: Indian Journal of Pharmaceutical education and research, Vol. 41 (1) Jan­ Mar, 2007; 52­61. (www.ipper.org )

PHARMCEUTICAL CHEMISTRY LABORATORY – II 4 hrs/ week

1. Synthesis of heterocyclics: a) Benzimidazole from 0­phenylenediamine, b) 4­methyl carbostyril from Acetoacetanilide.

2. Perkin reaction: Cinnamic acid from benzaldehyde 3. Claisen/ Aldol Condensation acid from benzaldehyde. 4. Benzilic acid rearrangement: Benzilic acid from benzyl. 5. Holfmann rearrangement: Anthranilic acid from Phthalimide. 6. Reduction reaction: PABA from p nitrobenzoic acid. 7. Esterification: Benzocaine from PABA. 8. Condensation: Phenytoin. 9. Multistep reaction: Sulfanilamide from acetanilide.

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PHARMACOGNOSY LABORATORY II 4 hrs/ week

S. No. Topic Hours 1. Morphology, microscope and chemical test for identification of cinchona,

vasaka, ephedra, kurchi, datura, nux, vomica, senna, rauwolfia, ipeca. 8

2. TLC analysis: 1) Alkaloids of nux vomica cinchona 2) Glycosides of senna/ aloe

2

3. Morphological identification of drugs covered in theory (alkaloids and glycosides) any 20 samples

2

Total 12

PHARMACEUTICS LABORATORY IV

1. Preparation and monographic testing WFI (IP) 2. Processing & testing of glass containers & rubber closures (as per IP) 3. Preparation and documentation of following:

A) Injections (official) • Sodium chloride and Dextrose injection • Calcium gluconate injection • Ascorbic acid injection • One injection with oily vehicle • One suspension injection

B) Ophthalmic preparations • Sulphacetamide eye drops • One Antibiotic eye ointment • Contact lens solution

4. Calculation of Pharmacokinetic parameters (plasma samples provided)

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SYLLABUS COPY FOR FINAL YEAR B. PHARM. SEMESTER VIII

Pharmaceutical Medicinal Chemistry – IV 3 hrs/ week

S. No. Topic Hours Discussion of the following classes of drugs including, classification, chemical nomenclature, structure including stereochemistry, generic names, chemistry, physicochemical properties, SAR. Metabolism, molecular mechanism of action, and synthesis, introduction to rational development if any of the class of drugs:

1. CNS Drugs 1. Sedatives and hypnothics (mephobarbital, Phenobarbital

pentobarbital, secobarbital, diazepam, nitrazepam*. Oxazepam. Alprazolam. Midazolam, cholorodiazepoxide, choral hydrate, gluthethimde*, zolpidem, zopiclone)

2. Anticonsulvants (Phenobarbital, chlordizepoxide, diazepam, clonazepam*, phenytoin, trimethadione, paramethadione, ethosuximide*, phenosuximide, primidone, sodium valproate, carbamazepine*, progabide, lamotrigine, vigbatrin

3. Antipyschotics (chlorpromazine*, triflupromazine, thioridazine, fluphenazine, chlorprothixene, loxapine, clozapine, haloperidol*, droperiodol, risperidone*, pimozide, molindone

4. Antianxiety agents (meprobamate, tybamate, hydroxyzine, buspirone)

5. Antidepressants (imipramine, chlorimipramine, amitryptyline, nortriptyline, doxepine*, fluoxetine*, paroxetine, trazodone, iproniazid, pargline, isocarboxazide, tranylcypromine)

6. Antiparkinsons (carbidopa*, levodopa, selegiline, amantadine, bromocriptine, benzotropine*, procyclidine, trihexyphenidyl, orphenadrine)

7. Analgesics (opioids) (morphine, codeine, levophanol, dextromethorphan, phenazocine, pentazocine, meperidine*, α­ and β­prodine, pheniridine, anileridine, fentanyl, methadone*, phenadoxone, racemoramide, dextropropoxyphene*, nalorphine, naloxone, naltrexone)

5

5

5

1

5

2

7

2. NSAID’s (aspirin, paracetamol, phenylbutazone*, oxyphenbutazone, indomethacine, sulindac, mefenamic acid, ibuprofen, naproxen*, ketoprofen, nabumetone, diclofenac*, nimesulide, celecoxib, rofecoxib, piroxicam*, colchicines, sulfinpyrazone, allopurinol).

6

* indicates synthesis to be discussed

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Reference Books:

1. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry, 11 th Ed., Eds., John H Block and John M Beale, Lippincott Williams & Wilkins, 2004.

2. Foye’s Principles of Medicinal Chemistry, Eds., T. L. Lemke and D. A. Williams, Williams & Wilkins, Baltimore, 2002.

3. Medicinal Chemistry, Ashutosh Kar, 4 th Edition, New Age International Publishers, 2007.

4. The Art of Drug Synthesis, Eds., Douglas S Johnson and Jie Jack Li, Wiley Interscience, 2007.

5. Pharmaceutical Chemistry, Vol. 1: Drug Synthesis, Eds., H. J. Roth, A. Kleeman, and T. Beissewenger, Ellis Horwood Ltd., 1988.

6. The Organic Chemistry of Drug Synthesis, Daniel Lednicer, Vols. 1 to 7, Wiley.

PHARMACEUTICAL ANALYSIS V 3 hrs/ week

S. No. Topic Hours

1. Atomic absorption and Emission spectroscopy Principle, difference between atomic absorption spectroscopy and flame emission spectroscopy, Instrumentation­ Radiation sources, Flame atomization (types of flames, flame structure, flame atomizers), single and double beam spectrophotometers, advantages and disadvantages, Pharmaceutical applications.

3

2. Nuclear Magnetic Resonance Spectroscopy Introduction, Phenomenon (Spinning nucleus, effect of an external magnetic field, precessional motion, precessional frequency, energy transitions), theory, Chemical shift and its measurement (factors influencing chemical shift­shielding, deshielding, Vander Waals deshielding, anisotropic effect. e.g. alkanes, alkenes, carbonyl, aromatic and cyclohexane), solvents used in NMR (Choice of solvents, solvent shifts­concentration, temperature, hydrogen bonding effects), Spin­spin coupling constants and splitting (splitting of NMR signals, theory, coupling, constants, multiplicities, of signal, chemical and magnetic equivalence), spin­spin decoupling, Instrumentation (Magnets, magnetic field sweep, radiofrequency oscillator, receiver, recorder and integrators, applications.

6

3. Mass spectrometry Introduction, Basic principles, Instrumentation (single focusing and double focusing mass spectrometer, quadrupole mass spectrometer GC­MS, HPLC­MS), Electron impact, chemical ionisation, Field ionisation mass spectrometry, fast atom bombardment spectrometry), base peak, Molecular ion, metastable ions, Fragmentation processes, Applications.

6

4. Radiochemistry and Radiopharmaceuticals­ Fundamentals of radioactivity (radionuclide, Isotope, radioactive, decay,

5

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half­life of radionuclide, specific activity, Bccquerel, Curie), Properties of radiation, Radiation protection, measurement of radioactivity (Geiger­ Muller counter, liquid scintillating counting, gamma scintillation detector), Radiopharmaceuticals (Properties of radionuclide, pharmaceutical properties, chemical properties), 99m Tc generator, Quality control of radiopharmaceuticals (Physical, chemical and sterility control, radionuclide purity and radiochemical purity), Isotope dilution analysis.

5. Near IR spectroscopy­ Introduction, Principles, Advantages, Qualitative measurements­ NIR overtone bands of organic functional groups, Quantitative absorption­ Absorbance measurements, diffuse reflectance measurements, Instrumentation­ Radiation source, Wavelength selection, Detectors, Sample interface, Sample preparation, pharmaceutical applications of NIR.

3

6. X­Ray methods­ Introduction, Instrumentation, identification of crystalline compound, X­ray powder diffraction, Bragg reflections, diffraction methods, Pharmaceutical analytical applications.

3

7. Structural elucidation problems based on UV, IR, NMR, Mass spectroscopy (simple problems with molecular formula given).

8

8. Hyphenated Techniques­GC­MS, LC­MS (Interfaces and Applications only).

2

Reference Books:

1. Skoogh­Principles of Instrumental Analysis, 4 th edition, Saunders College Publishing, 1992, USA.

2. Browning­ Chromatography, 1969, McGraw Hill, London. 3. Willard H. H., L. L. Merritt & John Dean­Instrumental Method of Analysis, 6 th edition,

1986, CBS Publishers & Distributors, India. 4. Beckett & Stenlake­Practical Pharmaceutical Chemistry, 4 th edition, 1988, CBS

Publishers & Distributors, India. 5. I.P., U. S. P., B. P., European Pharmacopoeia. 6. William Kemp­Organic Spectroscopy, 3 rd edition, Reprinted 2005, Palgrave

Publishers Ltd., New York. 7. Clive Whiston­Analytical Chemistry by open learning, 1987, John Wiley & Sons New

York, Toronto.

PHARMACOGNOSY IV 3 hrs/ week

S. No. Topic Hours 1. Glycosides

Saponin glycosides (liquorice, quillaia, asparagus, ginseng, dioscorea, agave, fenugreek, bacopa, hydrocotyle, alpine, smilax Acacia concinna, sapiandus)

6

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Cardiac (digitalis, strophanthus, squill, nerium, thevetia) Biosynthesis of steroidal glycoside molecule.

2. Volatile oils: with respect to sources, composition & preparation of volatile oils and uses. Umbelliferous fruits (anise, caraway, dill, ajowan, fennel, coriander), clove, cardamom, cinnamon, Saussurea lappa, eucalyptus, sandalwood, star anise, patchouli oil, lemongrase, winter green, palmrosa, rose, abolmescus, rasana, nutmeg, lemon peel oil, orange peel oil, spearmint oil and peppermint oil, jatamansi, valerian, artmesia, vetiver.

9

3. Resins turpentine, cannabis hops, (Colophony, niyrrh, shellac, benzoin, balsams (tolu, peru), turmeric, guggulu, ginger, colocynth, guaiacum, asafetida, capsicum.

4

4. Flavonoids Quercetin, Rutin, hesperidin & Flavonoids from orange peel powder.

2

5. Phenylpropanoids & Lignans Podophyllum, psoralea, Ammi majus, phyllanthus

2

6. Polyketides – male fern, podophyllum 1 7. Terpenoids & iridoids (Structure, occurrence and uses)

Quassia, piccrorhiza, tinospora, Artemisia, taxus, carrot, gentian, chirata, andrographs

4

8. Biosynthesis of terpenoids (mono, sesqui, di and triterpenoids) (skeleton only)

2

9. Phytotoxins Abrus precatorius, aconite, belighia sapida, curare, datura, lily of the valley, ergot, poison hemlock, poison ivy, yew, mushrooms, psoralea.

2

10. Introduction to marine Drugs Cytotoxins with any two examples.

2

11. Special aspects of preparation of Ayurvedic formulations and herbal formulations. Preparation and Evaluation of plant extracts and formulations with respect to phytoconstituents.

2

Reference Books:

1. Trease D. & Evans W. C.: Textbook of Pharmacognosy; W. B., Saunders. 2. Tyler V. E. Brady L. R. & Robbers J. E.: Pharmacognosy; Lea Feibger, USA. 3. Wallis T. E.: Textbook of Pharmacognosy; CBS Publishers, Delhi. 4. Kokate C. K. Purohit A. P. & Gokhale S. B.: Pharmacognosy; Nirali Publications,

Pune. 5. Harbone J. B.: Phytochemical Methods: A guide to modern techniques of Plant

Analysis: Chapman & Hall, London. 6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants; Intercept Limited. 7. Vasudevan T. N. & Laddha K. S.: A Textbook of Pharmacognosy, Vrinda Publication

House, Jalgaon

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8. The Indian Pharmacopoeia: The Controller of Publication; Delhi. 9. Brain K. R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright,

Scientica, Bristol. 10. Iyenger M. A. & Nayak S. G.: Anatomy of Crude Drugs: Manipal Power Press,

Manipal. 11. Iyenger M. A.: Pharmacognosy of Powdered drugs: Manipal Power Press, Manipal. 12. Kokate C. K.: Practical Pharmacognosy: Vallabh Prakashan. 13. Wagner, Bladi & Zgainski: Plant Drug Analysis; Springer Verlag. 14. Khandelwal K. R.: Practical Pharmacognosy Techniques and Experiments; Nirali

Prakashan, Pune. 15. Vasudevan T. N., Laddha K. S.; Practical Pharmacognosy; New Vrinda Publishing

House, Jalgaon.

PHARMACEUTICS VII 3 hrs/ week

Note: References to latest amendments of schedule M and Schedule U of Drugs and Cosmetics Act 1940 to be made wherever it is appropriate.

S. No. Topic Hours

1. Quality assurance (discuss specimen documents) Raw material control, actives and inactive, in process control, sanitization, environmental and microbiological control, packaging and labeling control, finished product control, standard operating procedures, cGMP. Q. C. standards of identity, purity, quality and potency, Q. C. Charts, sampling & sampling plans.

8

2. Documentation – need/ importance, batch manufacturing records, SOPs, Maintenance & Retrieval of Documents.

3

3. Pilot plant scale up techniques – group’s responsibilities, facilities, example of scaling up of manufacturing of tablets, liquids and semisolids.

5

4. Validation – Definition, Types, Qualification Process Validation – steps & documentation (Brief), Examples – Raw Materials, mixing and granulation, mixer, granulator, Validation of sterilization process and equipment – microbial death kinetic terms, F Value applications, steps for validating steam sterilization method

5

5. Production management Pharma industry – current scenario Site selection and development – factors to be considered in designing a facility, layout of manufacturing facilities, environmental aspects, materials of construction, equipment selection, handling of components and containers, vendor audit, warehousing, maintenance and service aspects, Personnel – qualifications, selection, responsibilities & training. Materials management, sales forecasting, inventory control, production planning, elements of cost & cost controls.

8

6. Factory Layout­ considerations/ steps, Examples of Typical layout schemes for Tablets, capsule, liquids, sterile formulations manufacturing areas.

4

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Reference Books:

1. The theory and practice of industrial pharmacy, ed., by Leon Lachman, H. A. Liberman, J. L. Kanig, 3 rd ed., Verghese Publishing house, 1987.

2. The science and practice of Pharmacy, 21 st ed., Remington, Vol. I and II, B. L. Publications Pvt. Ltd., 2005.

3. Cole, Graham, “Pharmaceutical Production Facilities: Design and Application”, 1990. 4. Pharmaceutical Process Validation, 2 nd Edition, Nash Robert A. Berry Ira R. Volume

57, 1992, Marcel Dekker Inc., New York. 5. Pharmaceutical dosage forms; parenteral medications, Vol. I, II, III, ed., by Kenneth

A. Avis, Leon Lachman and H. A. Liberman, Marcel Dekker INC., 1986.

NOVEL DRUG DELIVERY SYSTEMS 3 hrs/ week

S. No. Topic Hours

1. Oral Controlled Drug Delivery Systems­ a) Multiparticulate drug delivery systems (Pellets)­ need and significance of pelletization, techniques­ pan coating, extrusion and spheronization, equipments, evaluation b) Osmotic Systems­ Basic principles, classification, oral osmotic pumps, applications & evaluation c) Gastroretentive drug delivery systems (GRDDS)­ Regional variability in intestinal absorption and concept of absorption window, Design of GRDDS technologies­ low density (Floating systems), Swelling and expanding systems, Mucoadhesive systems, high density systems, Evaluation of GRDDS.

2

1

2

2. Mucoadhesive drug delivery systems­ Mucoadhesion and theories, factors influencing mucoadhesion, in vitro­ in vivo methods to study mucoadhesion, bioadhesive polymers and systems.

4

3. Ocular drug delivery systems Limitations of conventional systems, ophthalmic insects­nonerodible and erodible inserts, pilocarpine ocular insert, Lacrisert, SCDI, Minidisc, NODS, polymers, particulates, enhancers, intraocular solutions, ocular iontophoresis, evaluation.

6

4. Transdermal drug delivery systems (TDDS) Skin and skin permeation, modes of percutaneous penetration, components of TDDS, different types of TDDS and release control mechanisms, production, evaluation of PSA and TDDS – in vitro, in vivo.

6

5. Introduction to targeting, Passive and active targeting 1

a) Targeting to lymphatic systems Anatomy of lymphatic system, lymphatics in intestine, factors enhancing intestinal drug uptake, approaches, prodrug and delivery systems examples, parental drug administration for lymphatic transport

2

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b) Liposomes Structural components and classification, methods of preparation, size reduction, characterization, stability, applications. c) Drug targeting to brain The blood brain barrier, transport through blood brain barrier, factors affecting drug permeation through BBB, strategies for brain drug delivery d) Nanoparticles Preparation techniques, characterization, biodistribution, evaluation and applications. e) Colonic targeting­ Physiology of colon, difficulties in colonic targeting, approaches­ prodrug, pH sensitive polymers, polysaccharides, time release systems, osmotic systems, azo polymers, evaluation.

2

1

2

3

Reference Books:

1. Advances in controlled and novel drug delivery, ed. by N. K. Jain, CBS publishers and distributors, 2001.

2. Modern Pharmaceutics, 4 th ed. Revised and Expanded ed. by Gilbert S. Banker and Christopher T. Rhodes, Marcel Dekker INC., 2002.

3. Targetted and controlled drug delivery, Novel carrier systems, S. P. Vyas and R. K. Khar, CBS publishers and distributors, 2002.

4. Controlled and Novel drug delivery, ed. by N. K. Jain, CBS publishers and distributors, 1997.

5. Controlled drug delivery, concepts and advances, S. P. Vitas and R. K. Khar, Vallabh Publishers, 2002.

6. The theory and practice of industrial pharmacy, ed. by Leon Lachman, H. A. Liberman, J. L. Kanig, 3 rd ed., Verghese Publishing house, 1987.

7. The science and practice of pharmacy, 21 st ed., Remington, Vol. I and II, B.L. Publications Pvt. Ltd., 2005.

8. Bioadhesive Drug Delivery Systems­ Fundamentals, Novel Approaches, and Development, Mathiowitz Edith, Chickening III, Donald E., Lehr Claus­Michael, Volume 98, Marcel Dekker INC, New York, 1995.

9. Nanoarticulate Drug Delivery Systems, Thassu Deepak, Dellers Michael, Pathak Yashwant, Volume 166, Marcel Dekker Inc., New York, 2007.

10. “Microencapsulation Methods and Industrial Applications”, Benita Simon, 2 nd Edition, Marcel Dekker Inc., New York, 2006.

11. Controlled and Novel Drug Delivery, Jain N. K. 1 st Edition, CBS Publishers and Distributors, New Delhi, 2004.

12. “Targeted and Controlled Drug Delivery­ Novel Carrier Systems”, Vyas S. P. Khar R. K., 1 st Edition, CBS Publishers and Distributors, New Delhi, 2002.

13. Ophthalmic Drug Delivery Systems, Mitra, Ashim K., Volume 58, Marcel Dekker Inc., New York, 1993.

14. “Encyclopedia of Pharmaceutical Technology, Swabrick, Boylan, Volumes 1,6,8,9,10,12,13,14,15,16,17,18,19,20.” Marcel Dekker Inc., New York.

15. Oral Mucosal Drug Delivery, Rathbone Michael J., Volume 74, 1996, Marcel Dekker Inc., New York, 1996.

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FORENSIC PHARMACY AND JURISPRUDENCE 3 hrs/ week

S. No. Topic Hours 1. Historical perspective including details of Chopra Committee and Hathi

Committee 1

2. An objective study of the following Acts mearporating the latest amendments Pharmacy Act 1948

• Definition • PCI and State Councils, Composition and Function • Preparation of Registers and qualifications for entry into registers • Educational Regulation and Approval of Courses and Institutions • Offences and Penalties

5

3. Drugs and Cosmetic Act 1945 • Definitions • Advisor bodies DLAB and DCC Composition and function • Drug Control Laboratories and Government Analysts • Drug inspectors, Licensing Authorities, Controlling Authorities and

Customs Collectors • Provisions Governing Import, Manufacture and Sale of Drugs. • Labeling and Packaging of Drugs • Provisions applicable to manufacture and Sale of Ayurvedic Drugs • Provisions Governing Import, Manufacture and Sale of

Homeopathic Drugs. • Various offences and corresponding Penalties • Broad content of various Schedules of the Drugs and Cosmetic Act

and Rules.

14

4. Drugs and Magic Remedies (Objectionable Advertisements) Act 1954. • Definitions, Prohibited Advertisement, Savings.

2

5. Narcotic Drugs and Psychotropic Substances Act • Definitions • Narcotics Commissioner and other officers • Illicit Traffic and measures to prevent illicit traffic of opium. • Offences and corresponding penalties.

2

6. Drug Price Control Order 1995 and new Drug Policy 2 7. Medicinal ad Toilet Preparations (Excise Duties) Act.

• Definitions, restricted and unrestricted preparations • Manufacturing in bond and outside bond

2

8. Prevention of Food Adulteration Act 1954 • Definitions • Central board of food standards, central food laboratory,

compositions and functions • Public analysis and food inspectors

2

9. Indian Patents Act 1975 2

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10. Bombay Shops and Establishments Act • Definitions and Provisions

1

11. Factories Act 1954 • Definitions and Provisions

1

12. Indian Penal Code and Code of Criminal Procedures • Provisions pertaining to different Courts, jurisdiction and power • Provisions governing entry, search, arrest, bailable and non­

bailable offences, Cognizable and non­cognizable offences

1

13. Insecticides Act • Definitions • Procedure for licensing and registration of Insecticides • Savings

1

Reference Books:

1. “Forensic Pharmacy”, Kuchekar and Kadtare and Itkar, Nirali Prakashan, 5 th edition, 2005.

2. “Textbook of Forensic Pharmacy” N. K. Jain, Vallabhprakashan, 4 th edition, 1999. 3. D & C Acts, 1940 and Rules, 1945, S. W. Deshpande and Nilesh Gandhi, Sumit

Publishers 2006, Mumbai. 4. Govt. of India Publication of above Acts and Rules.

CLINICAL PHARMACY AND DRUG INTERACTION 3 hrs/ week

S. No. Topic Hours 1. Concept of clinical pharmacy, community pharmacy and hospital

pharmacy (definition, scope and objectives) 6

2. Concept of therapeutic drug monitoring and patient compliance 6 3. Role of Pharmacist as a patient councilor 3 4. Rational use of drugs

­ Drug­ drug interactions – possible mechanisms and examples ­ Drug interaction with food, alcohol, tobacco ­ Adverse drug reactions – Types and examples ­ Detection and Prevention of ADR ­ Drugs used in geriatrics, pediatrics and pregnancy ­ Irrational drug combination ­ Dose adjustment in renal and hepatic dysfunction

16

5. General Introduction to drug discovery and development Pre­Clinical Stages Clinical development – phases of clinical trials Commercial Aspects

5

Reference Books:

1. Clinical Pharmacy Dr. Tipnis, Dr. Bajaj, 1 st Edition, Career Publications, 2003.

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2. Clinical Pharmacology­ P. N. Benett, M. J. brown, 9 th Edition, Churchill Livingstone, 2006.

3. Text Book of Clinical Pharmacy Practice­ G. Parthisarathi, Karin Nyfort Hansen, Milap C. Nahata, Orientlongman, 2004.

4. Clinical Pharmacy and Therapeutics­ Roger Walker, Clive Edwards, 3 rd Edition, Churchill Livingstone, 2003.

PHARMACEUTICS LABORATORY V 4 hrs/ week

1. S. R. oral tablets­ use of hydrophobic and hydrophilic matrix materials (monolithic and reservoir) ­ preparation and in vitro release evaluation.

2. Dissolution testing – Marketed formulations of conventional tablets – soluble drug & poorly soluble drug (selection of medium)

3. Ophthalmic DDS­ Mucoadhesive gel and evaluation.

4. Accelerated stability testing of any suitable drug/ formulation

5. Demonstration of sugar and film coating of tablets.

6. Microencapsulation by coacervation phase separation technique of a liquid (volatile oil) & a solid (Charcoal/ Paracetamol), evaluation of the products.

7. SR suppositories­ PEG base and Hydrogel base­ evaluation of in vitro release.

PHARMACOGNOSY LABORATORY III 4 hrs/ week

S. No. Topic Hours 1. Macroscopy­ microscopy of liquorice, clove, fennel, dill, cardamom,

cinnamon, coriander, quassia, kalmegh, picrorrhiza, asparagus. 8

2. Extraction and detection of phytoconstituents of following classes (Any two examples of each class) Flavonoids, glycosides (liquorice), volatile oils (clove, fennel, anise, dill)

2

3. Qualitative analysis of unorganized drugs as covered drugs as covered in theory (asafetida, myrrh, benzoin, guggul, and aloes).

2

4. Microscopic evaluation of Ayurvedic churna formulation & analysis of total tannins from Triphala churna.

1

5. Morphological identification of drugs covered in theory (volatile oils and glycosides) any 20 samples

1

Total 14

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PHARMACEUTICAL ANALYSIS LABORATORY III 4 hrs/ week

1. Determination of pka 1 and pka 2 of phosphoric acid. 2. Determination of HCl and phosphoric acid in a given mixture potentiometrically. 3. Assay of paracetamol tablets, propanolol tablets, albendazole tablets, Rifampicin

capsules as per I. P. 4. Assay of quinine sulphate by fluorimetry. 5. Study of quenching effects of iodide ions on fluorescence of quinine sulphate. 6. Assay of phenylephrine hydrochloride ophthalmic solution by difference

spectroscopy. 7. Assay of caffeine and sodium benzoate injection by simultaneous equation method

and absorbance ration method. 8. Assay of trimethoprim in cotrimoxazole tablets as per I. P. 9. Assay of nifedipine and atenolol tablets by UV. 10. Determination of streptomycin base colorimetrically from Injection. 11. Identification of sample by TLC.

Demonstration experiments:

1. Assay of sample by HPLC/ HPTLC/ GC. 2. Qualitative analysis by I. R. 3. Determination of K+ from KCI by flame photometry. 4. Selection of mobile phase for TLC. 5. Identification of amino acids by paper chromatography.

134

Shri. Yashwantrao Bhonsale Education Society’s

YASHWANTRAO BHONSALE COLLEGE OF PHARMACY

Bldg. No. 02, BKC, A/ P: Charathe - Vazarwadi, Tal: Sawantwadi, Dist.: Sindhudurg, Maharashtra- 416 510

Approved by AICTE, PCI, New Delhi, Govt. of Maharashtra, DTE. Affiliated to Mumbai University (B. Pharm, M. Pharm)

and MSBTE (D. Pharm) DTE Code: 3480; University Code: 1027; MSBTE Code: 1878

www.sybespharmacy.com +912363-272233/272299 Email:ybpharmacy@gmail.com

Mr. Achyut K. Sawantbhonsale Dr. Vijay A. Jagtap

Executive Chairman Principal

CBCS Syllabus Copy

(Revised in 2016-17)

135

AC 31/05/2017 Item Number 4.2 UNIVERSITY OF MUMBAI

Bachelor of Pharmacy

First Year B. Pharm. ( Semester I,II,III & IV), Revised course (REV- 2016)

from Academic Year 2016 -17

(As per Choice Based Credit and Grading System with effect from the academic year 2016–2017)

136

From Co-ordinator’s Desk:-

To meet the challenge of ensuring excellence in engineering education, the issue of quality needs to be addressed, debated taken forward in a systematic manner. Accreditation is the principal means of quality assurance in higher education. The major emphasis of accreditation process is to measure the outcomes of the program that is being accredited. In line with this Faculty of Technology of University of Mumbai has taken a lead in incorporating philosophy of outcome based education in the process of curriculum development.

Faculty of Technology, University of Mumbai, in one of its meetings unanimously resolved that, each Board of Studies shall prepare some Program Educational Objectives (PEO’s), give freedom to affiliated Institutes to add few (PEO’s) course objectives course outcomes to be clearly defined for each course, so that all faculty members in affiliated institutes understand the depth approach of course to be taught, which will enhance learner’s learning process. It was also resolved that, maximum senior faculty from colleges and experts from industry should to be involved while revising the curriculum. I am happy to state that, each Board of studies has adhered to the resolutions passed by Faculty of Technology, developed curriculum accordingly. In addition to outcome based education, Choice Based Credit and Grading System is also introduced to ensure quality of engineering education.

Choice Based Credit and Grading System enables a much-required shift in focus from teacher-centric to learner-centric education since the workload estimated is based on the investment of time in learning not in teaching. It also focuses on continuous evaluation which will enhance the quality of education. University of Mumbai has taken a lead in implementing the system through its affiliated Institutes. Faculty of Technology has devised a transparent credit assignment policy adopted ten points scale to grade learner’s performance. Credit grading based system was implemented for First Year of B. Pharmacy from the academic year 2016-2017. Subsequently this system will be carried forward for Second Year B. Pharmacy in the academic year 2017-2018, for Third Year and Final Year B. Pharmacy in the academic years 2018-2019, 2019-2020, respectively.

Dr. S. K. Ukarande Co-ordinator, Faculty of Technology, Member - Academic Council University of Mumbai, Mumbai

137

B. Pharm. Choice Based Credit and Grading System (CBCGS)[2016-17]

Scheme Examination Semesters I to VIII

& Syllabus Semesters I to IV

[REVISED 2016]

138

EXAMINATION SCHEME FOR THE CHOICE BASED CREDIT AND GRADING SYSTEM

(CBCGS) (2016-17)

SEMESTER I

Course Code Name Credits Hr/Wk Weightage

Internal Weightage

End Semester Exam

Total Marks

BPH_C_101_T General Chemistry 4 4 20 80 100 BPH_C_102_T Dispensing and

Community Pharmacy

4 4 20 80 100

BPH_C_103_T Anatomy, Physiology & Pathophysiology I

4 4 20 80 100

BPH_C_104_T Biochemistry I 4 4 20 80 100 BPH_C_105_T Communication

Skills and Ethics (NUES)

3 3 20 80 100

TOTAL Theory 19 19 100 400 500 BPH_C_106_L General Chemistry

Lab 2 4 10 40 50

BPH_C_107_L Dispensing and Community Pharmacy Lab

2 4 10 40 50

BPH_C_108_L Anatomy, Physiology & Pathophysiology Lab

2 4 10 40 50

TOTAL Lab 6 12 30 120 150 TOTAL SEM I 25 31 130 520 650

SEMESTER II

Course Code Name Credits Hr/Wk Weightage Internal

Weightage End Semester

Exam

Total Marks

BPH_C_201_T Anatomy, Physiology & Pathophysiology II

4 4 20 80 100

BPH_C_202_T Biochemistry II 4 4 20 80 100 BPH_C_203_T Pharmacognosy I 4 4 20 80 100 BPH_C_204_T Hospital Pharmacy and

Drug Store Management

4 4 20 80 100

BPH_C_205_T Environmental Science 3 3 20 80 100 TOTAL Theory 19 19 100 400 500 BPH_C_206_L Pharmacognosy Lab I 2 4 10 40 50 BPH_C_207_L Biochemistry Lab 2 4 10 40 50 BPH_C_208_L Computer Lab 2 4 10 40 50 TOTAL Lab 6 12 30 120 150 TOTAL SEM II 25 31 130 520 650

NO REMEDIAL FOR LATERAL ENTRY AS SEM I AND II SUBJECTS ARE COVERED IN DIPLOMA SYLLABUS

139

SEMESTER III

Course Code Name Credits Hr/Wk Weightage Internal

Weightage End Semester

Exam

Total Marks

BPH_C_301_T Organic Chemistry I 4 4 20 80 100 BPH_C_302_T Physical Pharmacy I 4 4 20 80 100 BPH_C_303_T Anatomy,

Physiology & Pathophysiology III

4 4 20 80 100

BPH_C_304_T Pharmaceutical Analysis I

3 3 20 80 100

BPH_C_305_T Pharmaceutical Engineering

3 3 20 80 100

TOTAL Theory 18 18 100 400 500 BPH_C_306_L Organic Chemistry

Lab I 2 4 10 40 50

BPH_C_307_L Physical Pharmacy Lab I

2 4 10 40 50

BPH_C_308_L Pharmaceutical Analysis Lab I

2 4 10 40 50

TOTAL Lab 6 12 30 120 150 TOTAL SEM III 24 30 130 520 650

SEMESTER IV

Course Code Name Credits Hr/Wk Weightage

Internal Weightage

End Semester Exam

Total Marks

BPH_C_401_T Organic Chemistry II 4 4 20 80 100 BPH_C_402_T Physical Pharmacy II 4 4 20 80 100 BPH_C_403_T Pharmaceutics I 3 3 20 80 100 BPH_C_404_T Pharmacology I 4 4 20 80 100 BPH_C_405_T Microbiology 3 3 20 80 100 BPH_C_406_T Mathematics and

Statistics 3 3 20 80 100

TOTAL Theory 21 21 120 480 600 BPH_C_407_L Physical Pharmacy

Lab II 2 4 10 40 50

BPH_C_408_L Pharmaceutics Lab I 2 4 10 40 50 BPH_C_409_L Pharmacology Lab I 2 4 10 40 50 TOTAL Lab 6 12 30 120 150 TOTAL SEM IV 27 33 150 600 750

140

SEMESTER V

Course Code Name Credits Hr/Wk Weightage Internal

Weightage End Semester

Exam

Total Marks

BPH_C_501_T Organic Chemistry III

4 4 20 80 100

BPH_C_502_T Pharmaceutics II 4 4 20 80 100 BPH_C_503_T Pharmaceutical

Biotechnology 4 4 20 80 100

BPH_C_504_T Pharmacology II 4 4 20 80 100 BPH_E_5xx_T Choice Based

Course I 2 2 10 40 50

BPH_E_5xx_T Choice Based Course II

2 2 10 40 50

TOTAL Theory 20 20 100 400 500 BPH_C_505_L Organic Chemistry

Lab II 2 4 10 40 50

BPH_C_506_L Pharmaceutics Lab II 2 4 10 40 50 BPH_C_507_L Experimental

Techniques in Microbiology and Biotechnology Lab

2 4 10 40 50

TOTAL Lab 6 12 30 120 150 TOTAL SEM V 26 32 130 520 650

SEMESTER VI

Course Code Name Credits Hr/Wk Weightage Internal

Weightage End Semester

Exam

Total Marks

BPH_C_601_T Pharmaceutical Chemistry I

4 4 20 80 100

BPH_C_602_T Pharmaceutics III 4 4 20 80 100 BPH_C_603_T Pharmaceutical

Analysis II 4 4 20 80 100

BPH_C_604_T Pharmacognosy II 4 4 20 80 100 BPH_E_6xx_T Choice Based

Course III 4 4 20 80 100

BPH_E_6xx_T Choice Based Course IV

2 2 10 40 50

TOTAL Theory 22 22 110 440 550 BPH_C_605_L Pharmaceutical

Chemistry Lab I 2 4 10 40 50

BPH_C_606_L Pharmaceutics Lab III

2 4 10 40 50

BPH_C_607_L Pharmaceutical Analysis Lab II

2 4 10 40 50

TOTAL Lab 6 12 30 120 150 TOTAL SEM VI 28 34 140 560 700

141

SEMESTER VII

Course Code Name Credits Hr/Wk Weightage Internal

Weightage End Semester

Exam

Total Marks

BPH_C_701_T Pharmaceutical Chemistry II

4 4 20 80 100

BPH_C_702_T Pharmacognosy III 4 4 20 80 100 BPH_C_703_T Pharmaceutical

Analysis III 4 4 20 80 100

BPH_C_704_T Pharmacology III 4 4 20 80 100 BPH_C_705_T Pharmaceutical

Jurisprudence 3 3 20 80 100

BPH_E_7xx_T Choice Based Course V

2 2 10 40 50

TOTAL Theory 21 21 110 440 550 BPH_C_706_L Pharmacognosy Lab

II 2 4 10 40 50

BPH_C_707_L Pharmaceutical Analysis Lab III

2 4 10 40 50

BPH_C_708_L Pharmacology Lab II 2 4 10 40 50 TOTAL Lab 6 12 30 120 150 TOTAL SEM VII 27 33 140 560 700

SEMESTER VIII

Course Code Name Credits Hr/Wk Weightage Internal

Weightage End Semester

Exam

Total Marks

BPH_C_801_T Pharmaceutical Chemistry III

4 4 20 80 100

BPH_C_802_T Pharmaceutics IV 4 4 20 80 100 BPH_E_8xx_T Choice Based

Course VI 4 4 20 80 100

BPH_E_8xx_T Choice Based Course VII

4 4 20 80 100

TOTAL Theory 16 16 80 320 400 BPH_C_803_L Pharmaceutical

Chemistry Lab II 2 4 10 40 50

BPH_C_804_L Pharmaceutics Lab IV

2 4 10 40 50

BPH_E_805_D Project 6 12 - 200 200 TOTAL Lab 10 20 20 280 300 TOTAL SEM VIII 26 36 100 600 700

142

SYLLABUS FOR F. Y. B. Pharm.

SEMESTER-I

BPH_C_101_T – General Chemistry – (4 Hr/Wk)

Course Objectives On completion of following theory topics, learner should be able to understand basic concepts of bonding, principles of chemical reaction and catalytic reaction, role of inorganic reagents as medicinal compounds.

Course Outcomes The learner should be able to:

1) Draw and explain the structures of various molecules or ions based on the concept of ionic and covalent bonding 2) Explain the Rate Law of a Chemical Reaction and Apply the knowledge of principles like Hammonds postulate, Reactivity

and Selectivity Microscopic reversibility to predict the nature of reaction and product formation rate 3) Differentiate the types of catalytic reactions and explain the role of catalyst 4) Classify Gastrointestinal Agents, Topical Agents, Saline Cathartics, Expectorants, Emetics, Antidotes and explain their mode

of action. Describe sclerosing agents and complexing agents 5) Classify electrolytes/ elements and elaborate their physiological role. Explain use of physiological ions in replacement

therapy, acid-base balance and combination therapy. 6) Explain the basic concepts of radiochemistry and biological effects of radiation; describe diagnostics and therapeutic uses of

radiopharmaceuticals.

No. Details Hours 1 Review of basic bonding concepts 10

1.1 Quantum numbers, atomic orbitals, electron configuration, electronic diagrams, polar covalent bonds, electronegativity group, electronegativities, electrostatic potential surfaces, inductive effects, bond dipoles, molecular dipoles.

4

1.2 Lewis structures, formal charge. 3 1.3 VSEPR, hybridization involving s, p and d orbitals, hybridization effects 3 2 Kinetics and reaction mechanism 7

2.1 Energy surfaces, reaction coordinate diagrams, activated complex/transition state rate and rate constants, reaction order and rate laws

2

2.2 Kinetic isotope effects 2 2.3 Hammond Postulate, reactivity vs selectivity, Curtin-Hammett Principle, microscopic

reversibility, kinetic vs thermodynamic control 3

3 Catalysis: 7 3.1 General principles of catalysis, Forms of catalysis – electrophilic catalysis, acid- base

catalysis, nucleophilic catalysis, covalent catalysis, phase transfer catalysis. 4

3.2 Bronsted Acid-base catalysis, correlation of reaction rates with acidity functions. 3 4 Gastrointestinal Agents 4

4.1 Acidifying agents 1 4.2 Antacids:Sodium bicarbonate, aluminum hydroxide, calcium carbonate, tribasic

calcium phosphate, magnesium hydroxide, magnesium trisilicate and combination antacid preparations.

1

4.3 Protectives and Adsorbents:Introduction; bismuth subnitrate, bismuth subcarbonate, kaolin, attapulgite and activated charcoal

1

4.4 Cathartics 1 5 Topical Agents 4

5.1 Protective Topical Agents: Definition; talc, insoluble zinc compounds (zinc oxide, calamine, zinc stearate), titanium dioxide.

1

5.2

Antimicrobials and Astringents: Antimicrobial terminology, mechanism of action Antimicrobial Astringent Products: Oxidative antimicrobial agents; (hydrogen peroxide, zinc peroxide, sodium carbonate, potassium permanganate, sodium hypochlorite, iodine preparation and compounds)

1

5.3 Protein Precipitant Antimicrobial Agents: Silver nitrate, mild silver protein and related products, ammoniated mercury, mercuric chloride, sulphur and sulphur compounds, sublimed sulphur and precipitated sulphur, boric acid and sodium borate, antimony potassium tartrate.

1

143

5.4 Astringents: Official compounds of aluminium and zinc 1

6 Complexing and chelating agents used in therapy, poisons and antidotes 2 7 Miscellaneous inorganic pharmaceutical agents: 2

7.1 Sclerosing agents, expectorants, emetics. 1 7.2 Antioxidants: Theory and principle, selection of antioxidants, official antioxidants

(hypophosphorous acid, sodium bisulphite, sodium thiosulphate, sodium nitrite and nitrogen).

1

8 Inorganic Radio Pharmaceuticals: Properties of α,β and γ radiation, biological effect of radiation, half-life, clinical application of radiopharmaceuticals (Chromium-51, Iodine-125 and 131, Technetium-99, Iron-59, Cobalt-57 and 60 and Gold-198)

4

9 Major Intra & Extracellular Electrolytes 5 9.1 Major physiological ions (Role and condition related to change in concentration of

following ions: chloride, phosphate, bicarbonate, sodium, potassium, calcium, magnesium)

2

9.2 Electrolytes used in replacement therapy: Sodium replacement (sodium chloride), potassium replacement (potassium chloride), calcium replacement (calcium chloride, calcium gluconate)

1

9.3 Physiological acid base balance: Acids and Bases: Buffers (Pharmaceutical and Physiological) Electrolytes used in acid base therapy (sodium acetate, sodium bicarbonate, sodium biphosphate, sodium citrate, sodium lactate, ammonium chloride). Electrolyte combination therapy.

2

10 Essential and Trace Elements: Iron and haematinics Copper, zinc, molybdenum, selenium and sulphur. Official iodine products (iodine,potassium iodide, sodium iodide).

3

TOTAL 48

Note: Only Uses of pharmaceutical agents mentioned to be covered. Monographs not to be discussed. Books: Latest Edition of all books to be referred.

1) Eric V Ansyln and Dennis A Dougherty, Modern Physical Organic Chemistry, John Wiley. 2) Inorganic medicinal and pharmaceutical chemistry, J. H. Block, E. B. Roche, T. O. Soine, and C. O. Wilson. Lea &Febiger,

Philadelphia, PA. 3) Modern Inorganic Pharmaceutical Chemistry, Clarence A. Discher. Wiley, New York. 4) Remington: the science and practice of pharmacy, Beringer, P. Lippincott Williams & Wilkins. 5) Inorganic Pharmaceutical Chemistry, Bothara, K. G., Nirali Prakashan. 6) Inorganic Pharmaceutical Chemistry, A. S. Dhake, H. P. Tipnis, Career Publication.

BPH_C_102_T – Dispensing and Community Pharmacy – (4 Hr/Wk)

Course Objectives On completion of the theory topics, the learner should have had an understanding of the concept of drug versus dosage forms, basic calculations relating to the practice of dispensing, prescriptions and their types and their compounding and the role of a community pharmacy in healthcare

Course Outcomes The learner should be able to: 1. Define and identify various dosage forms 2. Solve problems relating to pharmaceutical calculations 3. Have knowledge of different prescription types 4. Identify and comprehend different steps involved in dispensing of formulations 5. Understand principles involved in compounding of different dosage forms 6. Identify physical and chemical incompatibilities among different active ingredients and formulations 7. Understand the organization of community pharmacy, provide optimal patient care under the direct personal interaction/ counseling

144

No. Details Hours

1

Concept of formulation: Definition of drug and dosage form Introduction to routes of administration Classification of dosage form and their applications

4

2 Introduction to compounding and dispensing. 1

3

Prescription: Prescription and its parts. Types of prescriptions. Pricing and recording of prescriptions.

2

4

General dispensing: Fundamentals of compounding and dispensing including good practices. Containers and closures/packaging for dispensed products. Storage and stability of dispensed products. Labeling of dispensed preparations. Dispensing of proprietary medicines.

5

5

Pharmaceutical Calculations: Reduction and enlargement of formulae, formula by weight(w/v, w/w, v/v), in parts Calculations based on expressions of concentration and dilution (percentage, parts, alligation), proof strength. Posology.

4

6 General compounding of Products (includes excipients used and compounding procedure): Solutions, suspensions, emulsions and creams, ointments and pastes, gels, suppository and pessaries, powders, granules. and capsules

10

Self-Study: Compounding of dosage forms such as lozenges, pastilles, pills, tablet triturates. 5

7 Incompatibilities: Physical Incompatibilities, Chemical Incompatibilities. 3

8

Community Pharmacy: Definition and scope Pharmacy and heath care system in India Roles and responsibilities of community pharmacist

2

9 Health education: WHO Definition of health, and health promotion Health screening services- definition, importance, methods for screening

3

Self-Study: Commonly occurring Communicable Diseases, causative agents, Balance diet, treatment & prevention of deficiency disorders, Family planning – role of pharmacist 3

10 Pharmaceutical care: Definition and Principles of Pharmaceutical care, definition and outcomes of patient counseling 2

11 OTC Medication 2

12 Pharmaceutical ethics: Principle and Significance of professional ethics, code of ethics for a pharmacist 2

TOTAL 48 Books:

1. Cooper and Gunn’s Dispensing for Pharmaceutical Students, Edns. 11 and 12; Edited by S.J.Carter, IndianEdition, CBS Publishers, Delhi.

2. Pharmaceutical Practice; Edited by D.M.Collet and M.E.Aulton; Churchill Livingstone, ELBS Edition, 1991. 3. Pharmaceutical Practice Edited by A.J.Winfield and R.M.E. Richards, Second Edition, Churchill Livingstone, 1998.] 4. Pharmaceutical Practice; Edited by A.J. Winfild and R.M.E. Richards, Third Edition, Churchill Livingstone,2004. 5. Husa’s Pharmaceutical Dispensing, Edited by Eric Martin, Sixth Edition, Mack Publishing Company, 1996. 6. Pharmaceutical Calculations, A.C. Ansel and M.J.Stoklosa, Lippincott Williams and Wilkins, 2006. 7. Pharmaceutical Calculations – Bradley, Gustafson and Stoklosa, Third Edition, Lea and Febiger, 1957. 8. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBSPublishers & Distributers; 2008. 9. Merchant S.H. and Dr. J.S.Quadry. A Textbook of Hospital Pharmacy, 4th ed. Ahmadabad: B.S. Shah Prakakshan; 2001

145

10. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A Textbook of Clinical Pharmacy Practice- essential concepts and skills, 1 st ed. Chennai: Orient Longman Private Limited; 2004

BPH_C_103_T - Anatomy, Physiology and Pathophysiology – I (4 Hr/Wk)

Course Objectives To familiarize the learner with the anatomical organization and physiology of the human body and the pathophysiology of some disease states

Course Outcomes The learner should be able to: 1. Outline and categorize the various body structural levels (cells, tissues, organs, and systems) and recall the structure, composition and functions of plasma membrane and methods of movement of substances across plasma membrane. 2. Explain anatomy, physiology of lymphatic system, recall & interpret the types of hypersensitivity reactions, and make use of the knowledge of the pathophysiology of AIDS and autoimmune diseases. 3. Tell the composition and functions of blood, explain the process of hemostasis and blood coagulation as well as recall & apply the knowledge of pathophysiology of common haematological disorders. 4. Comprehend the mechanisms of inflammation and repair. 5. Recall the anatomy of skeletal, cardiac and smooth muscle, explain the transmission at the neuromuscular junction and energy metabolism in the muscle as well as the mechanism of skeletal muscle contraction and demonstrate various types of skeletal muscle contractions.

No. Details Hours 1. Brief introduction to human body and organization of human body 1 2. Structural and functional characteristics of following tissues

1) Epithelial 2) Connective 3) Nervous 4) Muscle

2

3. Detailed structure of cell membrane and trans-membrane movement of substances 2 4. Components and functions of lymphatic system

• Lymphatic organs and tissues • Organization of lymph vessels • Formation and flow of lymph

4

5. Pathophysiology of following diseases • AIDS • Autoimmune diseases (Rheumatoid arthritis, Grave’s disease, Myasthenia

Gravis, Rheumatic fever) • Hypersensitivity and types of hypersensitivity reactions.

6

7. Haematology • Composition of blood • Functions of blood elements • Erythropoiesis and life cycle of RBC. • Synthesis of Haemoglobin • Leucopoiesis • Immunity: Basics and Types • Coagulation of blood • Blood groups

10

8. Pathophysiology of following diseases • Anaemias – Types of anaemias • Polycythemia : Physiological and polycythemia vera • Leucopenia • Leukocytosis • Thrombocytopenia • Leukemia

5

6. Basic mechanism involved in the process of inflammation and repair. • Alteration in vascular permeability and blood flow. • Migration of WBC • Acute and chronic inflammation • Brief outline of the process of repair.

7

146

9. Structure and properties of following muscles • Cardiac muscles • Smooth muscles • Skeletal muscles • Neuromuscular transmission and contraction of skeletal muscle • Energy metabolism in the muscle • Types of muscle contractions • Muscle tone

11

TOTAL 48 Books: Latest editions of the following books can be referred 1. Ross & Wilson, Anatomy & Physiology in Health & Illness by Anne Waugh and Allison Grant, Published by Churchill Livingstone 2. Gerard J. Tortora & Bryan Derrickson, Principals of Anatomy & Physiology, Published by John Wiley and Sons, Inc. 3. A. C. Guyton & J. E. Hall, Textbook of Medical Physiology, Published in India by Prism Books Ltd. on arrangement with W. B. Saunders Company, USA. 4. McNaught & Callander, Illustrated Physiology by B. R. Mackenna & R. Callander, Published by Churchill Livingstone 5. Kaplan, Jack, Opheim, Toivola, Lyon, Clinical Chemistry: Interpretation & Techniques 6. Praful B. Godkar, Textbook of Medical Laboratory Technology, Published by Bhalani Publishing House, Mumbai, India 8. Harsh Mohan, Textbook of Pathology, Published by Jaypee Brothers Medical Publishers Pvt. Ltd., New Delhi

BPH_C_104_T - Biochemistry I (4 Hr/Wk)

Course Objectives At the end of the theory lectures, the learner should be familiar with the basic building blocks of the biomolecules and the biomacromolecules themselves in a biological system, understand the role of vitamins as cofactors in enzyme reactions and be aware of the principles of thermodynamics as they apply to biosystems.

Course Outcomes

The learner should be able to: 1. List and identify the commonly occurring carbohydrates, amino acids and fatty acids 2. Describe higher order structures like oligo- and poly-saccharides/peptides and membrane lipids 3. Classify the different vitamins in terms of their aqueous solubility and the biochemical reactions/role they are involved in. 4. Define the laws of thermodynamics and explain the concepts of Gibbs free energy, favorable and unfavorable reactions and role of ATP and NADH as energy carriers 5. Describe the process of digestion, absorption, storage and retrieval of different cellular nutrients

No. Details Hours 1. Introduction to Carbohydrates:

Introduction to common monosaccharides ranging from trioses to hexoses Introduction to common disaccharides sucrose, cellobiose, maltose, lactose Introduction to common polysaccharides starch and glycogen Introduction to Proteins: Introduction to amino acids, their classification, three letter and one letter codes Introduction to hierarchy of protein structures Introduction to Lipids: Introduction to common saturated and unsaturated fatty acids Introduction to triacyl glycerol, phospholipids, sphingolipids Introduction to Nucleic acids: Introduction to nitrogen bases, nucleosides and nucleotides Introduction to the structure of DNA (helices), melting and annealing of DNA, melting temperature and introduction to higher order packaging of DNA Introduction to the concept of glycoproteins, proteoglycans, lipopolysaccharides, glycolipids, lipoproteins, proteolipids, nucleoproteins, with examples.

22

2. Vitamins Vitamins as co-enzymes and their significance. Biochemical roles of all the vitamins with details of the mechanisms of their functions. (riboflavin, thiamine, pyridoxal, nicotinamide, biotin, folic acid, ascorbic acid, pantothenic acid,

15

147

cyanocobolamine, inositol, vitamins A, D, E, K) 3. Biochemical Energetics

Introduction to the concept of free energy, standard free energy, transformed free energy. Thermodynamically favorable or unfavorable reactions. Spontaneous versus thermodynamically favorable reactions. Oxidations as a source of energy in biological systems. ATP, NADH and FADH2 as energy carriers. Introduction to the concepts of anabolism and catabolism. Convergence of metabolic pathways and divergence of anabolic pathways

8

4. Digestion Digestion of food and absorption of food (carbohydrates, lipids and carbohydrates). Fate of absorbed nutrients and the relationship with regard to immediate use, storage, release and interconversion. Role of liver, muscle, adipose tissue, brain and special features of rbcs.

3

TOTAL 48 Books: 1. Lehninger, Principles of Biochemistry, Replika Press. 2. Stryer L, Biochemistry, W. H. Freeman & Co. 3. Harper’s Biochemistry, Appleton and Lange, USA. 4. Conn E, Stumpf PK, Brueing G and Doi Roy H, Outlines of Biochemistry, Wiley Liss, USA. 5. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry, Lippincott Willliams and Wilkins, USA 6. Foye’s Principles of Medicinal Chemistry, Lippincott Williams and Wilkins, USA.

BPH_C_105_T - Communication Skills and Ethics (3 Hr/Wk)

Course Objectives To teach the learner the importance of English language, the vocabulary and grammar for effective scientific and non-scientific communication and inculcate the importance of Life Skills and Ethics in fulfilling the role as a pharmacist, healthcare provider and a world citizen.

Course Outcomes The leaner should be able to: 1. List and identify verbs and the passive voice 2. Apply skills learnt to confidently stand in a group discussion 3. Apply skills learnt to communicate effectively – technically/businesswise 4. Appreciate and imbibe the importance of ethics, human values, honesty and integrity

No. Details Hours 1. Introduction on language and communication: Review of grammar and vocabulary,

Effective use of dictionary, Phonetics, Meaning and importance of communication, Objectives of Communication. Need for Communication. Types of communication. Written & Verbal communication. Formal and informal communication, upward and downward communication. Non‐Verbal, Body Language and Graphic Language. Barriers to effective communication and how to overcome them; brevity, clarity and appropriateness in communication.

5

2. Technical Communication: Nature, Origin and Development, Factors involved in Technical Communication (Audience, Purpose, Format & Style), Forms of Technical Communication, Five C’s of Technical Communication (Clear, Correct, Concise, Consistent, Comprehensive), Difference between Technical Communication & General Communication

2

3. Business communication: Objectives & Functions of Business Communication, Importance of written business correspondence, Types of Business correspondence: Enquiry, Order letter, Complaint letter, Adjustment letter, Official letters, electronic communication, Routine Letters and Goodwill Messages, Office Drafting: Circular, Notice, and Memo. Telephone Communication and Cell Phone etiquettes Assignment: Drafting of the above types of business correspondence

3

4. Career Skills: Interview skills, Applying for job, Cover letters, Resume and Effective 4

148

Profiling, group discussion, letter writing, e‐mail writing and Netiquettes, Academic Application Drafting, Report writing–preparing rough draft, editing and preparing final report, Presentation Skills: (i) How to make a Power Point presentation (ii) Body language during presentation Assignment: Oral presentations by the students, followed by discussion Mock Interview: Each student to face an interview and to demonstrate the above taught skills

5 Life Skills– Goal-setting; Self-esteem and Self-Confidence; Problem Solving; Decision Making; Time Management; Stress Management; Positive Thinking; Assertiveness; Teamwork; Interpersonal Relationships; Coping with Life Stresses; Suicidal Tendencies; Peer Pressure; Substance Abuse and Addiction. Basic Listening Skills:Introduction, Self-Awareness, Active Listening, Becoming an Active Listener, Listening in Difficult Situations

4

6. Effective and Ethical Communication at work: Flow of communication in organizations, Communication Skills & Success at work, How to overcome typical barriers of Communication and ethical response to office gossip

2

7. Introduction to Ethics and Human Values: Definition – Good Behaviour, Conduct and Character; Importance, Respects for Elders, Use and Relevance in Present-day Society, Individual and Society – Desirable Basic Human Characters - Honesty, Truthfulness, Respect, Punctuality, Responsibility, Courtesy, Discipline, Kindness, courage, Character, Forgiveness, Friendship, Compassion, Consideration, Contentedness, Simplicity, Empathy, Avoiding Greed; Family responsibilities, The 3 Cs of ethics – clarity, courage and creativity,

3

8. Professional Ethics: Need and Importance – Goals, Dignity of Labour dimensions of ethics; ethics in private and public relationships,Ethical Values in Different Professions – Management, Business, Teaching, Civil Services, Politics, Medicine, Policing, Judiciary.

2

9. Ethical Practice in Pharmaceutical Industry: Safety norms, quality norms, clinical trials, packaging, labelling, pricing, distribution, disposal of past-expiry products, advertising, use of medical channels for promotional activities, IPR, Role of R&D, profitability and its linkage to R&D

2

10. Ethics in Media and Technology– Impact on Youth; Cyber Ethics and Etiquette;Mobile Phones, Social Networking; Correct and Judicious Use

1

11. Leadership and Ethics: What is Ethical Leadership? Principles &commandments of ethical leadership, Characteristics of Ethical leader, Ethical decision making

2

12 Group Projects/ Field Work 6 Total 36

Group Projects: (6 Hrs) Students could go on a local field trip and submit an account in about 5 pages. Students can be divided into groups of 5 and one written account can be submitted per group. Different groups can undertake different projects so that the logistics are manageable and there is also sharing of experiences/ideas. Students are advised to prepare a list of questions before hand so that they are more focused. Some suggestions of locations include: Government hospital or dispensary , old age home, Pension Office, Local wholesale market, Industry, Cancer care centre, Orphange, Homes for mentally challenged, etc Books:

1. The right word at the right time A guide to the English language and how to use it, Elison John, The reader’s Digest 2. Study writing, Hamplyons Liz & Ben Heasley, Cambridge University Press. 3. Basic Business Communication, Lesiker Raymond.V and Maire E Hatley, New York, Tata McGraw Hill 4. Business Ethics- A Global and Managerial Perspective, David J. Fritzsche, Tata McGraw Hill 5. Values and Ethics in Organizations – Theory and Practice, S.K.Chakraborty, Oxford University Press (OUP) 6. Ethics Omnibus, S.K.Chakraborty, Oxford University Press (OUP) 7. KK Ramchandran Business communication (Macmilan) 8. Basic communication skills for Technology, Andreja. J. Ruther Ford, 2ndEdition, Pearson Education, 2011 9. Communication skills, Sanjay Kumar, Pushpalata, 1st Edition, Oxford Press, 2011

149

10. Organizational Behaviour, Stephen .P. Robbins, 1st Edition, Pearson,2013 11. Brilliant- Communication skills, Gill Hasson, 1st Edition, Pearson Life. 12. Personality development and soft skills, Barun K Mitra, 1st Edition,Oxford Press, 2011

BPH_C_106_L – General Chemistry – Lab (4 Hr/Wk)

Course Objective On completion of general chemistry Lab, learner should be able to prepare, purify and examine inorganic pharmaceutical agents.

Course Outcomes The learner should be able to:

1) Analyze inorganic mixtures qualitatively by semi-micro methods. 2) Identify different inorganic impurities in inorganic medicinal agents by performing Pharmacopoeial test. . 3) Prepare and purify inorganic pharmaceuticals

Practicals:

1) The background and systematic qualitative analysis of inorganic mixtures of up to four radicals. Six mixtures to be analyzed, preferably by semi-micro methods.

2) Identification tests for pharmacopoeial inorganic pharmaceuticals and qualitative tests for cations and anions should be covered (any two)

3) Limit Test for Impurities in Pharmaceutical Compounds: Chloride, Sulphate and Iron 4) Preparation of Selected Inorganic Pharmaceuticals: Potash alum and ferrous oxalate. 5) Purification of Selected Inorganic Pharmaceuticals: Copper sulphate and ferrous sulphate.

References 1) Svehla G. Vogel's Textbook of Micro and Semimicro-Qualitative Inorganic Analysis. Orient Longman, Hyderabad. Latest

Edition. 2) Indian Pharmacopoeia. The Indian Pharmacopeia Commission, Central Indian Pharmacopeia Laboratory,Govt. of India.

Ministry of Health and Family Welfare, Ghaziabad. Latest Edition.

BPH_C_107_L - Dispensing and Community Pharmacy – (4 Hr/Wk)

Course Objectives The train the learner in the requirements of a dispensing pharmacist and teach pharmacist-patient interactions at the professional level.

Course Outcomes The learner should be able to: 1. Read prescriptions, identify commonly used Latin terms in Pharmacy practice 2. Calculate the quantities of active ingredients and excipients required for compounding the required quantity of formulation (expansion and reduction of formula) 3. Compound, label and dispense extemporaneous formulations 4. Understand patient counseling and patient education methods

No. Details

1 Solutions: 1. Potassium Permanganate Solution 2. Paediatric Ferrous Sulphate Oral Solution BP 1988

2 Suspensions: 1. Paediatric Chalk Mixture BP 1988 2. Kaolin Mixture BP 1988

3

Emulsions: 1. Arachis Oil Emulsion 2. Calciferol Emulsion 3. Medicated cream

4 Ointment/paste: 1. Zinc and Castor Oil Ointment BP 1988 / Calamine Ointment IP 2010/Compound Zinc Paste BP 1988 5 Jelly: 1. Lubricating jelly

6

Powders: 1. Bulk Powder: Compound Magnesium trisilicate Oral Powder BP 1988 /Zinc, Starch and Talc Dusting Powder BPC 1973 2. Divided Powder : HyoscineHydrobromide Powder

150

7 Granules: 1. Isapguhl Granules 2. Effervescent Granules

8 Capsules: 1. Chlordiazepoxide capsules BP 9 Suppositories: 1. Compound Bismuth Subgallate Suppositories BP 1980

10 Incompatibility: 1. Eutectic mixture 11 Community Pharmacy project1: Disease state education flip charts, Video library development, Patient Education

12 Community Pharmacy project2: Presentations on patient counseling with reference to indications, mechanism of action, contraindications and drug interactions of a particular drug.

Patient Education: Training for blood glucose meters • Inhaler and other device use (placebo inhaler cartridge) • Smoking cessation products • Have students offer BP readings to patients picking up anti-hypertensive medications • Have students offer blood glucose logs and a review of medications to patients picking up diabetes medications

Video library development: Have the student develop a video library from which patients could check out videos. The student could gather videos, organize them, and create marketing for the library to advertise it to patients.

Disease state education flip charts: Have the student develop a flip chart (that fits into a standard 3-ring binder) that can be used to educate a patient on a disease state. This standardizes the education that is given to each patient

Books:

1. Cooper and Gunns Dispensing for Pharmaceutical Students, Edns. 11 and 12; Edited by S.J.Carter, IndianEdition, CBS Publishers, Delhi.

2. Pharmaceutical Practice; Edited by D.M.Collet and M.E.Aulton; Churchill Livingstone, ELBS Edition, 1991. 3. Pharmaceutical Practice Edited by A.J.Winfield and R.M.E. Richards, Second Edition, Churchill Livingstone, 1998.] 4. Pharmaceutical Practice; Edited by A.J. Winfild and R.M.E. Richards, Third Edition, Churchill Livingstone,2004. 5. Husa’s Pharmaceutical Dispensing, Edited by Eric Martin, Sixth Edition, Mack Publishing Company, 1996. 6. Pharmaceutical Calculations, A.C. Ansel and M.J.Stoklosa, Lippincott Williams and Wilkins, 2006. 7. Pharmaceutical Calculations – Bradley, Gustafson and Stoklosa, Third Edition, Lea and Febiger, 1957. 8. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBSPublishers & Distributers; 2008. 9. Merchant S.H. and Dr. J.S.Quadry. A textbook of hospital pharmacy, 4th ed. Ahmadabad: B.S. Shah Prakakshan; 2001 10. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of Clinical Pharmacy Practice- essential concepts and

skills, 1 st ed. Chennai: Orient Longman Private Limited; 2004

BPH_C_108_L - Anatomy, Physiology and Pathophysiology – Lab I (4 Hr/Wk)

Course Objectives To familiarize the learner with the diagnostic methods for determination of the pathology of some disease states

Course Outcomes The learner should be able to: 1. Perform RBC count, WBC count, Differential Leukocyte count, ESR, PCV, Bleeding time, clotting time and interpret the results and correlate with clinical conditions and record/measure blood pressure. 2. Identify and locate the bones in human skeleton. 3. Identify and describe the various body tissues and organs based on the structure and organisation of cells. 4. List the common diagnostic and biochemical tests performed in various clinical conditions and make use of it in diagnosis and prognosis of the diseases.

No. Details 1. HEMATOLOGY

1. Red Blood Cell (RBC) Count 2. Total Leukocyte Count 3. Differential Leukocyte (WBC) Count 4. Hemoglobin content of blood 5. Bleeding / Clotting Time 6. Blood groups 7. Erythrocyte Sedimentation Rate (ESR) / Hematocrit (Demonstration)

151

2. Study of human skeleton 3. Microscopic study of permanent slides

Tissues : - Columnar, Cuboidal, Squamous, Ciliated Epithelium - Cardiac / Skeletal / Smooth muscle - Ovary, Testis, Liver, Pancreas, Thyroid, Tongue, Stomach, Intestine, Kidney, Lung, Spinal Cord, Cerebrum, Artery, Vein

4. Measurement of blood pressure 5. Tutorial / Discussion on some common investigational procedures used in diagnosis

of diseases with the help of charts / slides Name and Importance of following tests : 1. Electroencephalogram (EEG) in diagnosis of Epilepsy 2. Use of Positron emission tomography (PET) Computed tomography scan

(CT Scan), Single photon emission computed tomography (SPECT) in diagnosis.

3. Use of flow cytometry as a diagnostic tool. 4. Electrocardiogram (ECG) in diagnosis of cardiac arrhythmia 5. Liver Function Tests –

- Serum Bilirubin, - serum glutamate oxaloacetate transaminase (SGOT) - serum glutamate pyruvate transaminase (SGPT) - Urine Bilirubin,

- Urine Urobilinogen, 6. Kidney Function Tests

– Serum Creatinine, – Serum Urea, Uric Acid – Blood Urea Nitrogen (BUN)

7. Blood Glucose 8. Serum Cholesterol / Triglycerides 9. Serum Alkaline phosphatase (ALT) 10. Serum Acid phosphatase (APT) 11. Serum Lipase 12. Serum Amylase 13. Serum Calcium 14. Serum lactate dehydrogenase (LDH) 15. Thyroid Function Tests – T3, T4 16. Prothrombin time (PT) 17. Partial thromboplastin time (PTT) 18. Activated partial thromboplastin time (APTT) 19. Diagnostic tests for infectious diseases like

- Malaria - Tuberculosis - Dengue - H1N1 swine flu -Typhoid

Books: 1. McNaught & Callander, Illustrated Physiology by B. R. Mackenna & R. Callander, Published by by Churchill Livingstone 2. Kaplan, Jack, Opheim, Toivola, Lyon, Clinical Chemistry: Interpretation & Techniques, Published by Elseviers Publications 3. Praful B. Godkar, Textbook of Medical Laboratory Technology, Published by Bhalani Publishing House, Mumbai, India 4. C. L. Ghai, Text book of Practical Physiology, Published by Jaypee Brothers Medical Publishers Pvt. Ltd., New Delhi

152

SEMESTER-II

BPH_C_201_T - Anatomy, Physiology and Pathophysiology – II (4 Hr/Wk)

Course Objectives To familiarize the learner with the anatomical organization and physiology of the different systems of the human body. To introduce the learner to cancer and the causes of cancer.

Course Outcomes

The learner should be able to: 1. Explain the types of and mechanisms of cellular injuries and cellular adaptation. 2. Compare and contrast between benign and malignant tumours, Classify malignant tumours and explain the etiology and pathogenesis of cancer. 3. Discuss the biological effects of radiations. 4. Explain the anatomy and physiology of the respiratory system, endocrine system, nervous system and the sensory organs. 5. Comprehend the aetiology, pathogenesis, signs, and symptoms of common diseases/disorders of respiratory system, endocrine system and nervous system.

No. Details Hours 1. Principles of cell injury and adaptation

• Causes of cell injury • Pathogenesis and morphology of cell injury. • Cellular adaptation • Cellular atrophy and hypertrophy.

4

2. - Disturbances of growth of cells • Differences between benign and malignant tumor • Classification of malignant tumors • Etiology and pathogenesis of cancer- Invasion, metastasis and patterns of

spread of cancer.

3

3. Biological effects of radiation • Nuclear radiation • U.V. radiation. • X-ray and other radiations.

3

4. Anatomy and Physiology of Respiratory System • Exchange of gases • External and internal respiration • Mechanism and regulation of respiration • Lung volumes and lung capacities

4

5. Pathophysiology of following diseases • Asthma • Pneumonia • Bronchitis • Emphysema • Respiratory Acidosis and Alkalosis

4

6. Endocrine System Anatomy and physiology of following endocrine glands : • Pituitary • Thyroid & Parathyroid • Adrenal • Pancreas

8

7. Pathophysiology of hypo and hyper secretion of above endocrine glands and related diseases

4

8. Nervous System Neurons, Neurotransmitter and neurotransmission Anatomy and physiology of :

• Central Nervous System (CNS) - Autonomic Nervous System (ANS)

- Cranial and spinal nerves

8

153

- Sensory and Motor pathways 9. Pathophysiology of following diseases

• Epilepsy • Parkinsonism • Alzheimer’s Disease • Cerebral Hypoxia • Stroke (Cerebrovascular disease) • Anxiety & Depression • Mania and Schizophrenia

4

10. Structure and Function of following sensory organs • Eye • Ear • Tongue • Nose • Skin

6

TOTAL 48 Books: Latest editions of the following books can be referred 1. Ross & Wilson , Anatomy & Physiology in Health & Illness by Anne Waugh and Allison Grant, Published by Churchill Livingstone 2. Gerard J. Tortora & Bryan Derrickson, Principals of Anatomy & Physiology, Published by John Wiley and Sons, Inc. 3. A. C. Guyton & J. E. Hall, Textbook of Medical Physiology, Published in India by Prism Books Ltd. On arrangement with W. B. Saunders Company, USA. 4. McNaught & Callander, Illustrated Physiology by B. R. Mackenna & R. Callander, Published by Churchill Livingstone 5. Kaplan, Jack, Opheim, Toivola, Lyon, Clinical Chemistry: Interpretation & Techniques 6. Praful B. Godkar, Textbook of Medical Laboratory Technology, Published by Bhalani Publishing House, Mumbai, India 8. Harsh Mohan, Text book of Pathology, Published by Jaypee Brothers Medical Publishers Pvt. Ltd., New Delhi

BPH_C_202_T – Biochemistry II (4 Hr/Wk)

Course Objectives To teach the learner the different pathways of intermediary metabolism, their interplay, metabolism based disorders and drugs to treat the same.

Course Outcomes

The learner should be able to: 1. Discuss carbohydrate metabolism with respect to different pathways, structures of intermediates, enzymes and cofactors involved, energy requirements/yields, regulation and drugs affecting metabolism 2. Discuss lipid metabolism with respect to different pathways, structures of intermediates, enzymes and cofactors involved, energy requirements/yields, regulation and drugs affecting metabolism 3. Discuss nucleic metabolism with respect to different pathways, structures of intermediates, enzymes and cofactors involved, energy requirements/yields, regulation and drugs affecting metabolism

No. Details Hours 1 Carbohydrate metabolism discussed with respect to the structures of

intermediates, enzymes and cofactors, energy yield/requirements and regulation. Examples of drugs modulating carbohydrate metabolism.

20

1.1 Glycolysis (Embden Meyerhoff Pathway), TCA cycle (Kreb’s Cycle, Citric acid Cycle) and glyoxalate shunt. Entry of sugars other than glucose into glycolytic pathway. Discussion of shuttle systems to transfer NADH to the mitochondria.

08

1.2 Electron Transport Chain discussed with respect to the components of the ETC, explanation of oxidative phosphorylation vs substrate level phosphorylation. Discussion of proton motive force and generation of ATP using proton gradients. Discussion of uncouplers of oxidative phosphorylation.

04

1.3 Discussion of pentose phosphate pathway, glycogenesis, glycogenolysis, gluconeogenesis and other systems involved in carbohydrate metabolism

08

2 Lipid metabolism discussed with respect to the structures of intermediates, enzymes and cofactors involved, energy yield/requirements and regulation.

18

154

2.1 Beta oxidation pathway for catabolism of saturated and unsaturated even number fatty acids, catabolism of odd number carbon containing fatty acids, formation of ketone bodies

08

2.2 Acetate mevalonate pathway to cholesterol biosynthesis, 04 2.3 Biosynthesis of fatty acids, prostaglandins, leukotrienes and phospholipids. 04 2.4 Examples of drugs modulating lipid/cholesterol metabolism. 02 3 Nucleic Acid Metabolism discussed with respect to the structures of

intermediates, enzymes and cofactors, energy yield/requirements and regulation 10

3.1 Discussion of biosynthesis of purines. 04 3.2 Discussion of biosynthesis of pyrimidines. 02 3.3 Salvage pathways for nucleic acid metabolism. Examples of drugs modulating

purine/pyrimidine biosynthesis. 04

TOTAL 48 Books 1. Lehninger, Principles of Biochemistry, Replika Press. 2. Stryer L, Biochemistry, W. H. Freeman & Co. 3. Harper’s Biochemistry, Appleton and Lange, USA. 4. Conn E, Stumpf PK, Brueing G and Doi Roy H, Outlines of Biochemistry, Wiley Liss, USA. 5. Wilson and Gisvolds Textbook of Organic Medicinal and Pharmaceutical Chemistry, Lippincott Willliams and Wilkins, USA 6. Foye’s Principles of Medicinal Chemistry, Lippincott Williams and Wilkins, USA.

BPH_C_203_T – Pharmacognosy I (4 Hr/Wk)

Course Objectives This subject highlights the understanding of natural drugs, their cultivation and preparation, phytochemistry and their derivatives used in Allopathic and Complementary Systems of Medicine.

Course Outcomes The learner should be able to: 1 Outline the Alternative and complementary systems of medicine, classify drugs of natural origin 2 Describe Primary and secondary plant metabolites their biosynthesis, evaluation and therapeutic

application 3 Understand the morphological and Microscopic features of medicinal plants 4 Elaborate commercial production, collection, preparation, storage and factors affecting cultivation of

medicinal plants 5 Describe chemistry, source, preparation, evaluation of carbohydrate containing crude drugs and their

commercial utility as Pharmaceutical Aids and Medicines 6 Describe the source, composition, preparation and applications of fibers, minerals, important protein and

enzymes of natural origin. No. Details Hours 1. Introduction, development, present status, significance and future scope of

pharmacognosy. Alternative and Complementary systems of medicine Ayurveda, Unani, Siddha, Homeopathy, Chinese medicine and Aromatherapy. Self study: Examples of sources of DONO • Examples of drugs used in different traditional systems of medicine.

2 1

2 Classification of drugs: Alphabetical, morphological, taxonomical, pharmacological and chemical

1

3 Techniques in microscopy of powdered drugs covering use of mountants, clearing agents, chemomicroscopic reagents, micrometer, quantitative microscopy

2

4 Plant description, morphology, cell differentiation and ergastic cell contents:Study of plant parts, cell and tissue, underground or subterranean drugs,roots, rhizomes, corms, bulb, tubers, stolen, runners, and suckers; Leaves: Simple and compound, stomata, stomata number, stomatal index, palisade - ratio, hydathodes and water pores, epidermal trichomes, calcium oxalate crystals, vein-islet number,vein termination number; Inflorescence and flowers; Fruits; Seeds; Barks, and wood. Unorganised drugs: Dried latex, dried juices, dried extracts, gums and mucilages, resins.

7

155

5 Introduction, classification with examples and important biological activities of following groups of plant constituents: Carbohydrates; Alkaloids, Glycosides, saponins, steroids and triterpenoids Flavonoids, lignans, coumarins, tannins and polyphenolic compounds, Lipids and volatile oils; Gums, mucilages, resins and resin combinations with examples. Details of Phytochemical test for the evaluation of each class

12

6 Cultivation, Collection, Processing and storage of crude drugs: Factors influencing cultivation of medicinal plants. Types of soils and fertilizers of common use. Pest management and natural pest control agents. Plant hormones and their applications. Polyploidy, mutation and hybridization with reference to medicinal plants.

4

7 Study of plant, animal & mineral fibres with respect to their classification, sources, production, chemistry, commercial utility and significance in Pharmaceutical Industry for the following: Absorbent & nonabsorbent cotton, jute, flax, hemp, asbestos, glass wool, silk, wool, rayon, viscose

3

8 Systematic pharmacognostic study of following a)Carbohydrates and derived products: agar, guar gum acacia, Honey, Isabgol, pectin, Starch, sterculia chitin, xanthan gum, tamarind kernel powder (TKP) and Tragacanth. b) Lipids: Bees wax, Castor oil, Arachis oil, Cocoa butter, Shea butter, Cod~liver oil, Hydnocarpus oil, Kokum butter, Lard, Linseed oil, Rice Bran oil, Wheat germ oil, Shark liver oil and Wool fat

7

9 Proteins and Enzymes Study of Proteins and Enzymes with respect to sources, preparation and uses - protein hydrolysates, gelatin, casein, thyroid hormones, proteolytic enzymes (Papain, bromelain, serratiopeptidase, urokinase, streptokinase, pepsin). Study of plant lectins with respect to sources, composition and applications for Abrin, ricin. Self study: • Marketed formulations containing serratiopeptidase and their applications

4 1

10 Biological source, chemical constituents and uses of the following: Chirata, Shatavari, Kalmegh, Karela, Punarnava, Guggul, Tinospora. Self study:Brahmi, Neem,Tulsi, Amla,

2 1

11 Self study: Minerals: Kiselghur, Chalk, Talc, and Bentonite. 1 TOTAL 48

Books 1. Trease D. & Evans W. C.: Text Book of Pharmacognosy: W. B. Saunders. 2. Tyler V.E., Brady L.R. & Robbers J. E.: Pharmacognosy; LeaFeibger, USA. 3. Wallis T. E.;Text Book of Pharmacognosy; CBS Publishers, Delhi. 4. Kokate C.K., Purohit A. P. &Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune. 5. Harbone J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman& Hall, London. 6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited. 7. Vasudevan T.N. &Laddha K.S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon. 8. The Indian Pharmacopeia: The Controller of Publication; Delhi. 9. Brain K.R. & Turner T. D.: ThePractical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol.

BPH_C_204_T – Hospital Pharmacy and Drug Store Management (4 Hr/Wk)

Course Objectives To introduce the learner to the organization and functioning of a retail pharmacy and a hospital pharmacy.

Course Outcomes

The learner should be able to: 1. Appreciate the difference in the functions, layout, legal requirements, organization, drug procurement, storage and dispensing of medicines in a retail versus hospital pharmacy setting. 2. Appreciate the importance of documentation in the functioning of a pharmacy 3. Understand the importance of a hospital level formulation and compounding of parenterals. 4. Understand the importance and functioning of the hospital sterile supply services department 5. Appreciate the dangers/detection/reporting of fraudulent pharmacy practices 6. Appreciate the concept of Rational Drug Therapy

156

Unit No.

Sub-unit

TOPICS DURATION (HOURS)

1 1.1 1.2 1.3

Hospitals: Definition, Organization Structure, Classification, Functions Hospital Pharmacy: Definition, Organization structure, Location, Layout and staff requirements and responsibilities and functions of hospital pharmacists. Budget of Hospital Pharmacy: Preparation and Implementation

2 2 2

2. 2.1 Drug Distribution Systems in Hospitals: Dispensing of drugs to inpatients, types of drug distribution systems, charging policy and labeling, Dispensing of drugs to ambulatory patients, and Dispensing of Controlled Substances including Hospital Control Procedures

4

3 3.1

Pharmacy and Therapeutics Committee (PTC): Objective, composition, Functions, Role of PTC in Drug Safety, Adverse Drug Reaction Monitoring and Emergency Drug Lists.

3

4 4.1 4.2

Hospital formulary: Definition, Advantages and Disadvantages, contents of hospital formulary, Differentiation of hospital formulary and Drug list, Preparation and revision, and addition and deletion of drug from hospital formulary. Medication errors and ASHP Guidelines to prevent errors, Infection control in hospitals (Self Study)

3 2

5 5.1 5.2 5.3

Drug Utilization Review(Self Study) Safe Use of Medications in Hospitals(Self Study) Handling of radiopharmaceuticals in hospitals

2 2 2

6 6.1 6.2 6.3 6.4

Central Sterile Supply Services Introduction to sterilization, basic techniques used for sterilization of hospital supplies Advantages, Plan, Location, Layout Sterilization of surgical dressings – methods of packing, loading and prevention of wetting of dressings. Sterilization of rubber gloves, syringes, needles, catheters, tubing, surgical instruments, mattresses, utensils and bedpans and other accessories Manufacturing and Bulk compounding of large volume parenterals, Total Parenteral Nutrition and Intravenous additives.

2 4 2

7 7.1 7.2 7.3

Planning of retail pharmacy and entrepreneurship (Self-study) Forms of Business Organization: Sole Proprietor, Partnership, Hindu Undivided Family, Joint Stock Company and Co-operative Society Channels of Distribution for Pharmaceuticals: Wholesaler, Retailer

2 2 1

8 8.1 8.2 8.3 8.4 8.5

Setting Up and management of a Drug Store- Legal Aspects and Registrations Selection of site, Space layout, Location Analysis and Layout design and staff Materials- Coding, stocking, maintenance of various registers, Use of Computers: Business and health care soft wares Sales promotion and window display

2 2 1 1 2

9 9.1 9.2

Purchasing and Inventory control in drug store: Purchasing procedure in retail trade Definition of inventory control, various methods of Inventory Control ( Want Book, Systematic Want Book, Open to Buy budgeting, ABC,VED, EOQ analysis),

1 1

10 10.1 Risk management, Insurance policies and Frauds in retail practice 1 TOTAL 48

Books: 1. Hospital Pharmacy, W. E. Hassan, Edition, Lea and Febiger, Philadelphia. 2. A text – book of Hospital Pharmacy, S.H. Merchant and Dr. J.S. Quadry, B.S. Shah Prakashan, Ahmedabad. 3. Hospital Pharmacy, Dr. H. P. Tipnis and Dr. Amrita Bajaj, Career Publication, Maharashtra. 4. Gennaro Alfonso R, Remington – The Science and Practice of Pharmacy”, Lippincott Williams and Wilkins. 5. Principles and methods of Pharmacy Management, Smith, Lea and Febiger, Philadelphia. 6. Drug store management, Nolen and Maynard. McGraw Hill. 7. Drug Store and Business Management, A. P. Battasse, Unique Publication. 8. Text book of Forensic Pharmacy, N. K. Jain, Vallabh Prakashan.

157

BPH_C_205_T - Environmental Science (3 Hr/Wk)

Course Objectives

1. To study the importance of environmental science and environmental studies 2. To know the importance of key to the future of mankind. 3. To study continuing problems of pollution, loss of forget, solid waste disposal, degradation of environment,

issues like economic productivity and national security 4. Study of Global warming, the depletion of ozone layer and loss of biodiversity have made everyone aware of

environmental issues.

Course Outcomes The learner should be able to: 1. Describe the basics of Environmental sciences like need and purpose of study the subject, Ecology, food chain and ecological pyramids, sustainable development 2. Outline, Environmental Legislation, role of different ministries and environment control boards 3. Classify and compare different sources of energies 4. Relate technology to control pollution and economic benefits thereof, infer, the concept of green building, carbon credit and disaster management Realize the environment related moral responsibilities and identify Legal (environmental) aspects for becoming entrepreneur in future

No. Details Hours 1. Multidisciplinary Nature of Environmental Studies:

• Scope and Importance • Need for Public Awareness • Depleting Nature of Environmental resources such as Soil, Water, Minerals,

and Forests. • Global Environmental Crisis related to Population, Water, Sanitation and Land. • Ecosystem: Concept, Classification, Structure of Ecosystem, overview of Food

chain, Food web and Ecological Pyramid

5

2. Sustainable Development • Concept of sustainable development • Social, Economical and Environmental aspect of sustainable development. • Control Measures: 3R (Reuse, Recovery, Recycle), Appropriate Technology,

Environmental education, Resource utilization as per the carrying capacity.

5

3. Environmental Pollution: • Air Pollution: Sources, Effects of air pollution with respect to Global Warming,

Ozone layer Depletion, Acid Rain, Photochemical smog, Two Control Measures, Bag house Filter, Venturi scrubber. Case Study: Bhopal Gas Tragedy

• Water Pollution: Sources and Treatment, Concept of waste waters - Domestic &Industrial and treatment. Case Study: Minamata Disease.

• Land Pollution: Solid waste, Solid waste Management by Land filling, Composting.

• Noise Pollution; Sources and Effects • E-Pollution: Sources and Effects.

11

4. Environmental Legislation: • Overview • Ministry of Environment and Forests (MoE&F). Organizational structure of

MoE&F. • Functions and powers of Central Control Pollution Board. • Functions and powers of State Control Pollution Board. • Environmental Clearance, Consent and Authorization Mechanism. • Environmental Protection Act • Any two case studies pertaining to Environmental Legislation.

5

5. Renewable sources of Energy: • Limitations of conventional sources of Energy.

5

158

Books: 1. Hazardous Waste Incineration, Brunner R.C., McGraw Hill Inc 2. Global Biodiversity Assessment, Heywood V.H and Waston R.T., Cambridge Univ. Press 3. Environmental Science systems & Solutions, Mckinney M.L. and School R.M., Web enhanced edition. 4. Fundamentals of Ecology, Odum E.P., W.B. Saunders Co. USA. 5. Textbook of Environmental studies by Erach Bharucha, University Press. 6. Environmental Studies by R. Rajagopalan, Oxford University Press. 7. Essentials of Environmental Studies by Kurian Joseph & Nagendran, Pearson Education 8. Renewable Energy by Godfrey Boyle, Oxford Publications. 9. Perspective Of Environmental Studies, by Kaushik and Kaushik, New Age International 10. Environmental Studies by. Anandita Basak, Pearson Education 11. Textbook of Environmental Studies by Dave and Katewa, Cengage Learning 12. Environmental Studies by Benny Joseph, Tata McGraw Hill

BPH_C_206_L – Pharmacognosy Lab I (4 Hr/Wk)

Course Objectives This subject highlights the morphological, microscopic and phytochemical evaluation of natural drugs used in Allopathic as well as Complementary Systems of Medicine.

Course Outcomes The learner should be able to: 1 Carry out quantitative microscopy for leaf constants 2 Determine different extractive and ash values as per pharmacopoeial requirements 3 Identify diagnostic features of plants such as calcium-oxalate, starch and trichomes 4 Differentiate between different plant parts based on morphological and microscopic evaluation 5 Identify fibers and carbohydrates based on chemical evaluation No. Experiments 1. Quantitative microscopy (Estimation of Leaf constants i.e. Stomatal Index, Vein islet number and

Vein termination number, Palisade ratio) 2 Determination of alcohol soluble and water soluble extractives, Total ash value and acid insoluble

ash and water soluble ash value for any one crude drug as per IP. 3 Study of different types of starch grains, calcium oxalate crystals, Trichomes and stomata 4 Identification of Fibres based on chemical tests as covered in theory. Tests for detection of honey,

starch, tragacanth, acacia, guar gum, agar 5 Microscopical Studies of basic tissues

a) Stem: Ephedra b) Leaves: Vasaka, Senna c) Roots: Rauwolfia d) Bark: Cinchona e) Seed: Nux vomica, Linseed f) Fruits: Fennel

Books: 1. Trease D. & Evans W. C.: Textbook of Pharmacognosy: W. B. Saunders.

• Various renewable energy sources. • Solar Energy: Principle, Working of Flat plate collector & Photovoltaic cell. • Wind Energy: Principle, Wind Turbines. • Hydel Energy: Principle, Hydropower generation. • Geothermal Energy: Introduction, Steam Power Plant

6. Environment and Technology • Role of Technology in Environment and health • Concept of Green Buildings, Indoor air pollution • Carbon Credit: Introduction, General concept. • Disaster Management: Two Events: Tsunami, Earthquakes, Techniques of

Disaster Management • Case Study: Earthquake in Japan

5

TOTAL 36

159

2. Tyler V.E., Brady L.R. & Robbers J. E.: Pharmacognosy; Lea Febiger, USA. 3. Wallis T. E.; Textbook of Pharmacognosy; CBS Publishers, Delhi. 4. Kokate C.K., Purohit A. P. &Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune. 5. Harborne J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman& Hall, London. 6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited. 7. Vasudevan T.N. & Laddha K.S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon. 8. The Indian Pharmacopeia: The Controller of Publication; Delhi. 9. Brain K.R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol.

BPH_C_207_L - Biochemistry Lab (4 Hr/Wk)

Course Objectives To teach the learner the methods for the detection and estimation of different biomolecules

Course Outcomes The learners should be able to understand the principles and methods for the estimation of: 1. Carbohydrates 2. Amino acids and proteins 3. Fats and Lipids 4. Nucleic acids 5. Enzyme kinetic parameters 6. Enzyme activity as diagnostic markers

EXPERIMENTS 1. Qualitative tests for carbohydrates and confirmatory tests by ozasone formation 2. Qualitative test and simple color reactions for amino acids and proteins. Precipitation reactions of proteins. 3. Chromatographic separation of amino acids. 4. Quantitative estimation of glucose (Willstaters and Lane & Eynon’s methods). Estimation of sucrose. Colorimetric estimation

of glucose. 5. Quantitative estimation of proteins by Biuret method and Folin method (one titrimetry and one by colorimetry) 6. Estimation of enzyme activity – ptyline (amylase) in saliva and alkaline phosphatase (including plotting of data to determine

Km and Vmax for any one of these enzymes) 7. Quantitative estimation of properties of lipids – acid value, iodine value, saponification value. 8. Quantitative estimation of RNA and DNA. 9. Demonstrations of estimation of blood glucose, SGOT or SGPT using commercial kits (suggest that students should

volunteer for fasting and post prandial glucose determinations) 10. Demonstration of isolation of DNA.

Books: 1. An Introduction to Practical Biochemistry – Plummer D.T., Tata Mcgraw Hill, N Delhi, India 2. Laboratory Manual In Biochemisty, Jayaraman J, Wiley Easter, N Delhi. India

BPH_C_208_L - Computer Lab (4 Hr/Wk)

Course Objectives To Introduce the learner to the importance of computers – hardware and software – and their potential applications to the pharmacy profession

Course Outcomes

The learner should be able to: 1. Describe the components of a PC 2. Compare the different operating systems 3. Record simple programs using BASIC and C programming languages 4. Apply knowledge gained for use of computers in pharmacy

No. Details Hours

1. Introduction to Computers. 2 2. History of Computer development and respective generation: Abacus, Napier's Bones, Slide

rule, Pascal's Calculator. General use of computers in everyday life. 5

160

Computer Classification: Mainframe, Mini and Micro Computers, comparison of Analog & Digital Computers, Hardware and Software. Calculator and Computer

3.1

3.2

Operating Systems: Introduction to types of operating systems, UNIX, MS-DOS, etc. RAM, ROM, Virtual Memory etc Students should learn on Windows and Linux OS based systems use of basic Windows and Linux commands

4 4

4.1

4.2

Type of Languages: Conventional languages; their advantages, limitations; C, Pascal, FORTRAN, Programming of these languages Students should be taught some programming in BASIC and C

4 4

5.1

5.2

Introduction to Computer Networks: Architecture of seven layers of communications Students should be taken to a computer lab with has a network and shown the basic connections and operation of different types of networks.

4 3

6.1

6.2

Introduction to Data Structure: Like Queues, list, trees, Binary trees algorithms, Flow chart, Structured Systems, Analysis and development, Ingress-SQL, Gateways etc. Statistics, methodologies. Basic Language: Constants and Variables: Character set, constants, variables, Naming the variables getting data into memory, LET, INPUT, READ. DATA, Print Statement Expressions: Arithmetic expression, Hierarchy of operations, Rules of Arithmetic, Evaluation of expressions, Relational expressions, Logical operations, Library functions Printer Control: Comma and semicolon control, the TAB function, PRINT, LPRINT Functions and Subroutines: User defined functions, subroutines, subscripted variables The above concepts should be introduced practically to students with examples, while working on a computer system.

8

7. Computer Graphics: 5 8. Computer applications in pharmaceutical area and in clinical studies 5

Books: 1. Basic Electronics and Computer Applications, Rajiv Khanna, New Age International Publishers 2. Fundamentals of Computers, V. Rajaraman, Prentice Hall of India Pvt. Ltd. 3. Schaums Outline Series, Theory and Problems of Introduction to Computer Science, Francis Scheid, McGraw Hill Book Co.

161

SYLLABUS FOR S. Y. B. Pharm.

SEMESTER-III

BPH_C_301_T – Organic Chemistry I – (4 Hr/Wk)

Course Objectives 1. To introduce the system of naming organic compounds generally encountered in Pharmacy profession 2. To introduce the learner to the structural features of organic compounds with respect to 2D and 3D features, resonance forms, tautomerism, conjugation, and aromaticity. 3. To introduce the learner to the properties of compounds as dictated by their structures especially the functional groups. 4. To introduce the learner to concepts of reaction kinetics, first/second/zero order rates and equilibrium phenomenon.

Course Outcomes The learner should be able to: 1. Assign IUPAC and stereochemical nomenclature of compounds containing multiple functional groups 2. Predict aromatic character, resonance and tautomerism of compounds 3. Explain the reactivity of compounds based on physicochemical properties 4. Understand the factors affecting equilibria, rates and reaction mechanisms 5. Explain the influence of structure on physicochemical properties and its application to various aspects of pharmaceuticals

No. Details Hours 1 Structure

1.1 Nomenclature of mono/polyfunctional compounds (trivial and IUPAC) (Heterocycles to be excluded).

4

1.2 Hybridization states of C, O and N. 1 1.3 Atomic orbitals, Molecular orbitals of sp3 (ethane), sp2 (ethene), and sp (acetylene) and C

attached to heteroatoms with lone pairs. HOMO and LUMO of ethene and the C=O group.

2

1.4 Basic concepts of electronegativity, hydrogen bonding, inductive effect, dipole moment, log P with examples of monofunctional compounds.

2

1.5 Concept of aromaticity: Huckel’s rule, identification of aromatic, non-aromatic and anti-aromatic systems based on planarity, conjugation and Huckel’s rule.

2

1.6 Resonance in aliphatic and aromatic systems: Rules of resonance and stability of the resonance structures. Tautomerism of keto-enol and imine-enamine systems. Hyperconjugation.

2

1.7 Stereochemistry: Concept of configuration and chirality, axes of symmetry, plane of symmetry, center of symmetry. Representation of molecules using projection formulae - Fischer, Wedge, Sawhorse and Newmann. Geometric Isomerism: Methods of determination of configuration of geometric isomers. Optical isomerism: Enantiomers and diastereomers. Nomenclature of stereoisomers including E and Z, D and L and R and S designations. Conformations of ethane, butane, cyclohexane with their energy profile diagrams. Conformational analysis of mono- and di-substituted cyclohexanes. Types of strains: Angle strain (Baeyer Strain), transannular strain (Prelog Strain), torsional strain (Pitzer strain).

6

2 Ionization, acidity, basicity and pKa (excluding heterocyclic compounds). 6 3 Geometry, stability and properties of the following reactive intermediates: carbocations,

carbanions, carbenes and carbon radicals. Electrophiles and nucleophiles (including charged and neutral species). Concept of leaving groups, alkyl shifts and migratory aptitude.

6

4 Equilibria, rates and mechanisms. 7 5 Mechanism of SN1, SN2, E1 and E2 reactions.

Factors affecting substitution and elimination reactions. Comparison of substitution and elimination reactions.

4

6 Reactivity of the following functional groups: Alkenes, alkynes, alcohols, phenols, alkyl halides, ethers, aldehydes, ketones, carboxylic

4

162

acid and derivatives, amines. (Molecular orbital diagrams for nucleophilic addition to carbonyl group and electrophilic addition to alkene).

7 Influence of the physicochemical properties of the above mentioned functional groups on the following aspects: receptor binding, formulation and degradation.

2

TOTAL 48 Books:

1. Organic Chemistry, Jonathan Clayden, Nick Greeves, and Stuart Warren, Oxford University Press. 2. Organic Chemistry, Stanley H. Pine, James B. Hendrickson, Donald J. Cram, and George S. Hammond, McGraw-Hill Book

Co. 3. Organic Chemistry, John E McMurry, Brooks/Cole Cengage Learning. 4. Textbook of Organic Chemistry, P. S. Kalsi, MacMillan India Limited.

BPH_C_302_T – Physical Pharmacy I – (4 Hr/Wk)

Course Objectives The objective of the course is to train the learner for understanding the basic physical principles underlying pre-formulation testing, formulation development and finished product testing of drug delivery systems.

Course Outcomes The learner should be able to: 1. Understand the various physical phenomena involved in designing of various formulations. 2. Determine various physical parameters of drugs and formulations 3. Predict and anticipate in-process problems based on raw materials and manufacturing methods. 4. Apply the knowledge of physical phenomena in selecting raw materials, including drug, inactive ingredients of appropriate quality leading to stable formulations.

No. Details Hours 1.

1.1 1.2

1.3 1.4

1.5

States of matter Binding Forces between molecules Gaseous state: Ideal and Real gases, ideal gas equation and van der waal’s equation (No derivation), Critical Phenomena Liquid state: Liquefaction of gases, aerosols, vapor pressure, latent heat, boiling point Solid state: Amorphous solids, crystalline solids: crystal lattice and unit cell, crystal defects, polymorphism, melting point, pharmaceutical significance of polymorphs and amorphous solids Liquid crystalline state and supercritical fluid state: Properties and pharmaceutical significance

11

1 2

2 4

2

2 2.1

2.2 2.3

2.4

Physical properties of Drug Molecules Additive, constitutive and colligative properties with examples; Concept of tonicity in pharmacy, methods to adjust isotonicity; Dipole moment, Dielectric constant and significance to pharmacy Refractive index and molar refraction, Principle and working of Abbe’s refractometer and Application of molar refraction to determine structures Optical rotation, Specific rotation, measurement of optical rotation and its applications

7 3

1

1 2

3 3.1

3.2 3.3 3.4

3.5 3.6

Solubility and distribution phenomena Solvent – solute interactions, Ideal and real solutions, Raoult’s law, deviation from Raoult’s law, Azeotropic mixtures. Phase equilibria and Phase rule (one, two and three component systems) Solubility of gases in liquids, Henry’s law and applications Solubility of liquids in liquids, miscible and partially miscible liquids, critical solution temperature and applications. Solubility of solids in liquids, solubility parameters Distribution law, its limitations, modification for weak electrolytes (No derivation) and applications

9 2

1 1 2

2 1

4 Ionic equilibria and buffers 6

163

4.1 4.2 4.3

Strong electrolytes and weak electrolytes, dissociation of weak electrolytes, dissociation constant pH, Sorensen’s pH scale, pH determination (glass electrode) Applications of buffers, buffer equation (Henderson- Hasselbalch equation), buffer capacity, buffers in pharmaceutical and biological systems

2 1 3

5

5.1 5.2

5.3

5.4

5.5

Interfacial phenomena Surface tension, Interfacial tension, Surface free energy Measurement of surface and interfacial tension-capillary rise method, drop number method, Drop weight method, Du Nuoy tensiometer method Spreading of liquids, Spreading coefficient, Surface active agents, Hydrophilic-Lipophilic balance, soluble monolayers Adsorption at solid interfaces, Adsorption isotherms, Freundlich adsorption isotherm, Langmuir adsorption isotherm Wetting, wetting agents and contact angle

9 1 1

3

3

1

6 6.1 6.2 6.3 6.4

Rheology Definition: Rheology, viscosity, Newton’s law of flow, viscosity coefficients for Newtonian fluids Non- newtonian systems: Plastic, pseudoplastic and dilatant, thixotropy and its significance Measurement of flow for newtonian and non-newtonian systems Deformation of solids: Introduction to Elastic, plastic, viscoelastic and fragmentation

6 1 2 2 1

TOTAL 48

Books: Refer to latest editions

1. P. J. Sinko, ‘Martin’s Physical Pharmacy and Pharmaceutical Sciences’ Fifth edition, Lippincott Williams and Wilkins, Indian Edition distributed by B.I. Publications Pvt. Ltd, 2006.

2. Pharmaceutical Dosage Forms And Drug Delivery Systems, Howard C. Ansel,Nicholas G. Popovich, Loyd V. 3. Pharmaceutics: The Science Of Dosage Form Design, Michael E.Aulton 4. Bahl and Tuli, ‘Essentials of Physical Chemistry’ S. Chand and Company Ltd. Ramnagar, New Delhi-110055. 5. Essentials of Physical Pharmacy , C.V.S Subrahmanyum, Vallabh Prakashan 6. Textbook of Physical Pharmaceutics, C.V.S Subrahmanyum, Vallabh Prakashan

BPH_C_303_T – Anatomy Physiology and Pathophysiology III – (4 Hr/Wk)

Course Objectives

1. To teach about anatomy and physiology of reproductive, cardiovascular, urinary and gastrointestinal system. 2. To teach pathophysiology of common diseases associated with reproductive, cardiovascular, urinary and gastrointestinal system.

Course Outcomes

The learner should be able to: TOPIC COURSE OUTCOMES BLOOM’S

LEVEL T1,T3, T5,T8

Explain the anatomy, and physiology of the reproductive system, cardiovascular system, urinary system and digestive system and know the concept, significance and application of ECG

2

T2,T4, T7, T9

Comprehend the etiology, pathogenesis, signs and symptoms of common diseases of the reproductive system, cardiovascular system, urinary system and digestive system

2

T5, T6 State the relevance of various body fluid compartments, electrolyte distribution and acid-base balance.

1

No. Details Hours

1 Reproductive system - Anatomical and Physiological considerations of male and female reproductive system

6

164

- Reproductive and endocrine functions of testes and ovaries - Menstrual cycle

2

Pathophysiology of following diseases - Infertility - Sexually transmitted diseases (STD) - Dysmenorrhea

3

3

Cardiovascular System ‐ Functional anatomy of heart ‐ Conducting system of heart ‐ Cardiac cycle, Electrocardiogram (ECG) ‐Physiology of blood circulation ‐ Functional anatomy of blood vessels ‐ Blood pressure and factors regulating blood pressure ‐ Baroreceptors, chemoreceptors, vasomotor centre ‐ Humoral and neuronal control of blood pressure and circulation

9

4

Pathophysiology of following diseases - Hypertension - Congestive Cardiac Failure - Cardiac Arrhythmia - Angina Pectoris - Ischemic Heart Disease - Arteriosclerosis/Atherosclerosis

5

5

Urinary system ‐ Anatomy and Physiology of Urinary System ‐ Formation of urine ‐ water balance, electrolyte balance & acid – base balance

6

6 Formation of body fluids and fluid compartments. 4

7

Pathophysiology of following diseases - Renal failure - Glomerulonephritis - Renal calculi / kidney stones - Urinary Tract Infections (UTI)

4

8 Digestive System ‐ Anatomy and physiology of digestive system ‐ Digestion and absorption of carbohydrates, proteins and fats

7

9

Pathophysiology of following diseases ‐ Peptic ulceration ‐ Zollinger – Ellison’s Syndrome ‐Inflammatory Bowel Disease (Ulcerative colitis, Crohn’s disease) ‐ Cholecystitis & Cholelithiasis ‐ Jaundice ‐ Hepatitis ‐ Pancreatitis ‐ Achalasia ‐ Reflux esophagitis

4

Total 48

Books: 1. Ross & Wilson, Anatomy & Physiology in Health & Illness by Anne Waugh and Allison Grant, Published by Churchill

Livingstone 2. Gerard J. Tortora & Bryan Derrickson, Principals of Anatomy & Physiology, Published by John Wiley and Sons, Inc. 3. C. Guyton & J. E. Hall, Textbook of Medical Physiology, Published in India by Prism Books Ltd. On arrangement with W.

B. Saunders Company, USA. 4. McNaught & Callander, Illustrated Physiology by B. R. Mackenna & R. Callander, Published by Churchill Livingstone 5. Kaplan, Jack, Opheim, Toivola, Lyon, Clinical Chemistry: Interpretation & Techniques. 6. Praful B. Godkar, Textbook of Medical Laboratory Technology, Published by Bhalani Publishing House, Mumbai, India 7. Harsh Mohan, Textbook of Pathology, Published by Jaypee Brothers Medical Publishers Pvt. Ltd., New Delhi.

BPH_C_304_T – Pharmaceutical Analysis I – (3 Hr/Wk)

165

Course Objectives 1. To introduce the learner to the scope and importance of sample preparation and analytical procedures, pharmacopoeial methods of analysis, and errors associated with analytical procedures. 2. To introduce the learner to the different titrimetric analytic methods like acid-base titrations, complexometric titrations, etc. 3. To introduce the learner to gravimetric and electro-analytical methods of analysis.

Course Outcomes The leaner should be able to: 1. Explain the role of pharmaceutical analysis in the field of pharmacy and industry and delineate between qualitative- quantitative, manual, automatic and electrochemical methods of analysis. 2. Describe volumetric, gravimetric, electrochemical and solvent extraction methods of analysis. 3. Solve numerical problems related to volumetric, gravimetric and solvent extraction methods of analysis and apply simple statistics to numerical data.

No. Details Hours 1 Introduction to Pharmaceutical Analysis 4 1.1 • Scope of Pharmaceutical Analysis, Classification of Quantitative Analytical techniques

(Instrumental and Non-Instrumental). • Introduction to pharmacopoeial monograph –Significance of a pharmacopoeial

monograph. (Only relevance of all the tests and principle of the assay procedures in the monographs mentioned below to be discussed). Active Pharmaceutical Ingredient (API): Aspirin, Calcium gluconate and Dried aluminium hydroxide gel. Formulations: Soluble Aspirin tablets.

2

1.2 • Types of Errors: Determinate and Indeterminate, Causes of errors and ways to minimize them.

• Concept and numericals of: Mean, Median, Standard deviation, relative standard deviation, Absolute and relative errors, precision, accuracy, significant figures.

2

2 Aqueous acid-base titrations. 6 2.1 • Theoretical terms: Titrimetric analysis, Titrant, Titrand, Theoretical end point or

equivalence point, end point of titration, Titration error, conditions for titrimetric analysis, classification of reactions for titrimetric analysis, Expression of concentration of Standard solutions-Molarity- (Analytical and equilibrium molarity), Molality, percent concentration, ppm, ppb, Normality, Primary and Secondary standards.

• Law of Mass Action, Equilibrium Constant, Application of Law of Mass Action to solutions of weak electrolytes, pH, pKa, pKb, hydrolysis of salts (weak base-strong acid, weak acid-strong base, weak acid-weak base), Buffer solutions, Buffer Capacity.

2

2.2 • Neutralization curves-(strong acid versus strong base, weak acid versus strong base, weak base versus strong acidand weak acid versus weak base).

• Neutralization indicators-different theories (Ostwald’s theory, Resonance theory), Mixed indicators, concept of range of indicators, Choice of indicators.

2

2.3 • Methods of titration: Direct titration, back titration and need, blank determination use, significance (one example for each type) and concepts of factor calculation for assay.

• Problems related to calculation of- pH and its numericals with respect to neutralization curve, Strength of Electrolytes (molarity, normality, and milliequivalence), and assay.

• Applications: Assay of benzoic acid, aspirin, sodium hydroxide.

2

3 Non-aqueous titrations 2 3.0 • Theoretical considerations-Need, Types of non-aqueous solvents (aprotic, protophilic,

protogenic, amphiprotic), characteristics of solvents for non-aqueous titrations (acid-base character, dielectric constant, leveling and differentiating effect), Indicators for non-aqueous titrations, Determination of Bases and Acids (solvent, titrants and indicator used).

• Applications: Assay of Sodium benzoate and Acetazolamide.

2

166

4 Complexometric titrations 3 • Terms-Complex, complexing agents (Complexones), chelate, ligand, co-ordination

number, chelating agent, sequestering agent, metal-ligand complex. • Aspects in complex formation with respect to Disodium edetate- Dissociation

constant, pH, Stability, colouration, titrability of polyvalent metal ions, pM indicators, presence of auxiliary complexing agent, and general structure of complexes formed with di-, tri- and tetravalent metal ions.

• Complexometric titrations: Direct method, back titration, replacement titration, titration of mixture of metal ions, masking agent (auxiliary ligand) and demasking agents and titration curve with respect to disodium edetate.

• Applications: Determination of individual cations (aluminium by back titration, nickel by direct titration), determination of mixture of lead, zinc and magnesium in a sample, and assay of calcium gluconate injection.

5 Oxidation – Reduction Titrations 6 5.1 • Terms: Oxidation, Reduction, oxidising and reducing agents, standard reduction

potential, Nernst equation, redox titration curve and equivalence point. 1

5.2 • Theory, indicators, and titrants for :

Permanganometry and Cerimetry, • Applications- Assay of hydrogen peroxide solution (Permanganometry), Assay of

Ascorbic acid tablets, Dried Ferrous sulphate, Paracetamol (Cerimetry).

2

5.3 • Theory, indicators, and titrants for :

Iodometry, iodimetry, potassium dichromate, potassium iodate and potassium bromate titrations.

• Applications- Assay of Ascorbic acid API (Iodimetry), Assay of potassium permanganate (Iodometry), Assay of Potassium iodide (Iodate titration)

2

5.4 • Balancing of redox equation-half cell reaction and net reaction. 1 6 Precipitation Titration 3 6.1

• Theoretical considerations-Common Ion Effect, Solubilty Product, Factors affecting solubility of precipitates, Fractional precipitation.

1

6.2 • Types of Precipitation Titration: Argentometric Titration methods -Mohr’s method, Volhard’s Method and Adsorption Indicator Method.

• Applications: Standardization of silver nitrate, Assay of sodium chloride and potassium chloride.

2

7 Gravimetry 3 7.1 • Theory: Mass as measurement signal and precipitation equilibria, Unit operations in

gravimetric analysis, Organic and inorganic precipitants, precipitation from homogeneous solution.

• Problems associated with gravimetric analysis and methods to overcome (co-precipitation and reprecipitation, Ostwald’s ripening, degree of supersaturation or Von Weimarn ratio, solubility of precipitate, peptisation).

2

7.2 • Applications-Assay of Nickel by dimethylglyoxime, Assay of aluminium by oxine reagent, Assay of Ba+2 as Barium sulphate..

• Numericals related to gravimetric factor

1

8 Miscellaneous methods 2

167

8.1 • Oxygen flask combustion method-technique, apparatus, principle and determination

of organically bound halogens, sulphur and phosphorus, Application- Diloxanide furoate.

• Nitrite titrations- Concept of external indicator and application- Assay of Sulphacetamide sodium

• Determination of nitrogen (Kjeldahl method)-Technique (direct and indirect method), reagents & apparatus used, reaction & factor calculation and numerical for estimation of nitrogen. Application-Assay of Urea (API)

9 Electro Analytical Techniques: 5 9.1 Polarography-

• Apparatus-Construction and working of Dropping mercury electrode (DME), advantages and disadvantages of DME.

• Theory-Current-Voltage curve (Polarogram), supporting electrolyte, Oxygen wave, polarographic maxima, Ilkovic equation, factors affecting limiting current, half wave potential.

• Applications-In brief. • Pulse polarography-Normal pulse polarography, Differential pulse polarography and

square wave polarography).

2

9.2 • Amperometry-DME cell, four types of end points in amperometric titrations, advantages, general applications and Biamperometric titrations.

• Aquametry by Karl Fischer titration: Principle, composition and stability of KFR, standardization of KFR as per I.P, determination of water in a sample-e.g. Amoxycillin trihydrate.

1

9.3 • Coulometry and High Frequency Titration-Faraday’s first law of electrolysis, Current vs Time plot, Cells for coulometric titration and generation of titrant, Types of coulometric methods (potentiostatic and amperostatic), primary and secondary coulometric titrations, advantages of coulometric titrations, and applications in brief.

1

9.4 • Electrogravimetry- Theory of electrolysis – constant current electrolysis and constant potential electrolysis, theory of electrogravimetry- Ohm’s Law, Faraday’s second law of electrolysis, Terminology: polarization, overvoltage, current density, current efficiency, decomposition potential, polarized electrode, types of polarization- concentration and kinetic, apparatus for electrogravimetric determinations, characteristics of the deposit, factors affecting physical properties of the deposit, applications in brief.

1

10 Liquid-Liquid Extraction 2 10.1 • Terms: Nernst Distribution law and partition coefficient, Distribution coefficient,

Distribution Ratio, Percent extraction or extraction efficiency, Separability factor. • Types-Single extraction (Batch), multiple extraction, Countercurrent Distribution and

Continuous extraction. • Factors influencing solvent extraction, Emulsion formation problem in extraction and

ways to minimize. • Examples –Assay of soluble Aspirin tablets.

2

10.2 • Problems based on distribution coefficient. Total 36

168

Books: 1. Practical Pharmaceutical Chemistry by Beckett, A H & Stenlake, J B, 2005, 4thedition, Part I and II, CBS Publishers and Distributors, India. 2. A Textbook of Pharmaceutical Analysis by Kenneth A Connors, 2002, 3rd edition, John Wiley and Sons, Canada. 3. Principles of Instrumental Analysis by Douglas A. Skoog, F. James Holler, 1992, 5thedition, Saunders College Publishing, USA. 4. Fundamentals of Analytical Chemistry by Douglas A. Skoog, Donald M. West, F. James Holler, 1991, 7th edition, Saunders College Publishing, USA. 5. Analytical Chemistry by Gary D. Christian, 6th edition, John Wiley & Sons, Singapore. 6. Vogel’s Textbook of Quantitative Chemical Analysis by Mendham J, R.C. Denney, J.D. Barnes, M. Thomas, 2002, 6th edition, Pearson Education Ltd. 7. Pharmaceutical Drug Analysis by Ashutosh Kar, 2005, 2nd edition, New Age International (P) Ltd Publishers, India. 8. Instrumental Methods of Analysis by S. S. Mahajan, 2010, 1st edition, Popular Prakashan Pvt Ltd, India. 9. Instrumental Methods of Chemical Analysis (Analytical Chemistry) by Gurudeep R. Chatwal and Sham. K. Anand, 2008, 5th revised and enlarged edition, Himalaya Publishing House Pvt Ltd. 10. Indian Pharmacopoeia, 2014 or latest edition. 11. Instrumental Method of Analysis by Willard H.H., L. L. Merritt& John A. Dean, 1986, 6th edition, CBS Publishers & Distributors, New Delhi. 12. Instrumental Method of Chemical Analysis by Ewing Galen W, 1969, 3rd edition, McGraw Hill Book Company, New York. 13. Undergraduate Instrumental Analysis by J.W. Robinson, E.M. Skelly Frame and G.M. Frame II, Pub. Marcel Deckker, 2009 14. Analytical Chemistry, 2nd edition, R. Kellnar, M. Mermet, M. Otto, M. Valcarcel, H. M. Widner.

BPH_C_305_T – Pharmaceutical Engineering – (3 Hr/Wk)

Course Objectives To provide learner with basic understanding of unit operations and related aspects involved in pharmaceutical industry.

Course Outcomes The learner should be able to: 1. Understand mechanics of fluid, fluid flow, and its measurements 2. Classify and describe pumps, heat measuring devices and conveyors 3. Understand basic principles involved in unit operations such as crystallization, evaporation, distillation and refrigeration and will able to describe the equipment and accessories involved therein. 4. Summarize construction material, discuss corrosion of equipment from pharmaceutical industry point. 5. Define and categorize the different industrial hazards.

Note: Under all topics no detailed derivations are to be considered.

No. Details Hours

1 Fluid flow Mention of fluid properties such as viscosity, compressibility and surface tension of fluids. Hydrostatics influencing fluid flow. Fluid dynamics‐ Bernoulli’s theorem, flow of fluids in pipes, laminar and turbulent flow.

3

2 Fluid and pressure measurements Measurement of flow‐ Classification of flow meters, venturi meter, Orifice meter, pitot tube, rotameter and current flow meters. Pressure measurement ‐ Classification of manometers, simple manometer, U tube manometer and modifications, Bourdon gauge.

3

3 Pumps: Positive displacement pumps‐reciprocating pumps, rotary pumps. Centrifugal pumps

2

4 Heat and Mass transfer Modes of heat transfer‐ conduction, convection and radiation, Heat exchangers‐tubular and plate. Temperature measurement‐basic principles and devices. Mass transfer in turbulent and laminar flow. Concept of interfacial mass transfer

3

5 Conveying of solids Belt conveyor, Bucket conveyor, Screw conveyor and Pneumatic conveyor.

1

6 Crystallization 4

169

Crystal forms and crystal habits, Mier’s theory of supersaturation, Nucleation, Crystal growth. Crystallizers‐ Classification, Tank crystallizers, Agitated tank crystallizers, Swenson Walker crystallizer, Vacuum crystallizer and its modifications, Krystal or Oslo crystallizer. Factors affecting crystallization and Caking of crystals

7 Evaporation: Introduction, concept of heat transfer across the wall of evaporator, factors influencing rate of evaporation, including scale formation Evaporators classification ‐ Pan evaporators, Tubular evaporators -Horizontal tube evaporator, Vertical tube evaporators‐ short tube vertical evaporator, Long tube evaporators ‐Climbing film evaporator, Falling film evaporator, Forced circulation evaporator, Wiped film evaporator , and Centrifugal rotary evaporator. Multiple effect evaporator-principle, operation, economy, capacity efficiency and feeding methods of evaporation. Vapor recompression- mechanical and thermal compression principle Evaporator accessories‐ condensers, vacuum pumps, expansion and bucket traps, entrainment separators

6

8 Distillation: Revision of Vapour‐liquid equilibrium. Distillation methods‐ Equilibrium distillation, Simple distillation Fractional distillation‐ Theory of batch fractionation, Columns (only construction and working) Bubble cap, sieve plate columns, valve plate column, packed columns. Concept of plate efficiency with respect to vapor equilibrium diagram and HETP (no detailed theories and derivations). Distillation under reduced pressure‐ Theory and applications of molecular distillation and equipment including falling film and centrifugal molecular distillation still. Azeotropic and Extractive distillation, Steam distillation‐ Theory and applications.

5

9 Refrigeration: Refrigeration – equipment and concept of refrigeration load, concepts of brine systems and absorption systems.

2

10 Materials of construction and Corrosion: Classification into metals and non‐metals. Ferrous and its alloys‐cast iron, mild steel and stainless steel. Copper and its alloys. Nickel and its alloys. Aluminium and its alloys. Plastics‐ Classification into thermoplastics and thermosetting plastics, properties and applications of polyvinyl chloride, polyethylene, polyporopylene, polystyrene, polyester, ABS, phenolic and epoxy plastics, fluorocarbon plastics, chlorinated plastics and polycarbonated plastics. Corrosion: Mechanism and types of corrosion. Factors influencing rate of corrosion. Methods of combating corrosion.

4

11 Industrial Hazards and safety regulations: Mechanical hazards and prevention. Electrical hazards and prevention Chemical hazards and prevention Fire hazards and extinguishers

3

TOTAL 36

Books:

1. K. Sambamurthy, Pharmaceutical Engineering, New age international (P) Limited Publishers, 1998. 2. Dr. A. R. Paradkar, Introduction to Pharmaceutical Engineering, 10th Edition, Nirali Parakashan, 2007. 3. James Swarbrick & James C. Boylon, Encyclopedia of Pharmaceutical Technology, Marcel Dekker, INC, New York, 1994. 4. Walter I. Badger & Julius T. Bancher, Introduction to Chemical Engineering, Mc Graw Hill Inc, 1995. 5. M. E. Aulton, Ed, Pharmaceutics‐The Science of Dosage Form Design, Churchill Livingstone Medical Division Of Longman

Group UK Ltd, 2002. 6. S. J. Carter, Cooper and Gunn’s Tutorial Pharmacy, 6th Edition, CBS Publishers & Distributors, New Delhi, 2005.

170

7. Robert H. Perry, Don W. Green, Perry’s Chemical Engineers Handbook,7th Edition, Don W. Green, James O. Maloney, McGraw Hill,1997.

8. G. K. Jani, Pharmaceutical Engineering, Vallabh Prakashan.

BPH_C_306_L – Organic Chemistry Lab I – (4 Hr/Wk)

Course Objectives 1. To discuss the aspects of occupational safety and hazards of working in a chemistry laboratory. 2. To teach the learner the method for determination of some common and useful physical properties of organic compounds. 3. To teach the learner the method for determination of some common functional groups present in organic compounds.

Course Outcomes The learner will be able to: 1. Practice and follow safety rules and precautionary measures in laboratory. 2. Explain theoretical aspects of physical constant determination, detection of functional groups and Log P 3. Characterize/ Identify/Spot monofunctional or bifunctional organic compounds by physical constant, elemental analysis and

functional group analysis

DETAILS 1. Laboratory safety measures to be taken for:

a. Fire and burns b. Spillage c. Inhalation of toxic fumes d. Dress code in a laboratory e. First aid measures to be taken in cases of accidents f. Use of fume hood, eye shower, body shower.

2. Discussion about theoretical aspects of physical constant determination, and detection of functional groups.

3. Organic spotting: Minimum eight samples of mono‐functional groups, and two samples of bi-functional groups to be taken.

Elemental analysis using environmentally friendly reagents should be done for at least two of the above samples of mono‐functional groups.

4. Demonstration: Determination of Log P of benzoic acid and substituted benzoic acids. Books: 1. A Laboratory Hand Book of Organic Qualitative Analysis and Separations, V. S. Kulkarni, S. P. Pathak, D. Ramchandra & Co., Pune 2. Textbook of Organic Practical Chemistry, V.S. Kulkarni, S. P. Pathak, D. Ramchandra & Co., Pune 3. The Systematic Identification of Organic compounds, R. L. Shriner, R. C. Fuson and D. Y. Curtin, 6th Ed., Wiley, New York, 1980 4. A Textbook of Practical Organic Chemistry, A. I. Vogel, 4th edition, Wiley New York, 1978 5. Comprehensive Practical Organic Chemistry: Qualitative Analysis, V.K. Ahluwalia, S. Dhingra, Universities Press (India) Limited,

2000 6. Comprehensive Practical Organic Chemistry: Preparation and Quantitative analysis, V.K. Ahluwalia, Renu Aggarwal, Universities

Press (India) Limited, 2000 7. DST Monographs

BPH_C_307_L – Physical Pharmacy Lab I – (4 Hr/Wk)

Course Objectives The objective of the course is to teach the learner the methods for the determination of different physical parameters underlying pre-formulation testing, formulation development and finished product testing of drug delivery systems.

Course Outcomes The learner should be able to: 1. To understand the principles and methods for the determination of various physical parameters of drugs and formulations. 2. To carry out various physical tests involved in characterization of drugs. 3. To demonstrate testing of various physical parameters involved in pre-formulation and formulation evaluation.

171

Experiments 1. Determination of refractive index of solid. 2. Polarimetry: Different concentrations of sugar, determination of unknown concentration and specific rotation. 3. Determination of solubility of a drug at room temperature 4. Viscosity determination of Newtonian liquids using Ostwald’s viscometer and to determine the composition of an unknown

binary mixture. 5. Phenol water system – Critical solution temperature and composition 6. Determination of surface tension of given liquids by drop count/ OR drop weight method and study the effect of surfactants in

reducing surface tension/enhance wetting properties. 7. To determine buffer capacity at various stages of titrations of a weak acid against a strong base and hence to determine pKa of the

acid. 8. Determination of partition coefficient of Iodine in CCl4 and water/ OR benzoic acid in benzene and water 9. Adsorption of acetic acid on activated charcoal and determination of specific surface area of charcoal. Demonstration: 10. Determination of HLB number of a surfactant by saponification method

Books:

1. Laboratory Manual of Physical Pharmaceutics, C.V.S. Subramanyam, J. Thimma settee. 2. Practical Physical Pharmacy, U. B. Hadkar, T.N. Vasudevan and K.S. Laddha,

BPH_C_308_L – Pharmaceutical Analysis Lab I– (4 Hr/Wk)

Course Objectives 1. To introduce the learner to pharmacopoeial methods of analysis. 2. To teach the learner the procedures for conducting different titrimetric analysis like acid-base titrations, complexometric titrations, etc. 3. To teach the learner gravimetric methods of analysis.

Course Outcomes The learner should be able to: 1. Employ practice of calibration and proper handling of volumetric apparatus, electronic analytical balance and safety measures in the laboratory. 2. Demonstrate eye- hand co-ordination required for titrimetric analysis. 3. Perform and record, calculate and interpret data obtained for experiments related to volumetric, gravimetric and solvent extraction methods of analysis. 4. Conduct and evaluate various tests mentioned in a pharmacopoeial monograph NOTE: For all the experiments, Indian Pharmacopoeia 2014/ latest edition has to be referred. No. Details Acid-Base titrations: 1. Assay of Aspirin (with special emphasis on the test for salicylic acid). 2. Assay of Aspirin tablets 3. Estimation of Total alkalinity in a solution of Sodium Hydroxide 4. Assay of Benzoic acid Redox titrations: 5. Assay of hydrogen peroxide solution (Permanganometry). 6. Assay of Ascorbic acid tablets (Iodimetry). 7. Assay of Sodium metabisulphite (Iodometry) 8. Assay of potassium permanganate (Iodometry) 9. Assay of Dried Ferrous sulphate/ Ferrous fumarate/ Paracetamol (Cerimetry). 10. Assay of Potassium iodide (Iodate titration) Complexometric titrations: 11. Assay of Calcium gluconate. 12. Assay of Zinc sulphate.

13. Assay of Magnesium sulphate. Miscellaneous titrations:

172

14. Assay of Sulphacetamide sodium using external indicator. 15. Assay of Soluble Aspirin tablets (Solvent extraction followed by Bromometry-iodometry Gravimetric analysis: 16. Ni2+ using Dimethyl glyoxime/ Al3+ as Aluminium oxinate. 17. Ba2+ as barium sulphate Introduction to the study of monograph: 18. Monograph of ascorbic acid tablets/ Calcium gluconate Demonstration titrations: 19. Assay of Pyridoxine hydrochloride/ Sodium benzoate using non-aqueous titration method 20. Assay of Sodium chloride 21. Assay of Potassium chloride

Books: 1. Indian Pharmacopoeia, 2014 or latest edition. 2. Practical Pharmaceutical Chemistry by Beckett, A H & Stenlake, J B, 2005, 4thedition, Part I and II, CBS Publishers and Distributors, India. 3. Analytical Chemistry by Gary D. Christian, 6thedition, John Wiley & Sons, Singapore. 4. Vogel’s Textbook of Quantitative Chemical Analysis by Mendham J, R.C. Denney, J.D. Barnes, M. Thomas, 2002, 6th edition, Pearson Education Ltd. 5. Pharmaceutical Analysis –A Textbook for Pharmacy Students and Pharmaceutical Chemists by David G Watson.

173

SEMESTER-IV

BPH_C_401_T – Organic Chemistry – (4 Hr/Wk)

Course Objectives 1. To introduce the learner to the synthetic methods for the introduction of different functional groups in a molecule and different methods for interconversion of some functional groups using synthetic methods. 2. To introduce the learner to the different nucleophilic reactions of carbonyl compounds and different electrophilic reactions of alkenes. 3. To introduce the learner to nucleophilic and electrophilic reactions of aromatic compounds.

Course Outcomes The learner should be able to: 1. Outline few methods of preparation for various functional groups 2. Understand how and why the C=O group reacts with nucleophiles (using molecular orbitals and curly arrows) to give varied products 3. Predict the molecules that can be synthesized by reaction of C=C groups with electrophiles 4. Understand reactivity of aromatic systems towards electrophiles and nucleophiles

Emphasis to be placed on reaction mechanisms of the reactions from Unit 2 onwards

No. Details Hours References

1.0 Preparation of following functional groups: (Only reactions to be discussed without mechanisms)

6 Organic Chemistry, R. T. Morrison, R. N. Boyd, S. K. Bhattacharjee, Pearson Education, 7th Ed. 1.1 Alcohols by Grignards reagent, phenols by hydrolysis of

diazonium salts 1.2 Aldehydes & ketones by oxidation of primary &

secondary alcohols, Oxidation of methyl benzenes 1.3 Amines by reduction of nitro compounds 1.4 Carboxylic acids by oxidation of alcohols and hydrolysis

of nitriles 2.0 Nucleophilic addition to C=O group 6 1. Organic Chemistry, Jonathan

Clayden, Nick Greeves, and Stuart Warren, Oxford University Press, 2nd Ed., Chapter 6. 2. Organic Chemistry, R. T. Morrison, R. N. Boyd, S. K. Bhattacharjee, Pearson Education, 7th Ed., Chapter 12.

2.1 Nucleophilic addition to aldehydes, ketones (e.g. attack of cyanide, hydride, organolithium, Grignard reagents, water and alcohols to form hemiacetals in acidic/basic conditions)

2.2 Cannizzaro and crossed - Cannizzaro reaction

3.0 Nucleophilic substitution to C=0 group 10 1. Organic Chemistry, Jonathan Clayden, Nick Greeves, and Stuart Warren, Oxford University Press, 2nd Ed., Chapter 10. 2. Organic Chemistry, R. T. Morrison, R. N. Boyd, S. K. Bhattacharjee, Pearson Education, 7th Ed., Chapter 14

3.1 Concept of leaving group based on stability and pKa with reference to carboxylic acid derivatives

3.2 Discussion of tetrahedral intermediate 3.3 Examples to be discussed: Conversion of acid chloride to

esters and amides, transesterification reaction. 3.4 Comparison of reactivity of various carboxylic acid

derivatives, Interconversion of carboxylic acid derivatives

3.5 Acid and base catalyzed hydrolysis of esters, amides. 3.6 Strategies of converting ketones to esters 3.7 Nucleophilic substitution at C=O with loss of carbonyl

oxygen. (Examples to be discussed: Conversion of aldehydes and ketones to imine, oxime, hydrazine, semihydrazone and semi carbazide.)

1. Organic Chemistry, Jonathan Clayden, Nick Greeves, and Stuart Warren, Oxford University Press, 2nd Ed., Chapter 11. 2. Organic Chemistry, R. T.

174

Morrison, R. N. Boyd, S. K. Bhattacharjee, Pearson Education, 7th Ed., Chapter 12

3.8 Wittig reaction 4.0 Electrophilic addition to alkene 8 1. Organic Chemistry, Jonathan

Clayden, Nick Greeves, and Stuart Warren, Oxford University Press, 2nd Ed., Chapter 19. 2. Organic Chemistry, R. T. Morrison, R. N. Boyd, S. K. Bhattacharjee, Pearson Education, 7th Ed., Chapter 6.

4.1 Addition of bromine*, water, HBr (in presence and absence of peroxide) to alkenes, dimerization, oxymercuration-demercuration*, hydroboration-oxidation*, oxidation of alkenes to epoxide*, periodate cleavage and ozonolysis*, reaction with N-bromo succinimide. (*Stereochemical aspects to be covered)

5.0 Enols and Enolates 6 1. Organic Chemistry, Jonathan Clayden, Nick Greeves, and Stuart Warren, Oxford University Press, 2nd Ed., Chapter 20

5.1 Formation and stability of enols (Pgs. 449-458) 5.2 Aldol condensation reaction, crossed Aldol and mixed

aldol reaction, Claisen and Crossed Claisen, Mannich reaction, Dickmann reaction.

2. Organic Chemistry, R. T. Morrison, R. N. Boyd, S. K. Bhattacharjee, Pearson Education, 7th Ed.

5.3 Conjugate addition : 1,2 and 1,4 Michael addition reaction

Organic Chemistry, Jonathan Clayden, Nick Greeves, and Stuart Warren, Oxford University Press, 2nd Ed., Pg. 504.

6.0 Electrophilic aromatic substitution 8 1. Organic Chemistry, Jonathan Clayden, Nick Greeves, and Stuart Warren, Oxford University Press, 2nd Ed., Chapter 21. 2. Organic Chemistry, R. T. Morrison, R. N. Boyd, S. K. Bhattacharjee, 7th Ed., Pearson Education.

6.1 Nitration, sulphonation, halogenation, Friedel-Crafts alkylation and Friedel Crafts acylation.

6.2 Kolbe reaction, Reimer-Tiemann reaction 6.3 Orientation and reactivity of mono and di-substituted

benzene towards electrophilic aromatic substitution reaction.

7.0 Nucleophilic aromatic substitution 4 1. Organic Chemistry, R. T. Morrison, R. N. Boyd, S. K. Bhattacharjee, Pearson Education, 7th Ed. Ch. 9

7.1 Mechanistic approach of nucleophilic aromatic substitution (Bimolecular displacement and benzyne formation)

TOTAL 48 Books: Already referred to in the syllabus outline

BPH_C_402_T – Physical Pharmacy II – (4 Hr/Wk)

Course Objectives On completion of the theory lectures, the learner should be familiar with the basic concepts of chemical kinetics, drug diffusion and dissolution, biopharmaceutics, complexation, coarse and colloidal dispersions, which in turn, will help the learner in design, development and evaluation of dosage forms.

Course Outcomes The learner should be able to: 1. Identify order of reactions, pathways of drug degradation and types of drug complexes 2. Describe Fick’s laws of diffusion, mechanism of drug dissolution and absorption 3. Acquire understanding of drug complexes, protein binding and their applications 4. Gain knowledge of the basic principles of coarse and colloidal dispersions 5. Apply basic principles of drug characterization to biopharmaceutical aspects of drug delivery

No. Details Hours 1

1.1 Chemical kinetics and drug stability Molecularity, order of a reaction, specific rate constant

11 2

175

1.2

1.3

1.4

Reaction kinetics: zero, pseudo-zero, first & second order (problems), units of basic rate constants, determination of reaction order, Energy of activation Physical and chemical factors influencing the chemical degradation of pharmaceutical product: temperature, solvent, ionic strength, dielectric constant, specific & general acid base catalysis. Accelerated stability testing in expiration dating of pharmaceutical dosage forms.

4

3

2 2

2.1 2.2

2.3 2.4 2.5 2.6

Dissolution and diffusion Diffusion: Concept, and applications, diffusion through biological membranes, drug release Fick’s Laws of diffusion, Steady state diffusion, driving forces for diffusion in pharmaceutical systems, permeability Measurement of diffusion Concept of dissolution, dissolution mechanism Noyes Whitney equation, factors affecting dissolution Intrinsic Dissolution Rate, Hixson – Crowell Law, measurement of dissolution rates

9 2

3 1 1 1 1

3 3.1 3.2 3.3 3.4

Complexation and protein binding Introduction, classification of complexes Pharmaceutical applications of complexes Method of analysis of complexes Protein binding, complexation and drug action, stability constants

6 2 1 1 2

4 4.1 4.2 4.3 4.4

4.5

Coarse dispersions Classification of dispersions, properties of coarse, colloidal and molecular dispersions Thermodynamic and kinetic stability of dispersed systems Electric Properties of Interfaces: Nernst and zeta potential, effect of electrolytes Suspensions: DLVO theory, flocculated and deflocculated systems, controlled flocculation, physical stability of suspensions Emulsions: Theories of emulsification, physical stability of emulsions

8 1 1 1 3

2 6

6.1 6.2 6.3 6.4

Colloids Classification and preparation Colloid properties: optical, kinetic and electrical Stability of colloids and Schultz Hardy rule, Protective colloid and gold number Pharmaceutical applications of colloids

7 2 2 2 1

7 7.1 7.2 7.3 7.4

Biopharmaceutics Introduction to biopharmaceutics and Pharmacokinetics, concept of ADME, bioavailability Mechanisms of drug absorption Factors affecting drug absorption: Physicochemical, physiological and dosage form factors Introduction to Biopharmaceutical Classification System of drugs

7 2 1 3 1

TOTAL 48

Books:

Refer to latest edition

1. P. J. Sinko, ‘Martin’s Physical Pharmacy and Pharmaceutical Sciences’ Fifth edition, Lippincott Williams and Wilkins, Indian Edition distributed by B.I. Publications Pvt. Ltd, 2006.

2. Pharmaceutical Dosage Forms And Drug Delivery Systems, Howard C. Ansel, Nicholas G. Popovich, Loyd V. 3. Pharmaceutics: The Science Of Dosage Form Design, Michael E.Aulton 4. Bahl and Tuli, ‘Essentials of Physical Chemistry’ S. Chand and Company Ltd. Ramnagar, New Delhi-110055. 5. Essentials of Physical Pharmacy , C.V.S Subrahmanyum, Vallabh Prakashan. 6. Textbook of Physical Pharmaceutics, C.V.S Subrahmanyum, Vallabh Prakashan

BPH_C_403_T – Pharmaceutics I – (3 Hr/Wk)

Course Objectives To furnish the students with introduction to Pharmaceutics and preliminary knowledge that is required in the field of formulation development and details of Monophasic liquids, Powders and Biological preparations.

Course Outcomes The learner should be able to: 1. Describe the status of Pharma Industry in India and elaborate on the different official compendia, recall the various types of dosage forms, routes of administration and describe the alternate systems of medicine. 2. Explain the concepts and need for GMP & QA and preformulation.

176

3. Summarize the packaging of pharmaceuticals 4. Explain the formulation considerations, unit operations, Q.A. aspects of monophasic systems, and powders. 5. Classify, describe the various biological products, viz. sutures & ligatures, blood products and plasma volume expanders.

No. Details Hours 1. Introduction-

Historical background of Profession of Pharmacy in India in brief Brief overview of status of Pharmaceutical Industry in India Pharmacopoeias-IP, BP & BPC, USP/NF, International Pharmacopoeia, Eur. Pharmacopeia

2

2. Overview – Revision of dosage forms and routes of administration Introduction to alternate systems of medicine-Ayurveda, Homeopathy, Unani & Siddha Concepts of GMP & Quality Assurance in Pharma Industry Preformulation-importance and need.

2

3. Packaging of Pharmaceuticals- General concept of package and its components-primary & ancillary packs, basic packaging materials- glass, plastics, metals, rubber and paper; types of containers and closures; quality control tests; brief on adhesives and printing inks.

2

4. Monophasic Liquid dosage forms:Preformulation & formulation aspects General considerations of liquid dosage form design and manufacture-selection of vehicle and excipients; solubility and solubilisation techniques, dissociation and partitition coefficient, polymorphism, organoleptic properties, stability with excipients. Large scale Manufacturing aspects-Unit operations and equipment used: liquid mixing, clarification and filtration, filling operations, packaging and quality control tests. Brief coverage of following monophasic dosage forms- Solutions, Aromatic waters, Syrups, Elixirs, Linctuses, Nasal & Ear drops, Paints, Sprays, Lotions & Liniments.

10

5. Micromeritics & Powder Technology: Preformulation & formulation aspects Basics of micromeritics-Fundamental and derived properties of powders and their measurement-particle shape & size, surface area, densities, flow properties, packing properties, fluidization of powders. Large scale manufacturing aspects- Unit operations and equipment used: Size reduction, size separation, powder mixing, segregation of mixed powders; packaging & Q.C. of powders. Brief coverage of following powders-Dusting powders, Oral rehydration powders, Dry syrup formulations.

10

6. Biological products- Sutures & ligatures- Definition, classification, cat gut manufacturing and processing, other absorbable sutures-natural & synthetic; Nonabsorbable sutures- silk, linen, polyamides, polyesters, polyolefins, and metallic wires; Quality control tests for sutures/ligatures Blood products: Need, problems/hazards, blood banking procedures Whole human blood, Red cell concentrate, Platelet concentrate, Plasmapheresis, plasma, serum; Fractionation of plasma, study of some fractions-clotting factors like fibrinogen, AHF, factor IX complex, prothrombin, albumin preparations, γ globulin preparations. Quality control aspects of blood products Plasma substitutes (plasma volume expanders)- Need, desired properties, examples- hydrolyzed gelatin based products, HETA starch, Dextran (in detail –source, preparation, official injections )

10

Total 36 Books- 1. Lachman Leon, Lieberman Herbert A, Kanig Joseph L., “The Theory and Practice of Industrial Pharmacy, Varghese Publishing House, Mumbai. 2. Remington, The Science and Practice of Pharmacy, Vol I & II, B.L. Publications Pvt. Ltd. 3. Martin A., Physical Pharmacy, 4th Edition, Lea & Febiger, Philadelphia, London. 4. M.E. Aulton, Ed, Pharmaceutics-The Science of Dosage Form Design, Churchill Livingstone Medical Divison of Longman Group, UK Ltd. 5. Rawlings, Bentley's Text Book of Pharmaceutics, Bailliere Tindall, London. 6. Atmaram Pawar, "Introduction to Pharmaceutics”, Career Publications, Nashik 7. Pharmacopoeias- IP, BP, USP

177

BPH_C_404_T – Pharmacology I – (4 Hr/Wk)

Course Objectives 1. To educate about general principles of Pharmacology, drug actions, routes of drug administration, pharmacodynamics and

pharmacokinetics. 2. To impart knowledge on the effect of drugs on the human body and the mechanisms by which they produce

biological/therapeutic/toxic effects. 3. To impart knowledge about the pharmacology of drugs acting via receptors of Autonomic nervous system. 4. To educate on the pharmacology of drugs used for cardiovascular disorders. 5. To educate on pharmacology of diuretic drugs.

Course Outcomes The learner should be able to:

TOPIC COURSE OUTCOMES BLOOM’S LEVEL T1 Define the scope, general principles and applications of Pharmacology.

Comprehend pharmacokinetic and pharmacodynamic principles along with ability to compare and contrast various routes of administration with advantages and disadvantages. Understand the factors modifying drug action.

1 and 2

T2 Classify receptors and elucidate their role in drug/neurotransmitter/hormone action. Understand the mechanisms of drug action.

2

T3 Explain autonomic transmission and discuss the pharmacology of drugs acting on ANS and rationalize their therapeutic applications.

2 and 3

T4, T5 Explain the pharmacology of drugs acting on cardiovascular system and as diuretics and discuss their use in associated diseases

2 and 3

No. Details Hours

1

General Principles of Pharmacology • Introduction to Pharmacology • Routes of drug administration with special reference to their advantages and disadvantages. • Drug Absorption, Distribution, Metabolism & Excretion (ADME)

• Factors modifying action of drug

8

2

Mechanisms of drug action • Brief introduction to physiological receptors • Structural and functional families of receptors • Mechanisms of drug action: ‐Drug receptor interaction ‐Dose response curve (DRC) ‐Drug antagonism

8

3

Autonomic nervous system • Autonomic neurotransmission • Parasympathomimetics • Parasympatholytics • Sympathomimetics • Sympatholytics • Drugs acting on autonomic ganglia • Skeletal muscle relaxants

16

4

Cardiovascular system • Drugs used in the treatment of: ‐ Congestive cardiac failure ‐ Hypertension ‐ Cardiac arrhythmia ‐ Angina pectoris ‐ Hyperlipoproteinemia

13

5 Diuretics 3 Total 48

178

Books: 1. Goodman & Gilman’s Pharmacological Basis of Therapeutics; Joel. G, Hardmon Lee, E. Limbird, Alfred Goodman Gilman;

11th Ed.; The Mcgraw‐Hill Companies, Inc; 2011. 2. Pharmacology and Pharmacotherapeutics; R.S. Satoskar, S.D. Bhandarkar, Nirmala N. Rege; 20th Ed.; Popular Prakashan;

2007. 3. Pharmacology; Rang and Dale; 7th Ed.; Churchill Livingstone; 2012. 4. Lippincott’s Illustrated Reviews: Pharmacology, Lippincott‐Raven; 3rd Ed.; Howland & Nycets Publishers, N.Y.; 2006. 5. Lewis Pharmacology; Crossland; 5th Ed. Churchill Livingstone. 6. Clinical Pharmacology‐ Lawrence, D.R and Bennet‐ 9th Ed.; Elsevier, N.Y. 2006. 7. Clinical Pharmacology‐ B.G. Katzung; 11th Ed.; Appleton & Lange Publications, 2009. 8. Pharmacology; George M. Brenner, Craig W. Stevens; 2nd Ed.; Elsevier Publishers, 2006. 9. Essentials of Medical Pharmacology, K. D. Tripathi, 7th ed, Jaypee Publishers.

BPH_C_405_T – Microbiology – (3 Hr/Wk)

Course Objectives 1. To discuss the scope, history of microbiology and applications in pharma industry, classification of microorganisms and Learn different microscopy techniques and principles of different staining techniques. 2. To understand Structural organization and multiplication of bacteria, viruses, algae, protozoa, and fungi, Nutritional requirements of bacteria and study diseases related to them ; different media used for bacterial culture; growth curve and different methods to quantify bacterial growth 3. To study physical and chemical control of microorganisms, different methods of sterilization, validation of sterilization methods 4. To learn Microbiological standardization of Pharmaceuticals: Bioassay, Microbial limit tests, Sterility testing of pharmaceutical products and preservation of pharmaceutical products

Course Outcomes The learner should be able to: 1. Describe the classification of microorganisms and list some of the common diseases caused by them. 2. Use different microscopic techniques, staining techniques, and differential media for the identification of some common disease causing microorganisms. 3. Describe different methods for the control of growth of microorganisms and methods of preservation/sterilization of pharmaceutical products. 4. Describe the importance of microbial testing and microbial limit tests for some pharmaceutical products

No. Details Hours

1 5 1.1 Introduction to Microbiology, Brief history, Scope of Microbiology‐Basic & Applied,

Relevance and Applications in Pharmaceutical Industry. 1

1.2 Classification of Microorganisms, Prokaryotic and eukaryotic microorganisms, Microbes and the environment.

1

1.3 Microscopy, Simple microscope, Compound microscope, resolving power, magnification, angular aperture, numerical aperture, Dark field microscopy, phase contrast microscopy, fluorescent microscopy, electron microscopy.

2

1.4 Information used to characterize and identify microorganisms (in brief) ‐ morphological, cultural, biochemical (metabolic), antigenic, pathogenic, genetic characteristics.

1

2 15 2.1 Bacteria - Morphology, Cell characteristics, Habitat, Nutritional requirements, Cultivation

of bacteria, Culture media‐ Cultivation & Storage media, Cultivation of aerobes and anaerobes.

3

2.2 Pure culture, Methods to isolate pure cultures, Preservation of cultures. Reproduction of bacteria, Growth phases, Measurement of growth (enumeration), factors affecting growth, continuous cultivation.

2

2.3 Overview of bacterial diseases and the pathogens causing them‐ Mycobacterium sp., Salmonella sp., Shigella sp., Staphylococci sp., Pseudomonas sp., Klebsiella sp., Clostridium sp, Vibrio sp.

2

2.4 Viruses & related microorganisms - Morphological characteristics, Nutritional aspects, Cultivation and reproduction, HIV and Oncogenic viruses.

2

2.5 Rickettsiae and Chlamydiae‐ Morphological characteristics, Cultivation, Rickettsial & 1

179

Chlamydial diseases. 2.6 Major groups of Eukaryotic microorganisms -

Fungi‐Morphological characteristics, Classification, Reproduction of fungi, Cultivation of fungi, Culture media, Study of some important fungi‐ Penicillium, Aspergillus, Candida, Saccharomyces. Fungal infections‐Mycoses

2

Algae ‐ Classification, Morphological characteristics, reproduction, economic significance of algae.

1

Protozoa‐ Morphological characteristics and classification, reproduction, pathogenic protozoa like Amoeba, Paramecium, Trichomonas, Plasmodium

2

3 11 Control of Microorganisms

3.1 Fundamentals of Microbial Control ‐ Pattern of Death in a Microbial population, Conditions affecting Antimicrobial activity, Mechanisms of microbial cell damage, Survivor curves and concepts of D ‐ value and Z‐ value. Inactivation factor.

2

3.2 Sterilization methods & Equipment‐ Heat Sterilization methods (Moist heat, dry heat, low temperature sterilization methods), Radiation Sterilization, Ionizing and non‐ionizing radiations, Filtration Sterilization, Gaseous Sterilization. Evaluation of the efficiency of sterilization methods, Equipment employed in large scale sterilization, Sterility indicators.

5

3.3 Chemical agents used for control of microorganisms‐ Terminology of Chemical agents, Ideal properties, Major groups of disinfectants and antiseptics (with mechanisms and applications), Chemical sterilants, Evaluation of potency‐ Tube dilution & Agar plate methods, Phenol Coefficient technique, Tissue toxicity index

4

4 5 4.1 Introduction to Aseptic techniques (no equipment) Designing of aseptic area, laminar flow

equipment; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification as per ISO and USFDA. General aspects-environmental cleanliness and disposal of microbial waste.

1

4.2 Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP

1

4.3 Principles and methods of different microbiological assay. Methods for standardization of antibiotics, vitamins and amino acids. Assessment of a new antibiotic and testing of antimicrobial activity of a new substance

1

4.4 Microbial limit tests : Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources and types of microbial contaminants, assessment of microbial contamination and spoilage.

1

4.5 Preservation of pharmaceutical products using antimicrobial agents, evaluation of microbial stability of formulations.

1

Total 36

Books: (Latest editions should be referred) 1. M.J. Pelzer Jr., E.C.S. Chan and N.R. Krieg “Microbiology Concepts and Applications” McGraw Hill, Inc., USA, 1993. 2. M.Frobisher, R.D. Hinsdill, K.T. Crabtree and C.R. Goodheart “Fundamentals of Microbiology”, 9th Edn. Saunders College Publishing, Philadelphia 1968. 3. W. B. Hugo and A. D. Russel “Pharmaceutical Microbiology” 6th Edn. Blackwell Science Ltd. UK, 2003. 4. R. Ananthanarayan and Ck. J. Panicker “Textbook of Microbiology”, 7th edn. Orient Longman Pvt. Ltd. Hyderabad, 2005.

BPH_C_406_T – Mathematics and Statistics – (3 Hr/Wk)

Course Objectives

180

1. To teach the learner the basic principles of calculus, differentiation and integration, and determinants and matrices and their application in several other specialized pharmacy subjects. 2. To convey to the learner the importance of statistics and statistical methods in data analysis and results interpretation and as an extension in experimental design.

Course Outcomes The learner should be able to: 1. Know the theoretical concepts of topics and their application in Pharmacy 2. Solve the different types of problems by applying theoretical concepts. 3. Appreciate the important application of mathematics and statistics in Pharmacy.

No. Details Hours

1 Calculus: Differentiation 5

Introductions, Derivative of a function, Derivative of a constant, constant and a function, sum or difference of two functions, product/quotient of two functions(product/quotient formula),Derivative of 𝑥𝑛w.r.t x, 𝑙𝑜𝑔𝑒𝑥, 𝑎𝑛, Successive differentiation, Lagrange's and Rolle's Mean Value Theorems(Statements only), Taylors and Maclaurins Series with application.

2 Analytical Geometry: Integration 5

Definition, standard formulas, rules of integration, method of substitution, integration by parts, definite integration, Application(determination of the length of the curve, area and volume)

3 Differential Equations 4

Formation of differential equations, solution of first-order and first-degree equation, linear differential equations of higher order with constant coefficients.

4 Determinants and Matrices 4

Properties of determinants and application of Cramers method, types of matrices, inverse of matrix, rank of matrix.

Statistics

5 Measurement of Central Tendency 4

Arithmetic Mean, median and mode

6 Measures of Dispersion 7

Range, quartile deviation, mean deviation and standard deviation, coefficient of variation, probability, Binomial, Poisson and Normal distribution, Fitting of curves by the method of least squaresY= a + bX, Y=𝑎𝑏𝑥, Y=𝑎𝑋𝑏

7 Sampling distribution for mean and proportion 7

Test of hypothesis for specified values of mean and proportion for large samples, Testing equality of two means and proportions, Students “t” test for single sample and paired observation, F-test and analysis of variance, testing of attributes, Chi-square distribution.

Total 36 Books: Latest editions to be adopted 1. Mathematics for Pharmacy Students (Vol.I), Gujar K. N., Bhavale Ashok, Career Publication. 2. Mathematics for Pharmacy Students (Vol.II), Gujar K. N., Bhavale Ashok, Career Publication. 3. Fundamentals of Statistics, Gupta S.C., Himalaya Publication. 4. Integral Calculus, Shanti Narayan, S. Chand Publication. 5. Differential Calculus, Shanti Narayan, S. Chand Publication. 6. Textbook of Applied Mathematics, Vols. I and II, Warlikar, P. N., Pune Vidyarthi Griha Prakashan.

BPH_C_407_L – Physical Pharmacy Lab II – (4 Hr/Wk)

Course Objectives

181

To familiarize the learner with methods to evaluate shelf life and physical stability of products and teach the learner characterization methods and protocols for determination of physical parameters.

Course Outcomes The learner should be able to: 1. Determine reaction rate constant, order of a reaction for different reactions 2. Predict shelf life by carrying out accelerated stability studies 3. Calculate physical parameters such as stability constants, molecular weight, and critical micellar concentration

Experiments: 1. Determination of reaction rate constant, order of a reaction and relative strength of acids (first order). 2. Determination of reaction rate constant and order of a reaction (second order, a=b). 3. Determination of order of reaction by Ostwald isolation method 4. Accelerated stability studies 5. Determination of stability constant and donor acceptor ratio of PABA-Caffeine complex by solubility method OR Determination

of stability constant and donor acceptor ratio of Cupric-Glycine complex by pH titration method 6. Determination of wetting property of solid by Wet point method or Flow point method 7. Determination of molecular weight of polymer using intrinsic viscosity 8. Determination of critical micellar concentration of a surfactant Demonstration 9. Demonstration of Brookfield viscometer or any other rotational/multipoint viscometer.

Books: 1. Laboratory Manual of Physical Pharmaceutics, C.V.S. Subramanyam, J. Thimma Settee 2. Practical Physical Pharmacy, U. B. Hadkar, T.N. Vasudevan and K.S. Laddha

BPH_C_408_L – Pharmaceutics Lab I– (4 Hr/Wk)

Course Objectives To train the learner in preparation of typical monophasic liquid and powder formulations and carry out their Q.C. tests, and acquaint them with some biological preparations available in market.

Course Outcomes The learner should be able to: 1) Prepare monophasic liquid systems and powder systems, justify the components and method of preparation. 2) Demonstrate the properties of the developed dosage forms and biological products, comment on the quality. 3) Perform experiments as per GLP and record in the journals. Experiments:

No. Details 1 Aromatic waters- Chloroform Water IP 1966, Conc. Dill water IP 1966, Conc. Anise water IP 1973, Gripe water 2 Syrups- Syrup IP 1966, Artificial syrup, Cough Syrup-Codeine phosphate syrup-BPC 3 Linctus- Simple linctus BPC 4 Elixirs- Piperazine Citrate elixir BPC 5 Ear drops- Chloramphenicol ear drops BPC 6 Nasal Drops- Ephedrine sulphate nasal drops BPC 7 Glycerites-Glycerin of starch IP 1955, Glycerin of boric acid IP 1955, Glycerin of tannic acid IP 1966 8 Solutions-Aqueous Iodine solution IP 1966, Paracetamol solubilized paediatric drops, Cresol with soap solution IP,

Magnesiun Citrate oral solution NF XIV, Chlorinated soda solution, surgical-BPC, Iodine paint compound BP 1968 9 Powders-Oral rehydration salt (ORS)

10 Quality evaluations- a) Liquids for –organoleptic properties, specific gravity, pH, viscosity b) Powders for-particle size, bulk density, flow properties (flow rate & angle of repose) c) Packaging materials-simple testing of dimensions, thickness, volume etc of containers and flexible packaging

materials (films, paper, laminates). 11 Biological products-Assignment

a) Sutures & ligatures- survey on marketed products- one absorbable & one non-absorbable, learn about its monographic testing and labelling.

b) Blood products- survey on one blood product and one plasma volume expander (marketed), and its monographic

182

testing. Books: 1. Lachman Leon, Lieberman Herbert A, Kanig Joseph L., “The Theory and Practice of Industrial Pharmacy, Varghese Publishing House, Mumbai. 2. Remington, The Science and Practice of Pharmacy, Vol I & II, B.L. Publications Pvt. Ltd. 3. Martin A., Physical Pharmacy, 4th Edition, Lea & Febiger, Philadelphia, London. 4. M.E. Aulton, Ed, Pharmaceutics-The Science of Dosage Form Design, Churchill Livingstone Medical Division of Longman Group, UK Ltd. 5. Rawlings, Bentley's Textbook of Pharmaceutics, Bailliere Tindall, London. 6. Atmaram Pawar, "Introduction to Pharmaceutics”, Career Publications, Nashik 7. Pharmacopoeias- IP, BP, USP

BPH_C_409_L – Pharmacology Lab I– (4 Hr/Wk)

Course Objectives 1. To impart practical (Laboratory) training in basic laboratory techniques like tissue (cock ileum) mounting and in vitro experimentation. 2. To teach plotting of dose response curve of acetylcholine in presence of antagonist and agonist. 3. To demonstrate the effect of various drugs on isolated organ (frog heart) using interactive audiovisuals. 4. To convey about ethical guidelines followed in animal experimentation.

Course Outcomes

The learner should be able to: TOPIC COURSE OUTCOMES BLOOM’S LEVEL

P1 Perform in vitro experiment on cock ileum (tissue) to evaluate effect of drug (Ach) and its dose on response (contraction) to comprehend and infer drug effects on receptors and its outcomes.

1 and 2

P1, P4 State the principles behind plotting dose-response of drugs/agonist/antagonist and its applications. Define pA2 value and calculate pA2 value of antagonist.

1 and 3

P3 Summarize the impact of drugs on eye and GI and discuss their potential therapeutic utility.

2

P4 Observe and explain the mechanisms of action of neurotransmitters, drugs and ions on isolated frog heart.

2

P5 Knowledge of animal handling techniques and understanding of ethical guidelines governing animal experimentation.

1 and 2

No. Details

1 Dose response curve (DRC) of Acetylcholine using suitable isolated tissue preparation (e.g. Cock ileum)

2

Demonstrations: Effect of drugs on isolated frog heart (CDs) ‐Adrenaline, Acetylcholine ‐Atropine, propranolol ‐Effect of excess calcium and potassium on isolated heart ‐Effect of lack of calcium and potassium on isolated frog heart ‐Effect of digitalis on hypodynamic heart

3 Simulated experiments (CDs) ‐Effect of drugs on eye

4

Demonstration with the help of CDs or kymograph recordings: –Effect of neostigmine on DRC of Ach –Effect of pancuronium on DRC of Ach (Give the readings to the students and ask them to plot the graphs and draw conclusions from the results e.g. Identify type of antagonism existing between two drugs by studying the nature of the graphs, competitive and non- competitive. Find out the potency of the drugs by studying the DRC and

183

determining IC50 values) ‐Calculation of pA2 value of atropine using Ach as an agonist

5 Tutorials ‐Laboratory animal handling ‐Care and ethics in animal experimentation

Books:

1. Kulkarni, S.K. Handbook of Experimental Pharmacology; 3rd Ed.; Vallabh Prakashan, New Delhi. 2005. 2. Gosh M.N. Fundamentals of Experimental Pharmacology, 3rd Ed.; Hilton & Company, Calcutta. 2005. 3. S.B. Kasture A Handbook of Experiments in Pre‐Clinical Pharmacology‐ 1st Ed. Career Publications. 2006. 4. W.I.M. Perry, Pharmacological Experiments on Isolated Preparations. 2nd Ed.; E & S Livingstone, Edinburgh & London,

1970.

184

RULES FOR ENTRY OF B. PHARM. CBSGS STUDENTS TO

B. PHARM CBCS SYLLABUS AT THE THIRD YEAR LEVEL

All the students who have previously joined the B. Pharm. Program with CBSGS

syllabus and have cleared First and Second B. Pharm. with CBSGS syllabus and are

now in eligible to start T. Y. Pharm. will be permitted to integrate into the T.Y. B.

Pharm. CBCS program with the following conditions.

The students will not have to take Pharmaceutics II Theory and Practical that is part

of Semester V of T.Y. Pharm. CBCS syllabus

The students will have to take Pharmacognosy I - Theory and Practical of B. Pharm

CBCS syllabus in the semester V of their T.Y B. Pharm.

The students will have to take Hospital Pharmacy and Drug Store Management -

Theory of B. Pharm CBCS syllabus in the semester VI of their T.Y B Pharm.

The students will be permitted to clear these subjects upto semester VII and will be

awarded their degree only on successful completion of these courses

185

AC 14/6/2018

Item No. 4.53

UNIVERSITY OF MUMBAI

Bachelor of Pharmacy

Third Year B. Pharm. and Final Year B. Pharm

( Semester V to Semester VIII),

Revised course (REV- 2016)

from Academic Year 2016 -17

(As per Choice Based Credit and Grading System with

effect from the academic year 2016–2017)

186

From Coordinator’s Desk:

To meet the challenge of ensuring excellence in engineering education, the issue of quality needs to be addressed, debated

taken forward in a systematic manner. Accreditation is the principal means of quality assurance in higher education. The

major emphasis of accreditation process is to measure the outcomes of the program that is being accredited. In line with

this Faculty of Technology of University of Mumbai has taken a lead in incorporating philosophy of outcome based

education in the process of curriculum development.

Faculty of Technology, University of Mumbai, in one of its meetings unanimously resolved that, each Board of Studies

shall prepare some Program Educational Objectives (PEO’s), give freedom to affiliated Institutes to add few (PEO’s)

course objectives course outcomes to be clearly defined for each course, so that all faculty members in affiliated institutes

understand the depth approach of course to be taught, which will enhance learner’s learning process. It was also resolved

that, maximum senior faculty from colleges and experts from industry should to be involved while revising the

curriculum. I am happy to state that, each Board of studies has adhered to the resolutions passed by Faculty of

Technology, developed curriculum accordingly. In addition to outcome-based education, Choice Based Credit and

Grading System is also introduced to ensure quality of engineering education.

Choice Based Credit and Grading System enables a much-required shift in focus from teacher-centric to learner-centric

education since the workload estimated is based on the investment of time in learning not in teaching. It also focuses on

continuous evaluation which will enhance the quality of education. University of Mumbai has taken a lead in

implementing the system through its affiliated Institutes. Faculty of Technology has devised a transparent credit

assignment policy adopted ten points scale to grade learner’s performance. Credit grading-based system was implemented

for First Year of B. Pharmacy from the academic year 2016-2017. Subsequently this system was carried forward for

Second Year B. Pharmacy in the academic year 2017-2018, Third Year in the academic years 2018-2019 and Final Year

B. Pharmacy in the academic year 2019-2020.

Dr. S. K. Ukarande

Dean – Faculty of Science and Technology,

Member - Academic Council

University of Mumbai, Mumbai

187

B. Pharm. Choice Based Credit and Grading System (CBCS) [2016-17]

Scheme Examination Semesters V to VIII

&

Syllabus Semesters V to VIII

[REVISED 2016]

188

EXAMINATION SCHEME FOR THE

CHOICE BASED CREDIT AND GRADING SYSTEM (CBCS) (2016-17)

SEMESTER V

Course Code Name Credits Hr/Wk Weightage

Internal

Weightage

End Semester

Exam

Total Marks

BPH_C_501_T Organic Chemistry

III

4 4 20 80 100

BPH_C_502_T Pharmaceutics II 4 4 20 80 100

BPH_C_503_T Pharmaceutical

Biotechnology

4 4 20 80 100

BPH_C_504_T Pharmacology II 4 4 20 80 100

BPH_E_5xx_T Choice Based

Course I

2 2 10 40 50

BPH_E_5xx_T Choice Based

Course II

2 2 10 40 50

TOTAL Theory 20 20 100 400 500

BPH_C_505_L Organic Chemistry

Lab II

2 4 10 40 50

BPH_C_506_L Pharmaceutics Lab II 2 4 10 40 50

BPH_C_507_L Experimental

Techniques in

Microbiology and

Biotechnology Lab

2 4 10 40 50

TOTAL Lab 6 12 30 120 150

TOTAL SEM V 26 32 130 520 650

189

SEMESTER VI

Course Code Name Credits Hr/Wk Weightage

Internal

Weightage

End Semester

Exam

Total Marks

BPH_C_601_T Pharmaceutical

Chemistry I

4 4 20 80 100

BPH_C_602_T Pharmaceutics III 4 4 20 80 100

BPH_C_603_T Pharmaceutical

Analysis II

4 4 20 80 100

BPH_C_604_T Pharmacognosy II 4 4 20 80 100

BPH_E_6xx_T Choice Based

Course III

4 4 20 80 100

BPH_E_6xx_T Choice Based

Course IV

2 2 10 40 50

TOTAL Theory 22 22 110 440 550

BPH_C_605_L Pharmaceutical

Chemistry Lab I

2 4 10 40 50

BPH_C_606_L Pharmaceutics Lab

III

2 4 10 40 50

BPH_C_607_L Pharmaceutical

Analysis Lab II

2 4 10 40 50

TOTAL Lab 6 12 30 120 150

TOTAL SEM VI 28 34 140 560 700

190

SEMESTER VII

Course Code Name Credits Hr/Wk Weightage

Internal

Weightage

End Semester

Exam

Total Marks

BPH_C_701_T Pharmaceutical

Chemistry II

4 4 20 80 100

BPH_C_702_T Pharmacognosy III 4 4 20 80 100

BPH_C_703_T Pharmaceutical

Analysis III

4 4 20 80 100

BPH_C_704_T Pharmacology III 4 4 20 80 100

BPH_C_705_T Pharmaceutical

Jurisprudence

3 3 20 80 100

BPH_E_7xx_T Choice Based

Course V

2 2 10 40 50

TOTAL Theory 21 21 110 440 550

BPH_C_706_L Pharmacognosy Lab

II

2 4 10 40 50

BPH_C_707_L Pharmaceutical

Analysis Lab III

2 4 10 40 50

BPH_C_708_L Pharmacology Lab II 2 4 10 40 50

TOTAL Lab 6 12 30 120 150

TOTAL SEM VII 27 33 140 560 700

191

SEMESTER VIII

Course Code Name Credits Hr/Wk Weightage

Internal

Weightage

End Semester

Exam

Total Marks

BPH_C_801_T Pharmaceutical

Chemistry III

4 4 20 80 100

BPH_C_802_T Pharmaceutics IV 4 4 20 80 100

BPH_E_8xx_T Choice Based

Course VI

4 4 20 80 100

BPH_E_8xx_T Choice Based

Course VII

4 4 20 80 100

TOTAL Theory 16 16 80 320 400

BPH_C_803_L Pharmaceutical

Chemistry Lab II

2 4 10 40 50

BPH_C_804_L Pharmaceutics Lab

IV

2 4 10 40 50

BPH_E_805_D Project 6 12 - 200 200

TOTAL Lab 10 20 20 280 300

TOTAL SEM VIII 26 36 100 600 700

192

SYLLABUS FOR T. Y. B. Pharm.

SEMESTER-V

BPH_C_501_T – Organic Chemistry III- (4 Hr/Wk)

Course Objective

Organic chemistry provides a foundation for understanding:

1) synthesis, nature, nomenclature of various heterocycles and their importance in medicinal chemistry,

2) nomenclature, nature and significant role of biomolecules like steroid hormones, peptide and DNA molecules in the organic and

pharmaceutical chemistry and

3) To learn the basic concepts of polymers. Polymerization methods, measurement of molecular weight and its application in

pharmaceutical industries

Course Outcomes

1. Upon successful completion of this course, a learner will be able to

2. Identify, nomenclate, and to employ fundamental heterocyclic organic reactions in the synthetic design of biologically active

molecules containing heterocyclic nucleus

3. Recognize the steroid molecules, synthetic methods, nature and their role in our body.

4. Outline the synthesis, chemical reactions of steroids, conversion of cholesterol to progesterone, estrone and testosterone and

elucidation of structure of cholesterol.

5. State basic terminologies in polymers, different mechanisms involved in the polymer preparation, different polymerization

techniques, details about the glass transition temperature and the factors affecting it and the types of polymers with some specific

examples of each

No. Details Hours

1 1 Heterocyclic Chemistry

1.1

Nomenclature of mono, bi- and tri-cyclic hetero-aromatic, fused heterocyclic ring and bridge head

system of the drug molecules along with drug examples.

Synthesis, Discussion of aromaticity, resonance, properties of heterocycles, acidity and basicity and

reaction of the following heterocycles

1.2

Five membered Heterocycles with One Heteroatom: a. Furan: Synthetic methods including synthesis using carbohydrates, Paal-Knorr synthesis

b. Pyrrole: Synthetic methods including synthesis using furan, Knorr synthesis, Paal-Knorr synthesis,

Hantzsch synthesis.

c. Thiophene: Synthetic methods including synthesis using Paal-Knorr synthesis.

Reactions of Furan, Pyrrole and Thiophene: With acids, Electrophilic Aromatic Substitution (EAS),

Nucleophilic Aromatic substitution (NAS) reaction, oxidizing and reducing agents.

1.3.

Five membered heterocycles with Two heteroatoms:

a. Imidazole: Synthetic methods including synthesis from imidazolines, α-haloketones, Radiszewskii

reaction.

b. Oxazole: reaction between acid amides and α-halogenoketones eg. Acetamide and bromoacetone form

2,4-dimethyloxazole, Robinson–Gabriel synthesis by dehydration of 2-acylaminoketones, Reaction with

Tosylmethyl isocyanide and aldehydes (The Van Leusen reaction)

c. Thiazole: preparation α-chlorocarbonyl compound and thioacid amide– Hantzsch synthesis, Gabriel

synthesis by reaction of a-Acylamino Ketones with Phosphorus Pentasulfide, Cook-Heilborn’s synthesis

from a-Aminonitriles, Reactions of Imidazole, Thiazole, Oxazole with acids, Electrophilic Aromatic

Substitution (EAS), nucleophilic aromatic substitution (NAS), oxidizing and reducing agents,.

1.4

Six membered heterocycles with One and Two heteroatoms:

a. Pyridine: Synthetic methods including synthesis using 1,5-diketones and Hantzsch synthesis.

b. Pyrimidine: Synthesis using malonic ester; 2,4-dichloropyridine, amidine and maleic acid, Reactions

of pyridine and pyrimidine with acids, Electrophilic Aromatic Substitution (EAS), nucleophilic aromatic

5

4

5

4

193

substitution (NAS), Hetaryne formation, oxidizing and reducing agents and Reactions of pyridine-N-

oxide

1.5

Fused heterocycles with One heteroatoms a. Quinoline: Synthetic methods including Skraup synthesis, Doebner-Miller synthesis, Friedlander

synthesis, Conrad-Limpach synthesis. Reactions with acids, Electrophilic Aromatic Substitution (EAS),

nucleophiles, oxidizing and reducing agents

b. Isoquinoline: Synthetic methods including Bischler-Napieralski and Pomeranz-Fritsch, Reactions

including EAS, nucleophiles, oxidizing and reducing agents.

c. Indole: Synthesis by Fischer indole synthesis, Madelung synthesis. Reactions with acids, EAS,

Metallic K, Mannich reaction, oxidizing and reducing agents.

1.6

Non-aromatic heterocyclic chemistry: Synthesis and properties of the following heterocycles-

Morpholines, Piperazines, Piperidine

5

4

2 Biomolecules:

I. Chemistry of Steroids

2.1 Definition of steroids and sterols, numbering and ring letters, orientation of projection formulae,

stereochemistry of ring junction and side chain attachments, stereochemistry of substituents in the side

chain.

2.2 Types of steroid hormones: androgens, estrogens, progestins, corticosteroids. Structure and

biosynthesis of steroids from cholesterol. Conformation and chemical reactivity, steroid specific

reactions of A and B rings, Addition-elimination, epoxide opening, relative rates of esterification,

oxidation of epimeric alcohols, reduction of ketones.

II. Peptides:

Isoelectric point, synthesis of alpha amino acids (Strecker synthesis and amidomalonate and reductive

amination of alpha keto acids), co-valent bonding in peptides, structure determination of peptides,

sequencing of peptides (Edman synthesis, C-terminal residue determination- carboxy peptidase), partial

hydrolysis of peptides using chemical (aq. Acids) and enzymatic methods (trypsin and chymotrypsin),

synthesis of peptides – protection and deprotection of N and C-terminal amino acids, solution phase and

solid phase (Merrifield) peptide synthesis.

III. DNA: Merrifield solid phase synthesis of DNA

IV. Polymers

Chain growth polymers (free radical polymerization)

Stereochemistry of polymerization Ziegler Natta catalyst, co-polymer, step growth polymers, co-

polymers, polymer structure and physical properties, biodegradable polymers, characterization of

molecular weight – average molecular weight, molecular weight distribution, size exclusion

chromatography

7

5

3

6

TOTAL 48

Books:

Latest editions of following books to be adopted.

1. I. L. Finar: Organic chemistry- Volumes 1 and 2, Pearson Education, Ed:5

2. Morrison and Boyd, Organic chemistry, Prentice Hall.

3. Clayden and Greeves, Organic chemistry, Oxford University Press.

4. S. H. Pine et al, Organic chemistry, McGraw-Hill Science/Engineering/Math.

5. D. Lednicer: Steroid chemistry at a glance, Wiley.

6. Heterocyclic Chemistry, Volume I, Volume II, Volume III by R. R. Gupta, M. Kumar, V. Gupta, Publisher: Springer Nature (SIE)

(2009)

7. Fundamental Principles of Polymeric material, Stephen L. Rosen, Second edition, John Wiley and sons, Inc. (1993)

BPH_C_502_T – Pharmaceutics II- (4 Hr/Wk)

Course Objectives

To provide knowledge to the students related to dosage forms such as biphasic liquid dosage forms, Semisolids, Suppositories and

Aerosols with emphasis on their formulation and evaluation, and an introduction to cosmetics

194

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Understand the formulation of liquid biphasic, semisolid, suppository and aerosol dosage forms

2. Describe the evaluation of such dosage forms

3. Summarize the packaging of liquid biphasic, semisolid, suppository and aerosol dosage forms

4. Explain the basic concepts of cosmetic science

No. Details Hours

1 Biphasic Systems: Suspensions and Emulsions 15

1.1 Physicochemical aspects: surface & interfacial tension, surface free energy, Gibb’s equation,

thermodynamic & kinetic stability of disperse systems

Definition, advantages and disadvantages, desirable features and pharmaceutical dispersions

1

1.2 Suspensions

Wetting phenomenon, particle‐particle

interactions, DLVO theory, flocculated and deflocculated systems, Schulze Hardy rule, Sedimentation

process, Ostwald ripening and crystal factors, rheology

3

1.3 Formulation of suspensions: Excipients & additives

Methods of preparation, Large scale manufacture (including equipment), filling and packaging, Layout

of manufacturing area

3

1.5 Quality evaluation and stress testing, Official formulation examples 1

1.6 Emulsions

Emulsifiers‐ need and mechanisms, droplet stabilization, classification,

Selection of emulsifiers‐HLB method, Davies method, PIT method,

Cloud point method

3

1.7 Preparation of Emulsions‐formulation additives, rheological aspects,

physical stability of emulsions, symptoms of instability.

2

1.8 Methods of preparation, Large scale manufacture (including equipment), filling and packaging, Layout

of manufacturing area. Concept of low energy emulsification.

1

1.9 Quality evaluation and stress testing, Examples of Official formulations 1

2 Semisolids: Ointments, Creams, Pastes and Gels 10

2.1 Factors influencing skin penetration‐physiological and physicochemical factors, vehicles and

penetration enhancers, methods to evaluate skin penetration.

3

2.2 Raw materials for semisolids, types of vehicles, ointment bases, creams, pastes, gels: Formulation

additives; Rheological aspects.

4

2.4 Large scale manufacture with equipment involved in each step and layout.

Quality evaluation, Examples of Official formulations.

3

3 Suppositories 6

3.1 Suppositories:

Introduction, definition, advantages and disadvantages, desirable features of suppositories, factors

affecting rectal absorption.

1

3.2 Suppository bases‐ specifications and desired features, classification and selection of suppository bases,

special bases.

2

3.3 Formulation and specific problems involved in formulating suppositories, large scale manufacture with

equipment, packaging.

2

3.4 Quality control tests, Examples of official formulations. 1

4 Pharmaceutical Aerosols 9

4.1 Definition, advantages & disadvantages, desirable features. Components of aerosol package, Two phase

& three phase aerosol systems

1

4.2 Components in detail-Propellants-types – Liquefied propellants and Gaseous propellants, selection of

propellants.

Containers – Tin Plate, Aluminium, Glass, Plastics

Valve and Actuator, Metered dose valve

Product concentrate - Different formulation systems- solution, dispersions, foams.

Dry Powder Inhalations-concept.

6

4.3 Manufacture of Aerosols-Cold filling and Pressure filling.

Quality Control testing, Stability studies

2

5 Introduction to Cosmetics 8

5.1 Definition of cosmetics, classification. 1

5.2 Raw materials including water, Oils, Fats, Waxes, Emulsifiers, Thickeners and Gums, colours, 3

195

Books:

Latest

Editions

1. Lachman Leon, Liberman Herbert A., Kaing Joseph L., “Theory and practice of Industrial Pharmacy” 3rd edition,1987, Varghese

Publishing house,Mumbai.

2. Liberman Herbert A., rieger, “Pharmaceutical dosage Forms-Disperse Systems”, vol 1/2/3, 2nd edition,2005, Marcel Dekker Inc.,

New York.

3. Allen, Loyd v V.Jr, “Remingtons- the Science and Practice of Pharmacy, Vol 1 / 2, 22nd edition, Pharmaceutical Press

4. Patrik Sinko Ed.”Martin’s Physical Pharmacy and Pharmaceutical Sciences”, 6th edition, 2010,Lippincott Williams and Wilkins.

5. M.E. Aulton Ed.,”Pharmaceutics-The Science of Dosage Form Design”3rd edition,2007,

Churchill livingstone Elsevier Ltd., UK.

6. E.A. Rawlins Ed.,”Bentley’s Textbook of Pharmaceutics”, 2010, Elsevier Publications.

7. S.J.Carter Ed.,”Tutorial Pharmacy-Cooper & Gunn”, 6th edition,1986, CBS Publishers & distributors, India.

8. Pharmacopeias-IP, BP, USP-latest editions

9. Harry’s Cosmeticology Edited by J. B. Wilkinson and R. J. Moore, Longman Scientific & Technical Publishers

10. Cosmetics Science and Technology, Edited by M. S. Balsam, E. Sagarin, S. D. Gerhon, S. J. Strianse and M. M. Rieger, Volumes

1,2 and 3.Wiley-Interscience, Wiley India Pvt. Ltd.

11. Poucher’s Perfumes, cosmetics & Soaps, Editor- Hilda Butler, Klewer Academic Publishers,Netherlands

12. Cosmetic Technology, Ed. By S. Nanda, A. Nanda and R. Khar, Birla Publications Pvt. Ltd., New Delhi

13. Encyclopedia of Pharmaceutical Technology, Vol. 6, Eds. James Swarbrick, James C. Boylan, Marcel Dekker Inc.

14. BIS Guidelines for different cosmetic products.

15. Formulation and function of cosmetics by Jellinek Stephan, Wiley Interscience.

16. Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins, 2006.

BPH_C_503_T – Pharmaceutical Biotechnology- (4 Hr/Wk)

Course Objectives

On completion of following theory topics, learner should be able to understand basic of modern biotechnology, fermentation

technology, enzyme technology and immunology, working of tools used in molecular biotechnology, applications of conventional,

modern biotechnology in pharmaceutical industries.

Course Outcomes

1. To discuss the tools, techniques, ethics and environmental safety involved in gene cloning, and the applications of Recombinant

DNA technology

2. Discuss basics of immunology and explain the antigen-antibody interactions and defense mechanism and explain technique of

monoclonal antibodies production for treating the human diseases

3. Study fermentation technology and understanding the basic concepts for production of safer vaccines and antibiotics

4. To study different techniques and applications of microbiological assay, enzyme immobilization and cell culture

No. Details Hours

1 Introduction to Biotechnology 1

1.1 Definitions, scope, relevance to Pharma Industry.

1

2 Fermentation Technology 5

2.1 Types of fermenters (mechanically stirred, air-lift, tray), Batch and continuous

fermentation, design of fermenter, factors affecting fermentation (innoculum

preparation, temperature, pH, media composition, aeration, agitation, antifoam agents,

strain optimization, growth kinetics), Example of products of fermentation (microbial,

animal and plant), and downstream process.

4

2.2

Production of penicillin

Self-study: Production of dextran, Vitamin B12

1

antioxidants, preservatives, perfumes, Fragrance selection, stability and Testing

5.3 Microbiological aspects of cosmetics. 1

5.4 Safety testing and toxicology, Efficacy Testing

Instrumental and Sensorial Evaluation of cosmetics

2

5.5 Labelling, Legislation and regulations for cosmetics (Drug and Cosmetics Act, 1940 & Rules 1945),

BIS specifications

1

TOTAL 48

196

3 Recombinant DNA technology 10

3.1 Steps involved in rDNA technology, Enzymes involved in DNA technology, Cloning

vectors (Plasmid, Cosmid, YAC), Gene expression System

7

3.2 Application of rDNA technology and genetic engineering for production of

pharmaceutical products e.g. Hormone (Insulin), Hepatitis B (Vaccines) and

Interferon.

Self-study: Preparation of a list of approved biotech derived products.

3

4 Techniques used in molecular biology 7

4.1 Introduction to following molecular biology tools.

Polymerase chain reaction, DNA sequencing (Sangers dideoxynucleotide method and

Maxam and Gilbert method), Restriction Fragment Length Polymorphism, cDNA

library, Blotting techniques (Southern, Northern and Western blotting), Gene therapy.

6

4.2 Transgenic animal, transgenic plants, ethics in Biotechnology and disposal of

biological waste

Self-study: SDS- PAGE.

1

5 Enzyme and cell immobilization. 5

5.1 Methods for enzyme immobilization (adsorption, covalent binding, entrapment,

microencapsulation) with examples and its applications in Pharmaceutical Industries.

2

5.2 Biosensor- Working and applications in Pharmaceutical Industries e.g. glucose

oxidase, penicillinase.

2

5.3 Use of microbes in industry. Production of Enzymes-General consideration e.g

Amylase

1

6 Immunology 11

6.1 a) Host-microbe interactions, Introduction to terms-infection, infestation, pathogen,

resistance, susceptibility etc.

b) Factors affecting pathogenicity and infection,

c) Innate defense mechanism – first line of body defense, physiological phenomena-

inflammatory response, fever, cellular, mediators; soluble (humoral) mediators,

phagocytosis.

d) Specific defense Mechanism – Characteristics, Antigen, Cell-mediated immunity,

humoral immunity.

e) Antibody structure and types, pathways of immune response, clonal selection

theory.

Self-study: Innate defense mechanism, Specific defense Mechanism, organization of

immune system-organs & cells involved.

5

6.2 Serology-Precipitation, agglutination, complement fixation tests,

immunofluorescence, RIA, ELISA.

2

6.3 Introduction to Hypersensitivity & Allergy. Immunodeficiency states- Primary &

acquired, autoimmunity.

Hybridoma technology – Production and application of monoclonal antibodies.

4

7 Vaccines & Sera 4

7.1 Definitions and classification, outline of general method of preparation of bacterial &

viral vaccines, typical examples of each type (diphtheria, TAB, polio), antisera (anti-

tetanus sera)

2

7.2 Q. C. aspects, Storage conditions and Stability of official vaccines, recent trends in

vaccines (recombinant vaccines)

Self-study: Outline of general method of preparation of BCG and rabies vaccine

2

8 Cell culture (plant and animal) 2

8.1 Tissue culture media, primary cell culture, continuous cell culture, pharmaceutical

applications of animal cell culture.

2

9 Microbial biotransformation 1

9.1 Introduction to Microbial biotransformation and Applications. 1

197

10

10.1

Introduction to Bioinformatics

Definition, History and Application of Bioinformatics in Pharmaceutical Industry.

2

TOTAL 48

Books:

Latest editions of the following books to be adopted.

1. R. C. Dubey, A textbook of biotechnology

2. B. D. Singh, Biotechnology.

3. S. P. Vyas and Dixit, Pharmaceutical Biotechnology, CBS publisher & distributers.

4. S. S. Kori, Pharmaceutical Biotechnology.

5. H. D. Kumar, Biotechnology, Affiliate East-West press Pvt. Ltd New Delhi.

6. Ananthnarayan, A textbook of microbiology, Orient Longman Pvt. Ltd.

7. W. B. Hugo and A. D. Russell, Pharmaceutical Microbiology, Blackwell Science.

8. David, Nelson, Lehninger - Principle of Biochemistry, W. H. Freeman & Co.

9. Pelezar, Chan & Krieg, Microbiology-Concepts and Applications, International Edn., McGraw Hill, Inc.,

10. Weir Stewart: Immunology, Churchill Livingstone.

11. Chandrakant Kakote, Pharmaceutical Biotechnology.

12.Desmond S.T. Nicholl, An introduction to genetic engineering, Panima Publishing Corporation, New Delhi.

13. Stanbury F. P., Whitakar A., and Hall J.S. Principles of fermentation technology,2nd edition. Aditya books LTD., New Delhi.

BPH_C_504_T – Pharmacology II- (4 Hr/Wk)

Course Prerequisites

Basic knowledge of receptors and their physiological role in the human body.

Understanding of concepts of immunology and endocrinology.

Basic knowledge about blood and blood components.

Course Objectives

1. Study of drugs used in treatment of Bacterial, fungal, viral and microbial infections, cancer, HIV, endocrine and hematological

disorders.

Course Outcomes

1. Discuss pharmacology of drugs used in chemotherapy and justify the need for rational use of antimicrobials.

2. Explain pharmacology of drugs used as immunomodulators.

3. Explain pharmacology of drugs used in endocrine disorders & haematological disorders.

No. Details Hours

1 Chemotherapy 28

1.1 Introduction to chemotherapy including drug resistance. 2

1.2 Sulfonamides, trimethoprim, fluoroquinolones, nitrofurantoin. 3

1.3 Penicillins, cephalosporins and cephamycins. 3

1.4 Tetracyclines, chloramphenicol, macrolides, clindamycin, linezolid, streptogramins and

fusidic acid.

3

1.5 Aminoglycosides. 2

1.6 Antifungal agents. 2

1.7 Antiviral agents. 3

1.8 Chemotherapy of tuberculosis and leprosy. 3

1.9 Chemotherapy of malaria and amoebiasis. 3

1.10 Anthelmintic drugs. 1

1.11 Chemotherapy of neoplastic diseases (Anticancer drugs). 3

2 Immunomodulators 3

2.1 Immunology: Regulation of immune system, signaling pathways for its activation and

inhibition.

1

2.2 Immunostimulants and immunosuppressants. 2

3 Drugs in Endocrine Disorders 11

198

3.1 Thyroid and anti-thyroid drugs. 2

3.2 Insulin, anti-diabetic agents including DPP-IV inhibitors. 3

3.3 Agents affecting bone mineral homeostasis. 2

3.4 Oxytocics. 1

3.5 Oral contraceptives. 1

3.6 Corticosteroids 2

4 Drugs in Haematological Disorders 6

4.1 Drugs used in anemia. 2

4.2 Coagulants and anti-coagulants. 2

4.3 Thrombolytics and anti-platelet agents. 2

TOTAL 48

Books:

Latest editions of the following books to be adopted

1. Goodman & Gilman’s Pharmacological Basis of Therapeutics, McGraw Hill Companies Inc.

2. Satoskar R.S. Bhandarkar S.D. & Rege N. N. Pharmacology & Therapeutics, Popular Prakashan.

3. Rang & Dale Pharmacology, Churchill Livingstone.

4. Lippincott’s Illustrated Reviews: Pharmacology- Lippincott-Raven Howland & Nyeets Publishers NY.

5. Laurence D. R. & Bennett Clinical Pharmacology, Elsevier NY.

6. Kulkarni S. K. Handbook of Experimental Pharmacology, Vallabh Prakashan, New Delhi.

7. Katzung B. G. -Basic and Clinical Pharmacology, Appleton and Lange publications.

8. Ghosh M. N. Fundamentals of Experimental Pharmacology Hilton & Company, Kolkata.

BPH_C_505_L – Organic Chemistry Lab II- (4 Hr/Wk)

Course Objectives

1. To introduce the learner to the basic techniques of separation of compound mixtures.

2. To introduce the learner to the procedure for identification of organic compounds

3. To introduce the learner to the methods for recrystallization of compounds

Course Outcomes

The learner will be able to:

1. To carry out the separation of simple compound mixtures.

2. To identify organic compounds based on simple tests

3. To recrystallize compounds use single solvent and binary solvent mixtures

List of Experiments:

1) Separation and quantification of binary mixtures by physical and chemical methods.

Identification of one component and confirmation by preparation of a suitable derivative.

Minimum eight binary mixtures, covering a wide variety of types to be studied

2) Theoretical aspects of recrystallization

3) Recrystallization of organic compounds: at least two with the use of different solvents.

Books:

Latest editions to be adopted

1. A laboratory handbook of organic qualitative analysis and separation, V.S. Kulkarni, S. P. Pathak, D.

Ramchandra & Co., Pune.

2. Text book of organic practical chemistry, V.S. Kulkarni, S. P. Pathak, D. Ramchandra & Co., Pune.

3. R. L. Shriner, R. C. Fuson and D. Y. Curtin, The systematic Identification of Organic compounds, 6th

Ed., Wiley, New York, 1980.

4. A. I. Vogel, A textbook of practical organic chemistry, 4th edition, Wiley New York, 1978.

5. Comprehensive Practical Organic Chemistry: Qualitative Analysis, V. K. Ahluwalia, S. Dhingra,

Universities Press (India) Limited, 2000.

6. Comprehensive Practical Organic Chemistry: Preparation and Quantitative analysis, V.K. Ahluwalia,

Renu Aggarwal, Universities Press (India) Limited, 2000.

199

BPH_C_506_L – Pharmaceutics Lab II- (4 Hr/Wk)

Course Objectives

To teach the learner the practical aspects of preparation and evaluation of biphasic suspensions and emulsions, semisolid ointments

and creams, suppositories and aerosols formulations for pharmaceutical and cosmetic applications.

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Understand the formulation aspects of biphasic and semisolid dosage forms

2. Explain calculations involved in formulations

3. Describe the importance of quality evaluation of biphasics, semisolids, suppositories, aerosols

No. Details

Formulation and Preparation of the following:

1 Biphasics: Suspensions and Emulsions 1. Paracetamol Paediatric Oral Suspension IP

2. Dry suspension for reconstitution (any one)

3. Antacid Suspension

5. Liquid Paraffin Emulsion IP

6. White Liniment BPC/ Turpentine Liniment IP

7. Evaluation of any one suspension & one emulsion

Evaluation Parameters: Organoleptic Properties, Particle/droplet size, Sedimentation/Creaming volume ,

pH, stability studies, rheology of any one preparation

2 Semisolids

1. Compound Benzoic acid Ointment IP

2. Aqueous Calamine Cream IP

3. Cetrimide Cream IP

4. Diclofenac Gel BP

Evaluation of any one Ointment / Cream

3 Suppositories

1. Glycerin Suppositories USP

2. Paracetamol Suppositories BP/Indomethacin Suppositories IP /

Bisacodyl suppositories IP/ Aspirin Suppositories USP

Evaluation of any one suppository

4 Pharmaceutical Aerosols

Introduction to different devices for inhalation and demonstration of evaluation of a suitable commercial

product for simple tests related to spray and weight / drug content per discharge

5 Cosmetics: Preparation & Evaluation

1. Toothpaste

2. Clear liquid Shampoo

3. Lipstick/ Nail lacquer

4. Vanishing Cream/Cold cream

Books:

Latest Editions

1. Indian Pharmacopoeia, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare.

2. The United States Pharmacopoeia

3. British Pharmacopoeia

4. Theory and Practice of Industrial Pharmacy by Liberman & Lachman

5. Pharmaceutical dosage form disperse system by Liberman & Lachman

6. Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins, 2006.

7. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill Livingston

8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea & Febiger, Philadelphia

9. Cosmetic formularies

BPH_C_507_L– Experimental Techniques in Microbiology and Biotechnology Lab- (4 Hr/Wk)

Course Objectives

200

To introduce the learner to some of the common techniques used in microbiological work and biotechnology experiments.

Course Outcomes

1. Characterization and identification of bacteria using various staining techniques (morphological study), colony characterization,

serological and biochemical characteristics

2. Analyze quality of raw material, food and water and assessment of extent of microbial contamination using counting technique

and Evaluate sterility of products.

3. To impart the knowledge of bioassay of antibiotic and test antibiotic sensitivity of few antibiotics.

LIST OF EXPERIMENTS:

1. Study of microscope and common laboratory equipment e.g., B.O.D. incubator, laminar air flow unit, aseptic hood, autoclave,

hot-air sterilizer, deep freezer, refrigerator.

2. Sterilization of glassware and preparation and sterilization of nutrient broth, agar slants, plates and inoculation techniques.

3. Isolation of pure culture by T plate, pour plate and streak plate methods. Colony characterization and growth patterns in broth,

slant.

4. Study various staining techniques such as Gram Staining, Spore, Negative staining, Cell wall staining, Capsule,

Motility by hanging drop technique.

5. Bacteriological analysis of water (IMVIC and MPN)

6. Test for sterility as per IP (Injection water/ nonabsorbent cotton/soluble powder/ear drops).

7. Antimicrobial assay of antibiotic using cup plate method, introduction to zone of inhibition and calculation.

8. Study drug resistance using antibiotic sensitivity testing

9. Biochemical tests (Catalase, Oxidase, Urease, Nitratase, Protease, Gelatinase, Phosphatase, Amylase).

10. Demonstration experiments

a. Thermal death time and thermal death point.

b. Effect of Ultra-Violet exposure on growth of E. coli.

c. Selection and isolation of bacteria by replica plating.

d. Widal test

e. Counting of bacteria by total count, viable count, and biomass determination methods

Books:

1. C. R. Kokare “Pharmaceutical Microbiology Experiments and Techniques”, Career Publication, Nashik.

2. R. S. Gaud and G. D. Gupta “Practical Microbiology”, Nirali prakashan, Pune.

3. C. H. Collins, Patricia M. Lyne, J. M. Grange “Microbiological Methods “7th Edn. Butterworth‐Heinemann Ltd, Oxford, London

ANY TWO SUBJECTS FROM THE FOLLOWING 2 CREDIT SUBJECTS TO BE CHOSEN AS

ELECTIVES FOR A TOTAL OF 4 CREDITS

BPH_E_508_T – Nutraceuticals and Dietary Supplements -(2 Hr/Wk)

Course Objectives

1. To make the learner understand the concept of nutraceuticals and dietary supplements along with the classification with respect to

health benefits, chemical nature and mechanism of action

2. To expose the learner to the health benefits of various classes of phytochemicals along with their salient chemical features,

pharmacokinetics, doses and marketed preparations

3. To introduce to the learner the formulation challenges of nutraceuticals and health supplements and the importance of the safety and

stability of nutraceutical formulations

4. To make the learner aware of the regulatory aspects of nutraceuticals in India and major countries

Course Outcomes

Upon completion of the course student will be able to –

1. Explain concept of nutraceuticals and dietary supplements, classify these based on chemical nature, health benefits and mechanism

of action

2. Discuss the chemistry of phytochemicals, their health benefits, pharmacokinetics, interactions with food and recommended doses

along with the marketed preparations

3. Explain the challenges in formulating nutraceuticals

4. Understand the significance of safety and stability studies of nutraceuticals

5. Describe the labeling and regulatory aspects for manufacture and sale of nutraceutical products.

201

No. Details Hours

1 Introduction to Nutraceuticals

Definitions of Nutraceuticals, Functional foods, and Dietary supplements, Nutrigenomics. Link between Food and

Medicine. Food and No- food sources of nutraceutical factors, Nutraceutical factors in specific foods. Classification

of Nutraceutical. Factors based on chemical nature and mechanism of action. Safety, Scientific evidence and

market trends: Local and Global.

Self-study: Public health nutrition, maternal and child nutrition, nutrition and ageing, nutrition education in

community, Limitations of Nutraceuticals

3

1

2 Phytochemicals as Nutraceuticals:

Occurrence, Structure, Properties, Metabolism and Pharmacokinetics, Therapeutic uses, Recommended Doses and

Marketed Preparations of following

a) Carotenoids- Lycopene, Lutein, Zeaxanthene, Astaxanthene

b) Phenolics and Polyphenolics as Antioxidants - - Reservetrol , Grapeseed

extract, Tea, Pycnogenol, Avenanthramides from Oats, Rutin, Soy Isoflavones,

Curcumin

c) Sulphur Compounds- Glucosinates

d) Prebiotics / Probiotics-Fructo-oligosaccharides, Lactobacillum.

e) Dietary fibres – Soluble and insoluble any two examples each.

f) Lignans – Flax Lignans

g) Essential Fatty acids- Fish oils, α- Linolenic acid from Flax.

h) Quinones- Tocopherol.

i) Proteins and Minerals- Melatonin, Glutathione, Shilajit, Carnitine.

j) Marine nutraceuticals – Collagen from fish skin

9

3 Formulations and Challenges

Challenges involved in processing, extraction and concentration of nutraceutical constituents, formulations and

delivery systems, safety, storage and stability evaluation of formulations.

Labeling of Nutraceuticals

4

4 Safety and Toxicity of Nutraceuticals

Adverse Effects, Interactions, Adulteration- Intentional, counterfeiting, undeclared labeling, toxic contaminants

3

5 Regulatory issues of Nutraceuticals and Dietary Supplements

a) EU, US and Indian guidelines.

b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and

GMPs on Food Safety. Adulteration of foods.

c) Pharmacopoeial Specifications for dietary supplements and nutraceuticals

4

TOTAL 24

Books:

1. Handbook of Nutraceuticals and Functional Foods, Second Edition, Eds Robert E.C. Wildman, CRC Press, Taylor and Francis

2. Nutraceuticals: A Guide for Healthcare Professionals, Brian Lockwood

3. Nutraceuticals in Health and Disease Prevention edited by Klaus Kramer, Peter-Paul Hoppe, Lester Packer, Marcel Decker New

York

4. Nutraceuticals: Efficacy, Safety and Toxicity edited by Ramesh C. Gupta Academic Press, Elsevier Publication

5. Handbook of Nutraceuticals Volume I: Ingredients, Formulations, and Applications edited by Yashwant Vishnupant Pathak, CRC

Press, Taylor and Francis

6. Nutraceuticals edited by Alexandru Grumezescu, Academic Press Elsevier

7. Nutraceuticals, Glycemic Health and Type 2 Diabetes, Eds Vijai K. Pasupuleti, James W. Anderson, Wiley Blackwell Publications

8. Regulation of Functional Foods and Nutraceuticals: A Global Perspective, Ed Clare M. Hasler, Blackwell Publishing

9. Developing New Functional Food and Nutraceutical Products edited by Debasis Bagchi, Sreejayan Nair, Academic Press, Elsevier

Publishing

10. Phytosterols as Functional Food Components and Nutraceuticals, Ed Paresh C. Dutta, Marcel Decker Publishing

11. Phenolics in Food and Nutraceuticals, Fereidoon Shahidi, Marian Naczk, CRC press

12. Bioactive Proteins and Peptides as Functional Foods and Nutraceuticals, Eds Yoshinori Mine, Eunice Li-Chan, Bo Jiang, Wiley

Blackwell

13. Marine Nutraceuticals and Functional Foods, Ed Colin Barrow, Fereidoon Shahidi, CRC press

14. Role of dietary fibres and nutraceuticals in preventing diseases, K. T Agusti and P.Faizal, B S Publication

202

15. Goldberg, I. Functional Foods. Chapman and Hall, New York.

16. Labuza, T.P. Functional Foods and Dietary Supplements: Safety, Good Manufacturing Practice (GMPs) and Shelf Life Testing in

Essentials of Functional Foods, Eds M.K. Sachmidl and T.P. Labuza, Aspen Press.

BPH_E_509_T – Microbial Genetics -(2 Hr/Wk)

Course Objectives:

1. To introduce the learner to the conceptual and practical tools for generating, processing and understanding biological genetic

information.

2. To develop a knowledge of the underlying theories of genetics and understanding of genetic exchange among prokaryotes.

3. To give the learner competence in fundamental molecular biology theories and laboratory techniques.

Course Outcomes:

The learner should be able to-

1. Understand basic concepts of homologous recombination and genetic exchange among prokaryotes.

2. Understand natural plasmids and transposons present in prokaryotes

3. Give an account of prokaryotic gene structure and the mechanisms controlling gene expression

No. Details Hours

1 GENETIC EXCHANGE - Gene transfer mechanisms in bacteria & homologous recombination

1.1. Transformation

i. Introduction and History

ii. Types of transformation in prokaryotes--Natural transformation in Streptococcus pneumoniae, Haemophilus

influenzae, and Bacillus subtilis

iii. Mapping of bacterial genes using transformation.

iv. Problems based on transformation.

1.2. Conjugation

i. Discovery of conjugation in bacteria

ii. Properties of F plasmid/Sex factor

iii. The conjugation machinery

iv. Hfr strains, their formation and mechanism of conjugation

v. F’ factor, origin and behavior of F’ strains, Sexduction.

vi. Mapping of bacterial genes using conjugation

(Wolman and Jacob experiment).

vii. Problems based on conjugation

1.3. Transduction

i. Introduction and discovery

ii. Generalised transduction

iii. Use of Generalised transduction for mapping genes

iv. Specialised transduction v. Problems based on transduction

1.4. Recombination in bacteria

General/Homologous recombination

i. Molecular mechanism

ii. Holliday model of recombination

Site –specific recombination

12

3

3

3

3

2 PLASMIDS, TRANSPOSONS & OPERONS (REGULATION)

2.1. Plasmids

a. Physical nature

b. Detection and isolation of plasmids

c. Plasmid incompatibility and Plasmid curing

d. Cell to cell transfer of plasmids

e. Types of plasmids

i. Resistance Plasmids,

ii. Plasmids encoding Toxins and other Virulence characteristics

12

3

203

iii. col factor

iv. Degradative plasmids

2.2. Transposable Elements in Prokaryotes

a. Insertion sequences

b. Transposons

i. Types

ii. Structure and properties

iii. Mechanism of transposition

iv. Transposon mutagenesis

c. Integrons

2.3. Lac operon and problems on Lac operon, Trp operon

3

6

TOTAL 24

Books:

1. Peter J. Russell (2006), “Genetics-A molecular approach”, 2nd ed.

2. Benjamin A. Pierce (2008), “Genetics a conceptual approach”, 3rd ed., W. H. Freeman and company.

3. R. H. Tamarin, (2004), “Principles of genetics”, Tata McGraw Hill.

4. D. Nelson and M. Cox, (2005), “Lehninger’s Principles of biochemistry”, 4th ed., Macmillan worth Publishers.

5. M. Madigan, J. Martinko, J. Parkar, (2009), “Brock Biology of microorganisms”, 12th ed., Pearson Education International.

6. Fairbanks and Anderson, (1999), “Genetics”, Wadsworth Publishing Company.

7. Prescott, Harley and Klein, “Microbiology”,. 7th edition Mc Graw Hill international edition.

8. Robert Weaver, “Molecular biology”, , 3rd edn. Mc Graw Hill international edition.

9. Nancy Trun and Janine Trempy, (2004), “Fundamental bacterial genetics”, Blackwell Publishing

10. Snustad, Simmons, “Principles of Genetics”, 3rd edn. John Wiley & sons, Inc.

BPH_E_510_T – Biochemistry III- (2 Hr/Wk)

Course Prerequisites

Basic knowledge of Cell Biology, Microbiology

Course Objectives

To introduce the learner to the details of DNA replication, DNA transcription and RNA translation, Gene regulation, DNA mutation,

and DNA repair

Course Outcomes

The learner will be able to:

1. Explain how DNA topology and chromatin structure affects the processes of DNA replication, repair, and transcription

2. Compare and contrast the mechanisms of bacterial and eukaryotic DNA replication, transcription, and translation.

3. Describe mechanisms by which DNA can be damaged, mutated and describe the molecular mechanisms by which protein

complexes repair different forms of DNA damage

4. Explain the molecular mechanisms behind different modes of gene regulation in bacteria

No. Details Hours

1 Genome organization in prokaryotes and eukaryotes: Structure of DNA, RNA, Chromosome,

chromatin, mitochondrial genome. Justification of the large nature of the genome, genome complexity,

tandem repeats, micro and mini satellites

2

2 Replication of DNA: Details of DNA replication, differences between prokaryotes/eukaryotes. Semi-

conservative DNA replication, DNA Polymerases and its role, E. coli Chromosome Replication,

Bidirectional Replication of Circular DNA molecules. Rolling Circle Replication, D-Loop model for

replication.

DNA Replication in Eukaryotes and differences with respect to prokaryotes.

DNA Recombination – Holliday Model for Recombination Transformation. Examples of drugs

modulating these pathways (polymerase inhibitors, telomerase inhibitors, topoisomerase inhibitors) and

polymorphisms involved in disease states. Brief description of telomeres and telomerase activity. DNA

8

204

polymorphisms and SNPs.

3 Transcription in prokaryotes and eukaryotes, (role of proteins and factors of transcription), RNA

splicing and RNA

2

4 Translation in Prokaryotes and Eukaryotes: Steps of translation, Initiation of translation, initiation

factors, role of Met-tRNA, elongation and its factors, termination and protein stability. Drugs

modulating translation.

2

5 Transcriptional and translational differences in prokaryotes and eukaryotes especially with respect to

post‐transcriptional and post‐translational modifications. Examples of drugs modulating these pathways

with emphasis on protein synthesis inhibitors used as drugs. Discussion of solid phase peptide synthesis,

peptide synthesizers and comparison between biosynthesis and chemical synthesis

4

6 DNA Repair: Photo repair, Base Excision Repair, Nucleotide Excision Repair, Mismatch Repair, SOS

Repair and Recombination Repair

2

7 Definition and Types of Mutations. Mutagenesis and Mutagens. (Examples of Physical, Chemical and

Biological Mutagens)

2

8 Gene regulation in prokaryotes, operon models, Gene regulation in eukaryotes, gene activators,

enhancers and silencers, Lac Operon and Catabolite repression

2

TOTAL 24

Books:

1. Meyers, R. A., Molecular Biology and Biotechnology, Wiley-VCH, 2000.

2. Lodish, H. Molecular Cell Biology, 6th Edition, W. H. Freeman and Co., NY, USA.

3. Rose, P. Molecular Biotechnology, Panima, 2000.

4. Brown, T. A., Molecular Biology, Vol. I and II, Academic Press, 2000.

5. B. Lewin, Genes IX, 9th Edition, Jones and Barlett Pub., USA, 2007.

6. Watson J. D. Molecular Biology of the Gene, Benjamin Cummings; 6th Edition, 2007.

7. D,.Nelson and M.Cox, (2005), “Lehninger’s Principles of biochemistry”, 4th ed., Macmillan worth Publishers.

BPH_E_511_T – Synthon Approach - (2 Hr/Wk)

Course Objectives

1. To teach the learner to analyse a target structure in order to design a synthetic scheme.

2. To acquire the expertise toward synthesis by the manipulation of both activation methods and selectivity control.

Course Outcomes

1. Learner will also gain confidence for drawing the schematic retrosynthetic pathway from the course.

2. Learner will be able to analyze the retrosynthetic scheme synthesis planning and route analysis for any given target molecule.

No. Details Hours

1.

Definition of retrosynthesis or disconnection approach, synthon, disconnection, synthetic

equivalent, functional group interconversion, functional group addition, functional group

removal.

1

2.

Guidelines for disconnection

a. Order of events

b. Reversal of polarity

c. Protecting groups

4

3.

3.1

3.2

3.3

Disconnection of simple alcohols, alkyl halide, ethers, olefins, esters, carboxylic acids,

aldehydes, ketones and amines.

Two group disconnections – 1,2-, 1,3-, 1,4- difunctionalized compounds

Strategies for synthesis of aromatic heterocycles pyrrole, thiophene, furan, pyridine,

pyrimidine

8

3

3

2

205

4 Design of retrosynthesis of drugs: Paracetamol, benzocaine, sulfadiazine, ibuprofen,

propranolol, nifedipine, isoniazid, ranitidine, diphenhydramine

4

TOTAL 24

Books:

1. Designing organic syntheses: A programmed introduction to the synthon approach, Stuart Warren; Wiley India Pvt Ltd., 2012

2. Designing Organic Syntheses: A Programmed Introduction to the Synthon Approach; Stuart Warren; ISBN: 978-0-471-99612-5,

285 pages, January 1991

3. Organic Synthesis the Disconnection Approach, Stuart Warren, 391pages, ISBN 0 471 10161 3 Paper 1982 by John Wiley and Sons

LTD

4. Synthesis of Drug, A synthon approach by Radhakrishnan P. Iyer & Anant v. prabhu, 1st Edition, (1985) Sevak Publications,

Mumbai.

5. Clayden and Greeves, Organic Chemistry, Oxford University Press (2001)

6. site for solving synthon problems

http://highered.mheducation.com/sites/0073375624/student_view0/chapter22/synthesis_problem_1-2.html

BPH_E_512_T – Cosmeticology- (2 Hr/Wk)

Course Objectives

To provide the learner with knowledge of cosmeticology with respect to the types of formulations, evaluation and regulatory aspects

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Discuss the various raw materials for cosmetics

2. Understand the toxicological aspects and toxicity testing for cosmetics.

3. Discuss the various cosmetics products w.r.t. raw materials, large scale manufacturing and functional and physicochemical

evaluation

4. Know the regulatory guidelines and sensorial assessment for cosmetics

No. Details Hours

1. General Aspects of Cosmeticology 5

1.1 Definition of Cosmetics, historical background, classification

Structure of skin, hair, nails, teeth; Regulatory aspects- Schedules to Drug and

Cosmetics Rules - M II, S, Q; BIS specifications, Marketing aspects of Cosmetics

2

1.2 Raw materials including oils, fats, waxes, colours, perfumes, antioxidants, preservatives,

surfactants, and water, herbal ingredients (Self study and follow up)

1

1.4 Toxicology of cosmetics-irritation and sensitization reactions to cosmetics, sensitivity

testing and safety aspects

2

2. Cosmetic formulations: Raw materials, formulation, and functional evaluation of:

a) Skin creams-- Cleansing, cold, vanishing, moisturizing, hand and body

products, Face packs, antiacne, antiwrinkle, bleach products

b) Protective preparations- Barrier products; sunscreen, suntan & anti-sunburn

products, insect repellants.

c) Coloured cosmetics-Foundation products, face powders, lipsticks, rouge, eye

cosmetics (Large scale manufacture of lipsticks and face powders, including

compact face pwder)

d) Nail specialty products-cuticle softener, nail bleach, nail strengthener, nail

whites, nail lacquer

e) Hair care products-Shampoos (including antidandruff & anti lice), hair

grooming products [hair setting products, hair sprays, hair tonics, hair

conditioners, hair rinses, hair waving & hair straightening products (principles),

hair colorants]

f) Depilatories & Shaving products (Wet, Dry & After shave)

g) Oral and personal hygiene preparations-tooth powder, tooth paste, mouth

washes, denture cleansers, bath products (soaps, bath salts, bubble baths,

shower gels, body washes, anti-perspirants &deodorants

h) Baby toiletries-oils, creams, lotions, shampoos, powders

17

3

2

4

1

3

1

2

1

6. Sensorial evaluation of cosmetics- concept and need, sensory perception, requirements

for sensory testing, methods used, interpretation and documentation/representation. 2

TOTAL 24

206

Books:

Latest editions

1. Harry’s Cosmeticology Edited by J.B. Wilkinson and R. J. Moore, Longman Scientific & Technical Publishers

2. Cosmetics Science and Technology, Edited by M.S. Balsam, E. Sagarin, S.D. Gerhon, S.J.Strianse and M.M.Rieger, Volumes 1,2

and 3.Wiley-Interscience, Wiley India Pvt. Ltd.,2008

3. Poucher’s Perfumes, Cosmetics & Soaps, 10th Ed, Editor- Hilda Butler, Klewer Academic Publishers, Netherlands, 2000

4. Cosmetic Technology, Ed. By S.Nanda, A. Nanda and R. Khar, Birla Publications Pvt. Ltd., New Delhi, 2007

5. Handbook of Cosmetic Science and Technology, edited by M. Paye, A.O.Barel, H. I. Maibach, Informa Healthcare USA,Inc. 2007.

6. Encyclopedia of Pharmaceutical Technology, Vol. 6, Eds. James Swarbrick, James C. Boylan, Marcel Dekker Inc., 1992

7. Kemp S.E., Hollowood T, Hort J., “Sensory evaluation-A practical handbook,” John Wiley & Sons, 2009.

8. Sensory Evaluation Techniques, Fourth Edition, Morten C. Meilgaard, B. Thomas Carr, Gail Vance Civille, CRC Press

9. ISO 13299:2016(en) Sensory analysis — Methodology — General guidance for establishing a sensory profile

10. BIS Guidelines for different cosmetic products.

11. Formulation and function of cosmetics by Jellinek Stephan, Wiley Interscience.

BPH_E_513_T – Packaging of Pharmaceuticals - (2 Hr/Wk) Course Objectives

To provide the learner with knowledge of types of packaging materials, and packaging methods for Pharmaceuticals, evaluation and

regulatory guidelines for the same.

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Classify Packaging materials and explain the functions and design aspects

2. Discuss the different primary and ancillary packaging materials, their functions and evaluation

3. Elaborate on labelling aspects of pharmaceuticals

4. Discuss sterilization and stability of packaging materials.

No. Details Hours

1.0 Introduction to Packaging, Classification of Packaging materials into Primary & secondary

packaging, Essential Requirements, Functions of Packaging, Properties of Ideal Package,

Packaging formats in Pharma Industry, Packaging recycling symbols, FDA Definition;

Approach to package design.

3

2.0 Packaging Materials 21

2.1 Glass: Glass types, their manufacture, chemical composition, Performance testing and

quality control, Defects.

2

2.2 Plastics & polymers: Classification, physio-chemical, mechanical and biological properties,

Additives and fabrication processes, Plastic containers for Parenteral and transfusion sterile

drip kits, ophthalmic products; disposable devices. Quality control testing and issues related

to leachables, biocompatibility, biodegradation, environmental safety; evaluation aspects-

performance and toxicity

3

2.3 Metals: Aluminum and tinplate cans, drums and collapsible tubes. Aerosol containers,

Lacquering, coating and lining

2

2.4 Flexible packaging: Materials and laminates, Co-extruded films, foils, coating and

laminates, shrink and stretch films, blisters including ALU- ALU blisters and Strip

Packaging.

2

2.5

Strip and Blister Packaging-

Strip Packs- High Barrier Laminates, Strip Packaging Process, Properties of Materials,

Child-resistant strip package, Strip Sealing Machine, Strip Packing Machinery,

Multi-Dose Strip Packaging

Blister packs- Design parameters, Materials, Formation, Types of Blisters, Advantages and

disadvantages of Blister Packaging, Types of Problems/ Defects, Blister Packing

Machine, Other packages-shrink wrapping and stretch wrapping, sachets.

3

2.6 Caps and Closures: Types of caps, closures, liners, child resistant caps.

Elastomeric closures for parenterals, classification of Elastomers, physical chemical and

biological properties and their quality control.

2

2.7 Corrugated and solid fibre boards and boxes, Paper and paperboard

and Quality control, Common defects

1

207

3.0 Ancillary materials in packaging-

Cushioning materials-applications for impact, vibration, temperature & humidity protection

Fasteners, tapes

1

4.0 Sterilization of containers and closures 1

4.0 Labels and labelling:

Types of labels, adhesives,

Printing of labels- printing inks, toxicity and safety of printing inks, inject and bar coding

and printing of labels,

Quality control and common defects in printing of labels

2

5.0 Stability of Packages

Introduction, Legislation, Regulation, Pharmaceutical Stability Testing in Climatic Cabinets,

Pharmaceutical Stability Testing Conditions, Photo-Stability Testing, Review of

Pharmaceutical Product Stability, Packaging and the ICH Guidelines

2

TOTAL 24

Books:

Latest editions

1. D. A. Dean, Roy Evans, Ian Hall. Pharmaceutical packaging technology. Tylor and Francis, London.

2. Edward J. Bauer, Pharmaceutical Packaging Handbook. Bausch and Lomb, Rochester, New York, USA.

3. Wilmer A. Jenkins, Kenton R. Osborn. Packaging drugs and pharmaceuticals.

4. Salvatore J. Turco, Sterile dosage forms: their preparation and clinical applications

5. Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins, 2006.

6. Michael E. Aulton, Kevin Tylor (Ed.). Aulton’s Pharmaceutics: The design and Manufacture of Medicine.

7. Gilbert Banker and Christopher Rhodes. Modern Pharmaceutics.

8. Leon Lachman; Lieberman Herbert A.; Kanig, Joseph L. The theory and Practice of Industrial Pharmacy.

9. Hanlon J., Robert J. Kelsey, “Handbook of Package Engineering” 2nd Edition, McGraw-Hill, New. York. 1984

10. Paine A., “Packaging User's Handbook”, Springer, 1990

11. K. Avis, Liberman and Lachman, Pharmaceutical Dosage Forms: Parenterals, Vol. I, Marcel Dekker, Expanded ad revised edition,

2008.

208

SEMESTER-VI

BPH_C_601_T – Pharmaceutical Chemistry I- (4 Hr/Wk)

Course objectives

1. Learn about pharmacodynamic attributes like drug targets, drug-receptor binding, proteins as drug targets, receptors and enzyme as

drug targets, nucleic acids as drug targets and metabolism of drugs

2. Learn how physicochemical properties / QSAR play role to design and optimize the structure of leads

3. Learn about the Drug Metabolism, types of Phase I and Phase II Reactions by taking suitable drug examples

4. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of anti-

infective agents like antibiotics, sulfonamides and fluoroquinolones

5. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of

antiparasitic agents like antimalarials, antitubercular, anthelmintics, amoebiasis, giardiasis, trichomoniasis, pneumocystis,

trypanosomiasis, leishmaniasis and fungi

Course outcomes

Learner will be able to:

1. Identify and study the suitable drug targets for treatment of disorders

2. Identify the relationship between the physicochemical properties of the chemical entity and biological response

3. Draw a schematic metabolic pathway for any given drug

4. Identify the SAR of all the classes of antimalarial, antitubercular, anti-infective, antibiotic, antiparasitic disorders

No. Details Hours

1 Pharmacodynamics

1.1 Drug Targets at Molecular Level –

Lipids, Carbohydrates, Proteins and Nucleic Acids as drug targets 2

1.2 Intermolecular Bonding Forces like Electrostatic, Hydrogen Bonding, van der Waal’s

Interactions, Dipole-dipole and Ion-dipole Interactions and Hydrophobic Interactions 3

2 Proteins as Drug Targets

2.2 Proteins as Drug Targets / Drugs

Monoclonal Antibodies, Peptides

Introduction to Proteomics

2

2.3 Enzymes as Drug targets

2.3.1 Enzyme Inhibitors – Reversible and Irreversible (Self Study) 1

2.3.2 Enzyme Inhibitors against microorganisms, viruses, body’s own enzymes 1

2.4 Receptors as Drug Targets

2.4.1 Types of Receptors and signal transduction - Ion Channels, G-Protein Coupled Receptor

(GPCR), Kinases, Nuclear Receptors 6

2.4.2 Concept of Agonist, Antagonist, Partial agonist, Inverse agonist, Concept of

desensitization/sensitization, Tolerance, Affinity, Efficacy, Potency (Self Study) 1

3 Nucleic Acids as Drug target

3.1 Primary, Secondary and Tertiary Structure of DNA (Self Study) 1

3.2 DNA Intercalation, DNA Alkylation, Antisense Therapy 1

4 Pharmacokinetics and Physicochemical Properties of Drug Action

4.1 Solubility, Partition Coefficient, Acidity-Basicity, pKa, Bioisosterism, Stereochemistry

(geometrical, optical and conformational), Protein Binding 2

4.2 Drug Metabolism – Phase I and Phase II Reactions 6

Discussion on the following classes of drugs including classification, chemical nomenclature, structure including

stereochemistry, generic names, chemistry, SAR, metabolism, molecular mechanism of action, introduction to

rational development, drug resistance, if any, of following classes of drugs

5. Anti-infective Agents

5.1 Antibiotics

Penicillins (natural and semisynthetic penicillins like Penicillins G, Penicillins V,

ampicillin*, amoxicillin, cloxacillin*, oxacillin, naficillin, methicillin and ampicillin

prodrugs like bacampicillin and hetacillin);

β-lactamase inhibitors like clavulinic acid, (self study – tazobactam)

Cephalosporins (cephalexin, cefadroxil, cefazolin, cefamandole, cefoxitin, cefuroxime,

cefotaxime, ceftriaxone, cefpodoxime proxetil)

Tetracyclines (tetracycline, chlortetracycline, oxytetracycline, doxycycline, and

minocycline and its prodrug – rolitetracycline); Macrolides, (erythromycin,

roxithromycin, azithromycin - only highlights of structure to be discussed);

7

209

Aminoglycosides (gentamicins, and neomycins, - only highlights of structure to be

discussed);

Only highlight the structures of the following compounds: Carbapenems (Emepenem,

Meropenem) Monobactams (Aztreonam, Tigemonam) Linezolid,

5.3 Fluoroquinolones

Norfloxacin, ciprofloxacin*, sparfloxacin, gatifloxacin, levofloxacin, lomefloxacin 2

6 Antiparasitic Agents

6.1 Antimalarial Agents

Natural products like cinchona alkaloids (with stereochemistry and drug action) and

artemisinin and its derivatives like artether, artemether and artesunate, Synthetic

antimalarials such as 8- aminoquinolines eg. primaquine*, 4- aminoquinilines eg.

chloroquine*, Quinoline methanols eg. mefloquine; misc like halofantrine, lumefantrine

and; DHFR inhibitors like pyrimethamine* and proguanil, cycloguanil, atovaquone,

sulfadoxine

Combination therapy.

3

6.2 Drugs for treatment of amoebiasis, giardiasis and trichomoniasis (Self Study)

Metronidazole*, tinidazole, secnidazole, diloxanide furoate*, nitazoxanide 1

6.3 Anthelmintics (Self Study)

Albendazole, Mebendazole*, Thiabendazole, Diethylcarbamazine, Ivermectin,

Praziquantel, Pyrantel Pamoate

1

7 AntiMycobacterial Agents

Antitubercular drugs

PAS*, ethionamide, isoniazid, pyrazinamide, ethambutol*, antitubercular antibiotics

(streptomycin, rifampin, rifapentine, capreomycin, cylcoserine – the first four only

highlights of structure to be discussed), fluoroquinolones, bedaquiline, Antileprotic drugs

Dapsone*, clofazimine, rifampin, Combination therapy

4

8 Antifungal Agents

Natural products like griseofulvin, amphotericin B and nystatin (later two only general

aspects of structure related to activity)

Antifungal azoles like clotrimazole*, ketoconazole, fluconazole, and itraconazole

Allyl amines like naftifine, and terbinafine,

Flucytosine

Miconazole, econazole, flutrimazole, sulconazole, sertaconazole, voriconazole,

butenafine and tolnaftate (Self-Study)

3

1

TOTAL 48

Books:

Latest Editions of the following books should be used.

1. ‘An Introduction to Medicinal Chemistry’, Graham L. Patrick, Oxford University Press, (Latest Edition)

2. ‘Fundamentals of Medicinal Chemistry’, Gareth Thomas, Wiley, New York, (Latest Edition)

3. ‘The Organic Chemistry of Drug Design and Drug Action’, Richard B.Silverman, Academic Press

4. ‘Foye’s Principles of Medicinal Chemistry’, Thomas L. Lemke, David A Williams, Lippincott Williams & Wilkins

5. ‘Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry’, John M. Beale, John H. Block,

Lippincott Williams & Wilkins.

6. ‘Medicinal Chemistry’, Ashutosh Kar, New Age International Publishers

7. ‘Introduction to Medicinal Chemistry’, Alex Gringauz, Wiley

8. ‘The Organic Chemistry of Drug Synthesis’, Daniel Lednicer, Lester A. Mitscher, John Wiley and Sons

9. Pharmaceutical Chemistry, Volume 1, Organic Synthesis, H. J. Roth & A. Kleemann, Ellis Horwood Series in

Pharmaceutical Technology, Halsted Series.

10. ‘Synthesis of Essential Drugs’, Ruben Vardanyan and Victor Hruby, Elsevier

11. ‘Pharmaceutical Substances: Syntheses, Patents, Applications’, Kleemann & Engel, Thieme Publications.

BPH_C_602_T – Pharmaceutics III- (4 Hr/Wk)

Course Objectives

To familiarize the learner with various aspects of formulation development, large scale manufacturing and evaluation of solid oral

dosage forms. Also to teach the learner the important aspects of stability, quality control and quality assurance.

Course Outcomes

Upon completion of the course, the learner shall be able to:

210

1. Know the various solid oral dosage forms and their manufacturing techniques

2. Know various considerations in development of pharmaceutical dosage forms including stability

3. Formulate solid dosage forms and evaluate them for their quality

4. Understand the responsibilities of quality assurance & quality control departments

5. Appreciate the importance of documentation

No. Details Hours

1 TABLETS 15

1.1 Definition, advantages and limitations, ideal characteristics of tablets

preformulation aspects;

Types of tablets-Effervescent, buccal, chewable, sublingual,

dispersible, soluble, orodispersible, compression coated and layered tablets.

2

1.2 Tablet formulation and design, additives, excipients with examples. 3

1.3 Manufacture of tablets-

Direct compression, wet granulation, dry granulation;

Characterization and evaluation of granules

Large scale manufacturing process and equipment for: Mixing, drying,

wet granulation, slugging and roller compaction. Tablet tooling

Compression – (Single station tablet press and Rotary press), physics of tablet

compression (brief. Only the steps. No equations)

Layout of tablet section

6

1.4 Processing problems in tableting and tablet defects. 1

1.5 Packaging & labelling of solid dosage forms (tablets & capsules)- strip, blister & bulk packaging, including

flexible packaging materials (laminates), and equipment used (schematic).

1

1.6 In process quality control tests for tablets. Evaluation of tablets as per

IP, BP, USP

2

2 COATING OF TABLETS 8

2.1 Need for tablet coating, tablet core properties. 1

2.2 Types of tablet coating: Sugar, Film & Enteric coating., compression coating

Materials, and processes employed

3

2.3 Coating equipment – Conventional & modified pans, coating columns (fluidized bed coating), Spray equipment & other accessories.

Equipment for compression coating (schematic)

2

2.4 Problems encountered in coating, coating defects & remedies (in all types of coatings) 1

2.5 Evaluation of coated tablets 1

3 CAPSULES 9

3.1 Definition, types of capsules, advantages and limitations, and raw materials including gelatin and HPMC.

Manufacture of gelatin & HPMC (Schematic representation of steps)

2

3.2 Hard capsule shells: Manufacturing of empty capsule shells (gelatin & HPMC)-schematic representation of

steps only ; Additives, size, sealing, size selection, storage, defects of shells, Quality evaluation of

1

of empty shells.

3.3 Hard capsule fill formulation aspects: , types of fill and excipients;

Large scale manufacturing steps with detailed study of Filling of hard capsule shells;

Filling equipments : classification-volumetric, dosator type and tamping type.

(one example of each type of equipment-schematic representation only).

Problems in capsule filling & remedies

Layout of capsule section. Humidity control in capsule manufacturing and filling area.

Quality control aspects of hard capsules.

4

3.4 Soft gelatin capsules: Properties, nature of shell and contents,

Formulation aspects- types of fills and excipients, Concept (minim/gm)

Large scale manufacturing- Rotary Die Process, Quality control aspects of soft capsules

2

4 Stability Studies 7

4.1 Importance of stability studies, kinetic principles, Arrhenius equation and derivation of shelf life based

on Arrhenius equation, limitations and advantages of Arrhenius equation,

3

211

Books:

Latest Editions

1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman & J. B. Schwartz

2. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes.

3. Remington: The Science and Practice of Pharmacy, Pharmaceutical Science (RPS)

4. Theory and Practice of Industrial Pharmacy by Liberman & Lachman

5. Pharmaceutics- The science of dosage form design by M.E. Aulton, Churchill Livingstone.

6. Cole, Graham, “Pharmaceutical Production Facilities: Design and Applications”.

7. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, Marcel Dekker Series, Vol 107.

8. Quality Assurance Guide by organization of Pharmaceutical Products of India.

9. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I, WHO Publications.

10. How to Practice GMP’s - P. P. Sharma.

11. GMP for Pharmaceuticals, Sidney H. Willing, Marcel Decker Series

Note: References to latest amendments of Schedule M and Schedule U of Drugs and Cosmetics Act 1940 to be made wherever it is

appropriate

BPH_C_603_T – Pharmaceutical Analysis II- (4 Hr/Wk)

Course Objectives

On completion of following theory topics, learner should be able to describe the working principle, instrumentation and applications

of instrumental techniques useful for obtaining qualitative and quantitative information of an analyte and apply statistics for data

analysis.

Course Outcomes

The students will be able to:

1. Comprehend underlying principle, instrumentation, application and limitations in instrumental techniques involving molecular as

well as atomic absorption and emission techniques such as UV-Visible, Fluorescence, Infra-Red, Raman, Atomic absorption

spectroscopy and Atomic emission spectroscopy.

2. Explain fundamentals, working principle and applications of X-ray diffraction technique, potentiometric titrations and thermal

methods of analysis like TG, DSC and DTA.

3. Generalize the concepts and quality control aspects related to radiopharmaceuticals.

4. Calculate and interpret the results for spectral analysis and statistical data analysis.

No Details Hours

1 UV-Visible spectroscopy 10

1.1 Terms- Electromagnetic radiation, Visible light, electromagnetic spectrum, molecular spectra, absorption

spectroscopy, wavelength, wave number, frequency, absorbance, transmittance, auxochrome, bathochromic

shift, hypsochromic shift, hyperchromism, hypochromism, wavelength maxima, specific absorbance, molar

absorptivity, cut-off wavelength for solvents, isoabsorptive point, spectral bandwidth

2

4.2 Degradation pathways- hydrolysis, oxidation, photolytic degradation, methods to enhance stability of drugs

- Self-study with follow up.

1

4.3 Accelerated stability studies, introduction to ICH guidelines 2

4.4 Interactions with containers and closures 1

5.0 Quality Assurance: 6

Concepts of Quality Assurance & Quality Control, Responsibilities of Q.A. department.

Raw material control, actives and inactive, Q.C. standards for raw materials. (identity, purity,

quality and potency

Sanitization, environmental and microbiological control, packaging and labeling control, finished

product control,

Statistical Quality control-concept, Q.C. charts, sampling & Sampling Plans, Sampling tools.

6.0 Documentation

Documentation – need/importance, master formula records, batch manufacturing records, SOPs, Maintenance

& Retrieval of Documents.

3

TOTAL 48

212

1.2 Concepts-Types of absorbing electrons, electronic transitions.

• Beer-Lambert’s law-statement, derivation of mathematical expression, limitations

• Choice of solvents

• Chemical derivatization

2

1.3 Instrumentation of UV-VIS spectrophotometer:

Sources of UV-VIS radiation

Monochromators (Filters, prisms, gratings)

Sample cells

Detectors

Colorimeter and UV-VIS spectrophotometer (single beam and double beam with diagram)

3

1.4 Applications of UV-VIS spectrophotometry:

Application of Beer’s law in quantitative spectrophotometric assays-Single component assays-use of a

standard absorptivity value - use of a calibration graph-single and double point standardization

Measurement of Equilibria constant.

Measurement of rate constant.

2

1.5 Numericals based on Beer-Lambert’s law. 1

2 Fluorescence spectroscopy 4

2.1 Terms-singlet state, triplet state, fluorescence, phosphorescence and energy transitions, molecular emission

spectroscopy.

0.5

2.2 Origin of fluorescence and phosphorescence spectra

Fundamental equation for fluorescence intensity, factors affecting fluorescence intensity (intensity of radiation

source, quantum yield, molecular structure and rigidity, temperature, solvents, pH, dissolved oxygen, quenchers

& concentration)

1.5

2.3 Instrumentation of fluorimeter:

Filter fluorimeter and Spectrofluorimeter (including Block diagram)

Sources of radiation

Monochromators (Filters, gratings)

Sample cells

Detectors

Quantitative applications: Fluorescent compounds and non-fluorescent compounds (Chemical derivatization to

fluorescent compound, e.g. use of Dansyl chloride, Fluoresamine, o-phthalaldehyde) & Choice of fluorimetry

over UV-Vis spectroscopy with respect to Sensitivity and Specificity.

2

3 Infrared / Near IR spectroscopy 6

3.1 Theoretical concepts:

I.R regions, requirements for I.R. absorption, vibrational and rotational transitions, dipole changes,

types of molecular vibrations, potential energy diagrams (harmonic oscillator and anharmonic

oscillator), Vibrational frequency, factors influencing vibrational frequencies, force constants,

vibrational modes (normal mode, combination bands and overtone bands), fingerprint region

Instrumentation of FTIR

2

3.2

Sample preparation & applications of I.R. spectroscopy:

Sample preparation for I.R spectroscopy -Solids (mulling, pelleting and thin film deposition, and in

solution form), Liquids (Neat and in solution form).

Sample handling: Attenuated Total Reflectance and Diffuse Reflectance.

Pharmaceutical applications of IR spectroscopy (including characteristic IR absorption frequencies of

some common bond types such as hydroxyl stretch, nitrile stretch and carbonyl stretch of aldehydes

and ketones, aliphatic and aromatic C-H stretch)

Pharmaceutical applications of Near IR spectroscopy including PAT (Process Analytical Techniques)

4

4 Raman Spectroscopy 4

4.1 Principle of Raman scattering

Comparison between I.R Spectroscopy and Raman Spectroscopy

Raman instrumentation-Sources of light, Sample illumination system (Liquid, solid and fiber optic

sampling), Block diagram of Raman spectrometer.

Applications

4

5 Atomic absorption spectroscopy (AAS) and Atomic emission spectroscopy (AES) 4

5.1 Terms: Atomic spectra, atomic absorption spectroscopy, atomic emission spectroscopy 0.5

5.2 Instrumentation:

For AAS: Radiation sources (Hollow cathode lamp, Electrode discharge lamps)

Plasma sources: Inductively coupled plasma and Direct current plasma source

For AES- Flame atomization (types of flames, flame structure, flame atomizers)

1.5

213

5.3 Interferences & Applications:

Cationic, Anionic and Physical interferences in Flame photometry

Spectral Interferences and Chemical Interferences in AAS.

Pharmaceutical applications

2

6 X-Ray Diffraction Technique 4

6.1 Fundamentals & Applications:

Fundamentals- Origin of X-ray, Bragg’s law and its mathematical derivation, Bravais lattices and

Miller indices

Pharmaceutical applications- Crystal structure determination, polymorphism

2

6.2 Instrumentation & working principle:

X-Ray source (X-ray tube source)

X-ray monochromator and detector

2

7 Radiochemistry and Radiopharmaceuticals 4

7.1 Terms: Properties of radionuclide, Radioisotope, Radioactive decay, half-life of radioactivity, specific

activity, Becquerel, curie, Sievert and Gray

Relative biological effectiveness, Radionuclidic purity, Radiochemical purity

Safety aspects of radiopharmaceutical laboratory

1

7.2 Measurements of radioactivity- Geiger-Muller Counting, liquid Scintillation Counting

Requirements of radiopharmaceuticals- Properties of radionuclides, Pharmaceutical properties,

chemical properties

Radionuclide generator- 99m Tc generator

Quality control of radiopharmaceuticals: Physical, Chemical (Radionuclidic purity, Radiochemical

purity)

Radiochemical methods in analysis: Isotope dilution analysis (Direct and Inverse), Radioimmunoassay

3

8 Potentiometric titration 3

8.1 Construction and working of reference electrode (only Silver- silver chloride electrode to be studied)

Indicator electrode (only glass electrode to be studied)

Rejuvenation of glass electrodes

Potentiometric titrations (Only aqueous acid-base titrations -Strong acid vs strong base, strong acid vs

weak base, weak acid vs strong base, weak acid vs weak base)

Calibration of pH meter and measurement of pH

Determination of pKa by potentiometric titration

3

9 Thermal methods of analysis 4

9.1 Principle, Instrumentation, working and applications of:

a) Thermogravimetry (TG)

b) Differential thermal analysis (DTA)

c) Differential scanning calorimetry (DSC)

Factors affecting the above thermal methods of analysis

4

10 Statistical data handling 5

10.1 Normal Distribution numerical based on:

Confidence limits and Tests of significance (F-test, Student t-test-paired and unpaired)

Linear regression analysis and correlation coefficient

Rejection of results (Q-test)

5

TOTAL 48

Books:

Latest editions of the following books to be adopted

1. D. A. Skoog, F. J. Holler and S. R. Crouch, Principles of Instrumental Analysis, Saunders College Publishing, USA.

2. K. A. Connors, A Textbook of Pharmaceutical Analysis, John Wiley and Sons, Canada.

3. A. H. Beckett and J. B. Stenlake, Practical Pharmaceutical Chemistry, Part I and II, CBS Publishers and Distributors, India.

4. D. A. Skoog, D. M. West, F. J. Holler and S. R. Crouch, Fundamentals of Analytical Chemistry, Saunders College Publishing,

USA.

5. G. D. Christian, Analytical Chemistry, John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd.

6. H. H. Willard, L. L. Merrit and J. A. Dean, Instrumental Method of Analysis, CBS Publishers and Distributors, New Delhi.

7. Ashutosh Kar, Pharmaceutical Drug Analysis, New Age International (P) Ltd. Publishers, India.

8. S. S. Mahajan, Instrumental Methods of Analysis, Popular Prakashan Pvt Ltd., India.

9. G.R. Chatwal and S. K. Anand, Instrumental methods of chemical analysis, Revised and enlarged, Himalaya Publishing House Pvt.

Ltd.

10. Indian Pharmacopoeias, The Indian Pharmacopeia Commission, Ghaziabad, Government of India.

11. United States Pharmacopoeia.

214

12. J. Mendham, R. C. Denney, J. D. Barnes, M.J. K. Thomas, Vogel’s Textbook of Quantitative Chemical Analysis, 6th Ed., Pearson

Education Ltd.

13. D.G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists, Churchill Livingstone

Elsevier.

14. J.W. Robinson, E. M. S. Frame and G. M. Frame II, Undergraduate Instrumental Analysis, Marcel Dekker, New York, USA.

15. R. Kellnar, J. M. Mermet, M. Otto, M. Valcarceland, H. M. Widmer, Analytical Chemistry: A modern approach to analytical

science, Wiley-VCH, USA.

16. J. W. Munson, Pharmaceutical Analysis: Modern methods (in two parts), Marcel Dekker Inc., USA.

17. W. Kemp, Organic Spectroscopy, Reprinted, Palgrave Publishers Ltd., New York, USA.

18. R. M. Silverstein, F. X. Webster and D. J. Kiemle, Spectrometric identification of organic compounds, John Wiley & Sons, Inc.

(Indian edition), New Delhi.

19. D.B. Troy and P. Beringer, Remington-The Science and Practice of Pharmacy, Vol. I & II, Walters Kluwer/ Lippincott Williams

& Wilkins (Indian edition), New Delhi.

20. J.W. Robinson, E. M. S. Frame and G. M. Frame II, Undergraduate Instrumental Analysis, 6th Ed., Marcel Dekker, New York,

USA.

21. J.R. Dyer, Applications of Absorption Spectroscopy of Organic Compounds, Prentice- Hall of India Pvt. Ltd, New Delhi, India.

BPH_C_604_T – Pharmacognosy II- (4 Hr/Wk)

Course Objectives

1. To make the learner understand

a. Extraction of phytoconstitutents, concept of adulteration and substitution

b. Utility of natural products as excipients utilized in pharmaceutical preparations

c. Applications of plant tissue culture techniques for production of secondary metabolites and edible vaccines

2. To introduce the learner to the chemistry, sources, cultivation and collection of crude drugs containing phytoconstituents like

volatile oils, resins and tannins

3. To introduce the learner to the biosynthesis of volatile oil constituents belonging to the classes of monoterpenoids and

phenylpropanoids

4. To make the learner understand the chemistry of phytoconstituents belonging to the classes of iridoids, sesquiterpenes,

diterpenes, tetraterpenes and sulphur containing compounds along with sources and utility of representative examples of

crude drugs in therapeutics.

Course Outcomes

Upon completion of the course the learner will be able to –

1. Explain the concept of adulteration and substitution in crude drugs, extraction process for phyto-constituents using different

methods and principles.

2. Write the source, composition, general methods of extraction, evaluation, chemical tests, therapeutic uses of crude drugs

containing volatile oils, resins and tannins

3. Write the biosynthesis of monoterpenoids and phenypropanoid constituents of volatiles

4. Understand the chemistry of phytoconstituents belonging to the classes of terpenoids, sulfur containing constituents and

quinones and write source composition and structures of phytoconstituents of crude drugs belonging to these classes

5. Write the significance of excipients of natural origin, used in pharmaceutical formulations and describe various classes of

excipients like binders, colours, sweetners and flavorants along with the examples of their utility.

6. Describe the applications of plant tissue culture techniques with respect to production of secondary metabolites and edible

vaccines.

No. Details Hours

1 Evaluation of commercial crude drugs intended for use.

Adulteration &Substitution of drugs of natural origin.

Case Studies: Adulteration & Substitution with 4 examples

Evaluation by organoleptic, microscopic, physical, chemical and biological methods and properties as per

WHO guidelines for quality control of herbal drugs

6

2 Extraction: Basic principles of extraction with two examples each of extraction using physical (Solubility)

and chemical properties, general solvents to be used, Successive and exhaustive extraction, Soxhlet extraction,

microwave, supercritical extraction.

5

3 Volatile Oils: Source, Composition, chemistry, general methods of extraction, evaluation, chemical test,

therapeutic uses of volatile oils listed below.

Introduction and application of terpeneless volatile oils.

a. Umbelliferous fruits (Dill, Fennel, Coriander, Cumin, Caraway).

8

215

b. Alcohol – Peppermint, Cardomom

c. Aldehyde volatile oil –Lemongrass, Vanillin

d. Ketone volatile oil - Spearmint (mint oils)

e. Ester volatile oil - Oil of Wintergreen

f. Ether volatile oil - Eucalyptus oil

g. Miscellaneous - Sandalwood, Jatamansi.

h. Phenylpropanoids - Cinnamon, Clove, Nutmeg.

Salient features of cultivation, collection, preparation of Umbelliferous fruits, Clove, Cinnamon

Isolation, Identification and Analysis of Phytoconstituents

Terpenoids: Menthol, Citral

Interactive session

• Comparative study of Umbelliferous fruits (Dill, Fennel, coriander, cumin, caraway).

• Commercially significant volatile oils, eg. Palmarosa Oil, Citrus Peel Oil, Patchouli Oil, Primrose Oil, Tea

Tree Oil.

1

1

4 Biosynthetic Pathways: Acetate mevalonate pathway, shikimic acid pathway,

Biosynthesis of Menthol, citral, cinnamaldehyde

3

5 Resins and resin combinations

Study of occurrence, preparation, composition, uses and specific tests for identification of the following

a. Natural resins - Colophony, Benzoin, Asafoetida, Boswellia

b. Prepared resins - Turmeric, Ginger,

Separation, Identification and Analysis of Phytoconstituents –

Resin – Curcuminoids

Interactive Session:

Processing and Preparations for market - Ginger, Turmeric and Asafoetida

3

1

1

6 Study of the following Classes of Phytoconstituents with respect to sources, chemistry and therapeutic

uses.

a. Iridoids

Study of piccrohiza, gentian

b. Sesquiterpenes and Diterpenes

Artemisia, Andrographis.

c. Tetraterpenoids- carotenoids - lutein, crocin,

d. Organo sulphur- Allium cepa, Allium sativa

e. Quinones: Napthoquinones - Chitrak , Henna and Benzoquinone - Vidang

5

7 Tannins

Introduction of tannins and their definition, classification, Study of sources, composition, extraction and

applications of

Galls, Amla, Harda, Behra, Catechu (Pale & Black, Arjuna, Green Tea, Pomegranate Peel.

Isolation, Identification and Analysis of Phytoconstituents

Ellagic acid from Myrobalan

Interactive Session

Preparation containing tannins in healthcare with suitable examples

Commercial Application of tannins in synthesis of drugs eg. Trimethoprim

Abuse of Tannins

4

1

1

8 Plant Tissue Culture:

Different methods of manipulation of secondary metabolites

Introduction and application of transgenic plants with special reference to

Edible vaccines

4

9 Excipients of natural origin – Significance of substances of natural origin as excipients

a. colorants – bixin, saffron,

b. Sweeteners- thaumatin, stevia

c. binders, diluents, viscosity builders, disintegrants

d. Flavors & Perfumes with two suitable examples each from the class of volatile oils.

Interactive Session

Study of two examples of each type of excipient (binders, diluents, viscosity builders, disintegrants) from

natural sources and its applications in pharmaceutical formulations.

3

1

TOTAL 48

216

Books:

Latest editions of the following books to be adopted.

1. Trease D. & Evans W.C.: Text Book of Pharmacognosy: W.B. Saunders.

2. Tyler V. E. Brady L. R. & Robbers J. E.: Pharmacognosy; Lea Feibger, USA.

3. Wallis T. E.; Text Book of Pharmacognosy; CBS Publishers, Delhi.

4. Kokate C. K., Purohit A. P. & Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune.

5. Harbone J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman & Hall, London.

6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited.

7. Vasudevan T. N. & Laddha K. S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon.

8. The Indian Pharmacopeia: The Controller of Publication; Delhi.

9. R. S. Guad, S. J. Surana, G. S. Talele, S. G. Talele, Mr. S. B. Gokhale. Natural Excipients, Pragati Books Pvt. Ltd., 2006

10. Biren Shah, Avinash Seth, Textbook of Pharmacognosy and Phytochemistry , Elsevier Health Sciences,

11. Ashutosh Kar, Pharmacognosy And Pharmacobiotechnology, New Age International, 2003

12. Quality Control Methods for Medicinal Plant Materials, World Health Organization World Health Organization, 1998 - Botanical

drug industry

13. WHO Monographs on Selected Medicinal Plants, World Health Organization World Health Organization, 1999

14. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, ESCOP, European Scientific Cooperative on

Phytotherapy, Thieme, 2003 -

15. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, Max Wichtl CRC Press, 2004 - Health &

Fitness

16. Pulok K. Mukherjee Evidence-Based Validation of Herbal Medicine, Elsevier, 17-Feb-2015

17. Adverse Effects of Herbal Drugs 2, Springer Science & Business Media, 06-Dec-2012

18. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals, Pulok K. Mukherjee Business Horizons, 2002

19. Brain K. R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol.

20. Iyengar M. A. & Nayak S. G.: Anatomy of Crude Drugs: Manipal Power Press, Manipal

21. Iyengar M. A.: Pharmacognosy of Powdered Drugs; Manipal Power Press, Manipal

BPH_C_605_L – Pharmaceutical Chemistry Lab I- (4 Hr/Wk)

Traditional methods of synthesis to be followed for each of the Unit Operations in addition to specific methods as indicated.

1. Acetylation - Synthesis of aspirin using Microwave Procedure or Synthesis of Acetanilide as per Green Chemistry DST Monograph

2. Halogenation – Synthesis of p-bromoacetanilide as per Green Chemistry, DST Monograph

3. Esterification of PABA to benzocaine

4. Oxidation - Synthesis of benzoic by oxidation of toluene or benzyl alcohol with alkaline potassium

permanganate.

5. Hydrolysis of methyl benzoate.

6. Reduction - synthesis of m-nitroaniline by partial reduction of m- dinitrobenzene with sodium polysulfide.

7. Nitration: Synthesis of p-nitroacetanilide as per Green Chemistry, DST Monograph.

8. Synthesis of benzimidazole.

Books:

1. Vogel’s A Text book of Practical Organic Chemistry by Vogel, Longman group limited, London.

2. Practical Organic Chemistry by Mann FC & Saunders BC, Longman Group Limited, London.

3. Laboratory Techniques in Organic Chemistry, Ahluwalia V.K. I.K. Publishers.

4. Green Chemistry, V. K. Ahluwalia.

5. New Trends in Green Chemistry, V K Ahluwalia and M Kidwai, KluwerAcademic Publishers

6. Monograph on Green laboratory Experiments, Grenn Chemistry Task Force Committee, DST.

7. Practical Organic Synthesis: A Student's Guide - Reinhart Keese, Martin Brändle, Trevor Toube.

8. Advanced practical Medicinal Chemistry by Ashutosh Kar, New Age International Publications.

BPH_C_606_L – Pharmaceutics Lab III- (4 Hr/Wk)

Course Objectives

To teach the learner the practical course dealing with the various aspects of formulation and evaluation of solid oral dosage forms. To

familiarize the learner with the important aspects of accelerated stability testing and shelf life calculations.

Course Outcomes

217

Upon completion of the course, the learner shall be able to:

1. Formulate solid dosage forms like tablets and capsules and evaluate them for their quality.

2. Understand the tablet coating process.

3. Learn the concepts of accelerated stability testing and shelf life calculations.

No. Details

1. Evaluation of excipients

a. Bulking agents: Comparison of at least one excipient in conventional and directly compressible

form for: Flow properties, Bulk density, Tapped density, Carr’s index, Hausner’s ratio and

particle size by microscopy and sieve analysis.

b. Disintegrating agents-Swelling index

c. Lubricants and glidants: Influence on flow properties of granules.

2. Preparation and evaluation of any one tablet formulation based on each of the following:

a) Direct compression technique

b) Non-aqueous wet granulation technique

c) Aqueous wet granulation technique

3. Preparation and evaluation of any one formulation of the following types of tablets:

a) Mouth dissolving tablet

b) Chewable tablet

4. Filling and evaluation of any one hard gelatin capsule formulation

5. Evaluation of anyone marketed immediate release tablet formulation including dissolution testing as per

IP.

6. Accelerated stability testing of any suitable drug/ formulation. Problems based on Arrhenius equation for

shelf life calculations.

7. Demonstration of film coating of tablets

Books:

All books listed in the theory syllabus as well as current editions of IP, BP and USP.

BPH_C_607_L–Pharmaceutical Analysis Lab II- (4 Hr/Wk)

Course Objectives

On performing the following experiments, learner should be able to operate the instruments, understand its instrumentation, prepare

solutions with accurate concentrations, measure the readings, calculate and interpret the results obtained.

Course Outcomes

1. Record the absorbance and calculate concentration of analyte in formulation or as an API by use of A(1%, 1cm), single point and

double point standardisation by UV spectrophotometer.

2. Relate and construct linear regression analysis data for colorimetric assays and operate a colorimeter instrument.

3. Record and calculate the concentration of an analyte by measure of fluorescence of an analyte in absence and presence of quenching

agent.

4. Operate a pH meter, measure equivalence point by potentiometric titration, calculate pKa and normality for a given acid or mixture

of acids.

5. Understand the sample preparation technique for FTIR spectroscopy, interpret the IR spectra to identify the functional groups of an

analyte, and understand the working of a flame photometer.

No. Experiments

1 Assay of finished products by UV spectroscopy, using A (1%, 1 cm)-

Minimum assay of 5 formulations:

Paracetamol tablets

Propranolol tablets

Atenolol tablets

Hydrochlorothiazide tablets

Frusemide tablets

Albendazole tablet

Rifampicin capsules

2 Assay of drug by UV spectroscopy.

Use of single point and double point standardization method e.g. Paracetamol

3 Colorimetric assay

218

(Construction of calibration curve using linear regression analysis)

A. Assay of streptomycin injection

B. Assay of salicylic acid.

4 Fluorimetric analysis

A. Assay of quinine sulphate

B. Effect of different concentrations of iodide ions on fluorescence of quinine sulphate.

5 Potentiometric aqueous acid-base titrations using pH meter

(All experiments must be performed by use of titration curve and calculations based on equivalence

point determination)

A. Determination of pKa and normality of phosphoric acid (First & Second end-point)

B. Determination of normality of individual acids in a mixture of acids. (e.g: HCl and H3PO4)

C. Determination of normality of strong acid (HCl)Vs standard solution of strong base

(NaOH) as a titrant

D. Determination of Normality of weak acid (acetic acid) Vs standard solution of strong Base

(NaOH) as a titrant

6 Demonstration experiments:

A. Determination of Na+/K+ by Flame photometry.

B. Working of FTIR and Interpretation of IR spectra of any one drug.

Books:

Latest editions of books to be adopted

1. Indian Pharmacopoeia, The Indian Pharmacopoeia Commission, Ghaziabad, Government of India.

2. G. D. Christian, Analytical Chemistry, John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd.

3. A. H. Beckett and J. B. Stenlake, Practical Pharmaceutical Chemistry, Part I and II, CBS Publishers and Distributors, India.

4. United States Pharmacopoeia.

5. J. Mendham, R. C. Denney, J. D. Barnes, M. J. K. Thomas, Vogel’s Textbook of Quantitative Chemical Analysis, Pearson

Education Ltd.

6. D. G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists, Churchill Livingstone

Elsevier.

7. R. M. Silverstein, F. X. Webster and D. J. Kiemle, Spectrometric identification of organic compounds, John Wiley & Sons, Inc.

(Indian edition), New Delhi

ANY TWO SUBJECTS (ONE EACH OF 4 CREDIT AND 2 CREDIT SUBJECT) FROM THE

FOLLOWING SUBJECTS TO BE CHOSEN AS ELECTIVES FOR A TOTAL OF 6 CREDITS

BPH_E_608_T – Pharmaceutical Management- (4 Hr/Wk)

Course Objectives

1. To introduce the learner to the pharmaceutical industry with emphasis on Indian Market.

2. Give the learner an understanding of companies’ financial statements & its components.

3. To enhance the knowledge about marketing and its importance to a learner’s career.

4. To provide knowledge of management & its importance.

5. To introduce the importance of management in quality control & government regulation.

Course Outcomes

The learner will be able to

1. Study and interpret companies’ financial statements & its components.

2. State the importance of marketing in the pharma industry.

3. Outline the basic principles of management

4. Discuss the importance of management in quality control & government regulation.

No. Details Hours

1.1 Indian Pharmaceutical Industry 6

a) Structures

b) Components

219

c) Present Scenario

d) Foreign Trade

e) Future

1.2 Government Policy 2

a) Growth & Investment

b) Employment

c) Taxes & Subsidies

1.3 Share of Pharmaceutical Industry in the Economy

2 Financial Management 4

3 Management 4

a) Management Thoughts

b) Management Function

c) Organization

d) Motivation

e) Leadership

f) Conflicts & Measures to Solve it.

4 Marketing 8

a) Brand & Branding & Brand Plan

b) Market Segmentation

c) Product Positioning

d) Marketing Mix

e) Packaging

5.1 Product Life Cycle 4

5.2 New Product Development

5.3 Marketing Models (BCG & Porter’s 5 Force)

6 Production Management 8

a) Quality Control

Concepts of Quality Assurance & Quality Control, Responsibilities of Q.A. department.

Raw material control, actives and inactive, Q.C. standards for raw materials. (identity, purity,

quality and potency)

QA before start up- environmental and microbiological control, manufacturing working formula

procedures, cleaning, sanitization, in process control packaging and labelling control, finished

product control.

Specimen documents-formats

cGMP

Statistical Quality Control -Q. C. Charts, sampling and sampling plans, sampling tools.

b) Six Sigma’s

c) Quality Control Methods & Regulations

d) Inventory Management

e) Production Management & Control

f) Quality Control Standards in Pharmaceutical Industries

g) FDA & Other Regulations

7 Market 5

a) Perfect and Imperfect Competition

b) Mergers & Collaborations

c) Investments Trends in Pharmaceutical Industries

d) Distribution

Distributors, direct distribution, direct home delivery, dispensing, scheme, etc.

8 Costing & Pricing 4

a) Different types of costs including production cost, selling cost and overhead costs

b) Pricing of Products - Government Regulations including DPCO

9 Industrial Psychology 3

220

Books:

1. Sachin Itkar: Pharmaceutical Organisation

2. Vidya Sagar: Pharmaceutical Industry & Organisation

3. I.M. Pandey or Prasanna Chandra: Financial Management

4. L.M. Prasad: Principle & Practice of Management

5. Philips Kolter: Principle of Marketing

6. Rama Swamy & Nama Kumari: Marketing Management

7. I.M. Juram & F.M. Gryna: Quality Planning & Analysis (Tata Mcgraw Hill)

BPH_E_609_T – Biopharmaceutics and Pharmacokinetics- (4 Hr/Wk)

Course Objectives

To provide knowledge of basic concepts of Biopharmaceutics and Pharmacokinetics and corelate these concepts

to properties of drugs and dosage form design.

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Explain the basic terms used in Biopharmaceutics and Pharmacokinetics

2. Understand the concept of pharmacokinetics models and significance of various pharmacokinetic parameters

3. Understand BCS Classification, theories of Dissolution and methods of dissolution testing

4. Explain the concepts of Bioavailability and Bioequivalence and IVIVC

5. Solve problems based on principles of Pharmacokinetics

No. Details Hours

1. Introduction to Biopharmaceutics and Pharmacokinetics. Fate of drugs in the body.

Definitions of ADME, Bioavailability, Bioequivalence, Pharmacokinetics, Clinical

Pharmacokinetics. Different models to study the processes of ADME

2

2 ABSORPTION 6

2.1 Physiology of cell membrane and passage of drugs across cell membrane 1

2.2 Different Mechanisms of drug absorption 1

2.3 Factors affecting drug absorption-Physicochemical properties, formulation and dosage

form features, physiological conditions and parameters.

2

2.4 Absorption of drugs from extravascular routes 2

3 DISTRIBUTION 4

3.1 Factors affecting distribution, Physiological barriers, Tissue permeability and perfusion

limited distribution.

2

3.2 Volume of Distribution – Concept, significance of apparent volume of distribution, real

volume of distribution

1

3.3 Protein Binding of drugs and its significance 1

4 METABOLISM/BIOTRANSFORMATION 7

4.1 Phase I and Phase II reactions 3

4.2 Factors affecting drug metabolism: Age, species difference, genetic difference, induction

and inhibition, drug-drug interaction

2

4.3 First pass metabolism, concept of clearance, hepatic clearance and factors affecting hepatic

clearance, Hepatic extraction ratio, limits of values of organ clearance

2

5 EXCRETION 4

5.1 Renal excretion, Renal clearance, factors affecting renal clearance, renal function and

excretion ratio

2

5.2 Non-renal routes of excretion 2

6 DISSOLUTION 4

6.1 Introduction to Biopharmaceutical Classification System of drugs 1

6.2 Theories of dissolution,

Dissolution rate and methods of enhancing dissolution rate-Self-study with follow up

1

a) Human Relation

b) Stress & its Management

c) Present Life, Pharmaceutical Industry, Its Impact on Employees & health measures

d)

TOTAL 48

221

6.3 Official and nonofficial methods of dissolution rate testing. Application to different

dosage forms

2

7 PHARMACOKINETICS 17

7.1 Pharmacokinetics: Introduction to compartmental and physiological models.

Introduction to the one compartmental open model and its assumptions. Concept of zero

order and first order rate kinetics

2

7.2 Mathematical treatment of pharmacokinetics upon One compartment open model IV bolus

dosing: Importance of volume of distribution, Clearance, elimination rate constant, half-

life, area under the curve (trapezoid rule).

4

7.3 Mathematical treatment of pharmacokinetics upon One compartment open model

extravascular dosing; Absorption rate constant, absorption half- life, bioavailability, Area

under the curve and the method of residuals, concept of Cmax and tmax.

Introduction to Rate of excretion method and Sigma minus method for urine analysis after

IV administration.

3

7.4 Mathematical treatment of pharmacokinetics upon multiple IV bolus dosing, concept of

accumulation, fluctuation and steady state levels

3

7.5 Linear and non-linear kinetics and description of factors resulting in non- linear kinetics. 2

7.6 Application of PK principles through simple problem solving (for i.v. bolus, multiple i.v.

and oral).

3

8 BIOAVAILABILITY AND BIOEQUIVALENCE 4

8.1 Concept of absolute and relative bioavailability 1

8.2 Method of assessment and enhancement of bioavailability 1

8.3 Bioequivalence: Study design, IVIVC, introduction to the concept of biowaiver 2

TOTAL 48

Books:

Latest Editions to be adopted

1. Leon Shargel, Susanna Wu – Pong, Andrew B.C., Applied Biopharmaceutics and Pharmacokinetics, Singapore.

2. Brahmankar D.M. and Jaiswal Sunil B, Biopharmaceutics and pharmacokinetics – A Treatise, Vallabh Prakashan.

3. Robert E. Notari, Biopharmaceutics and Pharmacokinetics – An Introduction, Marcel Dekker Inc., New York.

4. Milo Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics, USA

5. Malcom Roland, Thomas Tozer, Clinical Pharmacokinetics: Concept and Applications, A Lea – Febiger book, USA.

6. Banakar Umesh, Pharmaceutical Dissolution Testing, Volume 49, Marcel Dekker Inc, New York.

BPH_E_610_T – Basic Principles of Toxicology- (2 Hr/Wk)

Course Prerequisites

Understanding of Anatomy, Physiology, Pharmacology and its applications.

Course Objectives 1. To define basic toxicological terminologies and explain mechanisms and factors behind the toxic effects.

2. To describe modes of action by which different chemicals produce toxic effects on different organs and systems of human body.

3. To explain different tests and their importance to discover toxic potential of drugs.

4. To introduce to regulatory toxicological frameworks within the professional disciplines and different risk assessment criteria.

Course Outcomes 1. Define toxicological terms mentioned in the course.

2. Discuss mechanism of toxicity, factors influencing toxicity and management of poisoning.

3. Explain metal poisoning and basic principles with suitable example of drug induced toxicity.

4. Discuss in brief about different types of toxicity test.

5. Demonstrate the knowledge of regulatory toxicology and able to apply this knowledge for design of nonclinical toxicology and

clinical development of drugs.

No. Details Hours

1 Introduction to toxicology 5

1.1 Definitions: Toxicology, Poisons, Hazards, Risk 1

222

Classification of toxicity

1.2 Factors influencing toxicity 1

1.3 Mechanisms of toxicity 2

1.4 General Management of poisoning 1

2 Drug induced toxicities 6

2.1 Introduction to the terms with suitable examples of drugs and its clinical repercussions:

genotoxicity, carcinogenicity, teratogenicity, mutagenicity, hepatotoxicity, nephrotoxicity,

cardiotoxicity, neurotoxicity, haematotoxicity and local toxicity

3

2.2 Clinical symptoms and management of alcohol, barbiturate and morphine poisoning. 3

3 Toxicity testing 5

3.1

3.2

Types of toxicological testing: Acute, Sub acute and Chronic toxicity studies

Brief introduction to alternatives to Animal Models for toxicological testing

4

1

4 Regulatory toxicology 8

4.1 Overview of regulatory laws and agencies: Local Drug Regulatory Agencies, OECD and

ICH

3

4.2 Schedule Y: Design of non-clinical toxicity studies and clinical development 3

4.3 Risk assessment and management of toxicological risks 2

TOTAL 24

Books:

Latest edition of the following books to be adopted:

1. General and applied toxicology by Bryan Ballantyne, Timothy Marrs, Paul Turner, Stockton Press.

2. Satoskar R.S. Bhandarkar S.D. & Rege N. N. Pharmacology & Therapeutics, Popular Prakashan.

3. Rang & Dale Pharmacology, Churchill Livingstone.

4. Toxicological and Risk assessment Principles, Methods and applications by Anna Fan, Louis Chang, Marcel Dekker.

5. Laurence D. R. & Bennett Clinical Pharmacology, Elsevier, NY.

6. Kulkarni S. K. Handbook of Experimental Pharmacology, Vallabh Prakashan, New Delhi.

7. Katzung B. G. -Basic and Clinical Pharmacology, Appleton and Lange publications.

8. Ghosh M. N. Fundamentals of Experimental Pharmacology Hilton & Company, Kolkata.

9. Curtis D. Klaassen, Casarett & Doull's Essentials of Toxicology, McGraw Hill.

10. Karen Stine, Thomas M. Brown. John B. Watkins, Principles of Toxicology, CRC Press

11. Harsh Mohan Text Book of Pathology, Jaypee publication.

12. Shayne C. Gad, Regulatory Toxicology, Taylor & Francis.

13. A. Wallace, Hayes Principles and Methods of Toxicology, CRC Press.

BPH_E_611_T – Cell and Tissue Culture- (2 Hr/Wk)

Course Prerequisites

Basic knowledge of Cell Biology, Microbiology and Animal Physiology.

Course Objectives

1. To examine and analyze practical and theoretical principles of cell culture.

2. To explain the conditions under which cells can be cultured outside the body.

3. To explain the advantages and limitations of cell culture in biomedical research and applications.

223

Course Outcomes:

The learner will be able to:

1. Understand the basic requirements of cell and tissue culture.

2. Plan experiments using cultured cells.

3. Carry out cell culture, and associated laboratory techniques.

4. Explore the concepts of cell and tissue culture in production of pharmaceutical products.

No. Details Hours

1 Introduction to Animal Cell culture: 1.1 Historical background. Advantages of Tissue Culture, Limitations, Major Types of

Tissue Culture - Primary and secondary cell culture.

1.2 Laboratory Design & Layout of Animal Tissue Culture (ATC) laboratory,

Equipment and Materials of a Tissue Culture Laboratory, Media Preparation and

Sterilization techniques.

1

1

2 Media and reagents: 2.1 Types of cell culture media, Ingredients of media, Physiochemical properties,

Antibiotics, growth supplements, Foetal bovine serum; Serum free media, Trypsin

solution, Conditioned media, Other cell culture reagents,

2.2 Selection of medium and serum.

2.3 Preparation and sterilization of cell culture media, serum and other reagents.

2

1

1

3 Cell culture Techniques:

3.1 Different types of cell cultures, Trypsinization, Cell separation, Continuous cell

lines, Suspension culture, Organ culture.

3.2 Cloning and selection of Animal cells, the Culture Environment, Cell Adhesion, Cell

Proliferation, Differentiation, Cell Signaling, Energy Metabolism, Maintenance of cell

lines, Cryopreservation.

3.3 Primary Culture: Initiation of a Primary Cell Culture, Isolation of the Tissue, Types

of Primary Culture, Subculture and Development of Cell Lines.

3.4 Common cell culture contaminants.

3.5 Scale-up & Automation.

2

3

1

1

1

4 Applications of Cell and Tissue Culture:

4.1 Stem cell Culture, Embryonic Stem Cell Culture: Current status and application in

medicine, Cell based therapies, Nanomedicine.

4.2 Application of animal cell culture for in vitro testing of drugs.

4.3 Application of cell culture technology in production of human and animal viral

vaccines and pharmaceutical proteins.

4.4 Production of recombinant hemoglobin, blood substituents, Artificial blood, General

account of in vitro regulation of blood cells production.

4.5 Antibody Engineering and Large-scale Production of Pharmaceutical Products.

2

2

2

2

2

TOTAL 24

Books:

1. Ed. John R.W. Masters, Animal Cell Culture - Practical Approach, 3rd Edition, Oxford University Press, 2000.

2. Ed. Martin Clynes, Animal Cell Culture Techniques., Springer, 1998.

3. B.Hafez, E.S.E Hafez, Reproduction in Farm Animals, 7th Edition, Wiley- Blackwell, 2000.

4. Louis-Marie Houdebine, Transgenic Animals: Generation and Use, 1st Edition, CRC Press, 1997.

5. Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications By R. Ian

Freshney; 5th Edition, Wiley-Liss, 2005

6. Animal Cell Culture (Introduction to Biotechniques): Sara j. Morgan, David C. Darling; Published by BIOS Scientific Publishers

Ltd., 1993

BPH_E_612_T – Pharmaceutical Process Chemistry and Technology- (2 Hr/Wk)

Course Objectives

224

On completion of the following theory topics, learner should be able to understand basic concepts from process chemistry, appreciate

importance of unit processes, regulations and safety aspects at manufacturing of Active Pharmaceutical Ingredients (APIs) and New

Chemical Entities (NCEs) at drug development stage

Course Outcomes

The learner will be able to:

1. Describe the basic concepts of process chemistry and process development

2. Describe chemical process, reaction systems and equipment used in API manufacturing

3. Outline the regulatory guidelines related to API manufacturing

4. Appreciate the importance of safety in pharmaceutical industry

No. Details Hours

1 Process chemistry 3

1.1 Overview of fine chemicals industry

1.2 Stages of scale up process: Bench, pilot and large-scale processes

1.3 Process control for large scale process:

Definitions: process, process control, Process variables and set point and

Importance of process control

2 Process development 5

2.1 Process development: Definition, steps involved with examples 1

2.2 Process equipment/ production plants

Dedicated plants, multipurpose and mixed plants

Typical equipment: reactors, filters, centrifuge, driers, extractors and evaporators

2

2.3 Chemical process kinetics:

Factors affecting chemical processes,

Reactor shape and effect of back mixing

2

3 Unit processes 12

3.1 Nitration:

Nitrating agents, Aromatic nitration,

Kinetics and mechanism of aromatic nitration,

Process equipment for technical nitration, mixed acid nitration

Examples to be covered: Nitrobenzene, p-nitroacetanilide

2

3.2 Amination by reduction:

Reduction methods for amines

Iron/acid reduction: Mechanism, chemical, physical factors, equipment

Sulfide reduction with example of manufacture of m-Niroaniline by Na2S:

Zinnin reduction

2

3.3 Halogenation:

Kinetics of halogenations, types of halogenations, catalytic halogenations.

Case study on industrial halogenation process: Chloral

2

3.4 Oxidation:

Introduction, types of oxidative reactions,

Liquid phase oxidation with oxidizing agents

Non-metallic Oxidizing agents: H2O2, sodium hypochlorite, Oxygen gas

2

3.5 Esterification:

Esterification of Organic acids, inorganic acids, case study: glyceryl trinitrate, cellulose

nitrate

1

3.6 Hydrolysis: Definition and scope, Hydrolyzing agents, Materials susceptible to

hydrolysis, mechanism of hydrolysis,

Equipment for hydrolysis, Case study

2

4 API technology 2

Impurities in API: Types and sources including genotoxic impurities

Brief overview of guidelines in API manufacturing

Chirality and polymorphism in API

5 Industrial Safety and environment 2

Basic knowledge about Material Safety Data Sheet (MSDS) for safety and handling of

chemicals without health hazards.

Fire hazards, types of fire & fire extinguishers

Occupational Health & Safety Assessment Series 1800 (OHSAS-1800) and

ISO-14001(Environmental Management System), Effluents and its management

TOTAL 24

225

Books:

1. A. Cybulski, Fine Chemicals Manufacture- Technology and Engineering, Elsevier Publication, 2001

2. Pharmaceutical Process Validation: An International Third edition, Revised and expanded, Edited by Robert Nash and Alfred

Wachter, Marcel Dekker, 2003

3. ICH Guidelines, www.ich.org (FDA Guidance for industry, Q3A, Q7)

4. Organic Synthesis, Groggins P. H, (Fifth edition). P. H. Groggins , McGraw-Hill, 1958

5. Neal G. Andreson, “Practical Process Research and Development” academic Press, 2000

6. Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-Up, Peter J. Harrington, John Wiley and Sons Inc.

Publication 2011

7. Process Chemistry in Pharmaceutical Industry, Kumar Gadamasetti, Vol I & II, CRC Press; First edition, 2007.

8. Performance of Pharmaceutical Companies in India: Contribution to economics Authors: Mazumdar, M. Springer Verlag

Berlin, 2013, Chapter 2, 17-44

9. Principles of Process Research and Chemical Development in the Pharmaceutical Industry by O. Repic, John Wiley & Sons.Inc

Publication New York, NY, 1998.

BPH_E_613_T – Pharmaceutical Excipients- (2 Hr/Wk)

Course Objectives

To provide the learner an understanding of types, functions, applications and regulatory aspects of excipients used in development

Pharmaceutical dosage forms

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Define, classify and elaborate on regulatory aspects of Pharmaceutical excipients.

2. Understand the characterization and interactions of excipients with APIs and packaging materials

3. Elaborate on common and novel excipients in Pharmaceuticals

4. Explain the role of polymers as excipients

No. Details Hours

1.0

1.1

1.2

Excipients - Introduction, Definition, Functional classification of excipients.

Excipient Characterization, Active–excipient interactions-Physical, Chemical and

Physiological/biopharmaceutical; Excipients-packaging material interactions,

storage conditions for excipients

Regulatory guidelines for the pharmaceutical excipients, Pharmacopoieal,

Harmonization of the Excipients, safety testing of excipients

1

4

3

2.0 Study of some common Conventional excipients with respect to source,

chemical nature, role/functions, manufacture/processing steps, interactions,

safety:

Lactose, Starch, Magnesium stearate, Talc, Bentonite, Glycerol, Paraffins,

Sodium Lauryl Sulphate, Sodium saccharin, Tweens and Spans, Arachis oil,

Wool fat, Glyceryl mono stearate

Self-study with follow up

4

3.0 Organoleptive additives- colours, flavours and sweeteners-sources,

mechanism/basic principles and examples

Self-study with follow up

2

4.0 Excipients for solubility/dissolution and permeation enhancement-Need,

basic principles and examples

Self-study with follow up

2

5.0 Excipients for stabilizing / preservation of dosage forms- Study of

antioxidants, chelating agents, buffering agents, antimicrobial preservatives with

respect to need, mechanisms and examples.

Self-study with follow up

2

6.0 Improved and Novel Excipients – Need, sources of new excipients-co-

processing and particle engineering, benefits of co-processed excipients,

characterisation, examples, regulatory aspects.

3

226

7.0 Polymers as excipients - Introduction to polymers, classification, important

properties for applications, use of polymers in conventional formulations,

modified /controlled release formulations,

Self-study with follow up-of following polymers-HPMC, Gelatin, Carbopol and

Eudragits

3

TOTAL 24

Books:

1. Rowe, R. C., Sheskey, P. J., & Owen, S. C. (Eds.)Handbook of pharmaceutical excipients (6th ed.). London: Pharmaceutical Press

and A.A.P.S., 2009

2. Robert, W. M., & Aloysius, O. A., Pharmaceutical Dosage Forms—Tablets Vol 3 (Revised and expanded). (H. A. Lieberman, L.

Lachman, & J. B. Schwartz, Eds.) Informa Health Care., 2008

3. Lachman, L., Lieberman, H. A., & Kanig, J. L.. The Theory and Practice of Industrial Pharmacy (3rd ed.). Mumbai: Varghese

Publishing House. ,1991.

4. Rawlins, E. A. Bentley’s text book of Pharmaceutics (8th ed.). London: Bailliere Tindal., 1995.

5. Rubinstein, M. H.,Tablets. In M. E. Aulton, Pharmaceutics: the science of dosage form design, London: ELBS Longman Group

Ltd., 1988.

6. Rudnic, E. M., & Schwartz, J. D. ,Remington: The Science and Practice of Pharmacy, (A. R. Gennaro, Ed.) Philadelphia: Lippincott

Williams & Wilkins, 2006

7. Saha, S., & Shahiwala, A. F.,Multifunctional coprocessed excipients for improved tabletting performance . Expert Opinion on Drug

Delivery , 6 (2), 2009.

8. Kadtare A. and Mahesh Chaube, Excipient Development for Pharmaceutical, Biotechnology and Drug Delivery Systems, Informa

Healthcare USA, Inc. 270 Madison Avenue, New York 10016, 2006.

227

SYLLABUS FOR Final. Y. B. Pharm.

SEMESTER-VII

BPH_C_701_T – Pharmaceutical Chemistry II- (4 Hr/Wk)

Course Objective

1. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of

anticancer agents

2. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of

antiviral agents

3. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of

cardiovascular drugs like antianginal agents, antiarrhythmic agents, diuretics, drug affecting the RAS pathway, vasodilators,

antihyperlipidemic agents drugs

4. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of

antihistaminics

5. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected synthesis of

hypoglycemic agents and insulin analogs

Course Outcome

Students will gain knowledge in the thurst areas chemotherapy for cancer, antiviral diseases, cardiovascular drugs like antianginal

agents, antiarrhythmic agents, diuretics, drug affecting the RAS pathway, vasodilators, antihyperlipidemic agents. They will be apply

this knowledge in research areas.

No Details Hours

Discussion of the following classes of drugs including classification, chemical

nomenclature, structure including stereochemistry, generic names, SAR and

metabolism, molecular mechanism of action, synthesis(*) and rational

development if any

1 Anti-Cancer agents: • Alkylating agents like mechlorethamine , chlorambucil* (self study),

melphalan*, cyclophosphamide*, busulfan, carmustine, lomustine,

streptozocin, dacarbazine and procarbazine, timozolomide

• Antimetabolites like azaserine, methotrexate*, pralatrexate, azacytidine, 5-

fluorouracil, cytarabine (Ara–C), 6-MP and 6-TG.

• Antibiotics like dactinomycin, daunorubicin, doxorubicin , bleomycin and

other natural products like vincristine, vinblastine, paclitaxel, docetaxel,

topotecan, irinotecan (only highlights of structure to be discussed for

bleomycin and natural products)

• Platinum compounds like cisplatin and oxaliplatin

• Histone Deacetylase Inhibitors: romidepsin, vorinostat

• Tyrosine Kinase Inhibitors: imatinib, dasatinib, lapatinib

• Combination therapy for breast cancer, leukemia (Self study)

7

1

2. Antivirals agents including anti-HIV agents:

Amantadine*, rimantadine, oseltamivir, zanamivir, acyclovir and its prodrugs,

ganciclovir, famciclovir, penciclovir, idoxuridine, vidarabine

Reverse transcriptase inhibitors: , azidothymidine*, stavudine, lamivudine,

zalcitabine, didanosine, abacavir, Non-nucleosides reverse-transcriptase inhibitors:

delaviridine, nevirapine, efavirenz.

HIV-protease inhibitors: raltegravir, saquinavir, ritonavir, (only highlights of structure

of protease inhibitors).

Drugs like nelfinavir, lopinavir, atazanavir, amprenavir, telaprevir and Combination

anti-therapy (Self Study)

4

2

3. Cardiovascular Drugs

3.1 Antianginal Agents Antianginal agents: Amyl nitrite, isosorbide dinitrate, pentaerythritol tetranitrate,

3

228

verapamil, bepridil, diltiazem, nifedipine, dipyridamole*

3.2 Antiarrythmic Agents Antiarrhythmic agents: quinidine, procainamide*, disopyramide, lidocaine, mexilitine,

amiodarone, propafenone, verapamil, diltiazem, propranolol, sotalol*

4

3.3 Diuretics • Site 1. Carbonic anyhydrase inhibitors: acetazolamide*, methazolamide,

brinzolamide, ethoxzolamide

• Site 2. High celing or loop diuretics: Sulphamoyl anthranilic acids like

furosemide*, azosemide and bumetanide and phenoxyacetic acids ethacrynic

acid*

• Site 3. Thiazide and Thiazide like diureties, chlorthiazide*(self study)

hydrochlorthiazide, benzthiazide, methyclothiazide, trichlormethiazide,

chlorthalidone, metolazone, quinethazone, indapamide

• Site 4. Potassium sparing diureties such as spironoloactone, eplerenone (self

study) triamterene and amiloride.

Osmotic diuretics- mannitol, isosorbide.

4

1

3.4 Agents affecting Renin-Angiotensin Pathway and Calcium Blockers • ACE Inhibitors- captopril* Lisinopril, perindopril

• Angiotensin II receptor blockers- losartan, valsartan, , telmisartan,

olmesartan, azilsartan.

• Also valsartan + sacubitril combination

• Calcium channel blockers- verapamil , diltiazem, nifedipine, amlodipine,

nimodipine, , cilnidipine, benidipine, efonidipine

• Renin Inhibitors- aliskiren(self study)

• Aldosterone antagonists: spironolacone, eplerenone (self study)

4

1

1

3.5 Vasodilators/Sympatholytics • Vasodilators- Hydralazine*

• Non-selective beta blockers- propranolol, nadolol

• Selective beta-1 blockers- acebutalol, atenolol, esmolol

• Selective alpha-2 blockers- prazosin* terazosin

• Mixed alpha-beta blockers- carvedilol, labetalol

• K-channel agonists- Minoxidil

4

3.6 Antihyperlipoproteinemics Clofibrate*, gemfibrozil, gemfibrate, fenofibrate

• HMG-CoA reductase inhibitors: lovastatin, atorvastatin, simvastatin,

rosuvastatin, ezetimibe.

3

4 Antihistaminics Antihistaminies:H1 and H2 receptors, general SAR of classical H1 antihistaminics,

Emphasis to be on the second generation H1 antagonists such as fexofenidine, ,

loratidine, cetrizine, , andacrivastine, ebastine and bepotastine; combination of H1

antihistaminics and monteleukast H2 receptor antagonists like cimetidine ranitidine*,

famotidine, nizatidine, lafutidine; proton pump inhibitors like omeprazole,

rabeprazole, pantoprazole and lansoprazole.

4

1

5 Hypoglycemics and Insulin Analogues Hypoglycemics (Insulin not to be discussed)

• Biguanides e.g. metformin

• Sulfonylureas: 1st Generation like tolbutamide, chloropropamide, tolazamide

and acetohexamide*(self study); 2nd Generation like glyburide* glypizide and

glimepride,glyclazide and meglitinides like repaglinide, nateglinide.

• Thiazolidinediones such as troglitazone, ciglitazone, rosiglitazone and

pioglitazone.

• GLP-1 agonists and DPP-IV inhibitors- exenatide and liraglutide (no

structures), saxagliptin, vildagliptin, sitagliptin, linagliptin

• β – Glucosidase inhibitors like voglibose, and miglitol.

Insulin analgoues:Lisproinsulin, glargineinsulin

4

Total 48

*Synthesis to be taught

Latest editions of the following books to be adopted.

1. An Introduction to Medicinal Chemistry, Graham L. Patrick, Oxford University Press.

2. Fundamentals of Medicinal Chemistry, Gareth Thomas, Wiley, New York.

3. The Organic Chemistry of Drug Design and Drug Action, Richard B.Silverman, Academic Press.

229

4. Foye’s Principles of Medicinal Chemistry, Thomas L. Lemke, David A Williams, Lippincott Williams & Wilkins.

5. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry, John M. Beale, John H. Block,

Lippincott Williams & Wilkins.

6. Medicinal Chemistry, Ashutosh Kar, New Age International Publishers.

7. Introduction to Medicinal Chemistry, Alex Gringauz, Wiley.

8. The Organic Chemistry of Drug Synthesis, Daniel Lednicer, Lester A. Mitscher, John Wiley and Sons.

9. Pharmaceutical Chemistry, Volume 1, Organic Synthesis, H. J. Roth & A. Kleemann, Ellis Horwood Series in

Pharmaceutical Technology, Halsted Series.

10. Synthesis of Essential Drugs, Ruben Vardanyan and Victor Hruby, Elsevier.

11. Pharmaceutical Substances: Syntheses, Patents, Applications, Kleemann& Engel, Thieme Publications.

BPH_C_702_T – Pharmacognosy III- (4 Hr/Wk)

Course Objectives

1. To introduce the learner to the chemistry, sources, cultivation and collection of crude drugs containing phytoconstituents like

steroidal, triterpenoidal, anthraquinone, flavonoid glycosides and alkaloids.

2. To introduce the learner to the biosynthesis of alkaloids obtained from different amino acids

3. To introduce the learner to glycoproteins with the representative examples and their utility in diagnosis or therapeutics.

4. To make the learner aware of regulatory requirements for manufacture and sale of Ayurvedic, Siddha and Unani (ASU) Medicines

and Phytopharmaceuticals, monographs of herbal drugs

5. To make the learner understand formulation aspects and challenges of Herbal formulations, standardization and interactions of

drugs of natural origin

6. To apply the spectroscopic techniques in characterization of phytoconstituents of both aliphatic and aromatic nature

Course Outcomes

Upon completion of the course student will be able to:

1. Write the source, composition, general methods of extraction, evaluation, chemical tests, therapeutic uses of crude drugs containing

phytoconstituents like steroidal, triterpenoidal, anthraquinone, flavonoidal glycosides, alkaloids glycoproteins.

2. Write the biosynthesis of biosynthesis of alkaloids obtained from different amino acids

3. Understand regulatory requirements for manufacture and sale of Ayurvedic, Siddha and Unani (ASU) Medicines and

Phytopharmaceuticals, monographs of herbal drugs

4. Apply the knowledge of excipients from natural origin and pharmaceutical technology to herbal formulation and understand the

challenges in herbal formulation

5. Understand the concept of herbal drug standardization and its application to herbal formulation

6. Apply the knowledge of pharmacology to understand pharmacodynamic and pharmacokinetic interactions of herbal drugs with food

7. Apply spectroscopic techniques to characterize small molecules both from the categories of aromatic and aliphatic nature

No. Details Hours

1 Steriodal and Triterpenoidal glycosides

Detailed study of drugs with respect source, chemistry, and therapeutic application of the following drugs –

Liquorice, Asparagus, Dioscorea, Fenugreek, Brahmi, Ginseng

Introduction to cardiac glycosides with respect to their classification, chemistry & general chemical tests.

Detailed study of drugs with respect source, chemistry cultivation and collection, preparation & biopotential

of the following drugs –

Digitalis lanata, Digitalis purpurea, Squill

Extraction, Identification and Analysis of Phytoconstituents –

Liquorice constituents

Commercial application of Diosgenin

Interactive Session

Potency, marketed preparation of all cardiac glycosides

Composition and indication of Fenugreek containing formulations

6

1

2 Alkaloids

Introduction to alkaloids - Classification, properties, general methods of extraction.

Study of following drugs containing alkaloids with respect to their sources, chemistry (structures), salient

features of extraction and specific tests for detection (if any) and therapeutic applications of:

a. Alkaloidal Amines – Ephedra, colchicum

b. Tropane - Datura, Coca, Ashwagandha

c. Indole - Rauwolfia, Vinca, Ergot

d. Steroidal –Kurchi

8

230

e. Quinazoline – Vasaka

f. Benzyl isoquinoline – Opium

g. Isoquinoline - Ipecac, Berberis aristata

h. Quinoline - cinchona

i. Pyridine-Piperidine –Pepper, Tobacco

j. Purine - Tea, Coffee, Cocoa

k. Imidazole – Pilocarpus

l. Glycoalkaloids- Solanum

Isolation, Identification and Analysis of Phytoconstituents

Piperine, Caffeine

Interactive Session

Market products and their therapeutic uses of Atropine, Pilocarpine, Vasaka, Kurchi, Ephedra, Pepper

1

1

3 Biosynthesis of lysergic acid, tropane alkaloids, emetine, quinine, 2

4 Glycoproteins – Castor, Pea and Oats 2

5 Glycosides

a) Anthracene derivative – Study of aloes, senna, rhubarb, with respect to Occurrence, chemistry, salient

features of cultivation, collection, preparation, chemical test and uses.

b) Source, chemistry and uses of Rubia, St. John`s wort

Occurrence, Chemistry, Test and Uses of

a) Isothiocyanate – Brassica, cabbage

b) Cyanogenetic - bitter almond, wild cherry bark, Biosynthesis of amygdaline

Isolation, Identification and Analysis of Phytoconstituents – Anthraquinone- Aloe emodin

3

2

6 Detailed study of Flavonoids and Coumarins:

a. Introduction, classification, chemical tests occurrence & their biopotential as exemplified by

Orange Peel, Soyabean, Buckwheat, Psoralea.

b. Monomeric, dimeric and related phenylpropanoid derivatives e.g.,

lignans- Podophyllum

Isolation, Identification and Analysis of Phytoconstituents - Rutin

3

7 Interactions with DONO :

Concept of pharmacokinetic interaction and pharmacodynamic interactions

herb- drug interactions – 3 examples each of synergistic and antagonistic interactions

herb- food interactions – 3 examples each of synergistic and antagonistic interactions

eg . Hypercium, Liquorice, Coffee, Ginseng, Ginkgo biloba, Digitalis, Garlic, Pepper & Ephedra.

3

8 Use of spectroscopy techniques in characterization of phytoconstituents.

a. Citral b. Rutin c. Gallic acid

2

9 Standardization of herbal drugs using various type of markers with examples.

Application of various chromatographic techniques in standardization of herbal products with two examples.

Stability testing of herbal medicines with respect to marker analysis.

Interactive session

Standardization of polyherbal formulation with respect to respective marker constituents emphasizing on

simultaneous estimation.

3

1

10 Monograph of herbal drugs & excipients in Indian Pharmacopoeia (Two examples each)

Interactive session

Comparative study of herbal monographs in IP, USP, Ayurvedic Pharmacopoeia, American herbal

Pharmacopoeia, British herbal Pharmacopoeia.

2

2

11 Regulatory Issues - ASU formulations, patent and proprietary medicine and Phytopharmaceuticals

Schedule T & Y of Drugs & Cosmetics Act for ASU drugs and phytopharmaceuticals

2

12

Study of herbal formulations & Ayurvedic formulations

a. Ayurvedic Formulations –Introduction to Ayurvedic formulations like aristas, asava, gutika,taila, churna,

avaleha, bhasma, ghrita.

b. Introduction to the concept of detoxification in Ayurveda (2eg).

c. c. Herbal formulations: Challenges in the preparation and evaluation of Herbal tablets, capsules, liquid oral,

semisolid dosage forms

d. NDDS of Herbal medicine: Limitation of conventional formulations, challenges in development of NDDS of

Herbal medicine, Phytosomes with one example each

3

231

Interactive session Phytopharmaceuticals in the market: Study of any two formulations under each category with respect to their

ingredients used and activities / claims of each ingredient used in them

1

TOTAL 48

Books:

Latest editions of the following books to be adopted.

1. Trease D. & Evans W.C.: Text Book of Pharmacognosy: W.B. Saunders.

2. Tyler V. E. Brady L. R. & Robbers J. E.: Pharmacognosy; Lea Feibger, USA.

3. Wallis T. E.; Text Book of Pharmacognosy; CBS Publishers, Delhi.

4. Kokate C. K., Purohit A. P. & Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune.

5. Harbone J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman & Hall, London.

6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited.

7. Vasudevan T. N. & Laddha K. S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon.

8. The Indian Pharmacopeia: The Controller of Publication; Delhi.

9. R. S. Guad, S. J. Surana, G. S. Talele, S. G. Talele, Mr. S. B. Gokhale. Natural Excipients, Pragati Books Pvt. Ltd., 2006

10. Biren Shah, Avinash Seth, Textbook of Pharmacognosy and Phytochemistry , Elsevier Health Sciences,

11. Ashutosh Kar, Pharmacognosy And Pharmacobiotechnology, New Age International, 2003

12. Quality Control Methods for Medicinal Plant Materials, World Health Organization World Health Organization, 1998 - Botanical

drug industry

13. WHO Monographs on Selected Medicinal Plants, World Health Organization World Health Organization, 1999

14. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, ESCOP, European Scientific Cooperative on

Phytotherapy, Thieme, 2003 -

15. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, Max Wichtl CRC Press, 2004 - Health &

Fitness

16. Pulok K. Mukherjee Evidence-Based Validation of Herbal Medicine, Elsevier, 17-Feb-2015

17. Adverse Effects of Herbal Drugs 2, Springer Science & Business Media, 06-Dec-2012

18. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals, Pulok K. Mukherjee Business Horizons, 2002

19. Brain K. R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol.

20. Iyengar M. A. & Nayak S. G.: Anatomy of Crude Drugs: Manipal Power Press, Manipal

21. Iyengar M. A.: Pharmacognosy of Powdered Drugs; Manipal Power Press, Manipal

BPH_C_703_T – Pharmaceutical Analysis III- (4 Hr/Wk)

Course Objectives

On completion of this course, the learner should be able to apply the principles of spectroscopy for multicomponent analysis and

describe working principle, instrumentation and applications of chromatographic and characterization techniques.

Course Outcomes

The learner should be able to:

1. Explain various methods used for multicomponent analysis of drugs by UV spectroscopy.

2. Summarize chromatographic and hyphenated techniques used for the separation, identification and quantification of analytes.

3. Describe the working of proton 1H NMR spectroscopy and mass spectrometry.

4. Interpret spectral data to predict structure of a given compound.

5. Summarize the parameters of ICH guidelines for analytical method validation.

No. Details Hours

1.0 Multicomponent analysis by UV Spectroscopy 4

1.1 Assay as a single component sample

Corrected interference

Assay after solvent extraction

Simultaneous Equation method

Absorbance Ratio method

Difference Spectroscopy method

4

232

Derivative Spectroscopy

2.0 Concepts of Chromatography 7

2.1 Terminologies: stationary phase, mobile phase, retention time, gradient and isocratic

elution, normal and reverse phase chromatography, planar chromatography, retention

factor, chromatogram, internal standard, reference standard, working standard, tailing

factor (symmetry factor), asymmetry factor, resolution, signal to noise ratio, column

chromatography, preparative chromatography, adsorption chromatography and

partition chromatography.

3

2.2 Classification of chromatographic methods (Self study-0.5 hr)

Quantitative analysis (Peak height, peak areas, calibration curve, internal

standard, and area normalization)

Optimization of column performance (Column efficiency and band broadening,

shape of peak-Gaussian, Plate height, Number of theoretical plates, van Deemter

equation, Capacity factor, Selectivity factor, Tailing factor, peak width, and

Resolution)

3

2.3 Numericals and justification based problems related to column performance 1

3.0 High Performance Liquid chromatography (HPLC) 4

3.1 Instrumentation:

Mobile phase reservoir

Pumps (reciprocating, displacement, pneumatic) (Self study-0.5 hr)

Sample injection systems (Rheodyne injector and autosampler)

Column types (analytical, guard and preparative columns) and column packing (

porous, pellicular and monolithic),

Detectors (Concept of solute and bulk property detector-Refractive index ,UV-

Vis, Phototodiode array, fluorescence, , Electrochemical, Evaporative Light

Scattering ),

Difference between UPLC and HPLC (Self study-0.5 hr)

Applications, Advantages and Limitations of HPLC (Self study-0.5 hr)

4

4.0 Gas chromatography (GC) 3

4.1 Introduction

Instrumentation

Carrier gas supply

Sample injection system including Head space analysis

Columns (Packed, Open tubular columns, Capillary columns) and column ovens

(Self study-0.5 hr)

Detectors (Thermal conductivity, Electron capture, Flame ionization)

Applications, Advantages and Limitations of GC (Self study-0.5 hr)

3

5.0 Planar chromatography 3

5.1 Paper chromatography-Principle, Developmental techniques (Ascending,

Descending, Radial and Two-dimensional), Spray reagents and Pharmaceutical

applications (Self study-0.5 hr)

TLC-Principle, types of adsorbents, Developmental techniques (Self study-0.5

hr), Visualisation techniques, factors affecting resolution, Pharmaceutical

applications of TLC and Preparative TLC.

HPTLC: Instrumentation- Applicator, photodensitometry, photodocumentation,

Advantages of HPTLC over TLC and HPLC (Self study-0.5 hr)

3

6.0 Ion exchange chromatography, Ion Pair and Size Exclusion chromatography 3

6.1 Principle, Stationary phases, Mobile phases and Applications (Self study-0.5 hr) 3

233

7.0 Nuclear Magnetic Resonance Spectroscopy (1H-NMR) 8

7.1 1H-NMR phenomenon- spinning nucleus, precessional motion, precessional

frequency, gyromagnetic ratio, energy transitions and relaxation processes, NMR

Spectra, Chemical shift, shielding and deshielding, Vanderwaal’s deshielding,

Deuterium exchange, Chemical and magnetic equivalence , anisotropic effect (eg.

Alkanes, alkenes, alkynes, carbonyl, aromatic and cyclohexane), Solvents, Reference

compounds and internal standards.

2

7.2 Measurement of chemical shift:

Scales used.

Factors affecting chemical shift (Electronegativity-Shielding and Deshielding,

Vanderwaal’s deshielding, anisotropic effect)

Instrumentation of NMR Spectrometer (including schematic representation) (Self

study-0.5 hr)

Principle of FT NMR (including representation of conversion of time domain

spectra to frequency domain spectra)

3

7.3 Spin-spin coupling-Spin-Spin splitting:

N+1 rule (Pascal’s triangle), theory of spin-spin splitting, formation of doublet,

triplet and quartet due to possible spin orientations, inverted tree diagram,

Coupling constants & values for alkyl, alkenyl , aromatic ).

Information obtained from proton NMR-Chemical shift, splitting, coupling constant,

integration. (Self study-0.5 hr)

3

8.0 Mass Spectrometry 4

8.1 Principle & basic theory- Mass spectrum, relative abundance, mass to charge ratio,

molecular ion, fragment ion (daughter ion), metastable ion, base peak, isotope peak,

mass to charge ratio.

1

8.2 Instrumentation:

Basic components of mass spectrometer (including block diagram).

Ionisation methods: Electron Ionisation, Chemical Ionisation, Desorption

Ionisation (MALDI), Fast Atomic Bombardment, Atmospheric Pressure

Ionisation (Electrospray, APCI, APPI).

Analysers: Quadrupole, Ion Trap and Time of Flight.

2

8.3 Examples of different mass fragmentation pathways 1

9.0 Hyphenated techniques 2

Significance, interfaces and applications of

LC-MS

GC-MS (Self study-1 hr)

10.0 Structure Elucidation by spectral techniques using UV, IR, 1H-NMR and Mass

spectrometry

8

10.1 UV-Woodward Fieser rules for predicting λmax (acyclic & cyclic dienes, and α, β

unsaturated ketones (acyclic and 6 membered ring).

(Note-only alkyl substituents to be studied). (Practice problems-Self study-0.5 hr)

2

10.2 Elucidation of structure of a compound using IR and 1H NMR data- Problems for

simple organic compounds with molecular formula given (Practice problems-Self

study-0.5 hr)

3

10.3 Mass spectrometry:

Fragmentation: Representation of fragmentation process, Basic types of

fragmentation:

3

234

Fissions (homolytic and heterolytic, α and β fission).

Rearrangement (Mclafferty, Retro Diel-Alders, 4 membered cyclic

rearrangement),

Nitrogen rule and Even electron rule. (Practice problems-Self study-0.5 hr)

11 Analytical method Validation. (Self study- 0.5 hr) 2

11.1 Analytical method Validation as per ICH guidelines.

Total 48

Books:

1. D. A. Skoog, F. J. Holler and S. R. Crouch, Principles of Instrumental Analysis, Saunders College Publishing, USA.

2. K. A. Connors, A Textbook of Pharmaceutical Analysis, John Wiley and Sons, Canada.

3. A. H. Beckett and J. B. Stenlake, Practical Pharmaceutical Chemistry, ,Vol. 6, Part I and II, CBS Publishers and Distributors,

India.

4. D. A. Skoog, D. M. West, F. J. Holler and S. R. Crouch, Fundamentals of Analytical Chemistry, Saunders College

Publishing, USA.

5. G. D. Christian, Analytical Chemistry, John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd.

6. H.H. Willard, L. L. Merrit and J. A. Dean, Instrumental Method of Analysis, CBS Publishers & Distributors, New Delhi.

7. Ashutosh. Kar, Pharmaceutical Drug Analysis, New Age International (P) Ltd. Publishers, India.

8. S. S. Mahajan, Instrumental Methods of Analysis, Popular Prakashan Pvt Ltd., India.

9. G. R. Chatwal and S. K. Anand, Instrumental methods of chemical analysis, Himalaya Publishing House Pvt. Ltd.

10. Indian Pharmacopoeia, The Indian Pharmacopoeia Commission, Ghaziabad, Government of India.

11. United States Pharmacopeia

12. J. Mendham, R. C. Denney, J. D. Barnes, M. J. K. Thomas, Vogel’s Textbook of Quantitative Chemical Analysis, Pearson

Education Ltd.

13. D. G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists. Churchill

Livingstone Elsevier.

14. J. W. Robinson, E. M. S. Frame and G. M. Frame II, Undergraduate Instrumental Analysis, Marcel Dekker, New York, USA.

15. R. Kellnar, J. M. Mermet, M. Otto, M. Valcarceland, H. M. Widmer, Analytical Chemistry: A modern approach to analytical

science, Wiley-VCH, USA.

16. J. W. Munson, Pharmaceutical Analysis: Modern methods (in two parts), Marcel Dekker Inc., USA.

17. W. Kemp, Organic Spectroscopy, Palgrave Publishers Ltd., New York, USA.

18. R. M. Silverstein, F. X. Webster and D. J. Kiemle, Spectrometric identification of organic compounds, John Wiley & Sons,

Inc. (Indian edition), New Delhi.

19. D. B. Troy and P. Beringer, Remington-The Science and Practice of Pharmacy, Vol-I & II, Wolters Kluwer/ Lippincott

Williams & Wilkins (Indian edition), New Delhi.

20. 20 J. W. Robinson, E. M. S. Frame and G. M. Frame II, Undergraduate Instrumental Analysis, Marcel Dekker, New York,

USA.

21. J. R. Dyer, Applications Of Absorption Spectroscopy Of Organic Compounds, Prentice- Hall of India Pvt Ltd, New Delhi,

India.

22. D. L. Pavia, G. M. Lampman, G. S. Kriz and J. R. Vyvyan, Introduction to Spectroscopy, Brooks/Cole Cengage Learning,

Australia.

23. Y. R. Sharma, Elementary organic spectroscopy-Principles and Chemical Applications, S. Chand & Company Ltd, New

Delhi, India.

24. L. R. Snyder, J. J. Kirkland, J. L. Glajch, Practical HPLC Method Development, Wiley-Interscience publication, John Wiley

& Sons, Inc., Canada.

25. S. Ahuja and M. W. Dong, Handbook of Pharmaceutical Analysis by HPLC, Volume 6 of Separation Science and

Technology, Elsevier Academic Press, Indian edition.

BPH_C_704_T – Pharmacology III- (4 Hr/Wk)

Course prerequisites

235

Knowledge of anatomy, physiology and pathophysiology of diseases/disorders of central nervous system and gastrointestinal

system

Concept of Inflammation

Information on endogenous receptors in the human body

Course objectives

1. To educate on different drugs acting on central nervous system and its associated diseases.

2. To educate on pharmacology of anti-inflammatory drugs.

3. Impart knowledge on pharmacology of drugs used in inflammatory disorders like asthma and gout.

4. Educate on autacoids and drugs impacting autacoids’ actions.

5. To provide understanding about drugs used in GIT associated disorders.

6. To convey principles of toxicity with briefing on common toxicants.

Course outcomes

1. Explain pharmacology of drugs acting on central nervous system and associated diseases.

2. Classify and explain pharmacology of anti-inflammatory drugs, make use of knowledge of these drugs to justify their use in

asthma and gout.

3. Discuss the pharmacology of drugs used in gastrointestinal disorders.

4. Know the toxic effects of heavy metals, drugs and environmental toxicants.

Books:

Latest editions of following books to be adopted

1. Goodman & Gilman’s Pharmacological Basis of Therapeutics, McGraw Hill Companies Inc.

No Details

Hours

1 Drugs acting on Central Nervous System 24

1.1

Aliphatic alcohols

2

1.2 General and Local anaesthetics 4

1.3 Sedatives, Hypnotic and anxiolytic agents 3

1.4 Antiepileptic drugs 2

1.5 Drugs Used in Parkinson’s disease 2

1.6 Drugs used in Alzheimer’s disease 2

1.7 Antipsychotic, antidepressant, anti-mania drugs 4

1.8 Opioid analgesics 3

1.9 CNS stimulants 2

2 Autacoids; Drug therapy of inflammation 13

2.1 Histamine, bradykinin and their antagonists 2

2.2 Serotonin, agonists and antagonists 2

2.3 Lipid derived autacoids, Eicosanoids and platelet activating factor 2

2.4 NSAIDs 3

2.5 Pharmacotherapy of Asthma 2

2.6

Pharmacotherapy of Gout 2

3 Drugs acting on gastrointestinal tract 8

3.1 Antacids and Drugs for peptic ulcers 3

3.2 Emetics, anti-emetics and Prokinetics 2

3.3 Drugs for constipation and diarrhoea 2

3.4 Drugs for Inflammatory Bowel Diseases 1

4 Principles of Toxicology 3

4.1 Heavy metals (Lead, Mercury, Arsenic) Poisoning, 2

4.2 Pesticide and Opioid Poisoning and treatment 1

TOTAL 48

236

2. Satoskar R.S. Bhandarkar S.D. & Rege N.N. Pharmacology & Therapeutics, Popular Prakashan.

3. Rang & Dale Pharmacology, Churchill Livingstone.

4. Lippincott’s Illustrated Reviews: Pharmacology- Lippincott-Raven Howland & Nyeets Publishers NY.

5. Laurence D.R. & Bennett Clinical Pharmacology, Elsevier NY.

6. Kulkarni S.K. Handbook of Experimental Pharmacology, Vallabh Prakashan, New Delhi.

7. B.G.Katzung-Basic and Clinical Pharmacology, Appleton and Lange publications.

8. Ghosh M.N. Fundamental of Experimental Pharmacology. Hilton and company, Kolkata

BPH_C_705_T – Pharmaceutical Jurisprudence- (3 Hr/Wk)

Course Objectives

To impart knowledge on important legislations related to the profession of Pharmacy

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Interpret Pharmaceutical Legislation

2. Understand pricing of drugs & pharmaceuticals

3. Summarize offences & penalties concerned with laws for drugs and pharmaceuticals

4. Gain an insight into Drug Regulatory Affairs

No. Details Hours

1 Pharmaceutical Legislation – A brief review of Historical perspectives, Study of Drugs

Enquiry Committee (Chopra Committee), Hathi Committee, Dr Mashelkar Committee 1

2 PHARMACY ACT 1948

2.1 Definitions 0.5

2.2 Pharmacy Council of India and State Councils: Composition and Functions

2.3

Registration of Pharmacists: Preparation of registers and qualifications for entry into

registers 2

2.4 Educational Regulations and Approval of Courses and Institutions

2.5 Offences and Penalties

2.6 Pharmacy Practice Regulations, 2015 1

3

DRUGS AND COSMETICS ACT 1940 AND RULES 1945

3.1 Definitions 0.5

3.2 Advisory Bodies: DTAB and DCC: Composition and Function

2

3.3 Analytical Bodies: Drug control Laboratories and Government Analyst

3.4 Executive Bodies: Licensing Authorities, Controlling Authorities, Drug Inspectors and

Customs Collectors

3.5 Provisions regarding Import of Drugs 3

3.6 Provisions regarding Manufacture of Drugs

3.7 Provisions regarding Sale of Drugs

3.8 Labeling and Packing of Drugs 1

3.9 Provisions applicable to Manufacture, Sale, labeling and Packing of Ayurvedic Drugs 1

237

3.10 Provisions applicable to Import, Manufacture, Sale, labeling and Packing of Homeopathic

Drugs 1

3.11 Provisions applicable to Import, Manufacture, Sale, labeling and Packing of Cosmetics 1

3.12 Offences and penalties 1

3.13 Schedules to the Drugs and Cosmetics Act & Rules (in brief), Schedule M and Schedule Y

in moderate details 1

3.14 Self-study: Case Studies

4.0 DRUGS AND MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENTS) ACT

1954 & RULES 1955

2

4.1 Definitions

4.2 Prohibited Advertisements, Savings

4.3 Self-study: Case Studies

5 NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT & RULES 1985 2

5.1 Definitions

5.2 Narcotics Commissioner and other Officers

5.3 Illicit Traffic and measures to prevent illicit traffic of opium

5.4 Essential Narcotic Drugs, Recognized Medical Institutions

5.4 Offences and penalties

6 DRUGS PRICES CONTROL ORDER 2013 2

6.1 Definitions

6.2 Calculation, fixation, revision of ceiling / retail price for a scheduled formulation and its

monitoring

6.3 Display of prices of non-scheduled formulations and price list thereof and Sale of splitSS

quantities of formulations

6.4 Manufacturer, distributor or dealer not to refuse sale of drug

6.5 National List of Essential Medicines and Schedule I

6.6 Draft Pharmaceutical Policy – 2017

7 MEDICINAL AND TOILET PREPARATIONS (EXCISE DUTIES ACT) 1955 2

7.1 Definitions, restricted and unrestricted preparations

7.2 Manufacturing in bond and outside bond

8 FOOD SAFETY AND STANDARDS ACT 2006 AND RULES 2011 3

8.1 Definitions: Food, Adulterant and Food additive

8.2 Authorities and bodies: Food Safety and Standards Authority of India, Central Advisory

Committee, Food safety Officer, Commissioner of Food Safety in the State, Analytical

Laboratories and Food Analysts

8.3 Different Food Safety and Standards Regulations

8.4 Food Safety and Standards (Packaging and Labeling) Regulation, 2011

238

9 INDIAN PATENTS ACT 2005 4

9.1 Intellectual Property and its types, PCT, Different Laws related to Intellectual Property in

India

9.2 Definitions, features of a patent

9.3 Criteria for patentability and inventions not patentable in India

9.4 Process of patenting in India

9.5 Working of Patents, Compulsory Licences

9.5 Self-study: Case Studies

10 BOMBAY SHOPS AND ESTABLISHMENTS ACT

10.1 Definitions of Shops and Commercial Establishments and Provisions under the Act in Brief 1

11 FACTORIES ACT 1954

11.1 Definitions 1

11.2 Provisions under the Act in Brief

12 INDIAN PENAL CODE AND CODE OF CRIMINAL PROCEDURES

12.1 Provisions pertaining to different courts, jurisdiction and power 1

12.2 Provisions governing entry, search, arrest, bailable and non-bailable offences, cognizable

and non-cognizable offences

13 INTRODUCTION TO DRUG REGULATORY AFFAIRS 2

13.1 Brief overview of Drug Regulatory Agencies of US, Australia, Europe, UK, Japan

13.2 Introduction to USFDA, European, ICH and WHO guidelines

TOTAL 36

Books:

Latest editions of the following

1. Kuchekar B. S., Khadtare A. M., Itkar S. C., Pharmaceutical Jurisprudence, Nirali Prakashan.

2. N.K. Jain, Pharmaceutical Jurisprudence, Vallabh Prakashan.

3. Mittal B. M., Forensic Pharmacy, Vallabh Prakashan

4. Deshpande S. W. & Nilesh Gandhi, Drugs & Cosmetics Act; 9th Edition;2018

5. Government of India Publications of above Acts and Rules

6. www.fda.gov

7. www.tga.gov.au

8. www.ema.europa.eu

9. www.mhra.gov.uk

10. www.ich.org

11. www.who.int

BPH_C_706_L – Pharmacognosy Lab II- (4 Hr/Wk)

Course Objectives

1. To study crude drugs representative to major parts of plants for their morphological features and microscopic characters including

histology, powder characteristics.

2. To apply the knowledge of microscopic characters of the crude drugs in ascertaining genuinely of powdered formulations.

3. To extract and perform qualitative chemical tests belonging to various classes of phytoconstituents viz. Anthraquinone Glycosides,

Cardiac Glycosides, Flavonoids, Cyanogenetic Glycosides, Alkaloids, Triterpenoid and Steroidal Glycosides, Saponins, Tannins.

239

4. To apply knowledge of analytical procedures in quantitative determination of total Aldehyde content / Phenol content / total

alkaloids from crude drugs

5. To understand principles involved and carry out extraction of active constituents

6. To identify crude drugs based on the morphological characters and quote some formulations available in market with their

therapeutic utility

Course outcomes

At the end of the course the learner will be able to

1. Identify crude drugs based on morphological characters, microscopic characters and give biological source with the chemical

constituents and therapeutic uses

2. Apply the knowledge of microscopic characters in ascertaining the genuinely of powdered formulations.

3. Extract and perform qualitative chemical rests on the crude drugs containing Anthraquinone Glycosides, Cardiac Glycosides,

Flavonoids, Cyanogenetic Glycosides, Alkaloids, Triterpenoid and Steroidal Glycosides, Saponins, Tannins

4. Apply analytical procedures and principles for quantitative determination of total Aldehyde content / Phenol content / total

alkaloids from crude drugs

5. Understand principles involved apply these for carrying out extraction of active constituents

6. Identify crude drugs based on the morphological characters and quote some formulations available in market with their therapeutic

utility

No. Details Hours

1 Study of morphology, histology, powder characteristics, Extraction Chemical test, and TLC. (TLC of any 5

drugs)

Clove, Fennel, Senna, Cinnamom bark, Ephedra, Kurchi, Liquorice

20

2 To ascertain the authenticity of the powder formulation using microscopy containing drugs listed in topic 1.

Qualitative Phytochemical Tests of all phytoconstituents – Anthraquinone Glycosides, Cardiac Glycosides,

Flavonoids, Cyanogenetic Glycosides, Alkaloids, Triterpenoid and Steroidal Glycosides, Saponins, Tannins,

8

3 Monograph analysis of 1 herbal drug or 1 herbal excepient from IP 4

4 Estimation of Aldehyde content / Phenol content / total alkaloids from crude drug (Beckett) 4

5 Exercise involving isolation & detection of active principles of any two – Piperine / Caffeine/ eugenol /

embelin / rutin)

8

6 To study morphological characters and one marketed formulation of Arjuna, Vasaka, Brahmi, Fenugreek,

Garlic, Guggul, Asafoetida, Pepper, Ergot, Mint, Jatamansi, Lemon grass, Digitalis, Vinca, Aloe vera, Vidang,

Myrobalans, Dill, Cumin, Lemon grass.

4

TOTAL 48

Books:

1. Trease D. & Evans W. C.: Textbook of Pharmacognosy: W. B. Saunders.

2. Tyler V.E., Brady L.R. & Robbers J. E.: Pharmacognosy; Lea Febiger, USA.

3. Wallis T. E.; Textbook of Pharmacognosy; CBS Publishers, Delhi.

4. Kokate C.K., Purohit A. P. &Gokhale S. B.: Pharmacognosy; Nirali Publications, Pune.

5. Harborne J. B.: Phytochemical Methods: A guide to modern techniques Analysis: Chapman& Hall, London.

6. Bruneton J.: Pharmacognosy, Phytochemistry, Medicinal Plants: Intercept Limited.

7. Vasudevan T.N. & Laddha K.S.: A Textbook of Pharmacognosy, Vrinda Publication House, Jalgaon.

8. The Indian Pharmacopeia: The Controller of Publication; Delhi.

9. Brain K.R. & Turner T. D.: The Practical Evaluation of Phytopharmaceuticals: Wright, Scientica, Bristol.

BPH_C_707_L – Pharmaceutical Analysis Lab III- (4 Hr/Wk)

Course Objectives

On performing the following experiments, the learner should be able to operate the instruments, understand their functioning, prepare

solutions accurately, conduct analysis using appropriate instrument, calculate, report and interpret the results of analysis.

Course Outcomes

The learner should be able to:

1. Record, calculate and interpret data obtained by UV spectrophotometric analysis for pKa determination and concentration

determination by multicomponent analysis techniques.

2. Apply ICH guidelines to validate an analytical method by UV spectroscopy and interpret results obtained.

3. Develop and optimize mobile phase composition for qualitative analysis by TLC and interpret qualitative analysis data by

TLC and paper chromatography.

4. Outline working and application of column chromatography, HPLC and GC.

240

No. Details

1. UV spectrophotometric estimation of two components formulation by simultaneous equation method, Eg-

Caffeine and Sodium benzoate injection.

2. UV spectrophotometric estimation of two components formulation by absorbance ratio method, Eg-

Caffeine and Sodium benzoate injection.

3. UV spectrophotometric estimation of formulation by Difference spectroscopy: Eg: Phenylephrine HCl

ophthalmic solution.

4. Assay of Trimethoprim in cotrimoxazole tablets

5. Determination of concentration of sample by UV spectroscopy (Construction of calibration curve using

linear regression analysis). Eg-Ibuprofen.

6. Determination of validation parameters by UV spectroscopy: Eg-Ibuprofen, Paracetamol.

Linearity

Precision

Accuracy

7. Separation and identification of compounds by TLC

8. Determination of pKa by UV spectroscopy eg. Phenylephrine HCl

9. Demonstration experiments:

Separation and identification of amino acids by paper chromatography.

Development of mobile phase for TLC

Working of HPLC, GC and HPTLC.

Separation of compounds by column chromatography

Note: Examples of drugs are provided for reference purpose only. Any other suitable drug can also be used.

Books:

1. A.H. Beckett and J.B. Stenlake, Practical Pharmaceutical Chemistry, 4th Edn., Part I and II, CBS Publishers and Distributors,

India.

2. G. D. Christian, Analytical Chemistry, 6th Edn., John Wiley & Sons, Singapore, reprint by Wiley India Pvt. Ltd.

3. Indian Pharmacopoeia, The Indian Pharmacopeia Commission, Ghaziabad, Government of India.

4. United States Pharmacopeia.

5. J. Mendham, R. C. Denney, J. D. Barnes, M.J. K. Thomas, Vogel’s Textbook of Quantitative Chemical Analysis, Pearson

Education Ltd.

6. D.G. Watson, Pharmaceutical Analysis –A textbook for pharmacy students and pharmaceutical chemists. 3rd Edn., Churchill

Livingstone Elsevier.

7. L. R. Snyder, J. J. Kirkland, J. L. Glajch, Practical HPLC Method Development, 2nd Edn., Wiley-Interscience publication,

John Wiley & Sons, Inc., Canada.

8. S. Ahuja and M. W. Dong, Handbook of Pharmaceutical Analysis by HPLC, Volume of Separation Science and Technology,

Elsevier Academic Press, Indian edition.

BPH_C_708_L– Pharmacology Lab II- (4 Hr/Wk)

Course prerequisites:

Ability to perform in vitro “dose response” experiments using cock ileum.

Course objectives:

1. Practical training on performing Bioassay of acetylcholine and atropine using cock ileum.

2. Demonstration of oxytocin bioassay and behavioural experiments using interactive CDs.

3. Information on Regulatory and toxicity guidelines.

Course outcomes:

1. Define Bioassay, list the types, methods and applications of bioassay and perform in vitro bioassay using cock ileum and record,

calculate and interpret unknown concentration of agonist/antagonist/drug.

241

2. Observe preclinical models which provide evidences on drug/lead pharmacological activity.

3. Relate to and apply the ethical, regulatory and toxicity guidelines/rules (ICH, OECD, CPCSEA, Schedule Y) in drug/lead testing

using preclinical animals.

No. Details

1. Experiments:

1. Bioassay of Acetylcholine using suitable isolated tissue preparation e.g. Cock ileum

2. Bioassay of Atropine using suitable isolated tissue preparation e.g. Cock ileum

2. Demonstrations: (with kymograph recordings or audio-visual aids)

1. Bioassay of oxytocin

2. Behavioral Pharmacology Demonstrations/ Simulated experiments (CDs).

To study effect of drugs on locomotor activity in rodents using actophotometer.

To study the muscle relaxant property of drug using Rota-rod.

To study analgesic activity of drug using an analgesiometer.

To study anticonvulsant activity of drugs using maximal electroshock/ chemically

induced seizures.

To study phenothiazines induced catalepsy using suitable animal model.

3. Toxicity studies

• Introduction to CPCSEA, OECD guidelines

• Introduction to acute, sub-acute and chronic toxicity studies

Books:

Latest editions of the following books to be adopted:

1. Kulkarni S. K. Handbook of Experimental Pharmacology, Vallabh Prakashan, New Delhi.

2. Ghosh M.N. Fundamentals of Experimental Pharmacology Hilton & Company, Kolkata.

3. S. B. Kasture. A handbook of Experiments in Pre-Clinical Pharmacology, Career Publications.

4. W. L. M. Perry, Pharmacological Experiments on isolated preparations, E & S Livingstone, Edinburg & London.

5. Patil C. R. X-cology (Software), Pragati Book Co. Pvt. Ltd, Pune.

ANY ONE SUBJECT FROM THE FOLLOWING 2 CREDIT SUBJECTS TO BE CHOSEN AS

ELECTIVE FOR A TOTAL OF 2 CREDITS

BPH_E_709_T – Intellectual Property Rights- (2 Hr/Wk)

Course Objectives

The course is framed to impart knowledge to the learners so that they get conversant with the Fundamentals of Intellectual

property Rights (IPR), their types and governing laws.

Course Outcomes

1. Correlate the knowledge of IPR with respect to pharmaceutical products.

2. Apply knowledge of IPR in designing strategy for pharmaceutical product development.

No. Details Hours

1 Intellectual Property Rights (IPR) – Introduction, definition, need history 2

2 Patents – Introduction, Indian Patent Act (1970), Patent and claim drafting, Process of filing and

prosecution, Rights achieved, Patentability with respect to Regional/ country’s

Requirement, Opposition of Patent

Self-Study - Case Study Presentations

8

1

3 Industrial Design – Introduction, filing and prosecution 2

4 Geographical Indication - Introduction, filing and prosecution 1

5 Natural biodiversity Act and Depository Bodies – Introduction and filing procedure 1

6 Patent Filing under PCT (Paris Convention Treaty/Patent Convention Treaty) - Introduction, filing and

prosecution, territorial specificity

3

7 Trademark – Introduction, filing and prosecution, opposition to trademark 3

8 Copyright – Introduction, filing and prosecution 1

9 Role of IPR in pharmaceutical product launch 1

10 IPR infringement and remedies 1

TOTAL 24

242

Books: 1. Intellectual Property Law, P. Narayanan, , Eastern Law House, Revised Edition, 2017.

2. www.wipo.int (World Intellectual Property Organization)

3. Indian Patent Act (www.ipindia.nic.in)

BPH_E_710_T – Green Chemistry and Catalysis- (2 Hr/Wk)

Course Objective

1. To introduce the learner with principles of green chemistry.

2. To study the source, disposal and prevention of chemical waste.

3. To learn basic level environmental management system.

4. To learn and select various kinds of catalysis with respect to industrial case studies.

Course Outcomes The learner should be able to:

1. Know the terms involved in green chemistry.

2. Understand the concept and techniques of waste management.

3. Know various guidelines of environmental management system.

4. Outline type of catalysis and their uses.

5. Learn greener process designing.

No. Details Hours

1 Principles and Concepts of Green Chemistry 2

1.1 Introduction and Twelve principles

1.2 Sustainable development and green chemistry

1.3 Atom economy, Atom economic reactions like rearrangement and addition reactions, Atom

uneconomic reactions like substitution, elimination

1.4 Reducing and measuring toxicity, E-Factor

2 Waste: Production, problems and prevention 3

2.1 Introduction, Problems caused by waste

2.2 Sources of waste from chemical industry, cost of waste

2.3 Waste minimization techniques: Approach, Process design, minimizing waste from existing

resources

2.4 Treatment of waste: Physical, Chemical, Biotreatment

2.5 Design for degradation: Degradation and surfactants, DDT, Polymer

2.6 Polymer recycling: Separation and sorting, Incineration, Mechanical and chemical recycling

of monomers

3 Environmental Management Systems (EMS)

ISO 4000, The European Eco-Management and Audit Scheme (EMAS) 2

3.1 Introduction to Life Cycle assessment system (LCA): Four stages, carbon foot printing

3.2 Eco labels, Integration Pollution Prevention and Control (IPPC), REACH

4 Catalysis and Green Chemistry 4

4.1 Introduction to catalysis, comparison of catalyst types

4.2 Heterogeneous catalysts: Basics, Zeolites and bulk chemical industry, heterogeneous catalyst

in Fine chemicals and pharmaceutical Industry, Catalytic converters

4.3 Homogeneous catalysts: Basics, Transition metal catalysts, Greener lewis catalyst,

asymmetric catalyst

4.4 Phase transfer catalysis: Basics, hazard reduction, C-C bond formation, oxidation using H2O2

4.5 Biocatalysis, Photocatalysis

5 Use of solvents 4

5.1 Organic solvents and volatile organic compounds, solvent free system, Supercritical fluids,

scCO2,scH2O

5.2 Water as reaction solvent

5.3 Ionic liquids as solvent and catalyst, Fluorous biophase solvents,

5.4 Greenness of solvent a comparison

6 Renewable resources 2

6.1 Biomass as renewable resource, Energy: from biomass, solar power, fuel cells

6.2 Chemicals from renewable feedstock: from fatty acids, polymers, natural resources

7 Emerging Greener technology 3

7.1 Photochemical reactions: Advantages and challenges, examples

7.2 Microwave assisted chemistry: Microwave heating and examples

243

7.3 Sonochemistry, Electrochemistry with examples

8 Designing green process 2

8.1 Conventional reactors: Batch reactors, continuous reactors

8.2 Inherently safer design using concept of minimization, simplification, substitution,

moderation, limitation

8.3 Process intensification: PI equipment with examples of intensified processes

8.4 In-process monitoring, Process safety

9 Industrial case studies:

Methyl Methcrylate, acetic acid manufacturing, Vitamin C, Dyes, Naproxen, Ibuoprofen 2

TOTAL 24

Books:

1. Green Chemistry: An Introductory Text, Mike Lancaster, 2nd edition, RSC publishing.

2. Green Chemistry: Theory and Practice, Anastas P T and Warner J C, Oxford University Press.

3. Introduction to Green Chemistry, Ryan M. A., Tinnesand M., American Chemical Society (Washington).

4. Handbook of Green Chemistry and Technology, Clarke J and Macquarrie D, Blackwell.

BPH_E_711_T – Preformulation Studies- (2 Hr/Wk)

Course Objectives

On completion of the course the learner will be able to understand the importance of physicochemical properties of a drug candidate in

design and development of an effective, stable, acceptable and safe formulation

Course Outcomes

At the end of the course the learners will be able to:

1. Explain physicochemical principles relevant to pharmaceutical dosage forms.

2. Comprehend the importance of solubility, stability and compatibility of drug substances with different excipients

3. Understand the role of preformulation studies in drug discovery, drug and product development

No Details Hours

1 Drug Discovery and Development Process in the Pharmaceutical Industry- Need,

Hurdles faced, Scheme of Steps in New Drug Development Process.

The concept of preformulation -Goals and scope of preformulation, Basic information

for designing preformulation studies.

Principal areas of Preformulation research

3

2 Bulk Characterization 10

2.1 Organoleptic properties: Appearance, odour and taste, Hygroscopicity 1

2.2 Crystallinity & Polymorphism: Crystal morphology & Crystal habit,

Pseudopolymorphism (solvates), True polymorphism. Methods to characterize

polymorphs-Melting point determination, Hot-stage microscopy, Differential scanning

calorimetry and thermal analysis, PXRD (basic principles of the methods only)

3

2.3 Fine particle characterization - Particle size distribution measurements, Microscopy,

sieve analysis. Laser diffraction method (basic principle)

Particle Size Reduction, effect of milling and micronization,

3

2.4 Powder flow and Compression properties: Bulk density, void volume, Carr’s

compressibility, Hausner’s ratio, Angle of repose.

Deformation behaviour of particles under the influence of applied forces-Elastic &

Plastic deformation, Fragmentation, Punch filming (sticking).

3

3 Solubility 7

3.1 Aqueous solubility: Intrinsic solubility (K0), pKa determination, pH solubility profile and

Common ion effect, effect of temperature,

Techniques of solubilization-Co solvents, Chelating agents, Surfactants Complexation.

4

3.2 Dissolution: Intrinsic dissolution rate, Measurement of intrinsic dissolution rate

Partition coefficient (Ko/w): Significance in preformulation studies as predictor of in vivo

absorption, methods to determine partition coefficient

3

4 Stability

Temperature, Order of reaction, Hydrolysis, Oxidation, photolysis (Self-study with

follow up)

Solid-state stability: bulk stability, effect of high humidity

Compatibility in presence of excipients

Solution phase stability: pH stability profile

3

244

5 Preformulation aspects for development of Tablets and Monophasic liquid dosage forms 1

TOTAL 24

Books:

1. M.E. Aulton. Pharmaceutics: The Design and manufacture of medicines. Third edition. 2007. Churchill Livingstone Elsivier.

2. David B. Troy, Paul Beringer. Remington’s - The Science and Practice of Pharmacy. Twenty first Edition. 2006. Lippincot

Williams & Wilkins.

3. Mark Gibson. Pharmaceutical Preformulation and Formulation: A Practical Guide from candidate selection to commercial dosage

form. Second edition. Informa Healthcare.

4. Leon Lachman, Herbert A. Lieberman. Theory and Practice of Industrial Pharmacy. Special Indian edition. 2009; CBS Publishers.

5. Herbert Lieberman, Leon Lachman, Joseph B. Schwartz. Pharmaceutical Dosage Forms: Tablets, Volume 1. 1989. Second Edition.

Marcel Dekker Inc. NY

245

SEMESTER-VIII

BPH_C_801_T – Pharmaceutical Chemistry III- (4 Hr/Wk)

Course Objectives

1. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected

synthesis of CNS active drugs like sedatives/hypnotics, anticonvulsants, antidepressants, anxiolytics and antipsychotics

2. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected

synthesis of ANS active drugs like adrenergic and cholinergic agents

3. Learn structure including stereochemistry, chemical name, SAR, metabolism, mechanism of action and selected

synthesis of testosterons and adrenocorticoids

Course Outcome

Students will gain knowledge in the thurst areas of CNS, ANS active drugs, analgesic agents and male female hormones. They will be

apply this knowledge in research areas.

No. Details Hours

Discussion of the following classes of drugs including classification, chemical

nomenclature, structure including stereochemistry, generic names, SAR and

metabolism, molecular mechanism of action, synthesis(*) and rational development

if any

1 CNS Drugs

1.1 Sedatives – Hypnotics

Benzodiadepines: chlordiazepoxide, diazepam, nitrazepam*, temazepam, alprazolam,

estazolam; zolpidem, eszopiclone, ramelteon (last 3 for self study – 1 hr).

3

1.2 Anticonvulsants

Types of seizures (Self study- 1 hr)

phenytoin, mephenytoin, ethotoin, trimethadione, diazepam, clonazepam,

carbamazepine*, valproic acid, vigabatrine, progabide, lamotrigine, tiagabine

3

1

1.3 Antidepressants

imipramine*, chlorimipramine, amitriptyline, nortriptyline, doxepine*

fluoxetine*, paroxetine, sertraline, escitalopram, amoxapine

3

1.4 Anxiolytics

Oxazepam, buspirone

1

1.5 Antipsychotics

chlorpromazine*, triflupromazine, thioridazine, fluphenazine, trifluperazine,

chlorprothixen(self study), droperidol , pimozide, risperidone, loxapine, clozapine,

sulpiride

4

1.6 Antiparkinson’s

carbidopa, levodopa, selegiline, amantadine, benztropine, procyclidine, orphenadrine

(last 3 for self study- 1 hr)

1

2 ANS Drugs

2.1 Adrenergic Drugs

Alpha adrenergic agonists: phenylephrine*, naphazoline, xylometazoline,

oxymetazoline, methyldopa, clonidine, guanabenz, guanafacine

Beta agonists : Isoproterenol, colterol, metaproterenol, terbutaline*, albuterol,

isoxsuprine, ritodrine

Alpha antagonist : tolazoline, phentolamine, phenoxybenzamine, prazosin, doxazosin

Beta Antagonists : pronethalol, propranolol*, sotalol, timolol, atenolol, metoprolol,

esmolol, acebutolol, carvedilol, labetalol* (last two for self study, including synthesis of

labetalol)

Other adrenergic agents (Self study-2 hrs) : pseudoephedrine, ephedrine, guanethidine,

propylhexedrine, reserpine

7

2.2 Cholinergic Drugs

Muscarinic agonists : methacholine, carbachol, bethanechol, pilocarpine

Acetylcholineesteraseinhibitors : physostigmine, neostigmine*, pyridostigmine,

edrophonium, echothiophate, malathion, parathion, pralidoxime

AntiAlzheimer’s :Tacrine*, donepezil, rivastigmine

7

246

Cholinergic antagonists : Atropine, scopolamine, homatropine, ipratropium

cyclopentolate*, dicyclomine*, benztropine, procyclidine, isopropamide, tropicamide

Neuromuscular blockers :(Self study) tubocurarine, gallamine, succinylcholine,

decamethonium

3. Analgesic Drugs

3.1 Opioid peptides(Self study)

Different types of opioid receptors, Potuguese and Becket Casy model, agonists, partial

agonists and antagonists of these receptors

Morphine, codeine, levorphanol, buprenorphine, phenazocine, pentazocine,

meperidine*, alpha and beta prodine, pheniridine, anileridine, fentanyl, methadone,

dextropropoxyphene*, tramadol, nalorphine, naloxone, naltrexone, flupirtine

Antidiarrhoeals (Self study-1 hr) : loperamide, diphenoxylate

6

3.2 NSAIDS

paracetamol, aspirin, indomethacin, sulindac, mefenamic acid, ibuprofen, naproxen*,

nabumetone, diclofenac*, piroxicam*, nimesulide, celecoxib, valdecoxib. Cytokine

inhibitors :(Self study-1 hr) infliximab, rituximab, anakinra, abatacept

Drugs in Gout : colchicine, probenecid, sulfinpyrazone, allopurinol, febuxostat

5

4 Drugs affecting Male and Female Health (Steroids)

4.1 Testosterone, 17-alphamethyltestosterone, oxymesterone, fluoxymesterone, stanazolol,

danazol (Self study)

estradiol, ethinyl estradiol, mestranol, medroxyprogesterone acetate, megestrol acetate,

norethindrone, norgestrel, diethylstilbestrol*(Synthesis for self study), clomiphene (Self

study), tamoxifen, anastrozole, letrozole, exemestane (Self study-1 hr)

medroxy progesterone acetate, megesterol acetate, norethindrone and norgestrel

3

4.2 Adrenocorticosteroids

cortisone, hydrocortisone, prednisone, prednisolone, dexamethasone and betamethasone,

flurometholone, fluocinolone, triamcinolone, aldosterone, fludrocortisone

2

TOTAL 48

Books:

Same as prescribed for Pharm. Chem. – III

BPH_C_802_T – Pharmaceutics IV- (4 Hr/Wk)

Course Objectives

To provide detailed insights into formulation and technology of sterile products including parenterals and ophthalmic dosage form, to

orient students about oral sustained and controlled release systems, to introduce important pharmacokinetics models and parameters

and to familiarize students with the concept of Pilot plant, Validation, cGMP etc. as important quality management systems in the

pharmaceutical industry.

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Apply the knowledge of sterile technology in designing safe and effective injectables and ophthalmic products

2. Study the rationale for oral SR/CR products, principles of design, development and evaluation of SR formulations

3. Understand the concepts of validation and pilot plant scale up for large scale manufacturing operations

4. Understand the concept of biopharmaceutics and significance of various pharmacokinetic parameters

No. Details Hours

1 Introduction to sterile dosage forms - Parenteral products 12

1.1 Various routes of parenteral administration, pyrogens, vehicle,

Water for Injection (WFI) - preparation, purity, storage and distribution, vehicles other than

WFI, additives in parenteral products.

3

1.2 Containers - glass and plastics- types and evaluation, rubber closures

– characteristics and testing.

2

1.3 Personnel, Manufacturing facilities- layout, environmental control,

cleanliness classes, air handling (HVAC systems), HEPA filters,

laminar flow

2

1.4 SVP: formulation considerations- solutions, suspensions, product procedures, freeze drying. 2

1.5 LVP – types, formulation aspects, packaging, FFS technology. 2

1.6 QA & QC- sterility test, pyrogen/ endotoxin test, particulate evaluation, leaker test. 1

247

2 Ophthalmic Products 5

2.1 Physiology of eye, lachrymal system, tears, precorneal tear film, cornea, ocular bioavailability

1

2.2 a) Formulations - additives and packaging of various ophthalmic products - solutions,

suspension, ophthalmic ointments and gels, preservatives and efficacy test

b) Contact lens solutions: types of lenses, cleaning solution,

disinfection solution, lubricants, multipurpose solutions and packages

3

2.3 QA and QC - sterility test, clarity, particle size for suspension,

tests on ointments and collapsible tubes

1

3 Oral sustained and controlled release systems 6

Need, definitions, Advantages of SR & CR systems, biopharmaceutical considerations;

Properties of drug with reference to the design of oral SR systems

Dose calculation of drug, calculation for dose- loading and maintenance

2

3.2 Matrix and reservoir type of systems, dissolution-controlled systems, diffusion-controlled

systems, ion exchange-controlled systems

3

3.3 Evaluation of sustained release systems 1

4 Microencapsulation 5

4.1 Definition, need/ reasons, concepts of core and coat 1

4.2 Methods of microencapsulation - phase separation coacervation (various techniques), Wurster

process, spray drying and related processes, interfacial polymerization, multiorifice

centrifugal process, pan coating, solvent evaporation; extrusion & spheronization

Evaluation of microcapsules

4

5 Introduction to Industrial Pharmacy 6

5.1 Pilot plant scale up techniques: Need, components, Factors considered while scaling up of

formulations: Mention the points for tablets, liquids (suspension, solutions, emulsions) and

semisolids

2

5.2 Validation: Definition, Types- Prospective, concurrent, Retrospective and revalidation.

Qualification of equipment-design, installation, operational, performance

2

5.3 Factory Layout: schedule M - general considerations/ steps,

Examples of Typical layout schemes for Tablets, capsule, liquids, sterile formulations

manufacturing areas (Individual layouts- Assignment with follow up)

2

6 Introduction to NDDS 8

6.1 Advantages of NDDS, concept of targeting-Active & Passive targeting 1

6.2 Concept, design and one suitable application of a typical system of

following NDDS:

a) Floating gastro-retentive systems,

b) Colon targeted drug delivery systems,

c) Mucoadhesive drug delivery systems,

d) Osmotic systems,

e) Transdermal DDS (membrane permeation systems),

f) Ocular inserts,

g) Colloidal DDS (liposomes, nanoparticles, microemulsions),

7

1 hour

for

each

system

8 Introduction to Pharmacokinetics 6

8.1 Definitions: Pharmacokinetics, ADME, bioavailability absolute and relative, bioequivalence.

Emphasis on the importance in drug discovery, development and clinical pharmacy

1

8.2 Pharmacokinetics: Introduction to compartmental and physiological models.

Introduction to the one compartmental open model and its assumptions

1

8.3 One compartment open model: IV bolus dosing: importance of volume of Distribution.

Clearance, elimination rate constant, half-life, area under the curve (trapezoidal rule)

2

8.4 One compartment open Model: Extra-vascular dosing.

Absorption rate constant, absorption half -life, bioavailability. Introduction of the Concept of

Cmax, Tmax, area under the curve, the trapezoidal rule and the method of Residuals.

2

TOTAL 48

Books:

Latest Editions

1. The theory and practice of Industrial Pharmacy, Ed. Leon Lachman, H. A. Liberman, J. L. Kanig; Varghese Publishing House.

2. Remington, The science and practice of Pharmacy, Vols. I and II, B. L. Publications Pvt. Ltd.

3. Cole Graham, Pharmaceutical Production Facilities, Design and Applications.

4. Pharmaceutical Process Validation, Nash Robert A., Berry Ira R., Volume 57, Marcell Dekker INC, New York.

248

5. Pharmaceutical Dosage Forms: Parenteral medications. Vols. I, II, III, Ed Kenneth A. Avis, Leon Lachman and H. A. Liberman,

Marcel Dekker INC.

6. Pharmacetuical Technology, Vols. I, II, R S R Murthy, Ashutosh Kar, New Age Int. Ltd.

7. Pharmaceutical dosage forms: Parental medications, Vol. I, II, III, ed. by Kenneth A. Avis, Leon Lachman and H. A. Liberman,

Marcel Dekker Inc., 1986.

8. Pharmaceutics. The Science of dosage form design ed. by M. E. Aulton, 2 nd ed., Churchill Livingstone, 2002.

9. Modern Pharmaceutics, 4 th ed. Revised and Expanded ed. by Gilbert S. Banker and Christopher T. Rhodes, Marcel Dekker INC.,

2002.

10. The theory and practice of industrial pharmacy, ed. by Leon Lachman, H. A. Liberman, J. I. Kanig, 3 rd ed., Verghese Publishing

house, 1987.

11. Ophthalmic drug delivery, ed. by Ashim K. Mitra, 1993, Marcel Dekker INC.

12. Turco and Kings, Sterile Dosage forms, 3 rd Edn., Lea & Febiger, Philadelphia, 1985.

13. Michael J. Akers, Quality Control of Parenterals, Marcel Dekker

14. Controlled drug delivery – Fundamentals and Applications”, Robinson Joseph R., Lee Vincent H., Vol. 29, Marcel Dekker Inc

15. Leon Shargel, Susanna Wu – Pong, Andrew B.C, Applied Biopharmaceutics and Pharmacokinetics, Singapor

16. Brahmankar D.M and Jaiswal Sunil B, Biopharmaceutics and Pharmacokinetics – A Treatise, Vallabh Prakashan.

Note: References to latest amendments of Schedule M and Schedule U of Drugs and Cosmetics Act 1940 to be made wherever

it is appropriate

BPH_C_803_L – Pharmaceutical Chemistry Lab II- 4 Hr/Wk)

Course Objectives

1) To introduce the learner to various hands-on experimental organic synthetic techniques including column chromatography

and thin layer chromatography.

2) To learn characterization of intermediates and final products by TLC and IR

3) To review important topics such as cyclization, reduction, rearrangement, condensation reactions.

4) To introduce the learner to the concepts of green chemistry.

5) To study the source, disposal and prevention of chemical waste.

Course Outcomes The learner should be able to

1) Design and perform various unit operations of organic synthetic reactions

2) Characterize reaction intermediates and final products.

3) Know the theoretical concepts behind organic synthesis.

4) Understand the concept and techniques of waste management.

Synthesis of the following Drugs and Drug Intermediates

1. Synthesis of Benzilic Acid: Conventional Method and Green Modification as in Green Chemistry DST Monograph

2. Three Component Synthesis of Pyrimidone using Ethylacetoacetate, Benzaldehyde and Urea as per Green Chemistry DST

Monograph

3. Hofmann rearrangement: Anthranilic acid from Phthalimide.

4. Reduction reaction: PABA from p-nitrobenzoic acid.

5. Pechmann condensation for coumarin synthesis using clay catalyst (Clay catalyzed solid state synthesis of 7-hydroxy-4-

methylcoumarin).

6. Synthesis of resacetophenone (Ref. Vogel page 983)

7. Synthesis of 4-methylcarbostyryl (old syllabus experiment)

8. Synthesis of Phenytoin

9. Synthesis of Hippuric Acid

(https://www.linfield.edu/assets/files/chem/Courses/CHEM%20322/3bAmide_synthesis_2015.pdf)

Or Synthesis of adipic acid (Ref. DST Monograph pg. 38)

Monitoring the progress of any two reactions by using TLC: Aim is to only monitor the completion of the reaction under

consideration. Student can comment on status of the reaction (completion/ incompletion) using TLC; they must develop the solvent

system

Books:

1. Vogel’s A Text book of Practical Organic Chemistry by Vogel, Longman group limited, London.

2. Practical Organic Chemistry by Mann FC & Saunders BC, Longman Group Limited, London.

3. Laboratory Techniques in Organic Chemistry, Ahluwalia V.K. I.K. Publishers.

4. Green Chemistry, V. K. Ahluwalia.

249

5. New Trends in Green Chemistry, V K Ahluwalia and M Kidwai, KluwerAcademic Publishers

6. Monograph on Green laboratory Experiments, Grenn Chemistry Task Force Committee, DST.

7. Practical Organic Synthesis: A Student's Guide - Reinhart Keese, Martin Brändle, Trevor Toube.

8. Advanced practical Medicinal Chemistry by Ashutosh Kar, New Age International Publications.

BPH_C_804_L – Pharmaceutics Lab IV- (4 Hr/Wk)

Course Objectives

To train the learner with the practical aspects of formulation, manufacturing and quality control tests of parenteral and ophthalmic

products.

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Demonstrate the intricacies of formulation and development of parenterals and ophthalmic products.

2. Understand and know about quality control and documentation of a manufacturing process.

3. Know about the pharmacopoeial tests for these products and their packaging materials.

4. Explain the concept of dissolution testing as an important quality control tool and relate to its importance from regulatory point of

view.

5. Apply pharmacokinetic principles of oral routes of administration.

6. Demonstrate oral and written communication skills and ability to plan the experimentation with proper time management

EXPERIMENTS

No. Details

1 Preparation & Testing of WFI as per IP

2 Processing and monographic testing of Glass containers and rubber closures as per IP.

3 Preparation and documentation of the following injections:

a. Calcium Gluconate injection IP

b. Ascorbic acid injection IP.

c. Sodium chloride & Dextrose Injection IP

4 Preparation and documentation of following ophthalmic products:

a. Sulphacetamide eye drops, IP

b. Official antibiotic eye ointment (any one)

5 Preparation and in vitro release evaluation of sustained release oral tablets (matrix type)

6 Dissolution testing of marketed formulations of conventional tablets containing poorlywater soluble

drug (selection of medium)

7 Calculations of pharmacokinetic parameters -i.v. administration (plasma samples provided).

8 Microencapsulation of solid/liquid core using phase separation coacervation technique

9 Preparation and evaluation of mucoadhesive buccal formulation (tablet/film)

10 Validation of process- mixing/milling

11 Assignment on SOP’s of dissolution apparatus/tablet press/coating equipment

12 Assignment on excipient/API specifications. (One example of each)

Books:

All books listed in the theory syllabus as well as Current editions of IP, BP and USP.

BPH_E_805_D– Project- (12 Hr/Wk)

ANY TWO SUBJECTS FROM THE FOLLOWING 4 CREDIT SUBJECTS TO BE CHOSEN AS

ELECTIVES FOR A TOTAL OF 8 CREDITS

BPH_E_806_T – Phytopharmaceutical Technology- (4 Hr/Wk)

Course Objectives

250

1. To make learners aware of various terms used in Phytopharmaceuticals and understand the concept of standardization of natural

products utilized in cosmetics, medicine and as nutraceuticals.

2. To understand industrial preparation of standardized extracts and isolation of phytoconstitutents.

3. To give an insight towards various Conventional and Novel Drug Delivery Systems (NDDS) of Herbal medicines and the

challenges faced along with the bioavailability aspects of Herbal formulations.

4. To introduce the concepts of QC and QA of Phytopharmaceuticals.

5. To learn role of herbs as Nutraceutical remedies for common disorders and in cosmeticeuticals.

6. To study the regulatory requirements for phytopharmaceuticals and Traditional Digital Knowledge Library (TKDL)

Course Outcomes

Upon completion of the course learners will be able to –

1. Understand terms related to phytopharmaceuticals and standardization of Natural Products.

2. Explain industrial preparation of standardized extracts, isolation of phytoconstitutents and their applications.

3. Discuss the challenges faced in formulation of conventional and NDDS of herbal medicines.

4. Explain the applications of QC and QA of Phytopharmaceuticals.

5. To suggest the use of herbs as nutraceuticals in common disorders and cosmeticeuticals.

6. Describe the regulatory requirements for phytopharmaceuticals.

No Topics Hours

1 Introduction to the terms

Phytopharmaceutical Technology – Phytopharmaceuticals, Active ingredient, Botanical Drug Substance,

Ethnomedicine, Herbal Medicine, Phytomedicine, Phytopharmaceutical Science, Regulatory affairs,

Traditional medicine, Folklore medicine, Herbal medicine, Finished herbal product, Pharmaco-vigilance

of herbals, Phytopharmacoepidemology and Phytopharmacoeconomics.

3

2 Herbal Extracts Processing and authentication,

Introduction to Preparation and Types of extracts with suitable examples – liquid, solid, semisolid, dried

and powdered

Large scale industrial method for preparation of extracts,

Process and equipment: Names of equipment and their uses, merits and demerits in the unit operations of

size reduction, Extraction, Filtration, Evaporation/ Distillation, Drying of Extracts

8

3 Formulations and drug delivery system A) Methods of preparations and evaluation of Herbal Tablets, Capsules, topical and liquid oral dosage

forms.

Study of any two examples of formulations under each dosage form with respect to their formulae

and activities / claims of each ingredient used in them.

B) NDDS of Herbal medicine: Limitation of Conventional, Challenges in Development of NDDS of

Herbal medicine, Phytosomes, Nanocarriers, Transdermal with one example each. Use of Bio-

enhancers in formulation development of herbal products.

Labeling of Phyto-pharmaceuticals. Preservation of Phyto-pharmaceuticals

8

4 Quality Assurance and Quality Control of Phytopharmaceuticals

A) For Herbal Extracts: Q.A by cultivation and Breeding,

Standardized extracts –Quantitative standardization using different types of Marker Compound. Stability

testing of Herbal extracts.

B) For Formulations: Stability of herbal formulation,

Bioavailability of Phytoconstituents from Herbal Formulations – Factors affecting bioavailability and

pharmacokinetics of some herbal drugs and phytoconstituents.

4

5 Herbs as Phytopharmaceutical Products Occurrence, Structure, Pharmacology, Metabolism and Pharmacokinetics, Therapeutic uses,

Recommended doses and Marketed preparations, Toxicity and Regulatory status of the following –

Ephedra Alkaloids, Ginger, Garlic, Kava kava, Ginkgo Biloba, Valerian, Chammomile, Echinacea,

Panax Ginseng, Cranberry, Acoruscalamus, Comfrey, Tomato, Liquorice, Senna, Cascara.

8

6 Non-Nutritive Sweeteners from Natural sources

Preparation, evaluation and salient features of Steveosides, Thaumatin, Glycyrrhizin. 2

7 Herbal Cosmeceuticals Role of Herbs and phytoconstituents in the following categories of cosmetic preparations. Formulation

aspects of the following cosmetic preparations and their market potential

Skin cosmetics –

herbs used as

Fairness agents- Turmeric (Curcumin), Uvaursi (Arbutin)

Moisturizers – Aloe vera (mannans), Coriander seed oil (SELENOL)

8

251

Anti-ageing agents- Rose and rosehip (Rosa canina), Chamomile (Matricariachamomilla)

Face packs -Apricot, Orange peel

Colour cosmetics advantages of natural dyes and colourants– Onosmaechioides, Carthamine,

Bixin - their use in lipsticks, rouges, eye shadows

Cosmetic products for eyes – Butcher’s broom, Chammomile

Hair cosmetics –

Colouring of hair- Tea extracts, Amla, Henna

Herbs used in improving health of hair -shampoos, oils, conditioners.

(Any two examples)

Dental hygiene Products: Salvadorepersica, clove, neem

8 Industrial production and estimation of the following phytoconstituents Preparation of their derivatives and products

Alkaloids -Berberine

Carotenoids- Capsanthin

Flavonoids- Naringenin, Hesperidin

Terpenoids- Citral, Forskolin, Gymnemic acid

Steroids -Diosgenin

Carbohydrates-Pectin

4

9 Regulatory issues in Phytomedicine Indian and International requirements.

TKDL (Traditional Knowledge Digital Library), Certification of Phytodrug industry.

(DSHE) Dietary Supplement Health and Education.

Acts related to banned or restricted phytoingredients.

Standardization Regulation for labeling purpose.

3

TOTAL 48

References:

1. Evidence-Based Validation of Herbal Medicine edited by Pulok K. Mukherjee Business Horizons Publishers

2. Phytotherapies: Efficacy, Safety, and Regulation. Ed Iqbal Ramzan John Wiley and Sons

3. Contemporary Phytomedicines. Amritpal Singh Saroya, CRC press

4. Journal of Ethnopharmacology 140 (2012) 513–518: www.elsevier.com/locate/jethpharm Pharmacovigilance of herbal

medicine Shaw Debbiea,, Ladds Graeme B, Duez Pierrec, Williamson Elizabeth D, Chan Kelvine,F

5. Textbook of Pharmacognosy by Trease & Evans.

6. Textbook of Pharmacognosy by Tyler, Brady & Robber.

7. Pharmacognosy by Kokate, Purohit and Gokhale

8. Essential of Pharmacognosy by Dr. S.H. Ansari

9. Pharmacognosy & Phytochemistry by V.D.Rangari

10. Pharmacopoeial standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy)

11. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers,

New Delhi, India, 2002

12. Toxicology and Clinical Pharmacology of Herbal Products,Steven B. Karch, Humana Press

13. Herbal Principles in Cosmetics Properties and Mechanisms of Action, Bruno Burlando, Luisella Verotta, Laura Cornara, and

Elisa Bottini-Massa, CRC Press.

BPH_E_807_T – Clinical Pharmacy- (4 Hr/Wk)

Course Prerequisites

Understanding of Pharmacology and its applications.

Course Objectives 1. Introduction to clinical pharmacy, Role of clinical pharmacist, patient case history, presentation of cases and counselling.

2. Educate on personalized drug therapy taking into consideration general and special population.

3. Teach basics of ADRs and pharmacovigilance.

4. Introduce the concept of therapeutic drug monitoring and its importance in therapy areas like epilepsy, cardiovascular disorders,

and others

5. Introduce the concepts of pharmacoepidemiology and pharmacoeconomics

Course Outcomes

252

1. Relate to the role of pharmacist in different setups like clinics, pharmacies and in the community and appraise the crucial role of

pharmacists in patient counselling and eventually in drug adherence and compliance to therapy.

2. Discuss the types, risk factors, classification, methods of detection, monitoring and reporting of ADRs, drug interactions,

pharmacovigilance and TDM in normal as well as special populations.

3. Outline the process of drug discovery and development, Ethical Guidelines/Schedules, Role of Ethics Committee, essential

documents in clinical trials/research, BA-BE studies and, apply and appreciate the role of GCP in conduct of clinical research.

4. Identify and analyze the trends in drug use to optimize health outcomes.

No. Details Hours

1 Introduction to Clinical Pharmacy: Concept of Clinical Pharmacy, Community

pharmacy and hospital pharmacy (Definition, scope and objectives)

4

2 Pharmacist-Patient Interaction 4

2.1 Patient Counselling: Role of Pharmacist in patient counselling 2

2.2 Patient Compliance, Methods of assessment of compliance, Reason for patient

noncompliance, Strategies to improve compliance, Precaution and directions for

medication, Administration instructions

2

3 Adverse Drug reactions: Epidemiology, Classification, Risk factors, Monitoring, Detecting and reporting of

ADR

5

4 Drug interactions:

Types, General Considerations and Mechanisms

3

5 Drug use in special population 6

5.1 Drugs used in Geriatrics 2

5.2 Drugs used in Paediatrics 2

5.3 Drugs used in Pregnancy 2

6 Therapeutic Drug Monitoring: Definition, indications and strategies 2

7 Drug discovery & development 14

7.1 Preclinical development 2

7.2 Clinical development- 5

a. History, terminologies, types of clinical research, phases of clinical trials, role of

clinical trial in new drug developments. Ethical issues in clinical trials: Principle of

regulatory requirements, responsible conduct, supervision of ethics, (Informed

Consent, Independent Ethics Committee, Institutional Review Board)

7.3 Good Clinical Practice (GCP): Concept and importance 1

7.4 Definitions of essential documents; SOP, protocol, Investigator’s brochure, 2

7.5 Introduction to BA/BE studies 2

7.6 Pharmacovigilance: Definition, scope and aims of Pharmacovigilance 2

8 Pharmacoepidemiology: Definition, types, methods, factors affecting drug utilization, applications of

pharmacoepidemiology

4

9 Pharmacoeconomics and outcomes Research: Theories and methodologies of pharmacoeconomics and outcomes research,

applications to pharmacotherapy and managed health care

6

Total 48

Books:

Latest editions of the following books to be adopted

1. Clinical Pharmacy and Therapeutics, Roger Walker, Clive Edwards, Churchill Livingstone.

2. Clinical Pharmacy, H. P. Tipnis, A. Bajaj, Career Publications.

3. Clinical Pharmacology, P.N. Benett, M. J. Brown, Churchill Livingstone.

4. Text Book of Clinical Pharmacy Practice, G. Parthisarathi, Karin Nyfort Hansen, Milap C. Nahata, Orient Longman.

5. Strom BI, Limmel SE. Textbook of Pharmacoepidemiology. Chichester, West Sussex, England: John Wiley & Sons Ltd; 2006.

6. Rascati, Karen L. Essentials of Pharmacoeconomics. Philadelphia, Pa.: Lippincott Williams and Wilkins, 2009.

253

7. M. F. Drummond, M. J. Sculpher and G. W. Torrance, Methods for the economic evaluation of health care programmes. Oxford

University Press, USA, 2005.

8. Brenda Waning; Michael Montagne; William W McCloskey, Pharmacoepidemiology: Principles and practice, New York,

McGraw-Hill, 2001.

BPH_E_808_T – Pharmacovigilance- (4 Hr/Wk)

Course Prerequisites

Basic/core courses in Pharmacology.

Course Objectives 1. Provide an opportunity for the student to learn about development of pharmacovigilance.

2. Learn the basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance.

3. Train students on establishing pharmacovigilance programme in an organization.

4. Various methods that can be used to assess adverse drug reactions generate safety data and signal detection.

5. Regulatory aspects of pharmacovigilance.

Course Outcomes

1. Relate to the role of pharmacovigilance and its prevalence in different setups.

2. Discuss the different facets of ADRs in normal as well as special populations with their relation to pharmacovigilance methods.

3. Integrate knowledge of resources of drug information, safety data and drug utilization.

4. Outline the regulatory processes in pharmacovigilance.

5.

No. Details Hours

1 Introduction to Pharmacovigilance 6

1.1 History and development of Pharmacovigilance 0.5

1.2 Importance of safety monitoring of Medicine 0.5

1.3 WHO international drug monitoring programme 1

1.4 Pharmacovigilance Program of India (PvPI) 1

1.5 Vaccine safety surveillance 1

Vaccine Pharmacovigilance, Vaccination failure

1.6 Establishing pharmacovigilance programme 2

Establishing in a hospital

Establishment & operation of drug safety department in industry

Contract Research Organizations (CROs)

Establishing a national programme

2 Adverse drug reactions 9

2.1 Definitions and classification of ADRs 1

2.2 Detection and reporting 3

2.3 Methods in Causality assessment 2

2.4 Severity and seriousness assessment 1

2.5 Predictability and preventability assessment 1

2.6 Management of adverse drug reactions 1

3 Pharmacogenomics of adverse drug reactions: Drug safety evaluation in special

population

6

3.1 Pediatrics 2

3.2 Pregnancy and lactation 2

3.3 Geriatrics 2

4 Pharmacovigilance methods 10

4.1 Passive surveillance – Spontaneous reports and case series 7

254

Stimulated reporting

Active surveillance – Sentinel sites, drug event monitoring and registries

Comparative observational studies – Cross sectional study, case control study and

cohort study

Targeted clinical investigations

4.2 Communication in pharmacovigilance 3

Effective communication in Pharmacovigilance

Communication in Drug Safety Crisis management

Communicating with Regulatory Agencies, Business Partners, Healthcare facilities &

Media

5 Drug dictionaries and coding in pharmacovigilance 10

5.1 WHO adverse reaction terminologies 2

MedDRA and Standardized MedDRA queries

WHO drug dictionary

5.2 Information resources in pharmacovigilance 2

drug information resources

Specialized resources for ADRs

5.3 Basic terminologies used in pharmacovigilance 1

Terminologies of adverse medication related events

Regulatory terminologies

5.4 Drug utilization: 2

Need, types of drug utilization studies

Drug use evaluation

5.5 Medication safety data: Safety data generation 3

Pre-clinical phase

Clinical phase

Post approval phase

6 Regulatory Aspects of Pharmacovigilance 7

6.1 ICH Guidelines for Pharmacovigilance 4

Organization and objectives of ICH

Expedited reporting

Individual case safety reports

Periodic safety update reports

Post approval expedited reporting

Pharmacovigilance planning

Good clinical practice in pharmacovigilance studies

6.2 CIOMS 1

CIOMS Working Groups

CIOMS form

6.3 CDSCO (India) and Pharmacovigilance 2

D & C Act and Schedule Y

Differences in Indian and global pharmacovigilance requirements

TOTAL 48

Books:

Latest editions of the following books to be adopted

1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.

255

2. Practical Drug Safety from A to Z, Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.

3. Mann's Pharmacovigilance: Elizabeth B. Andrews, Nicholas, Wiley Publishers.

4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.

5. An Introduction to Pharmacovigilance: Patrick Waller, Wiley Publishers.

6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert, Jones & Bartlett Publishers.

7. Textbook of Pharmacoepidemiology, Eds Brian L. Strom, Stephen E Kimmel, Sean Hennessy, Wiley Publishers.

8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills: G. Parthasarathi, Karin Nyfort Hansen, Milap C.

Nahata

9. National Formulary of India

10. Text Book of Medicine by Yashpal Munjal

11. Text book of Pharmacovigilance: Concept and Practice by GP Mohanta and PK Manna, PharmaMed Press/BSP Books.

12. http://www.cioms.ch/

13. http://cdsco.nic.in/

14. http://www.who.int/vaccine_safety/en/

15. http://www.ipc.gov.in/PvPI/pv_home.html

16. http://apps.who.int/medicinedocs/pdf/s4876e/s4876e.pdf

BPH_E_809_T – Pharmaceutical Regulatory Affairs- (4 Hr/Wk)

Course Objectives

The course is framed to impart knowledge to the learners so that they get conversant with drug regulatory practices and procedures

followed at national and international level for registration and approval.

Course Outcomes

The learner should be able to:

1. Understand the basics of new drug and generic product development.

2. Apply knowledge of regulatory requirements for preparing the documents for registration of pharmaceutical product in India and

overseas.

3. Understand various harmonized practices and integrate the knowledge required for various certifications.

No. Details Hours

1 Drug Regulatory Affairs

1.1 Introduction to Drug Regulatory Affairs(DRA)

1.2 DRA in Pharmaceutical Industry

1.3 Regulatory bodies across the world and different markets and brief introduction of registration process in

UK, Australia, Brazil, Canada, Japan, ASEAN countries, Commonwealth of Independent States, -Russian

Commonwealth (CIS)

4

1

1

2

2 Indian Regulations

2.1 Indian Pharmacopoeia (IP) commission - Introduction, IP review process with mentioning

monograph and IP reference substances (RS)

2.2 Pharmacovigilance Programme of India (PVPI)

2.3 Central Drug Standard Control Organization (CDSCO), Drug Controller General of India (DCGI), Food and

Drugs Administration (FDA), Centre Drugs Laboratory(CDL)- Structure, role, function and strategies of these

organizations

2.4 Procedure for obtaining test license (Form 29 and form 11), Export NOC, Loan License/Contract

manufacturing

9

3

1

3

2

3 US Regulations

3.1 USFDA - Structure, role and function

3.2 Drug price competition and patent term restoration act (Hatch Waxman Act 1984)- scope and objective

3.3 Type of filings- Type of application and relevant forms - Investigational New Drug (IND), New Drug

Application (NDA), Supplemental new drug application (SNDA), Abbreviated NDA (ANDA), Biologic License

Application (BLA)

3.4 Orange book Therapeutic Equivalent (TE) codes, Patent term and exclusivity

3.5 21 CFR- Brief introduction and mention of 21 CFR Part 11

3.6 Post Approval changes and SUPAC guidelines - Brief introduction

3.7 Drug master file (DMF) and different types

11

1

3

2

2

1

1

1

4 European Regulations (EU)

4.1 EMEA- Structure role and function 10

2

256

4.2 Types of filing- Centralized, Decentralized, Mutual recognition procedure, National

4.3 Type of applications for marketing authorization - New drug, Hybrid drug, Generic, similar biologic, Fixed

combination

4.4 Active Substance master file (ASMF) – Brief introduction, Certificate of suitability (COS)

4.5 Post Approval changes and handling variations

3

2

2

1

5 International Council for Harmonization (ICH)

5.1 Introduction- Composition, Role and responsibilities

5.2 ICH guidelines- Quality (Q), Safety (S), Efficacy (E), Multidisciplinary (M)

5.3 ICH quality guidelines – Terminologies

5.4 Introduction of ICH , multidisciplinary M4 guidelines

4

1

1

1

1

6 GMP certification and ISO 3

7 Clinical Trials

7.1 Regulatory perspective of clinical trials and brief overview of schedule Y and amendments

7.2 ICMR guidelines, Institutional Ethics committee for biomedical research (IRB/IEC)

7.3 Bioavailability and bioequivalence study, Biowaiver- Regulatory requirement

4

1

1

2

8 Intellectual Property rights and type Patent Act 1970, TRIPS, WTO, GATT and PCT-

Definition and Goals 3

TOTAL 48

Books:

1. New Drug Approval: Accelerating Global Registrations by Richard A Guarino, MD, 5th Edition, Drugs and the Pharmaceutical

Sciences, Vol.190.

2. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143.

3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical

Sciences, Vol.185, Informa Health care Publishers.

4. Intellectual Property Law, P. Narayanan, , Eastern Law House, Revised Edition, 2017.

https://www.ich.org

https://www.fda.gov

https://www.ema.europa.eu

https://www.cdsco.nic.in

https://www.icmr.nic.in

https://www.gov.uk

BPH_E_810_T – Lead Optimization – Strategies and Methods- (4 Hr/Wk)

Course Objectives

1. To introduce the learner to the concepts of druggability and physicochemical/ADME/Toxicity property optimization in new drug

discovery.

2. To study the fundamentals, structure modification strategies and methods of determination of various physicochemical and

pharmacokinetic properties of lead compounds.

Course Outcomes The learner should be able to:

1. Understand the importance of druggability and physicochemical/ADME/Toxicity property optimization in new drug discovery.

2. Understand the fundamentals of various physicochemical and pharmacokinetic properties and their significance in lead

optimization.

3. Know various strategies for structure modification for optimizing druggability of lead molecules.

4. Describe different methods of determination of various physicochemical and pharmacokinetic properties of lead compounds.

No. Details Hours

1 Drug-like Properties 4

1.1 Introduction, drug-likeness and Drug Discovery

1.2 Property profiling and optimization

1.3 Rules for rapid property profiling from structure

1.4 Lead-like compounds

1.5 Strategies for integrating drug-like properties into Drug Discovery

2 Lipophilicity and pKa 4

2.1 Fundamentals, effects and structure modification strategies

2.2 Lipophilicity determination Methods: in silico lipophilicity methods,

experimental lipophilicity methods, in-depth lipophilicity methods

257

2.3 pKa determination methods: in silico methods, experimental methods, in-depth

methods

3 Solubility 4

3.1 Fundamentals of solubility, dissolution rate, structural properties affecting

solubility, kinetic solubility and thermodynamic solubility

3.2 Effects of solubility, IV formulations, solubility classification, effects of physiology

on solubility and absorption

3.3 Structure modification strategies to improve solubility, strategies for improving

dissolution rate, salt forms

3.4 Methods for solubility determination: solubility calculation methods and

commercial software, kinetic solubility methods, thermodynamic solubility methods

4 Permeability 4

4.1 Permeability fundamentals: passive diffusion permeability, endocytosis

permeability, active uptake permeability, paracellular permeability, efflux

permeability, combined permeability

4.2 Permeability effects: effect of permeability on bioavailability, effect of permeability

on cell-based activity assays

4.3 Permeability structure modification strategies

4.4 Methods for permeability determination:

in silico permeability methods, in vitro permeability, in depth permeability methods

5 Transporters 4

5.1 Transporter fundamentals

5.2 Transporter effects, efflux transporters: p-glycoprotein (MDR1, ABCB1) , breast

cancer resistance protein (BCRP, ABCG2), multidrug resistance protein 2 (MRP2,

ABCC2) , efflux transporters in the BBB

5.3 Uptake transporters, structure modification strategies

5.4 Methods: in silico transporter methods, in vitro transporter methods, in vivo

methods for transporters

6 Blood Brain Barrier 4

6.1 BBB fundamentals: BBB permeation mechanisms, brain distribution mechanisms,

brain–CSF barrier, interpreting data for brain penetration

6.2 Effects of brain penetration

6.3 Structure–BBB penetration relationships, structure modification strategies to

improve brain penetration

6.4 Methods for determining BBB: in silico methods, in vitro methods, in vivo

methods,

7 Metabolic Stability, Plasma Stability, Solution Stability 6

7.1 Metabolic stability fundamentals: Phase I metabolism, Phase II metabolism,

metabolic stability effects

7.2 Structure modification strategies for metabolic stability: Phase I, Phase II,

consequences of chirality on metabolic stability

7.3 Plasma Stability: fundamentals, effects, structure modification strategies to improve

plasma stability

7.4 Solution Stability: fundamentals, effects, structure modification strategies to

improve solution stability

7.5 Methods: In silico metabolic stability methods, in vitro metabolic stability methods,

plasma stability methods, solution stability methods

8 Plasma Protein Binding 3

8.1 Plasma Protein Binding Fundamentals: consequences of chirality on PPB

8.2 Plasma Protein Binding Effects: Impact of PPB on distribution, clearance and

pharmacology

8.3 Structure modification strategies for PPB

8.4 Methods for determining PPB: in silico methods, in vitro Methods

9 Cytochrome P450 inhibition 4

9.1 CYP inhibition fundamentals and effects

9.2 Structure modification strategies to reduce CYP inhibition

9.3 Reversible and irreversible CYP inhibition

9.4 Methods for determining CYP inhibition: in silico methods, in vitro methods

10 hERG Blocking 3

10.1 hERG Fundamentals, hERG blocking effects

258

10.2 hERG Blocking Structure–Activity Relationship, structure modification strategies

for hERG

10.3 hERG methods: In silico hERG methods, in vitro hERG methods, in vivo hERG

methods

11 Toxicity 4

11.1 Toxicity Fundamentals: toxicity terms and mechanisms

11.2 Structure modification strategies to improve safety

11.3 Methods: in silico toxicity methods, in vitro toxicity assays, in vivo toxicity

12 Pharmacokinetics 4

12.1 Pharmacokinetic parameters: volume of distribution, Area Under the Curve,

clearance, half-life, bioavailability

12.2 Effects of plasma protein binding on PK parameters, tissue uptake

12.3 Using PK data in drug discovery

12.4 Pharmacokinetic methods: PK dosing (single-compound dosing, cassette dosing),

PK sampling and sample preparation, instrumental analysis

Total Hours 48

Books:

1. Drug-like Properties: Concepts, Structure Design and Methods from ADME to Toxicity Optimization, Li Di, Edward Kerns,

Academic Press.

2. Lead Optimization for Medicinal Chemists: Pharmacokinetic Properties of Functional Groups and Organic Compounds, Florencio

Zaragoza Dörwald, Wiley-VCH.

3. Pharmacokinetics and Metabolism in Drug Design, Volume 31, Dennis A. Smith, Han van de Waterbeemd ,Don K .Walker ,Series

Editors - Raimund Mannhold ,Hugo Kubinyi and Gerd Folkers ,Wiley-VCH.

BPH_E_811_T – Novel Drug Delivery Systems- (4 Hr/Wk)

Course Objectives

To provide the learner with knowledge of basic principles and the different types of Novel Drug Delivery Systems

Course Outcomes

Upon completion of the course, the learner shall be able to:

1. Understand the basic concept of NDDS

2. Discuss the different NDDS for different routes-oral, transdermal, ocular, transmucosal and implantable

3. Explain the need and concepts of targeting and active & passive targeting

4. Elaborate on principles and targeting systems for brain, colon, lymphatics and tumors

5. Discuss the various multiparticulate systems for targeting

No. Details Hours

1.0 Fundamentals of Novel drug delivery systems: Basic Concepts, Advantages and

Disadvantages, Limitations of conventional dosage forms

1

2.0 Polymers: Introduction, classification, Role and applications in NDDS, Biodegradable and

biocompatible polymers.

3

3.0 Particulate NDDS:

Microspheres, liposomes, nanoparticles, aquasomes, niosomes, dendrimers-Classification,

components & design, methods of preparation, characterization and applications of each

system.

4

3.0 Oral Controlled Drug Delivery Systems:

a) Matrix and reservoir systems- Diffusion and dissolution-controlled systems

b) Multiparticulate drug delivery systems (Pellets)- need and significance of pelletization,

techniques- pan coating, extrusion and spheronization, equipments, evaluation

c) Osmotic Systems- Basic principles, classification- Implantable osmotic pumps, oral

osmotic pumps, applications & evaluation

d) Gastroretentive drug delivery systems (GRDDS)-

Regional variability in intestinal absorption and concept of absorption window, Design of

GRDDS technologies- low density (Floating systems), Swelling and expanding systems,

Mucoadhesive systems, high density systems. Evaluation of GRDDS.

8

4.0 Ocular drug delivery systems:

Limitations of conventional systems, in situ gelling systems, Ocular inserts: Non-erodible

and Erodible inserts, Particulate systems for ocular delivery-liposomes & nanoparticles,

4

259

ocular iontophoresis, evaluation.

One example of each system

5.0 Transdermal Drug Delivery Systems (TDDS):

Permeation through skin, factors affecting permeation, Advantages and disadvantages of

TDDS, basic components of TDDS, Different types of TDDS and release control

mechanism, pressure sensitive adhesives, Evaluation

4

6.0 Transmucosal drug delivery systems:

Concept of bioadhesion/ mucoadhesion, Advantages and disadvantages of transmucosal

drug delivery, Bioadhesive polymers, Theories of mucoadhesion, Factors affecting

mucoadhesion, transmucosal permeability, Formulation considerations: emphasis on

buccal drug delivery, Evaluation of mucoadhesive strength

4

7.0

Parenteral Controlled drug delivery systems- Need and Various approaches, Details of

Implantable Systems – Characteristics desired, routes employed, diffusion-controlled

systems, activation-controlled systems and feedback-regulated systems. One example of

each.

Biocompatibility issues of implantable systems

5

8.0 Nasal and Pulmonary Drug Delivery Systems-Advantages and limitations;

Nasal drug delivery-absorption pathways of intranasally administered drugs, permeation

enhancers, intranasal formulations, nose-to-brain delivery

Pulmonary delivery- Weibel model of Lungs (Pulmonary tree), aerosol deposition

mechanisms and pattern in lungs, concepts of mass median aerodynamic diameter

(MMAD) and Fine particle fraction (FPF); Delivery systems (nebulised, systems, pMDIs

and DPIs), Active and Passive devices, Evaluation methods.

7

9.0 . Targeted drug delivery systems:

a) Introduction to targeting, concepts of active and passive targeting.

b) Particulate systems for targeting- microspheres, aquasomes, niosomes,

dendrimers, and solid lipid nanoparticles, liposomes

c) Targeting to colon: Difficulties in colonic targeting, Approaches of colon

targeting, Evaluation

d) Targeting to Brain: Blood brain barrier (BBB), transport through BBB, factors

affecting drug permeation through BBB, strategies for brain drug delivery

e) Lymphatic targeting-need and approaches-

f) Targeting to tumor – EPR effect, ligand-based active targeting with two

examples

8

TOTAL 48

Books:

Latest editions

1. Advances in controlled and novel drug delivery, ed. by N. K. Jain, CBS publishers and distributors, 2001.

2. Modern Pharmaceutics, 4th ed. Revised and Expanded, ed. by Gilbert S. Banker and Christopher T. Rhodes, Marcel Dekker INC.,

2002

3. Targetted and controlled drug delivery, Novel carrier systems, S. P. Vyas and R. K. Khar, CBS publishers and distributors, 2002.

4. Controlled and novel drug delivery, ed. by N. K. Jain, CBS publishers and distributors, 1997.

5. Controlled drug delivery, concepts and advances, S. P. Vyas and R. K. Khar, Vallabh Publishers, 2002.

6. The theory and practice of industrial pharmacy, ed. by Leon Lachman, H. A. Liberman, J. L. Kanig, 3rd ed., Verghese Publishing

house, 1987.

7. The science and practice of pharmacy, 21st ed., Remington, Vol I and II, B. L. Publications Pvt. Ltd., 2005.

8. Bioadhesive Drug Delivery Systems – Fundamentals, Novel Approaches, and Development, Mathiowitz Edith, Chickering III,

Donald E., Lehr Claus-Michael, Volume 98, Marcel Dekker Inc., New York, 1995.

9. Nanoparticulate Drug Delivery Systems, Thassu Deepak, Dellers Michael, Pathak Yashwant, Volume 166, Marcel Dekker Inc.,

New York, 2007.

10. Microencapsulation – Methods and Industrial Applications”, Benita Simon, 2nd Edition, Marcel Dekker Inc., New York, 2006.

11. Controlled and Novel Drug Delivery, Jain N. K., 1st Edition, CBS Publishers and Distributors, New Delhi, 2004.

12. Targeted and Controlled Drug Delivery- Novel Carrier Systems”, Vyas S. P., Khar R. K., 1st Edition, CBS Publishers and

Distributors, New Delhi, 2002.

13. Ophthalmic Drug Delivery Systems, Mitra, Ashim K., Volume 58, Marcel Dekker Inc., New York, 1993.

14. Encyclopedia of Pharmaceutical Technology, Swabrick, Boylan, Volumes 1,6,8,9,10,12,13,14,15,16,17,18,19,20, Marcel Dekker

Inc., New York.

260

Shri. Yashwantrao Bhonsale Education Society’s

YASHWANTRAO BHONSALE COLLEGE OF PHARMACY

Bldg. No. 02, BKC, A/ P: Charathe - Vazarwadi, Tal: Sawantwadi, Dist.: Sindhudurg, Maharashtra- 416 510

Approved by AICTE, PCI, New Delhi, Govt. of Maharashtra, DTE. Affiliated to Mumbai University (B. Pharm, M. Pharm)

and MSBTE (D. Pharm) DTE Code: 3480; University Code: 1027; MSBTE Code: 1878

www.sybespharmacy.com +912363-272233/272299 Email:ybpharmacy@gmail.com

Mr. Achyut K. Sawantbhonsale Dr. Vijay A. Jagtap

Executive Chairman Principal

PCI Syllabus Copy

(Revised in 2019-20)

261

262

263

UNIVERSITY OF MUMBAI

Manual on

CHOICE BASED CREDIT SYSTEM

for

Undergraduate Programme

(Bachelor of Pharmacy, B. Pharm.)

in

PHARMACY

Revised Course (Revised 2019)

from the academic year 2019-2020

264

INTRODUCTION

RECOMMENDATIONS OF NATIONAL REGULATORY AUTHORITIES

The University Grants Commission (UGC), the National Assessment and

Accreditation Council (NAAC), the Distance Education Council (DEC) and the

National Knowledge Commission (NKC) have time and again come out with

recommendations for improving the quality and effectiveness of Higher education

provisions in the country. The ministry of Human Resource Development at the

Central level and the Ministry of Higher & Technical Education, Govt. of

Maharashtra have also repeatedly stressed on the need for universities to pay prompt

attention to improve the quality of education. The National Knowledge Commission

(NKC), in its report to the Prime Minister on 29th November 2006) has also reiterated

the importance of higher education and the contribution it has made to economic

development, social progress and political democracy in independent India.

An important concern voiced more strongly in recent times, is the need to develop a

Choice-Based Credit System (CBCS) in tune with global trends and the adoption of a

sound grading system for reflecting learner performance. This is in line with the

recommendation of the UGC in its Action Plan for Academic and Administrative

Reforms (Ref. UGC letters January 2008; March 2009) “……. Curricular flexibility

and learners’ mobility is an issue that warrants our urgent attention. These can be

addressed by introducing credit based courses and credit accumulation. In order to

provide with some degree of flexibility to learners, we need to provide flexibility in

course selection and also a minimum as well as a maximum permissible span of time

in which a course can be completed by a learner… The Choice-Based Credit System

(CBCS) imminently fits into the emerging socioeconomic milieu, and could effectively

respond to the educational and occupational aspirations of the upcoming generations.

In view of this, institutions of higher education in India would do well to invest

thought and resources into introducing CBCS. Aided by modern communication and

information technology, CBCS has a high probability to be operationalized efficiently

and effectively — elevating learners, institutions and higher education system in the

country to newer heights…”.

265

RATIONALE FOR INTRODUCTION OF CREDIT AND GRADING SYSTEM

The UGC while outlining the several unique features of the Choice-Based Credit

System (CBCS) has, in fact, given in a nutshell, the rationale for its introduction.

Among the features highlighted by the UGC are: Enhanced learning opportunities,

ability to match learners’ scholastic needs and aspirations, inter-institution

transferability of learners (following the completion of a semester), part-completion

of an academic programme in the institution of enrolment and part-completion in a

specialized (and recognized) institution, improvement in educational quality and

excellence, flexibility for working learners to complete the programme over an

extended period of time, standardization and comparability of educational

programmes across the country, etc.

This Choice Based Credit System enables a much-required shift in focus from

teacher-centric to learner-centric education since the workload estimated is based on

the investment of time in learning, not in teaching. It also focuses on continuous

evaluation which will enhance the quality of education. It can be concluded from the

above discussion that it is very much essential to implement the Choice Based Credit

System in higher education in India. Course credit structure, examination/assessment

and grading are mainly focused aspects of this manual and discussed in subsequent

chapters.

DIRECTIVES OF PHARMACY COUNCIL OF INDIA

The Pharmacy Council of India (PCI) in exercise of the powers conferred to it under

the sections 10 and 18 of the Pharmacy Act 1948 (8 of 1948), with the approval of the

Central Government, had made the Bachelor of Pharmacy (B. Pharm.) Course

Regulations, 2014 and Master of Pharmacy (M. Pharm.) Course regulations vide

Gazette dated December 10, 2014. Further as per regulations 6 and 8 of the above

course regulations the PCI has also prescribed the Rules and Syllabus for B. Pharm.

course and Scheme and Syllabus for M. Pharm., its letter Ref 14-136/2016-PCI and

Ref 14-154/2015 PCI dated December 21, 2016, with the subject heading “Statutory

Scheme/Rules and syllabus for B. Pharm and M. Pharm. courses”. It is thus

mandatory to implement the directives of PCI with regard to the

Rules/Regulations/Syllabus for recognition and extension of approval of B. Pharm.

and M. Pharm. programs of institutes/Universities by the PCI

266

1. ADMISSION CRITERIA

Admission to the B. Pharm. program of University of Mumbai is governed by the

rules and regulations of University of Mumbai and is as per norms of the Govt. of

Maharashtra through the State CET-CELL (Maharashtra State), the All India Council

for Technical Education (AICTE, New Delhi), and Pharmacy Council of India (PCI,

New Delhi). Minimum qualification for admission into Bachelor of Pharmacy

program would be according to the rules and regulations of AICTE, PCI, Government

of Maharashtra and University of Mumbai in force at the time of admission.

Admission criteria for First Year B. Pharm is as follows:

In general, a learner who has passed HSC or its equivalent examination with Physics

and Chemistry as compulsory subjects along with one of the Mathematics or

Biotechnology or Biology and obtained at least 50% marks (at least 45 marks in case

of candidates of backward category and persons with disability belonging to

Maharashtra state only.) in the above subjects taken together and obtained score in

CET/ NEET / any other equivalent exam is eligible for admission to Semester I of

First Year B. Pharm. However, the rules/regulations and qualifications for admission

will be those in effect at the day and time of admission.

Admission criteria for admission into Semester III of Bachelor of Pharmacy

(Lateral Entry to Second Year B. Pharm.) is as follows:

In general, a learner who has passed Diploma course in Pharmacy with an aggregate

of 45% (at least 40 marks in case of candidates of backward category and persons

with disability belonging to Maharashtra state only.) from an All India Council for

Technical Education or Pharmacy Council of India or Central or State Government

approved institutions or its equivalent. However, the rules/regulations and

qualifications for admission will be those in effect at the day and time of admission.

2. COURSE STRUCTURE

2.1. Duration of the program

The course of study for B. Pharm. shall extend over a period of eight semesters (four

academic years) and six semesters (three academic years) for lateral entry students.

The medium of instruction shall be English.

267

2.2. Working days in each semester

Each semester shall consist of not less than 100 working days. The odd semesters

shall be conducted from the month of July to November/December and the even

semesters shall be conducted from December/January to May/June in every calendar

year.

As the requirements for a particular degree (undergraduate or postgraduate), a certain

quantum of academic work measured in terms of credits is laid down in general.

Learner earns credits every semester by satisfactorily clearing courses/other academic

activities. The amount of credit associated with a course is dependent upon the

number of hours of instruction per week in that course. Similarly the credit associated

with any of the other activities is dependent upon the quantum of work expected to be

put in for each of the other activity per week.

2.3. Attendance and progress

A candidate is required to put in at least 75% attendance in individual courses

considering theory and practical separately. The candidate shall complete the

prescribed course satisfactorily to be eligible to appear for the respective

examinations.

2.4. Credit Assignment

2.4.1. Theory and Laboratory Courses:

Courses are broadly classified as Theory courses and Laboratory Courses. Theory

courses consist of lecture (L) and /or tutorial (T) hours. Laboratory courses consist of

practical hours, but may have attached tutorial hours in special cases. Credit (C) for a

course is dependent on the number of hours of instruction per week in that course, and

is obtained by using a multiplier of one (1) for lecture and tutorial hours, and a

multiplier of half (1/2) for laboratory hours. Thus, for example, a theory course

having four lectures and one tutorial per week throughout the semester carries a

credit of 5. Similarly, a laboratory course having two laboratory hours per week

throughout semester carries a credit of 1.

For example –

Theory course Laboratory course

L T = C P T = C

3 1 4 4 0 2

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2.4.2. Projects/Dissertations

Project is a requirement for the B. Pharm. degree, wherein under the guidance of a

faculty member, a group of not more than five learners in the eighth semester, is

required to do some innovative work with the application of knowledge gained while

learning various courses in the earlier years. The learner/s is/are expected to do a

survey of literature in the subject, work out a Project plan and carry it out through

survey, experimentation and/or modeling / computation. Through the Project work the

learner has to exhibit skills for both analysis and critical thinking. The complete

details of the project have to submitted as a report of not less than 25 pages (A4, 1

inch margins, single line space, font Times Roman, font size 12, excluding count of

reference pages) to the College before the prescribed date. The credits assigned for

Project is 6 credits.

2.4.3. Practice School

In the VII semester, every candidate shall undergo practice school for a period of 150

hours evenly distributed throughout the semester. The student shall opt any one of the

domains for practice school declared by the program committee from time to time.

At the end of the practice school, every student shall submit a printed report (in

triplicate) on the practice school he/she attended (not more than 25 pages). Along with

the exams of semester VII, the report submitted by the student, knowledge and skills

acquired by the student through practice school shall be evaluated by the subject

experts at college level and grade point shall be awarded. The credits assigned for

Practice School is 6 credits.

2.4.4. Industrial training (Desirable)

Every candidate shall be required to work for at least 150 hours spread over four

weeks in a Pharmaceutical Industry/Hospital. It includes Production unit, Quality

Control department, Quality Assurance department, Analytical laboratory, Chemical

manufacturing unit, Pharmaceutical R&D, Hospital (Clinical Pharmacy), Clinical

Research Organization, Community Pharmacy, etc. After the Semester – VI and

before the commencement of Semester – VII, and shall submit satisfactory report of

such work and certificate duly signed by the authority of training organization to the

head of the institute.

269

2.5. Minimum Credit Requirements

The minimum credit points required for award of a B. Pharm. degree is 208 plus

credit of 1 for extra-curricular and co-curricular activities. These credits are divided

into Theory courses, Tutorials, Practical, Practice School and Project over the

duration of eight semesters. The credits are distributed semester wise as shown in the

structure and syllabus manual. Courses generally progress in sequences, building

competencies and their positioning indicates certain academic maturity on the part of

the learners. Learners are expected to follow the semester wise schedule of courses

given in the syllabus.

The lateral entry students shall get 52 credit points transferred from their D. Pharm

program. Such students shall take up additional remedial courses of „Communication

Skills‟ (Theory and Practical) and „Computer Applications in Pharmacy‟ (Theory and

Practical) equivalent to 3 and 4 credit points respectively, a total of 7 credit points to

attain 59 credit points, the maximum of I and II semesters.

2.6. Course/Subject codes:

In the syllabus manual of each programme of a particular discipline, subject code is

assigned for each course as follows:

First two characters are alphabets and indicate the program of a particular

discipline (BP indicates B. Pharm.).

Third digit indicates semester number (1 indicates first Semester).

The next two digits indicate chronological order of the course in the list of the

subjects of the respective semester (01 indicates first course in the list of all

courses of the respective semester).

Alphabets onward sixth indicates nature of the course i.e. T indicates Theory, P

indicates Practical and ET indicates Elective Theory, R indicates Remedial, PS

indicates Practice School, PW indicates Project Work.

For example –

BP101T indicates a B. Pharm. course of semester one and first theory course

BP107P indicates a B. Pharm. course of semester one and seventh practical course

BP807ET indicates a B. Pharm. course of semester eight and seventh elective

theory course

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3. EXAMINATION / ASSESSMENT AND GRADING

Semester wise performance assessment of every registered learner is to be carried out

through various modes of examinations, in both theory and laboratory classes. These

include Internal Assessment and End Semester Examination.

3.1. End semester examinations

The End Semester Examinations in Semesters I, II, III, IV, V and VI of the B. Pharm.

Degree course will be conducted by the respective institutions/colleges where the

learner has been admitted following rules and regulations. The examinations in

Semesters VII and VIII will be conducted by the university. All Non University

Examination Subjects (NUES) marked with asterisk symbol (*) syllabus structure,

will have examinations conducted by the subject experts at college level and the

marks/grades shall be submitted to the university.

A common time-table and common question papers for all the theory examinations of

different semesters will be prepared/set by the university as per the procedure.

The question papers for the Theory courses in Semesters I, II, III, IV, V, VI, VII, and

VIII will be set by examiners and paper-setters appointed by the University.

The assessment and moderation of the answer booklets for the examinations in

Theory courses in Semesters I to VI will be carried out by respective

institutions/colleges by the examiners and moderators appointed by the principals of

the institutions/colleges for each paper from the panel approved by the Ad-hoc Board

of Studies in Pharmacy.

Principals of the respective institutions/colleges are authorized to appoint examiners

in the Practical examinations at Semesters I to VI on behalf of the university, only

from the panel of suitable persons for appointment as examiners prepared by the Ad-

hoc Board of Studies in Pharmacy.

The assessment and moderation of the answer booklets of the Theory courses in

Semesters VII and VIII will be conducted by the University through Central

271

Assessment Programme (CAP) or On Screen Marking (OSM) or as directed by the

University of Mumbai.

The End Semester Examination for Laboratory classes for Semesters I to VI would be

done at the institutional level by a pair of examiners appointed by the institution. For

Semesters VII and VIII, the University would appoint two examiners for each

Laboratory prescribed in Semesters VII and VIII. Evaluation would be done by the

examiners appointed by the University at the place and time announced by the

University.

3.2. Internal assessment: Continuous mode

The marks allocated for Continuous mode of Internal Assessment shall be awarded

as per the scheme given below.

Table-1: Scheme for awarding internal assessment: Continuous mode

Theory

Criteria Maximum Marks

100 M

Course

50 M

Course

Attendance (Refer Table – 2) 4 2

Academic activities (Average of any 3 activities e.g. quiz,

assignment, open book test, field work, group discussion and

seminar) 3 1.5

Student – Teacher interaction 3 1.5

Total 10 5

Practical

Attendance (Refer Table – 2) 2

Based on Practical Records, Regular viva voce, etc. 3

Total 5

Table- 2: Guidelines for the allotment of marks for attendance

Percentage of

Attendance Theory Practical

90 – 100 4 2

95 – 99 3 1.5

80 – 84 2 1

75 – 79 1 0.5

272

Less than 75 0 0

3.3. Sessional Exams

Two Sessional exams shall be conducted for each theory / practical course as per the

schedule fixed by the college(s). The scheme of question paper for theory and

practical Sessional examinations is given below. The average marks of two Sessional

exams shall be computed for internal assessment as per the requirements given in

tables of Schemes for internal assessments and end semester examinations.

Sessional exam shall be conducted for 30 marks for theory and shall be computed for

15 marks. Similarly Sessional exam for practical shall be conducted for 40 marks and

shall be computed for 10 marks.

Question paper pattern for theory Sessional examinations

For subjects having University examination

I. Multiple Choice Questions (MCQs)

(Answer all the questions) = 10 x 1 = 10

I. Long Answers (Answer 1 out of 2) = 1 x 10 = 10

II. Short Answers (Answer 2 out of 3) = 2 x 5 = 10

-----------------

Total = 30 marks

For subjects having Non University Examination

I. Long Answers (Answer 1 out of 2) = 1 x 10 = 10

II. Short Answers (Answer 4 out of 6) = 4 x 5 = 20

------------------

Total = 30 marks

Question paper pattern for practical sessional examinations

I. Synopsis = 10

II. Experiments = 25

III. Viva voce = 05

------------------

Total = 40 marks

4. PROMOTION AND AWARD OF GRADES

A student shall be declared PASS and eligible for getting grade in a course of B.

Pharm. programme if he/she secures at least 50% marks in that particular course

including internal assessment. For example, to be declared as PASS and to get grade,

the student has to secure a minimum of 50 marks for the total of 100 including

continuous mode of assessment and end semester theory examination and has to

273

secure a minimum of 25 marks for the total 50 including internal assessment and end

semester practical examination.

5. CARRY FORWARD OF MARKS

In case a student fails to secure the minimum 50% in any Theory or Practical course,

then he/she shall reappear for the end semester examination of that course. However

his/her marks of the Internal Assessment shall be carried over and he/she shall be

entitled for grade obtained by him/her on passing.

6. IMPROVEMENT OF INTERNAL ASSESSMENT

A student shall have the opportunity to improve his/her performance only once in the

Sessional exam component of the internal assessment. The re-conduct of the Sessional

exam shall be completed before the commencement of next end semester theory

examinations

7. RE-EXAMINATION OF END SEMESTER EXAMINATIONS

Reexamination of end semester examination shall be conducted as per the schedule

given in table 3. The exact dates of examinations shall be notified from time to time.

Table-3: Tentative schedule of end semester examinations

Semester For Regular Candidates For Failed Candidates

I, III, V and VII November / December May / June

II, IV, VI and VIII May / June November / December

Question paper pattern for end semester theory examinations

For 75 marks paper

I. Multiple Choice Questions(MCQs)

(Answer all the questions) = 20 x 1 = 20

I. Long Answers (Answer 2 out of 3) = 2 x 10 = 20

II. Short Answers (Answer 7 out of 9) = 7 x 5 = 35

------------------

Total = 75 marks

------------------

For 50 marks paper

I. Long Answers (Answer 2 out of 3) = 2 x 10 = 20

274

II. Short Answers (Answer 6 out of 8) = 6 x 5 = 30

------------------

Total = 50 marks

------------------

For 35 marks paper

I. Long Answers (Answer 1 out of 2) = 1 x 10 =10

II. Short Answers (Answer 5 out of 7) = 5 x 5 = 25

------------------

Total = 35 marks

------------------

Question paper pattern for end semester practical examinations

I. Synopsis = 5

II. Experiments = 25

III. Viva voce = 5

------------------

Total = 35 marks

8. ACADEMIC PROGRESSION:

Academic progression rules are applicable as follows:

A student shall be eligible to carry forward all the courses of I, II, and III semesters

till the IV semester examinations. However, he/she shall not be eligible to attend the

courses of V semester until all the courses of I and II semesters are successfully

completed.

A student shall be eligible to carry forward all the courses of III, IV and V semesters

till the VI semester examinations. However, he/she shall not be eligible to attend the

courses of VII semester until all the courses of I, II, III and IV semesters are

successfully completed.

A student shall be eligible to carry forward all the courses of V, VI and VII semesters

till the VIII semester examinations. However, he/she shall not be eligible to get the

course completion certificate until all the courses of I, II, III, IV, V and VI semesters

275

are successfully completed.

A student shall be eligible to get his/her CGPA upon successful completion of the

courses of I to VIII semesters within the stipulated time period as per the norms

specified in 10.

A lateral entry student shall be eligible to carry forward all the courses of III, IV and

V semesters till the VI semester examinations. However, he/she shall not be eligible

to attend the courses of VII semester until all the courses of III and IV semesters are

successfully completed.

A lateral entry student shall be eligible to carry forward all the courses of V, VI and

VII semesters till the VIII semester examinations. However, he/she shall not be

eligible to get the course completion certificate until all the courses of III, IV, V and

VI semesters are successfully completed.

A lateral entry student shall be eligible to get his/her CGPA upon successful

completion of the courses of III to VIII semesters within the stipulated time period as

per the norms specified in 10.

Any student who has given more than 4 chances for successful completion of I / III

semester courses and more than 3 chances for successful completion of II / IV

semester courses shall be permitted to attend V / VII semester classes ONLY during

the subsequent academic year as the case may be. In simpler terms there shall NOT be

any ODD BATCH for any semester.

Note: Grade AB should be considered as failed and treated as one head for deciding

academic progression. Such rules are also applicable for those students who fail to

register for examination(s) of any course in any semester.

9. GRADING OF PERFORMANCES

9.1. Letter grades and grade points allocations:

Based on the performances, each student shall be awarded a final letter grade at the

end of the semester for each course. The letter grades and their corresponding grade

276

points are given in Table – 4.

Table – 4: Letter grades and grade points equivalent to Percentage of marks and

performances

Percentage of

Marks Obtained

Letter Grade Grade Point Performance

90.00 – 100 O 10 Outstanding

80.00 – 89.99 A 9 Excellent

70.00 – 79.99 B 8 Good

60.00 – 69.99 C 7 Fair

50.00 – 59.99 D 6 Average

Less than 50 F 0 Fail

Absent AB 0 Fail

A learner who remains absent for any end semester examination shall be assigned a

letter grade of AB and a corresponding grade point of zero. He/she should reappear

for the said evaluation/examination in due course.

9.2. The Semester grade point average (SGPA)

The performance of a student in a semester is indicated by a number called

„Semester Grade Point Average‟ (SGPA). The SGPA is the weighted average of the

grade points obtained in all the courses by the student during the semester. For

example, if a student takes five courses(Theory/Practical) in a semester with credits

C1, C2, C3, C4 and C5 and the student‟s grade points in these courses are G1, G2,

G3, G4 and G5, respectively, and then students‟ SGPA is equal to:

C1G1 + C2G2 + C3G3 + C4G4+ C5G5

SGPA = ---------------------------------------------------------

C1 + C2 + C3 + C4+ C5

The SGPA is calculated to two decimal points. It should be noted that, the SGPA for

any semester shall take into consideration the F and AB grade awarded in that

semester. For example if a learner has an F or AB grade in course 4, the SGPA shall

then be computed as:

C1G1 + C2G2 + C3G3 + ZERO+ C5G5

SGPA = -------------------------------------------------------------

C1 + C2 + C3 + C4+ C5

277

9.3. Cumulative Grade Point Average (CGPA)

The CGPA is calculated with the SGPA of all the VIII semesters to two decimal

points and is indicated in final grade report card/final transcript showing the grades of

all VIII semesters and their courses. The CGPA shall reflect the failed status in case

of F grade(s), till the course(s) is/are passed. When the course(s) is/are passed by

obtaining a pass grade on subsequent examination(s) the CGPA shall only reflect the

new grade and not the fail grades earned earlier. The CGPA is calculated as:

C1S1 + C2S2 + C3S3 + C4S4+ C5S5+ C6S6+ C7S7+ C8S8

CGPA = -------------------------------------------------------------------------

C1 + C2 + C3 + C4+ C5+ C6+ C7+ C8

where C1, C2, C3,…. is the total number of credits for semester I,II,III,…. and S1,S2,

S3,….is the SGPA of semester I,II,III,…. .

9.4. Declaration of class

Although the GPA system is a stand-alone system of grading not amenable to

facile conversion to percent marks, in general the conversion of CGPA to percent

marks is: CGPA x 9.5 = Percent marks.

The class shall be awarded on the basis of CGPA as follows:

First Class with Distinction = CGPA of. 7.37 and above

First Class = CGPA of 6.32 to 7.36

Second Class = CGPA of 6.00 to 6.31

9.5. Project work

The internal and external examiner appointed by the college but approved by the

Board of Studies for Pharmacy shall evaluate the project at the time of the Practical

examinations of other semester(s). Students shall be evaluated in groups for four

hours (i.e., about half an hour for a group of five students). The projects shall be

evaluated as per the criteria given below.

Evaluation of Dissertation Book:

Objective(s) of the work done 15 Marks

Methodology adopted 20 Marks

Results and Discussions 20 Marks

Conclusions and Outcomes 20 Marks

TOTAL 75 Marks

278

Evaluation of Presentation:

Presentation of work 25 Marks

Communication skills 20 Marks

Question and answer skills 30 Marks

TOTAL 75 Marks

Explanation: The 75 marks assigned to the dissertation book shall be same for all the

students in a group. However, the 75 marks assigned for presentation shall be

awarded based on the performance of individual students in the given criteria

9.6. Industrial training (Desirable)

Every candidate shall be required to work for at least 150 hours spread over four

weeks in a Pharmaceutical Industry/Hospital. It includes Production unit, Quality

Control department, Quality Assurance department, Analytical laboratory, Chemical

manufacturing unit, Pharmaceutical R&D, Hospital (Clinical Pharmacy), Clinical

Research Organization, Community Pharmacy, etc. After the Semester – VI and

before the commencement of Semester – VII, and shall submit satisfactory report of

such work and certificate duly signed by the authority of training organization to the

head of the institute.

9.7. Practice School

In the VII semester, every candidate shall undergo practice school for a period of 150

hours evenly distributed throughout the semester. The student shall opt any one of the

domains for practice school declared by the program committee from time to time.

At the end of the practice school, every student shall submit a printed report (in

triplicate) on the practice school he/she attended (not more than 25 pages). Along with

the exams of semester VII, the report submitted by the student, knowledge and skills

acquired by the student through practice school shall be evaluated by the subject

experts at college level and grade point shall be awarded. The credits assigned for

Practice School is 6 credits.

9.8. Award of degree

Candidates who fulfill the requirements mentioned above shall be eligible for award

of degree during the ensuing convocation.

10. Duration for completion of the program of study

279

The duration for the completion of the program shall be fixed as per the norms of the

University of Mumbai

11. Re-admission after break of study

Candidate who seeks re-admission to the program after break of study has to get the

approval from the university by paying a condonation fee.

12. Program Committee

1. The B. Pharm. program shall have a Program Committee constituted by the Head

of the institution in consultation with all the Heads of the departments.

2. The composition of the Program Committee shall be as follows: A senior teacher

shall be the Chairperson; One Teacher from each department handling B.Pharm

courses; and four student representatives of the program (one from each academic

year), nominated by the Head of the institution.

3. Duties of the Program Committee:

i. Periodically reviewing the progress of the classes.

ii. Discussing the problems concerning curriculum, syllabus and the conduct of

classes.

iii. Discussing with the course teachers on the nature and scope of assessment for the

course and the same shall be announced to the students at the beginning of respective

semesters.

iv. Communicating its recommendation to the Head of the institution on academic

matters.

v. The Program Committee shall meet at least thrice in a semester preferably at the

end of each Sessional exam (Internal Assessment) and before the end semester exam.

280

1

SCHEME AND SYLLABUS

for

CHOICE BASED CREDIT SYSTEM

for

Undergraduate Programme

(Bachelor of Pharmacy, B. Pharm.)

in

PHARMACY

Revised Course (Revised 2019)

from the academic year 2019-2020

281

2

COURSE OFSTUDY

The course of study for B. Pharm shall include Semester Wise Theory & Practical as given in

Table – I to VIII. The number of hours to be devoted to each theory, tutorial and practical

course in any semester shall not be less than that shown in Table – I toVIII.

Table-I: Course of study for semester I

Course code Name of the course No.of

hours

Tuto

rial

Credit

points

BP101T Human Anatomy and Physiology I–

Theory 3 1 4

BP102T Pharmaceutical Analysis I – Theory 3 1 4

BP103T Pharmaceutics I – Theory 3 1 4

BP104T Pharmaceutical Inorganic Chemistry – Theory

3 1 4

BP105T Communication skills – Theory * 2 - 2

BP106RBT

BP106RMT

Remedial Biology/

Remedial Mathematics – Theory* 2 - 2

BP107P Human Anatomy and Physiology –

Practical 4 - 2

BP108P Pharmaceutical Analysis I – Practical 4 - 2

BP109P Pharmaceutics I – Practical 4 - 2

BP110P Pharmaceutical Inorganic Chemistry – Practical

4 - 2

BP111P Communication skills – Practical* 2 - 1

BP112RBP Remedial Biology – Practical* 2 - 1

Total 32/34$/36

# 4 27/29

$/30

#

#Applicable ONLY for the students who have studied Mathematics / Physics / Chemistry at HSC and

appearing for Remedial Biology (RB)course.

$Applicable ONLY for the students who have studied Physics / Chemistry / Botany / Zoology at HSC and

appearing for Remedial Mathematics (RM)course.

* Non University Examination (NUE)

282

3

Table-II: Course of study for semester II

Course

Code Name of the course

No.of

hours Tutorial

Credit

points

BP201T Human Anatomy and Physiology II – Theory 3 1 4

BP202T Pharmaceutical Organic Chemistry I – Theory 3 1 4

BP203T Biochemistry – Theory 3 1 4

BP204T Pathophysiology – Theory 3 1 4

BP205T Computer Applications in Pharmacy – Theory * 3 - 3

BP206T Environmental sciences – Theory * 3 - 3

BP207P Human Anatomy and Physiology II –Practical 4 - 2

BP208P Pharmaceutical Organic Chemistry I– Practical 4 - 2

BP209P Biochemistry – Practical 4 - 2

BP210P Computer Applications in Pharmacy – Practical* 2 - 1

Total 32 4 29

*Non University Examination (NUE)

Table-III: Course of study for semester III

Course

code Name of the course

No.of

hours Tutorial

Credit

points

BP301T Pharmaceutical Organic Chemistry II – Theory 3 1 4

BP302T Physical Pharmaceutics I – Theory 3 1 4

BP303T Pharmaceutical Microbiology – Theory 3 1 4

BP304T Pharmaceutical Engineering – Theory 3 1 4

BP305P Pharmaceutical Organic Chemistry II – Practical 4 - 2

BP306P Physical Pharmaceutics I – Practical 4 - 2

BP307P Pharmaceutical Microbiology – Practical 4 - 2

BP 308P Pharmaceutical Engineering –Practical 4 - 2

Total 28 4 24

283

4

Table-IV: Course of study for semester IV

Course

code Name of the course

No.of

hours Tutorial

Credit

points

BP401T Pharmaceutical Organic Chemistry III– Theory 3 1 4

BP402T Medicinal Chemistry I – Theory 3 1 4

BP403T Physical Pharmaceutics II – Theory 3 1 4

BP404T Pharmacology I – Theory 3 1 4

BP405T Pharmacognosy and Phytochemistry I– Theory 3 1 4

BP406P Medicinal Chemistry I – Practical 4 - 2

BP407P Physical Pharmaceutics II – Practical 4 2

BP408P Pharmacology I – Practical 4 - 2

BP409P Pharmacognosy and Phytochemistry I – Practical 4 - 2

Total 31 5 28

Table-V: Course of study for semester V

Course

code Name of the course

No.of

hours Tutorial

Credit

points

BP501T Medicinal Chemistry II – Theory 3 1 4

BP502T Industrial PharmacyI– Theory 3 1 4

BP503T Pharmacology II – Theory 3 1 4

BP504T Pharmacognosy and Phytochemistry II– Theory 3 1 4

BP505T Pharmaceutical Jurisprudence – Theory 3 1 4

BP506P Industrial PharmacyI – Practical 4 - 2

BP507P Pharmacology II – Practical 4 - 2

BP508P Pharmacognosy and Phytochemistry II –

Practical

4 - 2

Total 27 5 26

284

5

Table-VI: Course of study for semester VI

Course

code Name of the course

No.of

hours Tutorial

Credit

points

BP601T Medicinal Chemistry III – Theory 3 1 4

BP602T Pharmacology III – Theory 3 1 4

BP603T Herbal Drug Technology – Theory 3 1 4

BP604T Biopharmaceutics and Pharmacokinetics –

Theory 3 1 4

BP605T Pharmaceutical Biotechnology – Theory 3 1 4

BP606T Quality Assurance –Theory 3 1 4

BP607P Medicinal chemistry III – Practical 4 - 2

BP608P Pharmacology III – Practical 4 - 2

BP609P Herbal Drug Technology – Practical 4 - 2

Total 30 6 30

Table-VII: Course of study for semester VII

Course

code Name of the course

No.of

hours Tutorial

Credit

points

BP701T Instrumental Methods of Analysis – Theory 3 1 4

BP702T Industrial PharmacyII – Theory 3 1 4

BP703T Pharmacy Practice – Theory 3 1 4

BP704T Novel Drug Delivery System – Theory 3 1 4

BP705P Instrumental Methods of Analysis –Practical 4 - 2

BP706PS Practice School* 12 - 6

Total 28 5 24

* Non University Examination (NUE)

285

6

Table-VIII: Course of study for semester VIII

Course

code Name of the course

No.of

hours Tutorial

Credit

points

BP801T Biostatistics and Research Methodology 3 1 4

BP802T Social and Preventive Pharmacy 3 1 4

BP803ET Pharma Marketing Management

3 + 3 =

6

1 + 1 = 2

4 + 4 =

8

BP804ET Pharmaceutical Regulatory Science

BP805ET Pharmacovigilance

BP806ET Quality Control and Standardization of

Herbals

BP807ET Computer Aided Drug Design

BP808ET Cell and Molecular Biology

BP809ET Cosmetic Science

BP810ET Experimental Pharmacology

BP811ET Advanced Instrumentation Techniques

BP812ET Dietary Supplements And

Nutraceuticals - Theory

BP813ET Pharmaceutical Product Development -

Theory

BP814PW Project Work 12 - 6

Total 24 4 22

Table-IX: Semester wise credits distribution

Semester Credit Points

I 27/29$/30

#

II 29

III 26

IV 28

V 26

VI 26

VII 24

VIII 22

Extracurricular/ Co curricular activities 01*

Total credit points for the program 209/211$/212

#

* The credit points assigned for extracurricular and or co-curricular activities shall be given by the

Principals of the colleges and the same shall be submitted to the University. The criteria to acquire this

credit point shall be defined by the colleges from time to time.

$Applicable ONLY for the students studied Physics / Chemistry / Botany / Zoology at HSC and appearing

for Remedial Mathematics course.

286

7

#Applicable ONLY for the students studied Mathematics / Physics / Chemistry at HSC and appearing for

Remedial Biology course.

287

8

Schemes for internal assessments and end semester examinations semester wise

Semester I

Course

code

Name of the course

Internal Assessment End Semester Exams Total

Marks Continuous

Mode

Sessional Exams Total Marks Duration

Marks Duration

BP101T Human Anatomy and Physiology I– Theory

10 15 1 Hr 25 75 3 Hrs 100

BP102T Pharmaceutical Analysis I – Theory

10 15 1 Hr 25 75 3 Hrs 100

BP103T Pharmaceutics I – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP104T Pharmaceutical Inorganic Chemistry – Theory

10 15 1 Hr 25 75 3 Hrs 100

BP105T Communication skills – Theory *

5 10 1 Hr 15 35 1.5 Hrs 50

BP106RBT BP106RMT

Remedial Biology/ Mathematics – Theory*

5 10 1 Hr 15 35 1.5 Hrs 50

BP107P Human Anatomy and

Physiology – Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP108P Pharmaceutical Analysis I – Practical

5 10 4 Hrs 15 35 4 Hrs 50

BP109P Pharmaceutics I – Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP110P Pharmaceutical Inorganic Chemistry – Practical

5 10 4 Hrs 15 35 4 Hrs 50

BP111P Communication skills – Practical*

5 5 2 Hrs 10 15 2 Hrs 25

BP112RBP Remedial Biology – Practical*

5 5 2 Hrs 10 15 2 Hrs 25

Total 70/75$/80

# 115/125

$/130

# 23/24

$/26

#H

rs

185/200$/210

# 490/525

$/

540#

31.5/33$/

35# Hrs

675/725$/

750#

#Applicable ONLY for the students studied Mathematics / Physics / Chemistry at HSC and appearing for Remedial Biology (RB)course. $Applicable ONLY for the students studied Physics / Chemistry / Botany / Zoology at HSC and appearing for Remedial Mathematics

(RM) course.

* Non-University Examination (NUE)

288

9

Semester II

Course

code

Name of the course

Internal Assessment End Semester Exams Total

Marks Continuous

Mode

Sessional Exams Total Marks Duration

Marks Duration

BP201T Human Anatomy and Physiology

II – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP202T Pharmaceutical Organic

Chemistry I – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP203T Biochemistry – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP204T Pathophysiology – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP205T Computer Applications in

Pharmacy – Theory 10 15 1 Hr 25 50 2 Hrs 75

BP206T Environmental sciences – Theory 10 15 1 Hr 25 50 2 Hrs 75

BP207P Human Anatomy and Physiology

II –Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP208P Pharmaceutical Organic

Chemistry I– Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP209P Biochemistry – Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP210P Computer Applications in Pharmacy – Practical

5 5 2 Hrs 10 15 2 Hrs 25

Total 80 125 20 Hrs 205 520 30 Hrs 725

289

10

Semester III

Course

code

Name of the course

Internal Assessment End Semester Exams Total

Marks Continuous

Mode

Sessional Exams Total Marks Duration

Marks Duration

BP301T Pharmaceutical Organic

Chemistry II – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP302T PhysicalPharmaceuticsI –Theory 10 15 1 Hr 25 75 3 Hrs 100

BP303T Pharmaceutical Microbiology –

Theory 10 15 1 Hr 25 75 3 Hrs 100

BP304T Pharmaceutical Engineering –

Theory 10 15 1 Hr 25 75 3 Hrs 100

BP305P Pharmaceutical Organic

Chemistry II – Practical 5 10 4 Hr 15 35 4 Hrs 50

BP306P Physical Pharmaceutics I – Practical

5 10 4 Hr 15 35 4 Hrs 50

BP307P Pharmaceutical Microbiology –

Practical 5 10 4 Hr 15 35 4 Hrs 50

BP308P Pharmaceutical Engineering –

Practical 5 10 4 Hr 15 35 4 Hrs 50

Total 60 100 20 160 440 28Hrs 600

290

11

Semester IV

Course

code

Name of the course

Internal Assessment End Semester Exams Total

Marks Continuous

Mode

Sessional Exams Total Marks Duration

Marks Duration

BP401T Pharmaceutical Organic

Chemistry III– Theory 10 15 1 Hr 25 75 3 Hrs 100

BP402T Medicinal Chemistry I – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP403T Physical Pharmaceutics II – Theory

10 15 1 Hr 25 75 3 Hrs 100

BP404T Pharmacology I – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP405T Pharmacognosy I – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP406P Medicinal Chemistry I – Practical 5 10 4 Hr 15 35 4 Hrs 50

BP407P Physical Pharmaceutics II – Practical

5 10 4 Hrs 15 35 4 Hrs 50

BP408P Pharmacology I – Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP409P Pharmacognosy I – Practical 5 10 4 Hrs 15 35 4 Hrs 50

Total 70 115 21 Hrs 185 515 31 Hrs 700

291

12

Semester V

Course

code

Name of the course

Internal Assessment End Semester Exams Total

Marks Continuous

Mode

Sessional Exams Total Marks Duration

Marks Duration

BP501T Medicinal Chemistry II – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP502T Industrial PharmacyI– Theory 10 15 1 Hr 25 75 3 Hrs 100

BP503T Pharmacology II – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP504T Pharmacognosy and Phytochemistry II – Theory

10 15 1 Hr 25 75 3 Hrs 100

BP505T Pharmaceutical Jurisprudence–

Theory 10 15 1 Hr 25 75 3 Hrs 100

BP506P Industrial PharmacyI– Practical 5 10 4 Hr 15 35 4 Hrs 50

BP507P Pharmacology II – Practical 5 10 4 Hr 15 35 4 Hrs 50

BP508P Pharmacognosy II – Practical 5 10 4 Hr 15 35 4 Hrs 50

Total 65 105 17 Hr 170 480 27 Hrs 650

292

13

Semester VI

Course

code

Name of the course

Internal Assessment End Semester Exams Total

Marks Continuous

Mode

Sessional Exams Total Marks Duration

Marks Duration

BP601T Medicinal Chemistry III – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP602T Pharmacology III – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP603T Herbal Drug Technology –

Theory 10 15 1 Hr 25 75 3 Hrs 100

BP604T Biopharmaceutics and

Pharmacokinetics – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP605T Pharmaceutical Biotechnology–

Theory 10 15 1 Hr 25 75 3 Hrs 100

BP606T Pharmaceutical Quality Assurance– Theory

10 15 1 Hr 25 75 3 Hrs 100

BP607P Medicinal chemistry III –

Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP608P Pharmacology III – Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP609P Herbal Drug Technology –

Practical 5 10 4 Hrs 15 35 4 Hrs 50

Total 75 120 18 Hrs 195 555 30 Hrs 750

293

14

Semester VII

Course

code

Name of the course

Internal Assessment End Semester

Exams

Total

Marks Continuous

Mode

Sessional Exams Total Marks Duration

Marks Duration

BP701T Instrumental Methods of Analysis

– Theory 10 15 1 Hr 25 75 3 Hrs 100

BP702T Industrial Pharmacy – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP703T Pharmacy Practice – Theory 10 15 1 Hr 25 75 3 Hrs 100

BP704T Novel Drug Delivery System – Theory

10 15 1 Hr 25 75 3 Hrs 100

BP705 P Instrumental Methods of Analysis

– Practical 5 10 4 Hrs 15 35 4 Hrs 50

BP706 PS Practice School* 25 - - 25 125 5 Hrs 150

Total 70 70 8Hrs 140 460 21 Hrs 600

* The subject experts at college level shall conductexaminations

294

15

Semester VIII

Course

code

Name of the course

Internal Assessment End Semester Exams Total

Marks Continuou

s Mode

Sessional Exams Total Marks Duration

Marks Duration

BP801T Biostatistics and Research Methodology –

Theory 10 15 1 Hr 25 75 3 Hrs 100

BP802T Social and Preventive Pharmacy

– Theory 10 15 1 Hr 25 75 3 Hrs 100

BP803ET Pharmaceutical Marketing –

Theory

10 + 10

= 20

15 + 15

=

30

1 + 1 =

2 Hrs

25 + 25

=

50

75 +

75

= 150

3 + 3 = 6

Hrs

100 +

100 =

200

BP804ET Pharmaceutical Regulatory Science –

Theory

BP805ET Pharmacovigilance – Theory

BP806ET

Quality Control and Standardization of

Herbals – Theory

BP807ET Computer Aided Drug Design –

Theory

BP808ET Cell and Molecular Biology –

Theory

BP809ET Cosmetic Science – Theory

BP810ET Experimental Pharmacology –

Theory

BP811ET Advanced Instrumentation Techniques

– Theory

BP812ET Dietary Supplements And

Nutraceuticals - Theory

BP813ET Pharmaceutical Product Development -

Theory

BP814PW Project Work - - - - 150 4 Hrs 15

0

Total 40 60 4 Hrs 100 450 16 Hrs 550

295

16

SEMESTER I

296

17

BP101T HUMAN ANATOMY AND PHYSIOLOGY-I (Theory)3 L + 1T / Week

Scope: This subject is designed to impart fundamental knowledge on the structure

andfunctions of the various systems of the human body. It also helps in understanding

both homeostatic mechanisms. The subject provides the basic knowledge required to

understand the various disciplines of pharmacy.

Objectives: Upon completion of this course the student should be able to

1. Explain the gross morphology, structure and functions of various organs of the human

body.

2. Describe the various homeostatic mechanisms and their imbalances.

3. Identify the various tissues and organs of different systems of human body.

4. Perform the various experiments related to special senses and nervous system.

5. Appreciate coordinated working pattern of different organs of each system

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Introduction to human body

Definition and scope of anatomy and physiology, levels of structural

organization and body systems, basic life processes, homeostasis, basic

anatomical terminology

2

1.2 Cellular level of organization

Structure and functions of cell, transport across cell membrane, cell

division, cell junctions. General principles of cell communication,

intracellular signaling pathway activation by extracellular signal molecule,

Forms of intracellular signaling: a) Contact-dependent b) Paracrine c)

Synaptic d) Endocrine

4

1.3 Tissue level of organization

Classification of tissues, structure, location and functions of epithelial,

muscular and nervous and connective tissues

4

2 UNIT II 10

2.1 Integumentary system Structure and functions of skin 1

2.2 Skeletal system

Divisions of skeletal system, types of bone, salient features and functions

of bones of axial and appendicular skeletal system.

Organization of skeletal muscle, physiology of muscle contraction,

neuromuscular junction

6

2.3 Joints

Structural and functional classification, types of joints movements and its

3

297

18

articulation

3 UNIT III 10

3.1 Body fluids and blood

Body fluids, composition and functions of blood, hemopoeisis, formation

of hemoglobin, anemia, mechanisms of coagulation, blood grouping, Rh

factors, transfusion, its significance and disorders of blood, Reticulo

endothelial system.

6

3.2 Lymphatic system

Lymphatic organs and tissues, lymphatic vessels, lymph circulation and

functions of lymphatic system

4

4 UNIT IV 08

4.1 Peripheral nervous system:

Classification of peripheral nervous system: Structure and functions of

sympathetic and parasympathetic nervous system. Origin and functions of

spinal and cranial nerves.

3

4.2 Special senses

Structure and functions of eye, ear, nose and tongue and their disorders.

5

5 UNIT V 07

Cardiovascular system

Heart – anatomy of heart, blood circulation, blood vessels, structure and

functions of artery, vein and capillaries, elements of conduction system of

heart and hear beat, its regulation by autonomic nervous system, cardiac

output, cardiac cycle.

Regulation of blood pressure, pulse, electrocardiogram and disorders of

heart.

4

3

Total 45

Recommended Books (Latest Editions)

1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam. Jaypee

brothers medical publishers, New Delhi.

2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson, Churchill

Livingstone, New York

3. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins

Co,Riverview,MI USA

4. Text book of Medical Physiology- Arthur C,Guyton andJohn.E. Hall. Miamisburg, OH,

U.S.A.

5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A.

298

19

6. Textbook of Human Histology by Inderbir Singh, Jaypee brother‘s medical publishers,

New Delhi.

7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brother‘s medical publishers, New

Delhi.

8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma, Jaypee

brother‘s medical publishers, New Delhi.

Reference Books (Latest Editions)

1. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins Co,

Riverview, MI USA

2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg, OH,

U.S.A.

3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata

299

20

BP102T PHARMACEUTICAL ANALYSIS (Theory)3 L + 1T / Week

Scope: This course deals with the fundamentals of analytical chemistry and principles

ofelectrochemical analysis of drugs

Objectives: Upon completion of the course student shall be able to

1. understand the principles of volumetric and electro chemical analysis

2. carryout various volumetric and electrochemical titrations

3. develop analytical skills

Sr. No. Content Hours

1 UNIT I 10

1.1

Pharmaceutical analysis- Definition and scope

i) Different techniques of analysis

ii) Methods of expressing concentration

iii) Primary and secondary standards.

iv) Preparation and standardization of various molar and normal

solutions-Oxalic acid, sodium hydroxide, hydrochloric acid, sodium

thiosulphate, sulphuric acid, potassium permanganate and ceric

ammonium sulphate

6

1.2 Errors: Sources of errors, types of errors, methods of minimizing

errors,accuracy, precision and significant figures

2

1.3 Pharmacopoeia, Sources of impurities in medicinal agents, limit tests. 2

2 UNIT II 10

2.1 Acid base titration: Theories of acid base indicators, classification

ofacid base titrations and theory involved in titrations of strong, weak,

and very weak acids and bases, neutralization curve

5

2.2 Non aqueous titration: Solvents, acidimetry and alkalimetry titration

andestimation of Sodium benzoate and Ephedrine HCl

5

3 UNIT III 10

3.1 Precipitation titrations:Mohr‘s method, Volhard‘s, Modified 2

3.2 Complexometric titration: Classification, metal ion indicators,

maskingand demasking reagents, estimation of Magnesium sulphate,

and calcium gluconate.

4

3.3 Gravimetry: Principle and steps involved in gravimetric analysis.

Purity of the precipitate: co-precipitation and post precipitation,

Estimation of barium sulphate

2

3.4 Basic Principles,methods and application of diazotisation titration 2

300

21

4 UNIT IV 08

4.1 Redox titrations

Concepts of oxidation and reduction

4.2 Types of redox titrations (Principles and applications)

Cerimetry, Iodimetry, Iodometry, Bromatometry, Dichrometry,

Titration with potassium iodate

5 UNIT V - Electrochemical methods of analysis 07

5.1 Conductometry- Introduction, Conductivity cell,

Conductometrictitrations, applications.

2

5.2 Potentiometry - Electrochemical cell, construction and workingof

reference (Standard hydrogen, silver chloride electrode and calomel

electrode) and indicator electrodes (metal electrodes and glass

electrode), methods to determine end point of potentiometric titration

and applications.

3

5.3 Polarography - Principle, Ilkovic equation, construction and working of

dropping mercury electrode and rotating platinum electrode,

applications

2

Total 45

Recommended Books: (Latest Editions)

1. A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II,

Stahlone Press of University of London

2. A.I. Vogel, Text Book of Quantitative Inorganic analysis

3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry

4. Bentley and Driver's Textbook of Pharmaceutical Chemistry

5. John H. Kennedy, Analytical chemistry principles

6. Indian Pharmacopoeia.

301

22

BP103T PHARMACEUTICS- I (Theory)3 L + 1T / Week

Scope: This course is designed to impart a fundamental knowledge on the

preparatorypharmacy with arts and science of preparing the different conventional dosage

forms.

Objectives: Upon completion of this course the student should be able to:

1. Know the history of profession of pharmacy

2. Understand the basics of different dosage forms, pharmaceutical incompatibilities and

pharmaceutical calculations

3. Understand the professional way of handling the prescription

4. Preparation of various conventional dosage forms

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Historical background and development of profession of pharmacy:

Historyof profession of Pharmacy in India in relation to pharmacy

education, industry and organization, Pharmacy as a career,

Pharmacopoeias: Introduction to IP, BP, USP and Extra Pharmacopoeia.

3

1.2 Dosage forms: Introduction to dosage forms, classification and definitions 3

1.3 Prescription: Definition, Parts of prescription, handling of

Prescription andErrors in prescription.

2

1.4 Posology: Definition, Factors affecting posology. Pediatric dose

calculationsbased on age, body weight and body surface area.

2

2 UNIT II 10

2.1 Pharmaceutical calculations: Weights and measures–Imperial &

Metricsystem, Calculations involving percentage solutions, alligation, proof

spirit and isotonic solutions based on freezing point and molecular weight.

4

2.2 Powders: Definition, classification, advantages and disadvantages,Simple

&compound powders – official preparations, dusting powders, effervescent,

efflorescent and hygroscopic powders, eutectic mixtures. Geometric

dilutions.

3

2.3 Liquid dosage forms: Advantages and disadvantages of liquid dosage

forms.Excipients used in formulation of liquid dosage forms. Solubility

enhancement techniques

3

UNIT III 10

3.1 Monophasic liquids: Definitions and preparations of Gargles,

Mouthwashes,Throat Paint, Eardrops, Nasal drops, Enemas, Syrups, Elixirs,

3

302

23

Liniments and Lotions.

3.2 Biphasic liquids:

o Suspensions: Definition, advantages and disadvantages,

classifications,Preparation of suspensions; Flocculated and

Deflocculated suspension & stability problems and methods to

overcome.

o Emulsions: Definition, classification, emulsifying agent, test for the

identificationof type ofEmulsion, Methods of preparation & stability

problems and methods to overcome.

7

4 UNIT IV 08

4.1 Suppositories: Definition, types, advantages and disadvantages, types of

bases,methods of preparations. Displacement value & its calculations,

evaluation of suppositories.

5

4.2 Pharmaceutical incompatibilities: Definition, classification, physical,

chemicaland therapeutic incompatibilities with examples.

3

5 UNIT V 07

Semisolid dosage forms: Definitions, classification, mechanisms and

factorsinfluencing dermal penetration of drugs. Preparation of ointments,

pastes, creams and gels. Excipients used in semi solid dosage forms.

Evaluation of semi solid dosages forms

Total 45

Recommended Books (Latest edition)

1. H. C. Ansel et al., Pharmaceutical Dosage Form and Drug Delivery System, Lippincott

Williams and Walkins, New Delhi.

2. Carter S.J., Cooper and Gunn‘s-Dispensing for Pharmaceutical Students, CBS publishers,

New Delhi.

3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone,

Edinburgh.

4. Indian pharmacopoeia.

5. British pharmacopoeia.

6. Lachmann. Theory and Practice of Industrial Pharmacy,Lea& Febiger Publisher, The

University of Michigan.

7. Alfonso R. Gennaro Remington. The Science and Practice of Pharmacy, Lippincott

Williams, New Delhi.

8. Carter S.J., Cooper and Gunn‘s. Tutorial Pharmacy, CBS Publications, New Delhi.

9. E.A. Rawlins, Bentley‘s Text Book of Pharmaceutics, English Language Book Society,

Elsevier Health Sciences, USA.

10. Isaac Ghebre Sellassie: Pharmaceutical Pelletization Technology, Marcel Dekker, INC,

New York.

303

24

11. Dilip M. Parikh: Handbook of Pharmaceutical Granulation Technology, Marcel Dekker,

INC, New York.

12. Francoise Nieloud and Gilberte Marti-Mestres: Pharmaceutical Emulsions and

Suspensions, Marcel Dekker, INC, New York.

304

25

BP104T PHARMACEUTICAL INORGANIC CHEMISTRY (Theory)3 L + 1T / Week

Scope: This subject deals with the monographs of inorganic drugs and pharmaceuticals.

Objectives: Upon completion of course student shall be able to

1. know the sources of impurities and methods to determine the impurities in inorganic drugs

and pharmaceuticals

2. understand the medicinal and pharmaceutical importance of inorganic compounds

Sr. No. Content Hours

1 UNIT I 10

1.1 Impurities in pharmaceutical substances: History of

Pharmacopoeia,Sources and types of impurities, principle involved in

the limit test for Chloride, Sulphate, Iron, Arsenic, Lead and Heavy

metals, modified limit test for Chloride and Sulphate

4

1.2 General methods of preparation, assay for the compounds

superscripted with asterisk (*), properties and medicinal uses of

inorganic compounds belonging to the following classes

6

2 UNIT II 10

2.1 Acids, Bases and Buffers: Buffer equations and buffer capacity in

general,buffers in pharmaceutical systems, preparation, stability,

buffered isotonic solutions, measurements of tonicity, calculations and

methods of adjusting isotonicity.

4

2.2 Major extra and intracellular electrolytes: Functions of

major physiological ions, Electrolytes used in the replacement

therapy: Sodium chloride*, Potassium chloride, Calcium gluconate*

and Oral Rehydration Salt (ORS), Physiological acid base balance.

4

2.3 Dental products: Dentifrices, role of fluoride in the treatment of

dentalcaries, Desensitizing agents, Calcium carbonate, Sodium

fluoride, and Zinc eugenol cement.

2

3 UNIT III - Gastrointestinal agents 10

3.1 Acidifiers: Ammonium chloride* and Dil. HCl 1

3.2 Antacid: Ideal properties of antacids, combinations of antacids,

Sodium Bicarbonate*, Aluminum hydroxide gel, Magnesium

hydroxide mixture2

3

3.3 Cathartics: Magnesium sulphate, Sodium orthophosphate, Kaolin

andBentonite

2

305

26

3.4 Antimicrobials: Mechanism, classification, Potassium permanganate,

Boricacid, Hydrogen peroxide*, Chlorinated lime*, Iodine and its

preparations

4

4 UNIT IV - Miscellaneous compounds 08

4.1 Expectorants: Potassium iodide, Ammonium chloride*. 1

4.2 Emetics: Copper sulphate*, Sodium potassium tartarate 2

4.3 Haematinics: Ferrous sulphate*, Ferrous gluconate 2

4.4 Poison and Antidote: Sodium thiosulphate*, Activated charcoal,

Sodiumnitrite

2

4.5 Astringents: Zinc Sulphate, Potash Alum 1

5 UNIT V 07

Radiopharmaceuticals: Radio activity, Measurement of

radioactivity,Properties of α, β, γ radiations, Half life, radio isotopes

and study of radio isotopes - Sodium iodide I131

, Storage conditions,

precautions & pharmaceutical application of radioactive substances.

Total 45

Recommended Books: (Latest Editions)

1. A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II,

Stahlone Press of University of London, 4th

edition.

2. A.I. Vogel, Text Book of Quantitative Inorganic analysis

3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry, 3rd

Edition

4. M.L Schroff, Inorganic Pharmaceutical Chemistry

5. Bentley and Driver's Textbook of Pharmaceutical Chemistry

6. Anand & Chatwal, Inorganic Pharmaceutical Chemistry

7. Indian Pharmacopoeia

306

27

BP105T COMMUNICATION SKILLS (Theory) 2hours/week

Scope: This course will prepare the young pharmacy student to interact effectively

withdoctors, nurses, dentists, physiotherapists and other health workers. At the end of

this course the student will get the soft skills set to work cohesively with the team as a

team player and will add value to the pharmaceutical business.

Objectives: Upon completion of the course the student shall be able to

1. Understand the behavioural needs for a Pharmacist to function effectively in the areas of

pharmaceutical operation

2. Communicate effectively (Verbal and Non-Verbal)

3. Effectively manage the team as a team player

4. Develop interview skills

5. Develop Leadership qualities and essentials

Sr. No. Content Hours

1 UNIT I 7

1.1 Communication Skills: Introduction, Definition, The Importance of

Communication,The Communication Process – Source, Message,

Encoding, Channel, Decoding, Receiver, Feedback, Context

3

1.2 Barriers to communication: Physiological Barriers, Physical Barriers,

CulturalBarriers, Language Barriers, Gender Barriers, Interpersonal

Barriers, Psychological Barriers, Emotional barriers

2

1.3 Perspectives in Communication: Introduction, Visual Perception,

Language, Otherfactors affecting our perspective - Past Experiences,

Prejudices, Feelings, Environment

2

2 UNIT II 7

2.1 Elements of Communication: Introduction, Face to Face

Communication - Tone ofVoice, Body Language (Non-verbal

communication), Verbal Communication, Physical Communication

3

2.2 Communication Styles: Introduction, The Communication Styles

Matrix with examplefor each -Direct Communication Style, Spirited

Communication Style, Systematic Communication Style, Considerate

Communication Style

4

3 UNIT III 7

3.1 Basic Listening Skills: Introduction, Self-Awareness, Active Listening,

Becoming anActive Listener, Listening in Difficult Situations

2

3.2 Effective Written Communication: Introduction, When and When Not 3

307

28

to Use WrittenCommunication - Complexity of the Topic, Amount of

Discussion‘ Required, Shades of Meaning, Formal Communication

3.3 Writing Effectively: Subject Lines, Put the Main Point First, Know

Your Audience,Organization of the Message

2

4 UNIT IV 5

4.1 Interview Skills: Purpose of an interview, Do‘s and Dont‘s of an

interview

2

4.2 Giving Presentations: Dealing with Fears, Planning your Presentation,

Structuring YourPresentation, Delivering Your Presentation,

Techniques of Delivery

3

5 UNIT V 4

Group Discussion: Introduction, Communication skills in group

discussion, Do‘s andDont‘s of group discussion

Total 30

Recommended Books: (Latest Edition)

1. Basic communication skills for Technology, Andreja. J. Ruther Ford, 2nd

Edition, Pearson

Education, 2011

2. Communication skills, Sanjay Kumar, Pushpalata, 1stEdition, Oxford Press, 2011

3. Organizational Behaviour, Stephen .P. Robbins, 1stEdition, Pearson, 2013

4. Brilliant- Communication skills, Gill Hasson, 1stEdition, Pearson Life, 2011

5. The Ace of Soft Skills: Attitude, Communication and Etiquette for success, Gopala

Swamy Ramesh, 5th

Edition, Pearson, 2013

6. Developing your influencing skills, Deborah Dalley, Lois Burton, Margaret, Green hall,

1st Edition Universe of Learning LTD, 2010

7. Communication skills for professionals, Konar nira, 2nd

Edition, New arrivals – PHI, 2011

8. Personality development and soft skills, Barun K Mitra, 1stEdition, Oxford Press, 2011

9. Soft skill for everyone, Butter Field, 1st Edition, Cengage Learning india pvt.ltd, 2011

10. Soft skills and professional communication, Francis Peters SJ, 1stEdition, Mc Graw Hill

Education, 2011

11. Effective communication, John Adair, 4th

Edition, Pan Mac Millan,2009

12. Bringing out the best in people, Aubrey Daniels, 2nd

Edition, Mc Graw Hill, 1999

308

29

BP106RBT REMEDIAL BIOLOGY (Theory) 2hours/week

Scope: To learn and understand the components of living world, structure and

functionalsystem of plant and animal kingdom.

Objectives: Upon completion of the course, the student shall be able to

1. know the classification and salient features of five kingdoms of life

2. understand the basic components of anatomy & physiology of plant

3. know understand the basic components of anatomy & physiology animal with special

reference to human

Sr. No. Content Hours

1 UNIT I 7

1.1 Living world:

Definition and characters of living organisms

Diversity in the living world

Binomial nomenclature

Five kingdoms of life and basis of classification. Salient features of

Monera, Potista, Fungi, Animalia and Plantae, Virus,

4

1.2 Morphology of Flowering plants

Morphology of different parts of flowering plants – Root, stem,

inflorescence, flower, leaf, fruit, seed.

General Anatomy of Root, stem, leaf of monocotyledons &

Dicotylidones.

3

2 UNIT II 7

2.1 Body fluids and circulation

Composition of blood, blood groups, coagulation of blood

Composition and functions of lymph

Human circulatory system

Structure of human heart and blood vessels

Cardiac cycle, cardiac output and ECG

Human alimentary canal and digestive glands

Role of digestive enzymes

Digestion, absorption and assimilation of digested food

4

2.2 Breathing and respiration

Human respiratory system

Mechanism of breathing and its regulation

3

309

30

Exchange of gases, transport of gases and regulation of respiration

Respiratory volumes

3 UNIT III 7

3.1 Excretory products and their elimination

Modes of excretion

Human excretory system- structure and function

Urine formation

Rennin angiotensin system

2

3.2 Neural control and coordination

Definition and classification of nervous system

Structure of a neuron

Generation and conduction of nerve impulse

Structure of brain and spinal cord

Functions of cerebrum, cerebellum, hypothalamus and medulla

oblongata

2

3.3 Chemical coordination and regulation

Endocrine glands and their secretions

Functions of hormones secreted by endocrine glands

2

3.4 Human reproduction

Parts of female reproductive system

Parts of male reproductive system

Spermatogenesis and Oogenesis

Menstrual cycle

1

4 UNIT IV 5

4.1 Plants and mineral nutrition:

Essential mineral, macro and micronutrients

Nitrogen metabolism, Nitrogen cycle, biological nitrogen fixation

3

4.2 Photosynthesis

Autotrophic nutrition, photosynthesis, Photosynthetic pigments,

Factors affecting photosynthesis.

2

5 UNIT V 4

5.1 Plant respiration: Respiration, glycolysis, fermentation (anaerobic). 1

5.2 Plant growth and development

Phases and rate of plant growth, Condition of growth,Introduction to

plant growth regulators

1

5.3 Cell - The unit of life

Structure and functions of cell and cell organelles.Cell division

1

310

31

5.4 Tissues

Definition, types of tissues, location and functions.

1

Total 30

Text Books

1. Text book of Biology by S. B. Gokhale

2. A Text book of Biology by Dr. Thulajappa and Dr. Seetaram.

Reference Books

1. A Text book of Biology by B.V. Sreenivasa Naidu

2. A Text book of Biology by Naidu and Murthy

3. Botany for Degree students By A.C.Dutta.

4. Outlines of Zoology by M. Ekambaranatha ayyer and T. N. Ananthakrishnan.

5. A manual for pharmaceutical biology practical by S.B. Gokhale and C. K. Kokate

311

32

BP106RMT REMEDIAL MATHEMATICS (Theory) 2hours/week

Scope: This is an introductory course in mathematics. This subject deals with

theintroduction to Partial fraction, Logarithm, matrices and Determinant, Analytical

geometry, Calculus, differential equation and Laplace transform.

Objectives:Upon completion of the course the student shall be able to:

1. Know the theory and their application in Pharmacy

2. Solve the different types of problems by applying theory

3. Appreciate the important application of mathematics in Pharmacy

Sr.

No.

Content Hours

1 UNIT I 6

1.1 Partial fraction

Introduction, Polynomial, Rational fractions, Proper and Improper

fractions, Partial fraction , Resolving into Partial fraction, Application of

Partial Fraction in Chemical Kinetics and Pharmacokinetics

1.2 Logarithms

Introduction, Definition, Theorems/Properties of logarithms, Common

logarithms, Characteristic and Mantissa, worked examples, application of

logarithm to solve pharmaceutical problems.

1.3 Function:

Real Valued function, Classification of real valued functions

1.4 Limits and continuity :

2 UNIT II 6

Matrices and Determinant:

Introduction matrices, Types of matrices, Operation on matrices,

Transpose of a matrix, Matrix Multiplication, Determinants, Properties of

determinants , Product of determinants, Minors and co-Factors, Adjoint or

adjugate of a square matrix , Singular and non-singular matrices,

Inverse of a matrix, Solution of system of linear of equations using matrix

method, Cramer‘s rule, Characteristic equation and roots of a square

matrix, Cayley–Hamilton theorem, Applicationof Matrices in solving

312

33

Pharmacokinetic equations

3 UNIT III 6

Calculus

Differentiation : Introductions, Derivative of a function, Derivative of a

constant, Derivative of a product of a constant and a function , Derivative

of the sum or difference of two functions, Derivative of the product of two

functions (product formula), Derivative of the quotient of two functions

(Quotient formula) – Without Proof, Derivative of xn w.r.tx,where n is any

rational number, Derivative of ex,, Derivative of loge x , Derivative

of ax,Derivative of trigonometric functions from first principles (without

Proof), Successive Differentiation, Conditions for a function to be a

maximum or a minimum at a point. Application

4 UNIT IV - Analytical Geometry 6

4.1 Introduction: Signs of the Coordinates, Distance formula,

4.2 Straight Line : Slope or gradient of a straight line, Conditions

forparallelism and perpendicularity of two lines, Slope of a line joining two

points, Slope – intercept form of a straight line

4.3 Integration: Introduction, Definition, Standard formulae, Rules of

integration , Method of substitution, Method of Partial fractions,

Integration by parts, definite integrals, application

5 UNIT V 6

5.1 Differential Equations : Some basic definitions, Order and

degree,Equations in separable form , Homogeneous equations, Linear

Differential equations, Exact equations, Application in

solvingPharmacokinetic equations

5.2 Laplace Transform : Introduction, Definition, Properties of

Laplacetransform, Laplace Transforms of elementary functions, Inverse

Laplace transforms, Laplace transform of derivatives, Application to solve

Linear differential equations, Application in solving Chemicalkinetics

and Pharmacokinetics equations

Total 30

Recommended Books (Latest Edition)

1. Differential Calculus by Shanthinarayan

2. Pharmaceutical Mathematics with application to Pharmacy by Panchaksharappa Gowda

D.H.

3. Integral Calculus by Shanthinarayan

4. Higher Engineering Mathematics by Dr.B.S.Grewal

313

34

BP107P HUMAN ANATOMY AND PHYSIOLOGY (Practical) 4 Hours/week

1. Study of compound microscope.

2. Microscopic study of epithelial and connective tissue

3. Microscopic study of muscular and nervous tissue

4. Identification of axial bones

5. Identification of appendicular bones

6. Introduction to hemocytometry.

7. Enumeration of white blood cell (WBC) count

8. Enumeration of total red blood corpuscles (RBC) count

9. Determination of bleeding time

10. Determination of clotting time

11. Estimation of hemoglobin content

12. Determination of blood group.

13. Determination of erythrocyte sedimentation rate (ESR).

14. Determination of heart rate and pulse rate.

15. Recording of blood pressure.

Recommended Books (Latest Editions)

1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam. Jaypee

brothers medical publishers, New Delhi.

2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson, Churchill

Livingstone, New York

3. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins

Co,Riverview,MI USA

4. Text book of Medical Physiology- Arthur C,Guyton andJohn.E. Hall. Miamisburg, OH,

U.S.A.

5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A

6. Textbook of Human Histology by Inderbir Singh, Jaypee brother‘s medical publishers,

New Delhi.

7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brother‘s medical publishers, New

Delhi.

8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma, Jaypee

brother‘s medical publishers, New Delhi.

Reference Books (Latest Editions)

1. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins Co,

Riverview, MI USA

2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg, OH,

U.S.A.

3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata.

314

35

BP108P PHARMACEUTICAL ANALYSIS (Practical) 4 Hours / Week

I Limit Test of the following

(1) Chloride

(2) Sulphate

(3) Iron

(4) Arsenic

II Preparation and standardization of

(1) Sodium hydroxide

(2) Sulphuric acid

(3) Sodium thiosulfate

(4) Potassium permanganate

(5) Ceric ammonium sulphate

III Assay of the following compounds along with Standardization of Titrant

(1) Ammonium chloride by acid base titration

(2) Ferrous sulphate by Cerimetry

(3) Copper sulphate by Iodometry

(4) Calcium gluconate by complexometry

(5) Hydrogen peroxide by Permanganometry

(6) Sodium benzoate by non-aqueous titration

(7) Sodium Chloride by precipitation titration

IV Determination of Normality by electro-analytical methods

(1) Conductometric titration of strong acid against strong base

(2) Conductometric titration of strong acid and weak acid against strong base

(3) Potentiometric titration of strong acid against strong base

Recommended Books: (Latest Editions)

1. A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II,

Stahlone Press of University of London

2. A.I. Vogel, Text Book of Quantitative Inorganic analysis

3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry

4. Bentley and Driver's Textbook of Pharmaceutical Chemistry

5. John H. Kennedy, Analytical chemistry principles

6. Indian Pharmacopoeia.

315

36

BP109P PHARMACEUTICSI (Practical) 4 Hours / week

1 .Syrups

a) Syrup IP‘66

b) Compound syrup of Ferrous Phosphate BPC‘68

2. Elixirs

a) Piperazine citrate elixir

b) Paracetamol pediatric elixir

3.Linctus

a) Terpin Hydrate Linctus IP‘66

b) Iodine Throat Paint (Mandles Paint)

4. Solutions

a) Strong solution of ammonium acetate

b) Cresol with soap solution

c) Lugol‘s solution

5. Suspensions

a) Calamine lotion

b) Magnesium Hydroxide mixture

c) Aluminimum Hydroxide gel

6. Emulsions

a) Turpentine Liniment

b) Liquid paraffin emulsion

7. Powders and Granules

a) ORS powder (WHO)

b) Effervescent granules

c) Dusting powder

d) Divded powders

8. Suppositories

a) Glycero gelatin suppository

b) Coca butter suppository

c) Zinc Oxide suppository

8. Semisolids

a) Sulphur ointment

b) Non staining-iodine ointment with methyl salicylate

c) Carbopal gel

9. Gargles and Mouthwashes

a) Iodine gargle

b) Chlorhexidine mouthwash

316

37

Recommended Books: (Latest Editions)

1. H. C. Ansel et al., Pharmaceutical Dosage Form and Drug Delivery System,

Lippincott Williams and Walkins, New Delhi.

2. Carter S.J., Cooper and Gunn‘s-Dispensing for Pharmaceutical Students, CBS

publishers, New Delhi

3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill

Livingstone, Edinburgh.

4. Indian pharmacopoeia.

5. British pharmacopoeia.

6. Lachmann. Theory and Practice of Industrial Pharmacy,Lea& Febiger Publisher, The

University of Michigan.

7. Alfonso R. Gennaro Remington. The Science and Practice of Pharmacy, Lippincott

Williams, New Delhi.

8. Carter S.J., Cooper and Gunn‘s. Tutorial Pharmacy, CBS Publications, New Delhi.

9. E.A. Rawlins, Bentley‘s Text Book of Pharmaceutics, English Language Book

Society, Elsevier Health Sciences, USA.

10. Isaac Ghebre Sellassie: Pharmaceutical Pelletization Technology, Marcel Dekker,

INC, New York.

11. Dilip M. Parikh: Handbook of Pharmaceutical Granulation Technology, Marcel

Dekker, INC, New York.

12. Francoise Nieloud and Gilberte Marti-Mestres: Pharmaceutical Emulsions and

Suspensions, Marcel Dekker, INC, New York.

317

38

BP110P PHARMACEUTICAL INORGANIC CHEMISTRY (Practical)

4 Hours / Week

I Limit tests for following ions

a) Limit test for Chlorides and Sulphates

b) Modified limit test for Chlorides and Sulphates Limit test for Iron

c) Limit test for Heavy metals Limit test for Lead

d) Limit test for Arsenic

II Identification test

a) Magnesium hydroxide Ferrous sulphate Sodium Bicarbonate Calcium

gluconate Copper sulphate

III Test for purity

a) Swelling power of Bentonite

b) Neutralizing capacity of aluminum hydroxide gel

c) Determination of potassium iodate and iodine in potassium Iodide

VI Preparation of inorganic pharmaceuticals

a) Boric acid

b) Potash alum

c) Ferrous sulphate

Recommended Books (Latest Editions)

1. A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II,

Stahlone Press of University of London, 4th

edition.

2. A.I. Vogel, Text Book of Quantitative Inorganic analysis

3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry, 3rd

Edition

4. M.L Schroff, Inorganic Pharmaceutical Chemistry

5. Bentley and Driver's Textbook of Pharmaceutical Chemistry

6. Anand & Chatwal, Inorganic Pharmaceutical Chemistry

7. IndianPharmacopoeia

318

39

BP111P COMMUNICATION SKILLS (Practical) 2 Hours / week

Thefollowing learning modules are to be conducted using wordsworth® English

language lab software

1. Basic communication covering the following topics

a. Meeting People

b. Asking Questions

c. Making Friends

d. What did you do?

e. Do‘s and Dont‘s

2. Pronunciations covering the following topics

a. Pronunciation (Consonant Sounds)

b. Pronunciation and Nouns

c. Pronunciation (Vowel Sounds)

3. Advanced Learning

a. Listening Comprehension / Direct and Indirect Speech

b. Figures of Speech

c. Effective Communication

d. Writing Skills

e. Effective Writing

f. Interview Handling Skills

g. E-Mail etiquette

h. Presentation Skills

Recommended Books: (Latest Edition)

1. Basic communication skills for Technology, Andreja. J. Ruther Ford, 2nd

Edition,

Pearson Education, 2011

2. Communication skills, Sanjay Kumar, Pushpalata, 1stEdition, Oxford Press,

2011

3. Organizational Behaviour, Stephen .P. Robbins, 1stEdition, Pearson, 2013

4. Brilliant- Communication skills, Gill Hasson, 1stEdition, Pearson Life, 2011

5. The Ace of Soft Skills: Attitude, Communication and Etiquette for success,

Gopala Swamy Ramesh, 5th

Edition, Pearson, 2013

6. Developing your influencing skills, Deborah Dalley, Lois Burton, Margaret,

Green hall, 1st Edition Universe of Learning LTD, 2010

7. Communication skills for professionals, Konar nira, 2nd

Edition, New arrivals –

PHI, 2011

8. Personality development and soft skills, Barun K Mitra, 1stEdition, Oxford

Press, 2011

9. Soft skill for everyone, Butter Field, 1st Edition, Cengage Learning India

pvt.ltd, 2011

319

40

10. Soft skills and professional communication, Francis Peters SJ, 1stEdition, Mc

Graw Hill Education, 2011

11. Effective communication, John Adair, 4th

Edition, Pan Mac Millan,2009

12. Bringing out the best in people, Aubrey Daniels, 2nd

Edition, Mc Graw Hill,

1999

320

41

BP112RBP REMEDIAL BIOLOGY (Practical) 2 Hours / week

1. Introduction to experiments in biology

a) Study of Microscope

b) Section cutting techniques

c) Mounting and staining

d) Permanent slide preparation

2. Study of cell and its inclusions

3. Study of Stem, Root, Leaf, seed, fruit, flower and their modifications

4. Detailed study of frog by using computer models

5. Microscopic study and identification of tissues pertinent to Stem, Root Leaf, seed,

fruit and flower

6. Identification of bones

7. Determination of blood group

8. Determination of blood pressure

9. Determination of tidal volume

Reference Books

1. Practical human anatomy and physiology. by S.R.Kale and R.R.Kale.

2. A Manual of pharmaceutical biology practical by S.B.Gokhale, C.K.Kokate

and S.P.Shriwastava.

3. Biology practical manual according to National core curriculum .Biology

forum of Karnataka. Prof .M.J.H.Shafi

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42

SEMESTER II

322

43

BP201T HUMAN ANATOMY AND PHYSIOLOGY-II (Theory)3 L + 1T / Week

Scope: This subject is designed to impart fundamental knowledge on the structure

andfunctions of the various systems of the human body. It also helps in understanding both

homeostatic mechanisms. The subject provides the basic knowledge required to understand

the various disciplines of pharmacy.

Objectives: Upon completion of this course the student should be able to:

1. Explain the gross morphology, structure and functions of various organs of the human

body.

2. Describe the various homeostatic mechanisms and their imbalances.

3. Identify the various tissues and organs of different systems of human body.

4. Perform the hematological tests like blood cell counts, haemoglobin estimation,

bleeding/clotting time etc and also record blood pressure, heart rate, pulse and

respiratory volume.

5. Appreciate coordinated working pattern of different organs of each system

6. Appreciate the interlinked mechanisms in the maintenance of normal functioning

(homeostasis) of human body.

Sr.

No.

Content Hours

1 UNIT I - Nervous system 10

1.1 Organization of nervous system, neuron, neuroglia, classification

and properties of nerve fibre, electrophysiology, action potential,

nerve impulse, receptors, synapse, neurotransmitters.

4

1.2 Central nervous system: Meninges, ventricles of brain and cerebrospinal

fluid. Structure and functions of brain (cerebrum, brain stem, and

cerebellum), spinal cord (gross structure, functions of afferent and efferent

nerve tracts,reflex activity).

6

2 UNIT II 6

2.1 Digestive system

Anatomy of GI Tract with special reference to anatomy and functions of

stomach, ( Acid production in the stomach, regulation of acid production

through parasympathetic nervous system, pepsin role in protein digestion)

small intestine and large intestine, anatomy and functions of salivary

glands, pancreas and liver, movements of GIT, digestion and absorption of

nutrients and disorders of GIT.

4

323

44

2.2 Energetics

Formation and role of ATP, Creatinine Phosphate and BMR.

2

3 UNIT III 10

3.1 Respiratory system 10 hours

Anatomy of respiratory system with special reference to anatomy of lungs,

mechanism of respiration, regulation of respiration

Lung Volumes and capacities transport of respiratory gases, artificial

respiration, and resuscitation methods.

5

3.2 Urinary system

Anatomy of urinary tract with special reference to anatomy of kidney and

nephrons, functions of kidney and urinary tract, physiology of urine

formation, micturition reflex and role of kidneys in acid base balance, role

of RAS in kidney and disorders of kidney.

5

4 UNIT IV 10

Endocrine system

Classification of hormones, mechanism of hormone action, structure and

functions of pituitary gland, thyroid gland, parathyroid gland, adrenal

gland, pancreas, pineal gland, thymus and their disorders

5 UNIT V 9

5.1 Reproductive system

Anatomy of male and female reproductive system, Functions of male and

female reproductive system, sex hormones, physiology of menstruation,

fertilization, spermatogenesis, oogenesis, pregnancy and parturition

6

5.2 Introduction to genetics

Chromosomes, genes and DNA, protein synthesis, genetic pattern of

inheritance

4

Total 45

Recommended Books (Latest Editions)

1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam. Jaypee

brothers medical publishers, New Delhi.

2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson, Churchill

Livingstone, New York

3. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins

Co,Riverview,MI USA

4. Text book of Medical Physiology- Arthur C,Guyton andJohn.E. Hall. Miamisburg, OH,

U.S.A.

324

45

5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A.

6. Textbook of Human Histology by Inderbir Singh, Jaypee brothers medical publishers,

New Delhi.

7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brothers medical publishers,

New Delhi.

8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma,

Jaypee brother‘s medical publishers, New Delhi.

Reference Books:

1. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins Co,

Riverview, MI USA

2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg,

OH, U.S.A.

3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata

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46

BP202T PHARMACEUTICAL ORGANIC CHEMISTRY –I(Theory)

3 L + 1T / Week

Scope: This subject deals with classification and nomenclature of simple

organiccompounds, structural isomerism, intermediates forming in reactions, important

physical properties, reactions and methods of preparation of these compounds. The

syllabus also emphasizes on mechanisms and orientation of reactions.

Objectives: Upon completion of the course the student shall be able to:

1. write the structure, name and the type of isomerism of the organic compound

2. write the reaction, name the reaction and orientation of reactions

3. account for reactivity/stability of compounds,

4. identify/confirm the identification of organic compound

Sr. No. Content

General methods of preparation and reactions of compounds superscripted

with asterisk (*) to be explained

To emphasize on definition, types, classification,

principles/mechanisms,applications, examples and differences

Hours

1 UNIT I 7

Classification, nomenclature and isomerism Classification of Organic

Compounds, Common and IUPAC systems of nomenclature of organic

compounds (up to 10 Carbons open chain and carbocyclic compounds)

Structural isomerisms in organic compounds.

2 UNIT II - Alkanes*, Alkenes* and Conjugated dienes* 10

2.1 SP3 hybridization in alkanes, Halogenation of alkanes, uses of paraffins.

Stabilities of alkenes, SP2 hybridization in alkenes

3

2.2 E1 and E2 reactions – kinetics, order of reactivity of alkyl halides,

rearrangement of carbocations, Saytzeffs orientation and evidences. E1

verses E2 reactions, Factors affecting E1 and E2 reactions. Ozonolysis,

electrophilic addition reactions of alkenes, Markownikoff‘s orientation,

free radical addition reactions of alkenes, Anti Markownikoff‘s

orientation.

Stability of conjugated dienes, Diel-Alder, electrophilic addition, free

radical addition reactions of conjugated dienes, allylic rearrangement

7

3 UNIT III 10

3.1 Alkylhalides*

SN1 and SN2 reactions - kinetics, order of reactivity of alkyl halides,

stereochemistry and rearrangement of carbocations.

SN1 versus SN2 reactions, Factors affecting SN1 and SN2 reactions

5

326

47

Structure and uses of ethylchloride, Chloroform, trichloroethylene,

tetrachloroethylene, dichloromethane, tetrachloromethane and iodoform.

3.2 Alcohols*- Qualitative tests, Structure and uses of Ethyl alcohol, Methyl

alcohol,chlorobutanol, Cetosteryl alcohol, Benzyl alcohol, Glycerol,

Propylene glycol

5

4 UNIT IV 10

Carbonyl compounds* (Aldehydes and ketones)

Nucleophilic addition, Electromeric effect, aldol condensation, Crossed

Aldol condensation, Cannizzaro reaction, Crossed Cannizzaro reaction,

Benzoin condensation, Perkin condensation, qualitative tests, Structure

and uses of Formaldehyde, Paraldehyde, Acetone, Chloral hydrate,

Hexamine, Benzaldehyde, Vanilin, Cinnamaldehyde

5 UNIT V 8

5.1 Carboxylic acids*

Acidity of carboxylic acids, effect of substituents on acidity, inductive

effect and qualitative tests for carboxylic acids ,amide and ester

Structure and Uses of Acetic acid, Lactic acid, Tartaric acid, Citric acid,

Succinic acid. Oxalic acid, Salicylic acid, Benzoic acid, Benzyl benzoate,

Dimethyl phthalate, Methyl salicylate and Acetyl salicylic acid

5

5.2 Aliphatic amines* - Basicity, effect of substituent on Basicity. Qualitative

test, Structure anduses of Ethanolamine, Ethylenediamine, Amphetamine

3

Total 45

Recommended Books (Latest Editions)

1. Organic Chemistry by Morrison and Boyd

2. Organic Chemistry by I.L. Finar , Volume-I

3. Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl.

4. Organic Chemistry by P.L.Soni

5. Practical Organic Chemistry by Mann and Saunders.

6. Vogel‘s text book of Practical Organic Chemistry

7. Advanced Practical organic chemistry by N.K.Vishnoi.

8. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz.

9. Reaction and reaction mechanism by Ahluwaliah/Chatwal.

327

48

BP203T BIOCHEMISTRY (Theory)3 L + 1T / Week

Scope: Biochemistry deals with complete understanding of the molecular levels of

thechemical process associated with living cells. The scope of the subject is providing

biochemical facts and the principles to understand metabolism of nutrient molecules in

physiological and pathological conditions. It is also emphasizing on genetic organization of

mammalian genome and hetero & autocatalytic functions of DNA.

Objectives: Upon completion of course student shell able to:

1. Understand the catalytic role of enzymes, importance of enzyme inhibitors in design of

new drugs, therapeutic and diagnostic applications of enzymes.

2. Understand the metabolism of nutrient molecules in physiological and pathological

conditions.

3. Understand the genetic organization of mammalian genome and functions of DNA in

the synthesis of RNAs and proteins.

Sr.

No.

Content Hours

1 UNIT I 8

1.1 Biomolecules

Introduction, classification, chemical nature and biological role of

carbohydrate, lipids, nucleic acids, amino acids and proteins

1.2 Bioenergetics

Concept of free energy, endergonic and exergonic reaction, Relationship

between free energy, enthalpy and entropy; Redox potential.

1.3 Energy rich compounds; classification; biological significances of ATP and

cyclic AMP.

2 UNIT II 10

2.1 Carbohydrate metabolism

Glycolysis – Pathway, energetics and significance Citric acid cycle-

Pathway, energetics and significance

HMP shunt and its significance; Glucose-6-Phosphate dehydrogenase

(G6PD) deficiency

Glycogen metabolism Pathways and glycogen storage diseases (GSD)

Gluconeogenesis- Pathway and its significance

Hormonal regulation of blood glucose level and Diabetes mellitus

2.2 Biological oxidation

Electron transport chain (ETC) and its mechanism

Oxidative phosphorylation & its mechanism and substrate level

328

49

phosphorylation

Inhibitors ETC and oxidative phosphorylation/Uncouplers

3 UNIT III 10

3.1 Lipid metabolism

β-Oxidation of saturated fatty acid (Palmitic acid)

Formation and utilization of ketone bodies; ketoacidosis De novo synthesis

of fatty acids (Palmitic acid)

Biological significance of cholesterol and conversion of cholesterol into bile

acids, steroid hormone and vitamin D

Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis, fatty

liver and obesity.

3.2 Amino acid metabolism

General reactions of amino acid metabolism: Transamination, deamination

& decarboxylation, urea cycle and its disorders

Catabolism of phenylalanine and tyrosine and their metabolic disorders

(Phenyketonuria, Albinism, alkeptonuria, tyrosinemia)

Synthesis and significance of biological substances; 5-HT, melatonin,

dopamine, noradrenaline, adrenaline

Catabolism of heme; hyperbilirubinemia and jaundice

4 UNIT IV 10

Nucleic acid metabolism and genetic information transfer Biosynthesis

of purine and pyrimidine nucleotides

Catabolism of purine nucleotides and Hyperuricemia and Gout disease

Organization of mammalian genome

Structure of DNA and RNA and their functions DNA replication (semi

conservative model) Transcription or RNA synthesis

Genetic code, Translation or Protein synthesis and inhibitors

5 UNIT V 07

Enzymes

Introduction, properties, nomenclature and IUB classification of enzymes

Enzyme kinetics (Michaelis plot, Line Weaver Burke plot)

Enzyme inhibitors with examples

Regulation of enzymes: enzyme induction and repression, allosteric

enzymes regulation

Therapeutic and diagnostic applications of enzymes and isoenzymes

Coenzymes –Structure and biochemical functions

Total 45

Recommended Books: (Latest Editions)

1. Principles of Biochemistry by Lehninger.

329

50

2. Harper‘s Biochemistry by Robert K. Murry, Daryl K. Granner and Victor W. Rodwell.

3. Biochemistry by Stryer.

4. Biochemistry by D. Satyanarayan and U.Chakrapani

5. Textbook of Biochemistry by Rama Rao.

6. Textbook of Biochemistry by Deb.

7. Outlines of Biochemistry by Conn and Stumpf

8. Practical Biochemistry by R.C. Gupta and S. Bhargavan.

9. Introduction of Practical Biochemistry by David T. Plummer. (3rd Edition)

10. Practical Biochemistry for Medical students by Rajagopal and Ramakrishna.

11. Practical Biochemistry by Harold Varley.

330

51

BP204T PATHOPHYSIOLOGY (Theory) 4 hours/week

Scope: Pathophysiology is the study of causes of diseases and reactions of the body tosuch

disease producing causes.This course is designed to impart a thorough knowledge of the

relevant aspects of pathology of various conditions with reference to its pharmacological

applications, and understanding of basic pathophysiological mechanisms. Hence it will not

only help to study the syllabus of pathology, but also to get baseline knowledge required to

practice medicine safely, confidently, rationally and effectively.

Objectives: Upon completion of the subject student shall be able to:

1. Describe the etiology and pathogenesis of the selected disease states;

2. Name the signs and symptoms of the diseases; and

3. Mention the complications of the diseases.

Sr. No. Content Hours

1 UNIT I 10

1.1 Basic principles of Cell injury and Adaptation:

Introduction, definitions, Homeostasis, Components and Types of

Feedback systems, Causes of cellular injury,Pathogenesis (Cell

membrane damage, Mitochondrial damage, Ribosome damage,

Nuclear damage),Morphology of cell injury – Adaptive changes

(Atrophy, Hypertrophy, hyperplasia, Metaplasia, Dysplasia),Cell

swelling, Intra cellular accumulation, Calcification, Enzyme leakage

and Cell Death Acidosis &Alkalosis,Electrolyte imbalance

5

1.2 Basicmechanism involved in the process of inflammation and

repair:

Introduction, Clinical signs of inflammation, Different types of

Inflammation,Mechanism of Inflammation – Alteration in vascular

permeability and blood flow, migration of WBC‘s,Mediators of

inflammation,Basic principles of wound healing in the

skin,Pathophysiology of Atherosclerosis

5

2 UNIT II 10

2.1 Cardiovascular System:

Hypertension, congestive heart failure, ischemic heart disease

(angina,myocardial infarction, atherosclerosis and arteriosclerosis)

4

2.2 Respiratory system:Asthma, Chronic obstructive airways diseases. 3

2.3 Renal system:Acute and chronic renal failure 3

3 UNIT III 10

331

52

3.1 Haematological Diseases:

Iron deficiency, megaloblastic anemia (Vit B12 and folic acid),

sickle cell anemia, thalasemia, hereditary acquired anemia,

hemophilia

3

3.2 Endocrine system: Diabetes, thyroid diseases, disorders of sex

hormones

3

3.3 Nervous system: Epilepsy, Parkinson‘s disease, stroke,

psychiatric disorders:depression, schizophrenia and

Alzheimer‘s disease.

3

3.4 Gastrointestinal system: Peptic Ulcer 1

4 UNIT IV 08

4.1 Inflammatory bowel diseases, jaundice, hepatitis (A,B,C,D,E,F)

alcoholic liver disease.

2

4.2 Disease of bones and joints: Rheumatoid arthritis, osteoporosis and

gout

2

4.3 Principles of cancer: classification, etiology and pathogenesis of

cancer

4

5 UNIT V 07

5.1 Infectious diseases: Meningitis, Typhoid, Leprosy,

TuberculosisUrinary tract infections

4

5.2 Sexually transmitted diseases: AIDS, Syphilis, Gonorrhea 3

Total 45

Recommended Books (Latest Editions)

1. Vinay Kumar, Abul K. Abas, Jon C. Aster; Robbins &Cotran Pathologic Basis of

Disease; South Asia edition; India; Elsevier; 2014.

2. Harsh Mohan; Text book of Pathology; 6th

edition; India; Jaypee Publications; 2010.

3. Laurence B, Bruce C, Bjorn K. ; Goodman Gilman‘s The Pharmacological Basis of

Therapeutics; 12th

edition; New York; McGraw-Hill; 2011.

4. Best, Charles Herbert 1899-1978; Taylor, Norman Burke 1885-1972; West, John B

(John Burnard); Best and Taylor‘s Physiological basis of medical practice; 12th ed;

united states;

5. William and Wilkins, Baltimore;1991 [1990 printing].

6. Nicki R. Colledge, Brian R. Walker, Stuart H. Ralston;Davidson‘s Principles and

Practice of Medicine; 21st edition; London; ELBS/Churchill Livingstone; 2010.

7. Guyton A, John .E Hall; Textbook of Medical Physiology; 12th

edition; WB Saunders

Company; 2010.

332

53

8. Joseph DiPiro, Robert L. Talbert, Gary Yee, Barbara Wells, L. Michael Posey;

9. Pharmacotherapy: A Pathophysiological Approach; 9th

edition; London; McGraw-Hill

Medical; 2014.

10. V. Kumar, R. S. Cotran and S. L. Robbins; Basic Pathology; 6th

edition; Philadelphia;

WB Saunders Company; 1997.

11. Roger Walker, Clive Edwards; Clinical Pharmacy and Therapeutics; 3rd edition;

London; Churchill Livingstone publication; 2003.

Recommended Journals

1. The Journal of Pathology. ISSN: 1096-9896 (Online)

2. The American Journal of Pathology. ISSN: 0002-9440

3. Pathology. 1465-3931 (Online)

4. International Journal of Physiology, Pathophysiology and Pharmacology. ISSN: 1944-

8171 (Online)

5. Indian Journal of Pathology and Microbiology. ISSN-0377-4929.

333

54

BP205T COMPUTER APPLICATIONS IN PHARMACY (Theory)3hours/week

Scope: This subject deals with the introduction Database, Database Management system,and

computer application in clinical studies and use of databases.

Objectives: Upon completion of the course the student shall be able to:

1. know the various types of application of computers in pharmacy

2. know the various types of databases

3. know the various applications of databases in pharmacy

Sr.

No.

Content Hours

1 UNIT I 6

1.1 Number system: Binary number system, Decimal number system,

Octalnumber system, Hexadecimal number systems, conversion decimal

to binary, binary to decimal, octal to binary etc, binary addition, binary

subtraction – One‘s complement ,Two‘s complement method, binary

multiplication, binary division

1.2

Concept of Information Systems and Software : Information gathering,

requirement and feasibility analysis, data flow diagrams, process

specifications, input/output design, process life cycle, planning and

managing the project.

2 UNIT II 6

2.1 Web technologies: Introduction to HTML, XML,CSS and Programming

languages, introduction to web servers and Server Products

2.2 Introduction to databases, MYSQL, MS ACCESS, Pharmacy Drug

database

3 UNIT III

Application of computers in Pharmacy –Drug information storage

andretrieval, Pharmacokinetics, Mathematical model in Drug design,

Hospital and Clinical Pharmacy, Electronic Prescribing and discharge

(EP) systems, barcode medicine identification and automated dispensing

of drugs, mobile technology and adherence monitoring

Diagnostic System, Lab-diagnostic System, Patient Monitoring System,

Pharma Information System

6

Hours

4 UNIT IV 6

Bioinformatics: Introduction, Objective of Bioinformatics,

BioinformaticsDatabases, Concept of Bioinformatics, Impact of

Bioinformatics in Vaccine Discovery

334

55

5 UNIT V

Computers as data analysis in Preclinical

development:Chromatographic dada analysis(CDS), Laboratory

Information management System (LIMS) and Text Information

Management System(TIMS)

6

Hours

Total 30

Recommended Books: (Latest Editions)

1. Computer Application in Pharmacy – William E.Fassett –Lea and Febiger, 600 South

Washington Square, USA, (215) 922-1330.

2. Computer Application in Pharmaceutical Research and Development –Sean Ekins –

Wiley-Interscience, A John Willey and Sons, INC., Publication, USA

3. Bioinformatics (Concept, Skills and Applications) – S.C.Rastogi-CBS Publishers and

Distributors, 4596/1- A, 11 Darya Gani, New Delhi – 110 002(INDIA)

4. Microsoft office Access - 2003, Application Development Using VBA, SQL Server, DAP

and Infopath – Cary N.Prague – Wiley Dreamtech India (P) Ltd., 4435/7, Ansari Road,

Daryagani, New Delhi - 110002

335

56

BP206T ENVIRONMENTAL SCIENCES (Theory) 3 hours/week

Scope: Environmental Sciences is the scientific study of the environmental system and the

status of its inherent or induced changes on organisms. It includes not only the study of

physical and biological characters of the environment but also the social and cultural factors

and the impact of man on environment.

Objectives: Upon completion of the course the student shall be able to:

1. Create the awareness about environmental problems among learners.

2. Impart basic knowledge about the environment and its allied problems.

3. Develop an attitude of concern for the environment.

4. Motivate learner to participate in environment protection and environment improvement.

5. Acquire skills to help the concerned individuals in identifying and solving environmental

problems.

6. Strive to attain harmony with Nature

7. Acquire skills to help the concerned individuals in identifying and solving environmental

problems.

Sr.

No.

Content Hours

1 UNIT I 10

The Multidisciplinary nature of environmental studies

Natural Resources

Renewable and non-renewable resources:

Natural resources and associated problems

a) Forest resources; b) Water resources; c) Mineral resources; d)

Food resources; e) Energy resources; f) Land resources: Role of

an individual in conservation of natural resources.

2 UNIT II 10

Ecosystems

Concept of an ecosystem.

Structure and function of an ecosystem.

Introduction, types, characteristic features, structure and function of the

ecosystems: Forest ecosystem; Grassland ecosystem; Desert ecosystem;

Aquatic ecosystems (ponds, streams, lakes, rivers, oceans, estuaries)

3 UNIT III 10

Environmental Pollution: Air pollution; Water pollution; Soil pollution

Total 30

336

57

Recommended Books (Latest edition):

1. Y.K. Sing, Environmental Science, New Age International Pvt, Publishers, Bangalore

2. Agarwal, K.C. 2001 Environmental Biology, Nidi Publ. Ltd. Bikaner.

3. Bharucha Erach, The Biodiversity of India, Mapin Pu blishing Pvt. Ltd., Ahmedabad –

380 013, India,

4. Brunner R.C., 1989, Hazardous Waste Incineration, McGraw Hill Inc. 480p

5. Clark R.S., Marine Pollution, Clanderson Press Oxford

6. Cunningham, W.P. Cooper, T.H. Gorhani, E & Hepworth, M.T. 2001, Environmental

Encyclopedia, Jaico Publ. House, Mumbai, 1196p

7. De A.K., Environmental Chemistry, Wiley Eastern Ltd.

8. Down of Earth, Centre for Science and Environment

337

58

BP207P HUMAN ANATOMY AND PHYSIOLOGY (Practical) 4 Hours/week

Practical physiology is complimentary to the theoretical discussions in physiology.

Practicals allow the verification of physiological processes discussed in theory classes

through experiments on living tissue, intact animals or normal human beings. This is

helpful for developing an insight on the subject.

1. To study the integumentary and special senses using specimen, models, etc.,

2. To study the nervous system using specimen, models, etc.,

3. To study the endocrine system using specimen, models, etc

4. To demonstrate the general neurological examination

5. To demonstrate the function of olfactory nerve

6. To examine the different types of taste.

7. To demonstrate the visual acuity

8. To demonstrate the reflex activity

9. Recording of body temperature

10. To demonstrate positive and negative feedback mechanism.

11. Determination of tidal volume and vital capacity.

12. Study of digestive, respiratory, cardiovascular systems, urinary and reproductive

systems with the help of models, charts and specimens.

13. Recording of basal mass index .

14. Study of family planning devices and pregnancy diagnosis test.

15. Demonstration of total blood count by cell analyser

16. Permanent slides of vital organs and gonads.

Recommended Books (Latest Editions)

1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam. Jaypee

brothers medical publishers, New Delhi.

2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson, Churchill

Livingstone, New York

3. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins

Co,Riverview,MI USA

4. Text book of Medical Physiology- Arthur C,Guyton andJohn.E. Hall. Miamisburg,

OH, U.S.A.

5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A.

6. Textbook of Human Histology by Inderbir Singh, Jaypee brothers medical publishers,

New Delhi.

7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brothers medical publishers,

New Delhi.

8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma,

Jaypee brother‘s medical publishers, New Delhi.

338

59

Reference Books:

1. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins Co,

Riverview, MI USA

2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg,

OH, U.S.A.

3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata

339

60

BP208P PHARMACEUTICAL ORGANIC CHEMISTRY -I (Practical)

4 Hours / week

1. Systematic qualitative analysis of unknown organic compounds like

a) Preliminary test: Color, odour, aliphatic/aromatic compounds, saturation

and unsaturation, etc.

b) Detection of elements like Nitrogen, Sulphur and Halogen by

Lassaigne‘s test

c) Solubility test

d) Functional group test like Phenols, Amides/ Urea, Carbohydrates,

Amines, Carboxylic acids, Aldehydes and Ketones, Alcohols, Esters,

Aromatic and Halogenated Hydrocarbons, Nitro compounds and

Anilides.

e) Melting point/Boiling point of organic compounds

f) Identification of the unknown compound from the literature using

melting point/ boiling point.

g) Preparation of the derivatives and confirmation of the unknown

compound by melting point/ boiling point.

h) Minimum 5 unknown organic compounds to be analysed systematically.

2. Preparation of suitable solid derivatives from organic compounds

3. Construction of molecular models

Recommended Books (Latest Editions)

1. Organic Chemistry by Morrison and Boyd

2. Organic Chemistry by I.L. Finar , Volume-I

3. Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl.

4. Organic Chemistry by P.L.Soni

5. Practical Organic Chemistry by Mann and Saunders.

6. Vogel‘s text book of Practical Organic Chemistry

7. Advanced Practical organic chemistry by N.K.Vishnoi.

8. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz.

9. Reaction and reaction mechanism by Ahluwaliah/Chatwal.

340

61

BP209P BIOCHEMISTRY (Practical) 4 Hours / Week

1. Qualitative analysis of carbohydrates (Glucose, Fructose, Lactose, Maltose, Sucrose and

starch)

2. Identification tests for Proteins (albumin and Casein)

3. Quantitative analysis of reducing sugars (DNSA method) and Proteins (Biuret method)

4. Qualitative analysis of urine for abnormal constituents

5. Determination of blood creatinine

6. Determination of blood sugar

7. Determination of serum total cholesterol

8. Preparation of buffer solution and measurement of pH

9. Study of enzymatic hydrolysis of starch

10. Determination of Salivary amylase activity

11. Study the effect of Temperature on Salivary amylase activity.

12. Study the effect of substrate concentration on salivary amylase activity.

Recommended Books (Latest Editions)

1. Principles of Biochemistry by Lehninger.

2. Harper‘s Biochemistry by Robert K. Murry, Daryl K. Granner and Victor W. Rodwell.

3. Biochemistry by Stryer.

4. Biochemistry by D. Satyanarayan and U.Chakrapani

5. Textbook of Biochemistry by Rama Rao.

6. Textbook of Biochemistry by Deb.

7. Outlines of Biochemistry by Conn and Stumpf

8. Practical Biochemistry by R.C. Gupta and S. Bhargavan.

9. Introduction of Practical Biochemistry by David T. Plummer. (3rd Edition)

10. Practical Biochemistry for Medical students by Rajagopal and Ramakrishna

11. Practical Biochemistry by Harold Varley.

341

62

BP210P COMPUTER APPLICATIONS IN PHARMACY (Practical) 2 hours/ week

1. Design a questionnaire using a word processing package to gather information

about a particular disease.

2. Create a HTML web page to show personal information.

3 Retrieve the information of a drug and its adverse effects using online tools

4 Creating mailing labels Using Label Wizard , generating label in MS WORD

5 Create a database in MS Access to store the patient information with the required

fields Using access

6. Design a form in MS Access to view, add, delete and modify the patient record in the

database

7. Generating report and printing the report from patient database

8. Creating invoice table using – MS Access

9. Drug information storage and retrieval using MS Access

10. Creating and working with queries in MS Access

11. Exporting Tables, Queries, Forms and Reports to web pages

12. Exporting Tables, Queries, Forms and Reports to XML pages

Recommended books (Latest edition):

1. Computer Application in Pharmacy – William E.Fassett –Lea and Febiger, 600 South

Washington Square, USA, (215) 922-1330.

2. Computer Application in Pharmaceutical Research and Development –Sean Ekins –

Wiley-Interscience, A John Willey and Sons, INC., Publication, USA

3. Bioinformatics (Concept, Skills and Applications) – S.C.Rastogi-CBS Publishers and

Distributors, 4596/1- A, 11 Darya Gani, New Delhi – 110 002(INDIA)

4. Microsoft office Access - 2003, Application Development Using VBA, SQL Server,

DAP and Infopath – Cary N.Prague – Wiley Dreamtech India (P) Ltd., 4435/7, Ansari

Road, Daryagani, New Delhi – 110002

342

63

SEMESTR III

343

64

BP301TPHARMACEUTICAL ORGANIC CHEMISTRY–II (Theory)

3 L + 1T / Week

Scope: This subject deals with general methods of preparation and reactions of

someorganic compounds. Reactivity of organic compounds are also studied here. The

syllabus emphasizes on mechanisms and orientation of reactions. Chemistry of fats and

oils are also included in the syllabus.

Objectives: Upon completion of the course the student shall be able to

1. write the structure, name and the type of isomerism of the organic compound

2. write the reaction, name the reaction and orientation of reactions

3. account for reactivity/stability of compounds,

4. prepare organic compounds

Sr.

No.

Content

General methods of preparation and reactions of compounds superscripted

with asterisk (*) to be explained

To emphasize on definition, types, classification, principles/mechanisms,

applications, examples and differences

Hours

1 UNIT I- Benzene and its derivatives 10

1.1 Analytical, synthetic and other evidences in the derivation of structure of

benzene, Orbital picture, resonance in benzene, aromatic characters,

Huckel‘s rule

3

1.2 Reactions of benzene - nitration, sulphonation, halogenation-reactivity,

Friedelcrafts alkylation- reactivity, limitations, Friedelcrafts acylation.

3

1.3 Substituents, effect of substituents on reactivity and orientation of mono

substituted benzene compounds towards electrophilic substitution reaction

3

1.4 Structure and uses of DDT, Saccharin, BHC and Chloramine 1

2 UNIT II 10

2.1 Phenols* - Acidity of phenols, effect of substituents on acidity, qualitative

tests, Structure and uses of phenol, cresols, resorcinol, naphthols

5

2.2 Aromatic Amines* - Basicity of amines, effect of substituents on basicity,

and synthetic uses of aryl diazonium salts

3

2.3 Aromatic Acids* –Acidity, effect of substituents on acidity and important

reactions of benzoic acid.

2

3 UNIT III - Fats and Oils 10

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65

3.1 Fatty acids – reactions. 4

3.2 Hydrolysis, Hydrogenation, Saponification and Rancidity of oils, Drying oils 3

3.3 Analytical constants – Acid value, Saponification value, Ester value, Iodine

value, Acetyl value, Reichert Meissl (RM) value – significance and principle

involved in their determination.

3

4 UNIT IV- Polynuclear hydrocarbons: 08

4.1 Synthesis, reactions 4

4.2 Structure and medicinal uses of Naphthalene, Phenanthrene, Anthracene,

Diphenylmethane, Triphenylmethane and their derivatives

4

5 UNIT V 07

Cyclo alkanes

Stabilities – Baeyer‘s strain theory, limitation of Baeyer‘s strain theory,

Coulson and Moffitt‘s modification, Sachse Mohr‘s theory (Theory of

strainless rings), reactions of cyclopropane and cyclobutane only

Total 45

Reference Books (Latest Editions to be adopted)

1. Organic Chemistry by R.T. Morrison and R.N.Boyd, 6th edition,Prentice Hall

Publications

2. Organic Chemistry by Pine, Stanley H.; Hendrickson, James B.; Cram, Donald J.;

Hammond, George S., 4th edition. The Macgraw hill publications

3. Organic Chemistry by I.L. Finar, Vol 1& 2, 6th edition, Pearson education

4. Advanced Organic Chemistry: Reactions, Mechanisms, Structures by Jerry March, John

Wiley and sons

5. Organic Chemistry, Part A: Structures and Mechanism, Part B: Reactions and Synthesis,

Francis and Carry, Richard J Sundberg. Springer publications

6. A Guidebook to Mechanism in Organic Chemistry, 6th edition, Peter Sykes, Pearson

Education Peter Sykes, Essentials of Organic chemistry by Paul M Dewick, Wiley, Pine

7. Essentials of Organic chemistry by Paul M Dewick, Wiley

8. Eliel, Kalsi, Organic Chemistry by L.G.Wade, Jr., Maya Shankar Singh, Pearson

Education, 6th Ed, Organic Chemistry, 2nd Ed., Thomas Sorrell, University Science

Books

9. Stereochemistry: Conformation and Mechanism, b) Organic Reactions And Their

Mechanisms. By P. S. Kalsi. New age International

10. Organic Chemistry through Solved Problems, Goutam Brahmachari. Edition, Morgan &

Claypool

11. Organic Name Reactions: A Unified Approach. Goutam Brahmachari. Alpha Science

publications

345

66

BP302T PHYSICAL PHARMACEUTICS-I (Theory) 3 L + 1T / Week

Scope:

The course deals with the various physical and physicochemical properties, andprinciples

involved in dosage forms/formulations. Theory and practical components of the subject help

the student to get a better insight into various areas of formulation research and development,

and stability studies of pharmaceutical dosage forms.

Objectives: Upon the completion of the course student shall be able to:

1. Understand various physicochemical properties of drug molecules in the designing the

dosage forms

2. Know the principles of chemical kinetics & to use them for stability testing and

determination of expiry date of formulations

3. Demonstrate use of physicochemical properties in the formulationdevelopment and

evaluation of dosage forms.

Sr.

No.

Content Hours

1 UNIT I- Solubility of drugs 10

1.1 Solubility expressions, mechanisms of solute solvent interactions, ideal

solubility parameters, solvation & association, quantitative approach to the

factors influencing solubility of drugs,

3

1.2 Dissolution & drug release, diffusion principles in biological systems.

Solubility of gas in liquids, solubility of liquids in liquids, (Binary

solutions, ideal solutions)

3

1.3 Raoult‘s law, real solutions, azeotropic mixtures, fractional distillation.

Partially miscible liquids, Critical solution temperature and applications.

Distribution law, its limitations and applications

4

2 UNIT II 10

2.1 States of Matter and properties of matter:State of matter, changes in the

state of matter, latent heats, vapour pressure, sublimation critical point,

eutectic mixtures, gases, aerosols – inhalers, relative humidity, liquid

complexes, liquid crystals, glassy states, solid-crystalline, amorphous &

polymorphism.

5

2.2 Physicochemical properties of drug molecules: Refractive index, optical

rotation, dielectric constant, dipole moment, dissociation constant,

5

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67

determinations and applications

3 UNIT III 10

Surface and interfacial phenomenon: Liquid interface, surface &

interfacial tensions,

surface free energy, measurement of surface & interfacial tensions,

spreading coefficient, adsorption at liquid interfaces, surface active agents,

HLB Scale, solubilisation, detergency, adsorption at solid interface.

4 UNIT IV 08

Complexation and protein binding: Introduction, Classification of

Complexation, Applications, methods of analysis, protein binding,

Complexation and drug action, crystalline structures of complexes and

thermodynamic treatment of stability constants.

5 UNIT V 07

pH, buffers and Isotonic solutions: Sorensen‘s pH scale, pH

determination (electrometric and calorimetric), applications of buffers,

buffer equation, buffer capacity, buffers in pharmaceutical and biological

systems, buffered isotonic solutions.

Total 45

Reference Books (Latest Editions to be adopted)

1. Physical pharmacy by Alfred Martin

2. Experimental pharmaceutics by Eugene, Parott.

3. Tutorial pharmacy by Cooper and Gunn.

4. Stocklosam J. Pharmaceutical calculations, Lea &Febiger, Philadelphia.

5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3,

MarcelDekkar Inc.

6. Liberman H.A, Lachman C, Pharmaceutical dosage forms. Disperse systems, volume 1, 2,

3. Marcel Dekkar Inc.

7. Physical pharmaceutics by Ramasamy C and Manavalan R.

347

68

BP303T PHARMACEUTICAL MICROBIOLOGY (Theory) 3 L + 1T / Week

Scope:

Study of all categories of microorganisims especially for the production of alchol

antibiotics, vaccines, vitamins enzymes etc..

Objectives: Upon completion of the subject student shall be able to:

1. Understand methods of identification, cultivation and preservation of various

microorganisms

2. To understand the importance and implementation of sterlization in pharmaceutical

processing and industry

3. Learn sterility testing of pharmaceutical products.

4. Carry out microbiological standardization of Pharmaceuticals.

5. Understand the cell culture technology and its applications in pharmaceutical industries.

Sr.

No.

Content Hour

s

1 UNIT I 10

1.1 Introduction, history of microbiology, its branches, scope and its importance 1

1.2 Introduction to Prokaryotes and Eukaryotes 1

1.3 Study of ultra-structure and morphological classification of bacteria,

nutritional requirements, raw materials used for culture media and physical

parameters for growth, growth curve, isolation and preservation methods for

pure cultures, cultivation of anaerobes, quantitative measurement of bacterial

growth (total & viable count).

6

1.4 Study of different types of phase constrast microscopy, dark field

microscopy and electron microscopy

2

2 UNIT II 10

2.1 Identification of bacteria using staining techniques (simple, Gram‘s &Acid

fast staining) and biochemical tests (IMViC).

3

2.2 Study of principle, procedure, merits, demerits and applications of Physical,

chemical and mechanical method of sterilization, Evaluation of the

efficiency of sterilization method, Equipments employed in large scale

sterilization, Sterility indicators

7

3 UNIT III 10

3.1 Study of morphology, classification, reproduction/replication and cultivation 3

348

69

of Fungi and Virus.

3.2 Classification and mode of action of disinfectants. Factors influencing

disinfection, antiseptics and their evaluation, for bacteriostatic and

bactericidal actions

4

3.3 Sterility testing of products (solids, liquids, ophthalmic and other sterile

products) according to IP, BP and USP

3

4 UNIT IV 08

4.1 Designing of aseptic area, laminar flow equipments; study of different

sources of contamination in an aseptic area and methods of prevention, clean

area classification.

3

4.2 Principles and methods of different microbiological assay. Methods for

standardization of antibiotics, vitamins and amino acids.

3

4.3 Assessment of a new antibiotic and testing of antimicrobial activity of a new

substance.

2

5 UNIT V 07

5.1 Types of spoilage, factors affecting the microbial spoilage of pharmaceutical

products, sources and types of microbial contaminants, assessment of

microbial contamination and spoilage.

2

5.2 Preservation of pharmaceutical products using antimicrobial agents,

evaluation of microbial stability of formulations.

2

5.3 Growth of animal cells in culture, general procedure for cell culture,

Primary, established and transformed cell cultures.

2

5.4 Application of cell cultures in pharmaceutical industry and research. 1

Total 45

Reference Books (Latest Editions to be adopted)

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific

publications, Oxford London.

2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,

Delhi.

3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.

4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.

5. Rose: Industrial Microbiology.

6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan

7. Cooper and Gunn‘s: Tutorial Pharmacy, CBS Publisher and Distribution.

8. Peppler: Microbial Technology.

9. I.P., B.P., U.S.P.- latest editions.

10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai

11. Edward: Fundamentals of Microbiology.

12. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi

349

70

BP304T PHARMACEUTICAL ENGINEERING (Theory) 3 L + 1T / Week

Scope: This course is designed to impart a fundamental knowledge on the art and scienceof

various unit operations used in pharmaceutical industry.

Objectives: Upon completion of the course student shall be able:

1. To know various unit operations used in Pharmaceutical industries.

2. To understand the material handling techniques.

3. To perform various processes involved in pharmaceutical manufacturing process.

4. To carry out various test to prevent environmental pollution.

5. To appreciate and comprehend significance of plant lay out design for optimum use of

resources.

6. To appreciate the various preventive methods used for corrosion control in Pharmaceutical

industries

Sr. No. Content Hours

1 UNIT I 10

1.1 Flow of fluids: Types of manometers, Reynolds number and its significance,

Bernoulli‘s theorem and its applications, Energy losses, Orifice meter,

Venturimeter, Pitot tube and Rotometer.

3

1.2 Size Reduction: Objectives, Mechanisms & Laws governing size reduction,

factors affecting size reduction, principles, construction, working, uses,

merits and demerits of Hammer mill, ball mill, fluid energy mill, Edge

runner mill & end runner mill.

4

1.3 Size Separation: Objectives, applications & mechanism of size separation,

official standards of powders, sieves, size separation Principles, construction,

working, uses, merits and demerits of Sieve shaker, cyclone separator, Air

separator, Bag filter & elutriation tank

3

2 UNIT II 10

2.1 Evaporation: Objectives, applications and factors influencing evaporation,

differences between evaporation and other heat process. principles,

construction, working, uses, merits and demerits of Steam jacketed kettle,

horizontal tube evaporator, climbing film evaporator, forced circulation

evaporator, multiple effect evaporator& Economy of multiple effect

evaporator.

4

2.2 Heat Transfer: Objectives, applications & Heat transfer mechanisms.

Fourier‘s law, Heat transfer by conduction, convection & radiation. Heat

interchangers & heat exchangers.

3

2.3 Distillation: Basic Principles and methodology of simple distillation,flash

distillation, fractional distillation, distillation under reduced pressure, steam

3

350

71

distillation & molecular distillation

3 UNIT III 10

3.1 Drying: Objectives, applications & mechanism of drying process,

measurements & applications of Equilibrium Moisture content, rate of

drying curve. principles, construction, working, uses, merits and demerits of

Tray dryer, drum dryer spray dryer, fluidized bed dryer, vacuum dryer,

freeze dryer

5

3.2 Mixing: Objectives, applications & factors affecting mixing, Difference

between solid and liquid mixing, mechanism of solid mixing, liquids mixing

and semisolids mixing. Principles, Construction, Working, uses, Merits and

Demerits of Double cone blender, twin shell blender, ribbon blender, Sigma

blade mixer, planetary mixers, Propellers, Turbines, Paddles & Silverson

Emulsifier

5

4 UNIT IV 08

4.1 Filtration: Objectives, applications, Theories & Factors influencing

filtration, filter aids, filter medias. Principle, Construction, Working, Uses,

Merits and demerits of plate & frame filter, filter leaf, rotary drum filter,

Meta filter & Cartridge filter, membrane filters and Seidtz filter.

4

4.2 Centrifugation: Objectives, principle & applications of Centrifugation,

principles, construction, working, uses, merits and demerits of Perforated

basket centrifuge, Non-perforated basket centrifuge, semi continuous

centrifuge & super centrifuge.

4

5 UNIT V 07

Materials of pharmaceutical plant construction, Corrosion and its

prevention: Factors affecting during materials selected for Pharmaceutical

plant construction, Theories of corrosion, types of corrosion and there

prevention. Ferrous and nonferrous metals, inorganic and organic non

metals, basic of material handling system

Total 45

Reference Books (Latest Editions to be adopted)

1. Introduction to chemical engineering – Walter L Badger & Julius Banchero, Latest

edition.

2. Solid phase extraction, Principles, techniques and applications by Nigel J.K. Simpson-

Latest edition.

3. Unit operation of chemical engineering – Mcabe Smith, Latest edition.

4. Pharmaceutical engineering principles and practices – C.V.S Subrahmanyam et al., Latest

edition.

5. Remington practice of pharmacy- Martin, Latest edition.

351

72

6. Theory and practice of industrial pharmacy by Lachmann., Latest edition.

7. Physical pharmaceutics- C.V.S Subrahmanyam et al., Latest edition.

8. Cooper and Gunn‘s Tutorial pharmacy, S.J. Carter, Latest edition.

352

73

BP305P PHARMACEUTICAL ORGANIC CHEMISTRY -II (Practical)

4 Hours / Week

I Experiments involving laboratory techniques

Recrystallization

Steam distillation

II Determination of following oil values (including standardization of reagents)

Acid value

Saponification value

Iodine value

III Preparation of compounds

Benzanilide/Phenyl benzoate/Acetanilide from Aniline/ Phenol /Aniline by

acylation reaction.

2,4,6-Tribromo aniline/Para bromo acetanilide from Aniline/

Acetanilide by halogenation (Bromination) reaction.

5-Nitro salicylic acid/Meta di nitro benzene from Salicylic acid / Nitro

benzene by nitration reaction.

Benzoic acid from Benzyl chloride by oxidation reaction.

Benzoic acid/ Salicylic acid from alkyl benzoate/ alkyl salicylate by

hydrolysis reaction.

1-Phenyl azo-2-napthol from Aniline by diazotization and coupling reactions.

Benzil from Benzoin by oxidation reaction.

Dibenzal acetone from Benzaldehyde by Claison Schmidt reaction

Cinnammic acid from Benzaldehyde by Perkin reaction

P-Iodo benzoic acid from P-amino benzoic acid

Reference Books (Latest Editions to be adopted)

1. Organic Chemistry by Morrison and Boyd

2. Organic Chemistry by I.L. Finar , Volume-I

3. Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl.

4. Organic Chemistry by P.L.Soni

5. Practical Organic Chemistry by Mann and Saunders.

6. Vogel‘s text book of Practical Organic Chemistry

7. Advanced Practical organic chemistry by N.K.Vishnoi.

8. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz.

353

74

BP306P PHYSICAL PHARMACEUTICS – I (Practical) 4 Hours/week

1. Determination the solubility of drug at room temperature

2. Determination of pKa value by Half Neutralization/ Henderson Hasselbalch equation.

3. Determination of Partition co- efficient of benzoic acid in benzene and water

4. Determination of Partition co- efficient of Iodine in CCl4 and water

5. Determination of % composition of NaCl in a solution using phenol-water system by CST

method

6. Determination of surface tension of given liquids by drop count and drop weight method

7. Determination of HLB number of a surfactant by saponification method

8. Determination of Freundlich and Langmuir constants using activated char coal

9. Determination of critical micellar concentration of surfactants

10. Determination of stability constant and donor acceptor ratio of PABA-Caffeine complex

by solubility method

11. Determination of stability constant and donor acceptor ratio of Cupric-Glycine complex

by pH titration method

Recommended Books: (Latest Editions)

1. Physical pharmacy by Alfred Martin

2. Experimental pharmaceutics by Eugene, Parott.

3. Tutorial pharmacy by Cooper and Gunn.

4. Stocklosam J. Pharmaceutical calculations, Lea &Febiger, Philadelphia.

5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3,

MarcelDekkar Inc.

6. Liberman H.A, Lachman C, Pharmaceutical dosage forms. Disperse systems, volume 1, 2,

3. Marcel Dekkar Inc.

7. Physical pharmaceutics by Ramasamy C and ManavalanR.

8. Laboratory manual of physical pharmaceutics, C.V.S. Subramanyam, J. Thimma settee

354

75

BP307P PHARMACEUTICAL MICROBIOLOGY (Practical)4 Hours/week

1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator,

laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator,

microscopes used in experimental microbiology.

2. Sterilization of glassware, preparation and sterilization of media.

3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations.

4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with

practical).

5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other

techniques.

6. Microbiological assay of antibiotics by cup plate method and other methods

7. Motility determination by Hanging drop method.

8. Sterility testing of pharmaceuticals.

9. Bacteriological analysis of water

10. Biochemical test (IMViC reactions)

11. Revision Practical Class

Recommended Books (Latest edition)

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific

publications, Oxford London.

2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,

Delhi.

3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.

4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.

5. Rose: Industrial Microbiology.

6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan

7. Cooper and Gunn‘s: Tutorial Pharmacy, CBS Publisher and Distribution.

8. Peppler: Microbial Technology.

9. I.P., B.P., U.S.P.- latest editions.

10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai

11. Edward: Fundamentals of Microbiology.

12. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi

13. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company

355

76

BP308P PHARMACEUTICAL ENGINEERING (Practical) 4 Hours/week

1. Determination of radiation constant of brass, iron, unpainted and painted glass.

2. Steam distillation – To calculate the efficiency of steam distillation.

3. To determine the overall heat transfer coefficient by heat exchanger.

4. Construction of drying curves (for calcium carbonate and starch).

5. Determination of moisture content and loss on drying.

6. Determination of humidity of air – i) From wet and dry bulb temperatures –use of Dew

point method.

7. Description of Construction working and application of Pharmaceutical Machinery such

as rotary tablet machine, fluidized bed coater, fluid energy mill, de humidifier.

8. Size analysis by sieving – To evaluate size distribution of tablet granulations –

Construction of various size frequency curves including arithmetic andlogarithmic

probability plots.

9. Size reduction: To verify the laws of size reduction using ball mill and determining Kicks,

Rittinger‘s, Bond‘s coefficients, power requirement and critical speed of Ball Mill.

10. Demonstration of colloid mill, planetary mixer, fluidized bed dryer, freeze dryer and such

othermajor equipment.

11. Factors affecting Rate of Filtration and Evaporation (Surface area, Concentration and

Thickness/ viscosity

12. To study the effect of time on the Rate of Crystallization.

13. To calculate the uniformity Index for given sample by using Double Cone Blender.

Recommended Books: (Latest Editions)

1. Introduction to chemical engineering – Walter L Badger & Julius Banchero, Latest

edition.

2. Solid phase extraction, Principles, techniques and applications by Nigel J.K. Simpson-

Latest edition.

3. Unit operation of chemical engineering – Mcabe Smith, Latest edition.

4. Pharmaceutical engineering principles and practices – C.V.S Subrahmanyam et al., Latest

edition.

5. Remington practice of pharmacy- Martin, Latest edition.

6. Theory and practice of industrial pharmacy by Lachmann., Latest edition.

7. Physical pharmaceutics- C.V.S Subrahmanyam et al., Latest edition.

356

77

SEMESTER IV

357

78

BP401T PHARMACEUTICAL ORGANIC CHEMISTRY –III (Theory)

3 L + 1T / Week

Scope: This subject imparts knowledge on stereo-chemical aspects of organic

compoundsand organic reactions, important named reactions, chemistry of important hetero

cyclic compounds. It also emphasizes on medicinal and other uses of organic compounds.

Objectives: At the end of the course, the student shall be able to:

1. understand the methods of preparation and properties of organic compounds

2. explain the stereo chemical aspects of organic compounds and stereo chemical reactions

3. know the medicinal uses and other applications of organic compounds

Sr.

No.

Content

Note: To emphasize on definition, types, mechanisms, examples,

uses/applications

Hours

1 UNIT I 10

Stereo isomerism

Optical isomerism –

i. Optical activity, enantiomerism, diastereoisomerism, meso compounds

ii. Elements of symmetry, chiral and achiral molecules

iii. DL system of nomenclature of optical isomers, sequence rules, RS

system of nomenclature of optical isomers

iv. Reactions of chiral molecules

v. Racemic modification and resolution of racemic mixture.

vi. Asymmetric synthesis: partial and absolute

2 UNIT II 10

Geometrical isomerism

i. Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)

ii. Methods of determination of configuration of geometrical isomers.

iii. Conformational isomerism in Ethane, n-Butane and Cyclohexane.

iv. Stereo isomerism in biphenyl compounds (Atropisomerism) and

conditions for optical activity.

v. Stereospecific and stereoselective reactions

3 UNIT III - Heterocyclic compounds: 10

Heterocyclic compounds:

Nomenclature and classification

Synthesis, reactions and medicinal uses of following compounds/derivatives

Pyrrole, Furan, and Thiophene

Relative aromaticity and reactivity of Pyrrole, Furan and Thiophene

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79

4 UNIT IV 08

Synthesis, reactions and medicinal uses of following compounds/derivatives

Pyrazole, Imidazole, Oxazole and Thiazole.

Pyridine, Quinoline, Isoquinoline, Acridine and Indole. Basicity of pyridine

Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their

derivatives

5 UNIT V - Reactions of synthetic importance 07

5.1

Metal hydride reduction (NaBH4 and LiAlH4), Clemmensen reduction,

Birch reduction, Wolff Kishner reduction

2

5.2 Oppenauer-oxidation and Dakin reaction. 2

5.3 Beckmanns rearrangement and Schmidt rearrangement 2

5.4 Claisen-Schmidt condensation 1

Total 45

Reference Books (Latest Editions to be adopted)

1. Organic chemistry by I.L. Finar, Volume-I & II.

2. A text book of organic chemistry – Arun Bahl, B.S. Bahl.

3. Heterocyclic Chemistry by Raj K. Bansal

4. Organic Chemistry by Morrison and Boyd

5. Heterocyclic Chemistry by T.L. Gilchrist

359

80

BP402T MEDICINAL CHEMISTRY – I (Theory) 3 L + 1T / Week

Scope: This subject is designed to impart fundamental knowledge on the

structure,chemistry and therapeutic value of drugs. The subject emphasizes on structure

activity relationships of drugs, importance of physicochemical properties and

metabolism of drugs. The syllabus also emphasizes on chemical synthesis of important

drugs under each class.

Objectives: Upon completion of the course the student shall be able to:

1. understand the chemistry of drugs with respect to their pharmacological activity

2. understand the drug metabolic pathways, adverse effect and therapeutic value of

drugs

3. know the Structural Activity Relationship (SAR) of different class of drugs

4. write the chemical synthesis of some drugs

Sr.

No.

Content

Study of the development of the following classes of drugs, Classification,

mechanism of action, uses of drugs mentioned in the course, Structure

activity relationship of selective class of drugs as specified in the course and

synthesis of drugs superscripted*

Hours

1 UNIT I - Introduction to Medicinal Chemistry 10

1.1 History and development of medicinal chemistry 1

1.2 Physicochemical properties in relation to biological action

Ionization, Solubility, Partition Coefficient, Hydrogen bonding, Protein

binding, Chelation, Bioisosterism, Optical and Geometrical isomerism

4

1.3 Drug metabolism

Drug metabolism principles- Phase I and Phase II.

Factors affecting drug metabolism including stereo chemical aspects

5

2 UNIT II - Drugs acting on Autonomic Nervous System 10

2.1 Adrenergic Neurotransmitters:

Biosynthesis and catabolism of catecholamine.

Adrenergic receptors (Alpha & Beta) and their distribution.

2

2.2 Sympathomimetic agents: SAR of Sympathomimetic agents

Direct acting: Nor-epinephrine, Epinephrine, Phenylephrine*,

Dopamine

Methyldopa, Clonidine, Dobutamine, Isoproterenol, Terbutaline,

Salbutamol*, Bitolterol, Naphazoline, Oxymetazoline and

4

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81

Xylometazoline

Indirect acting agents: Hydroxyamphetamine, Pseudoephedrine,

Propylhexedrine.

Agents with mixed mechanism: Ephedrine, Metaraminol.

2.3 Adrenergic Antagonists:

Alpha adrenergic blockers: Tolazoline*, Phentolamine,

Phenoxybenzamine, Prazosin, Dihydroergotamine, Methysergide.

Beta adrenergic blockers: SAR of beta blockers, Propranolol*,

Metibranolol, Atenolol, Betazolol, Bisoprolol, Esmolol, Metoprolol,

Labetolol, Carvedilol.

4

3 UNIT III - Cholinergic neurotranimitters 10

3.1 Biosynthesis and catabolism of acetylcholine.

Cholinergic receptors (Muscarinic & Nicotinic) and their distribution

2

3.2 Parasympathomimetic agents: SAR of Parasympathomimetic agents

Direct acting agents: Acetylcholine, Carbachol*, Bethanechol,

Methacholine, Pilocarpine.

Indirect acting/ Cholinesterase inhibitors (Reversible &

Irreversible): Physostigmine, Neostigmine*, Pyridostigmine,

Edrophonium chloride, Tacrine hydrochloride, Ambenonium chloride,

Isofluorphate, Echothiophate iodide, Parathione, Malathion.

Cholinesterase reactivator: Pralidoxime chloride.

4

3.3 Cholinergic Blocking agents: SAR of cholinolytic agents

Solanaceous alkaloids and analogues: Atropine sulphate,

Hyoscyamine sulphate, Scopolamine hydrobromide, Homatropine

hydrobromide, Ipratropium bromide*.

Synthetic cholinergic blocking agents: Tropicamide, Cyclopentolate

hydrochloride, Clidinium bromide, Dicyclomine hydrochloride*,

Glycopyrrolate, Methantheline bromide, Propantheline bromide,

Benztropine mesylate, Orphenadrine citrate, Biperidine hydrochloride,

Procyclidine hydrochloride*, Tridihexethyl chloride, Isopropamide

iodide, Ethopropazine hydrochloride.

4

4 UNIT IV - Drugs acting on Central Nervous System 08

4.1 Sedatives and Hypnotics:

Benzodiazepines: SAR of Benzodiazepines, Chlordiazepoxide,

Diazepam*, Oxazepam, Chlorazepate, Lorazepam, Alprazolam,

Zolpidem

Barbiturtes: SAR of barbiturates, Barbital*, Phenobarbital,

3

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82

Mephobarbital, Amobarbital, Butabarbital, Pentobarbital, Secobarbital

Miscelleneous:

Amides and imides:Glutethmide.

Alcohol & their carbamate derivatives: Meprobomate, Ethchlorvynol.

Aldehyde & their derivatives: Triclofos sodium, Paraldehyde.

4.2 Antipsychotics

Phenothiazeines: SAR of Phenothiazeines - Promazine hydrochloride,

Chlorpromazine hydrochloride*, Triflupromazine, Thioridazine

hydrochloride, Piperacetazine hydrochloride, Prochlorperazine maleate,

Trifluoperazine hydrochloride.

Ring Analogues of Phenothiazeines: Chlorprothixene, Thiothixene,

Loxapine succinate, Clozapine.

Fluro buterophenones: Haloperidol, Droperidol, Risperidone.

Beta amino ketones: Molindone hydrochloride.

Benzamides: Sulpieride.

3

4.3 Anticonvulsants: SAR of Anticonvulsants, mechanism of anticonvulsant

action

Barbiturates: Phenobarbitone, Methabarbital.

Hydantoins: Phenytoin*, Mephenytoin, Ethotoin

Oxazolidine diones: Trimethadione, Paramethadione

Succinimides: Phensuximide, Methsuximide, Ethosuximide*

Urea and monoacylureas: Phenacemide, Carbamazepine*

Benzodiazepines: Clonazepam

Miscellaneous: Primidone, Valproic acid , Gabapentin, Felbamate

2

5 UNIT V- Drugs acting on Central Nervous System 07

5.1

General anesthetics:

Inhalation anesthetics: Halothane*, Methoxyflurane, Enflurane,

Sevoflurane, Isoflurane, Desflurane.

Ultra short acting barbitutrates: Methohexital sodium*, Thiamylal

sodium, Thiopental sodium.

Dissociative anesthetics: Ketamine hydrochloride.*

3

5.2 Narcotic and non-narcotic analgesics

Morphine and related drugs: SAR of Morphine analogues, Morphine

sulphate, Codeine, Meperidine hydrochloride, Anilerdine hydrochloride,

Diphenoxylate hydrochloride, Loperamide hydrochloride, Fentanyl

citrate*, Methadone hydrochloride*, Propoxyphene hydrochloride,

Pentazocine, Levorphanol tartarate.

2

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83

Narcotic antagonists: Nalorphine hydrochloride, Levallorphan

tartarate, Naloxone hydrochloride

5.3 Anti-inflammatory agents: Sodium salicylate, Aspirin, Mefenamic acid*,

Meclofenamate, Indomethacin, Sulindac, Tolmetin, Zomepriac, Diclofenac,

Ketorolac, Ibuprofen*, Naproxen, Piroxicam, Phenacetin, Acetaminophen,

Antipyrine, Phenylbutazone

2

Total 45

Reference Books (Latest Editions to be adopted)

1. Wilson and Giswold‘s Organic medicinal and Pharmaceutical Chemistry.

2. Foye‘s Principles of Medicinal Chemistry.

3. Burger‘s Medicinal Chemistry, Vol I to IV.

4. Introduction to principles of drug design- Smith and Williams.

5. Remington‘s Pharmaceutical Sciences.

6. Martindale‘s extra pharmacopoeia.

7. Organic Chemistry by I.L. Finar, Vol. II.

8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.

9. Indian Pharmacopoeia.

10. Text book of practical organic chemistry- A.I.Vogel.

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BP403T PHYSICAL PHARMACEUTICS-II (Theory) 3 L + 1T / Week

Scope: The course deals with the various physical and physicochemical properties,

andprinciples involved in dosage forms/formulations. Theory and practical components of the

subject help the student to get a better insight into various areas of formulation research and

development, and stability studies of pharmaceutical dosage forms.

Objectives: Upon the completion of the course student shall be able to:

1. Understand various physicochemical properties of drug molecules in the designing the

dosage forms

2. Know the principles of chemical kinetics & to use them for stability testing and

determination of expiry date of formulations

3. Demonstrate use of physicochemical properties in the formulation development and

evaluation of dosage forms

Sr.

No.

Content Hours

1 UNIT I 7

Colloidal dispersions: Classification of dispersed systems & their general

characteristics, size & shapes of colloidal particles, classification of colloids

& comparative account of their general properties. Optical, kinetic &

electrical properties. Effect of electrolytes, coacervation, peptization&

protective action.

2 UNIT II 10

2.1 Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of

temperature, non-Newtonian systems, pseudoplastic, dilatants, plastic,

thixotropy, thixotropy in formulation, determination of viscosity, capillary,

falling Sphere, rotational viscometers

7

2.2 Deformation of solids: Plastic and elastic deformation, Heckel equation,

Stress, Strain, Elastic Modulus

3

3 UNIT III - Coarse dispersion 10

3.1 Suspension, interfacial properties of suspended particles, settling in

suspensions, formulation of suspensions. Emulsions and theories of

emulsification, microemulsion and multiple emulsions;

7

3.2 Physical stability of emulsions, preservation of emulsions, rheological

properties of emulsions, phase equilibria and emulsion formulation.

3

4 UNIT IV 8

Micromeretics: Particle size and distribution, mean particle size, number

and weight distribution, particle number, methods for determining particle

size by different methods, counting and separation method, particle shape,

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85

specific surface, methods for determining surface area, permeability,

adsorption, derived properties of powders, porosity, packing arrangement,

densities, bulkiness & flow properties.

5 UNIT V 10

5.1

Drug stability: Reaction kinetics: zero, pseudo-zero, first & second order,

units of basic rate constants, determination of reaction order. Physical and

chemical factors influencing the chemical degradation of pharmaceutical

product: temperature, solvent, ionic strength, dielectric constant, specific &

general acid base catalysis, Simple numerical problems. Stabilization of

medicinal agents against common reactions like hydrolysis & oxidation.

Accelerated stability testing in expiration dating of pharmaceutical dosage

forms. Photolytic degradation and its prevention

Total 45

Reference Books (Latest Editions to be adopted)

1. Physical Pharmacy by Alfred Martin, Sixth edition

2. Experimental pharmaceutics by Eugene, Parott.

3. Tutorial pharmacy by Cooper and Gunn.

4. Stocklosam J. Pharmaceutical calculations, Lea & Febiger, Philadelphia.

5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3,

Marcel Dekkar Inc.

6. Liberman H.A, Lachman C, Pharmaceutical dosage forms. Disperse systems, volume 1, 2,

3. Marcel Dekkar Inc.

7. Physical Pharmaceutics by Ramasamy C, and Manavalan R.

365

86

BP404T PHARMACOLOGY-I (Theory) 3 L + 1T / Week

Scope: The main purpose of the subject is to understand what drugs do to the livingorganisms

and how their effects can be applied to therapeutics. The subject covers the information about

the drugs like, mechanism of action, physiological and biochemical effects

(pharmacodynamics) as well as absorption, distribution, metabolism and excretion

(pharmacokinetics) along with the adverse effects, clinical uses, interactions, doses,

contraindications and routes of administration of different classes of drugs.

Objectives: Upon completion of this course the student should be able to

1. Understand the pharmacological actions of different categories of drugs

2. Explain the mechanism of drug action at organ system/sub cellular/ macromolecular

levels.

3. Apply the basic pharmacological knowledge in the prevention and treatment of various

diseases.

4. Observe the effect of drugs on animals by simulated experiments

5. Appreciate correlation of pharmacology with other bio medical sciences

Sr. No. Content Hours

1 UNIT I - General Pharmacology 8

1.1 Introduction to Pharmacology- Definition, historical landmarks and scope

of pharmacology, nature and source of drugs, essential drugs concept and

routes of drug administration, Agonists, antagonists( competitive and non-

competitive), spare receptors, addiction, tolerance, dependence,

tachyphylaxis, idiosyncrasy, allergy

4

1.2 Pharmacokinetics- Membrane transport, absorption, distribution,

metabolism and excretion of drugs .Enzyme induction, enzyme inhibition,

kinetics of elimination

4

2 UNIT II - General Pharmacology 12

2.1 Pharmacodynamics- Principles and mechanisms of drug action. Receptor

theories and classification of receptors, regulation of receptors. drug

receptors interactions signal transduction mechanisms, G-protein–coupled

receptors, ion channel receptor, transmembrane enzyme linked receptors,

transmembrane JAK-STAT binding receptor and receptors that regulate

transcription factors, dose response relationship, therapeutic index,

combined effects of drugs and factors modifying drug action.

6

2.2 Adverse drug reactions. 2

2.3 Drug interactions (pharmacokinetic and pharmacodynamic) 2

2.4 Drug discovery and clinical evaluation of new drugs -Drug discovery phase,

preclinical evaluation phase, clinical trial phase, phases of clinical trials and

2

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87

pharmacovigilance

3 UNIT III –Pharmacology of peripheral nervous system 10

3.1 Organization and function of ANS, Neurohumoral transmission,co-

transmission and classification of neurotransmitters

1

3.2 Parasympathomimetics, Parasympatholytics, Sympathomimetics,

sympatholytics

3

3.3 Neuromuscular blocking agents and skeletal muscle relaxants (peripheral). 2

3.4 Local anesthetic agents 3

3.5 Drugs used in myasthenia gravis and glaucoma 1

4 UNIT IV - Pharmacology of central nervous system 08

4.1 Neurohumoral transmission in the C.N.S.special emphasis on importance of

various neurotransmitters like with GABA, Glutamate, Glycine, serotonin,

dopamine.

1

4.2 General anesthetics and pre-anesthetics. 2

4.3 Sedatives, hypnotics and centrally acting muscle relaxants 2

4.4 Anti-epileptics 2

4.5 Alcohols and disulfiram 1

5 UNIT V - Pharmacology of central nervous system 07

5.1

Psychopharmacological agents: Antipsychotics, antidepressants, anti-

anxiety agents, anti-manics and hallucinogens

2

5.2 Drugs used in Parkinsons disease and Alzheimer‘s disease. 1

5.3 CNS stimulants and nootropics 1

5.4 Opioid analgesics and antagonists 2

5.5 Drug addiction, drug abuse, tolerance and dependence. 1

Total 45

Reference Books (Latest Editions to be adopted)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale‘s

Pharmacology,.Churchil Livingstone Elsevier

2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc

Graw-Hill

3. Goodman and Gilman‘s, The Pharmacological Basis of Therapeutics

4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K.,

Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott

Williams & Wilkins

5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott‘s Illustrated Reviews- Pharmacology

6. K.D.Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical Publishers

(P) Ltd, New Delhi.

7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher

367

88

8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,

9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.

10. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan

368

89

BP405T PHARMACOGNOSY AND PHYTOCHEMISTRY I (Theory)

3 L + 1T / Week

Scope: The subject involves the fundamentals of Pharmacognosy like scope, classification of

crude drugs, their identification and evaluation, phytochemicals present in them and their

medicinal properties.

Objectives: Upon completion of the course, the student shall be able:

1. to know the techniques in the cultivation and production of crude drugs

2. to know the crude drugs, their uses and chemical nature

3. know the evaluation techniques for the herbal drugs

4. to carry out the microscopic and morphological evaluation of crude drugs

Sr.

No.

Content Hour

s

1 UNIT I 10

1.1 Introduction to Pharmacognosy:

(a) Definition, history, scope and development of Pharmacognosy

(b) Sources of Drugs – Plants, Animals, Marine & Tissue culture

(c) Organized drugs, unorganized drugs (dried latex, dried juices, dried

extracts, gums and mucilages, oleoresins and oleo- gum -resins).

3

1.2 Classification of drugs:

Alphabetical, morphological, taxonomical, chemical, pharmacological,

chemo and sero taxonomical classification of drugs

2

1.3 Quality control of Drugs of Natural Origin:

Adulteration of drugs of natural origin. Evaluation by organoleptic,

microscopic, physical, chemical and biological methods and properties.

Quantitative microscopy of crude drugs including lycopodium spore method,

leafconstants, camera lucida and diagrams of microscopic objects to scale

with camera lucida.

5

2 UNIT II 12

2.1 Cultivation, Collection, Processing and storage of drugs of natural

origin:

Cultivation and Collection of drugs of natural origin

Factors influencing cultivation of medicinal plants.

Plant hormones and their applications.

Polyploidy, mutation and hybridization with reference to medicinal plants

10

2.2 Conservation of medicinal plants 2

3 UNIT III 7

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90

Plant tissue culture:

Historical development of plant tissue culture, types of cultures, Nutritional

requirements, growth and their maintenance.

Applications of plant tissue culture in pharmacognosy.

Edible vaccines

4 UNIT IV 10

4.1 Pharmacognosy in various systems of medicine:

Role of Pharmacognosy in allopathy and traditional systems of medicine

namely, Ayurveda, Unani, Siddha, Homeopathy and Chinese systems of

medicine

3

4.2 Introduction to secondary metabolites:

Definition, classification, properties and test for identification of Alkaloids,

Glycosides, Flavonoids, Tannins, Volatile oil and Resins

7

5 UNIT V - Study of biological source, chemical nature and uses of drugs of

natural origin containing following drugs

08

(a) Plant Products:

Fibers - Cotton, Jute, Hemp

Hallucinogens, Teratogens, Natural allergens

3

(b) Primary metabolites:

General introduction, detailed study with respect to chemistry, sources,

preparation, evaluation, preservation, storage, therapeutic used and

commercial utility as Pharmaceutical Aids and/or Medicines for the

following Primary metabolites:

(c) Carbohydrates: Acacia, Agar, Tragacanth, Honey

(d) Proteins and Enzymes :Gelatin, casein, proteolytic enzymes (Papain,

bromelain, serratiopeptidase, urokinase, streptokinase, pepsin).

3

(e) Lipids(Waxes, fats, fixed oils) : Castor oil, Chaulmoogra oil, Wool Fat,

Bees Wax

(f) Marine Drugs:

Novel medicinal agents from marine sources

2

Total 45

Reference Books (Latest Editions to be adopted)

1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,

London, 2009.

2. Tyler, V.E., Brady, L.R. and Robbers, J.E., Pharmacognosy, 9th Edn., Lea and Febiger,

Philadelphia, 1988.

370

91

3. Text Book of Pharmacognosy by T.E. Wallis

4. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution,

New Delhi.

5. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,

Nirali Prakashan, New Delhi.

6. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.

7. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi,

2007

8. Practical Pharmacognosy: C.K. Kokate, Purohit, Gokhlae

9. Anatomy of Crude Drugs by M.A. Iyengar

371

92

BP406P MEDICINAL CHEMISTRY – I (Practical) 3 L + 1T / Week

Recommended Books (Latest Editions)

1. Wilson and Giswold‘s Organic medicinal and Pharmaceutical Chemistry.

2. Foye‘s Principles of Medicinal Chemistry.

3. Burger‘s Medicinal Chemistry, Vol I to IV.

4. Introduction to principles of drug design- Smith and Williams.

5. Remington‘s Pharmaceutical Sciences.

6. Martindale‘s extra pharmacopoeia.

7. Organic Chemistry by I.L. Finar, Vol. II.

8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.

9. Indian Pharmacopoeia.

10. Text book of practical organic chemistry- A. I. Vogel.

I Preparation of drugs/ intermediates

1 1,3-pyrazole

2 1,3-oxazole

3 Benzimidazole

4 Benztriazole

5 2,3- diphenyl quinoxaline

6 Benzocaine

7 Phenytoin

8 Phenothiazine

9 Barbiturate

II Assay of drugs

1 Chlorpromazine

2 Phenobarbitone

3 Atropine

4 Ibuprofen

5 Aspirin

6 Furosemide

III Determination of Partition coefficient for any two drugs

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93

BP407P PHYSICAL PHARMACEUTICS- II (Practical) 3 L + 1T / Week

1. Determination of particle size, particle size distribution using sieving method

2. Determination of particle size, particle size distribution using Microscopic method

3. Determination of bulk density, true density and porosity

4. Determine the angle of repose and influence of lubricant on angle of repose

5. Determination of viscosity of liquid using Ostwald‘s viscometer

6. Determination sedimentation volume with effect of different suspending agent

7. Determination sedimentation volume with effect of different concentration of single

suspending agent

8. Determination of viscosity of semisolid by using Brookfield viscometer

9. Determination of reaction rate constant first order.

10. Determination of reaction rate constant second order

11. Accelerated stability studies

Recommended Books: (Latest Editions)

1. Physical Pharmacy by Alfred Martin, Sixth edition

2. Experimental pharmaceutics by Eugene, Parott.

3. Tutorial pharmacy by Cooper and Gunn.

4. Stocklosam J. Pharmaceutical calculations, Lea & Febiger, Philadelphia.

5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3,

Marcel Dekkar Inc.

6. Liberman H.A, Lachman C, Pharmaceutical dosage forms. Disperse systems, volume

1,

7. 2, 3. Marcel Dekkar Inc.

8. Physical Pharmaceutics by Ramasamy C, and Manavalan R.

BP408P PHARMACOLOGY I (Practical) 4Hours/Week

1. Introduction to experimental pharmacology.

2. Commonly used instruments in experimental pharmacology.

3. Study of common laboratory animals.

4. Maintenance of laboratory animals as per CPCSEA guidelines.

5. Common laboratory techniques. Blood withdrawal, serum and plasma separation,

anesthetics and euthanasia used for animal studies.

6. Study of different routes of drugs administration in mice/rats.

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94

7. Study of effect of hepatic microsomal enzyme inducers on the phenobarbitone sleeping

time in mice.

8. Effect of drugs on ciliary motility of frog oesophagus

9. Effect of drugs on rabbit eye.

10. Effects of skeletal muscle relaxants using rota-rod apparatus.

11. Effect of drugs on locomotor activity using actophotometer.

12. Anticonvulsant effect of drugs by MES and PTZ method.

13. Study of stereotype and anti-catatonic activity of drugs on rats/mice.

14. Study of anxiolytic activity of drugs using rats/mice.

15. Study of local anesthetics by different methods

Note: All laboratory techniques and animal experiments are demonstrated by simulated

experiments by softwares and videos

Recommended Books (Latest Editions)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale‘s

Pharmacology,.Churchil Livingstone Elsevier

2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc

Graw-Hill

3. Goodman and Gilman‘s, The Pharmacological Basis of Therapeutics

4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K.,

Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott

Williams & Wilkins

5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott‘s Illustrated Reviews- Pharmacology

6. K.D.Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical Publishers

(P) Ltd, New Delhi.

7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher

8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,

9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.

10. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,

374

95

BP409P PHARMACOGNOSY AND PHYTOCHEMISTRY I (Practical)

4 Hours/Week

1. Analysis of crude drugs by chemical tests: (i)Tragaccanth (ii) Acacia (iii)Agar (iv) Gelatin

(v) starch (vi) Honey (vii) Castor oil

2. Determination of stomatal number and index

3. Determination of vein islet number, vein islet termination and paliside ratio.

4. Determination of size of starch grains, calcium oxalate crystals by eye piece micrometer

5. Determination of Fiber length and width

6. Determination of number of starch grains by Lycopodium spore method

7. Determination of Ash value

8. Determination of Extractive values of crude drugs

9. Determination of moisture content of crude drugs

10. Determination of swelling index and foaming

Recommended Books: (Latest Editions)

1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,

London, 2009.

2. Tyler, V.E., Brady, L.R. and Robbers, J.E., Pharmacognosy, 9th Edn., Lea and Febiger,

Philadelphia, 1988.

3. Text Book of Pharmacognosy by T.E. Wallis

4. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution,

New Delhi.

5. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,

Nirali Prakashan, New Delhi.

6. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.

7. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi,

2007

8. Practical Pharmacognosy: C.K. Kokate, Purohit, Gokhlae

9. Anatomy of Crude Drugs by M.A. Iyengar

375

96

SEMESTER V

376

97

BP501T MEDICINAL CHEMISTRY – II (Theory) 3 L + 1T / Week

Scope: This subject is designed to impart fundamental knowledge on the structure,chemistry

and therapeutic value of drugs. The subject emphasizes on structure activity relationships of

drugs, importance of physicochemical properties and metabolism of drugs. The syllabus also

emphasizes on chemical synthesis of important drugs under each class.

Objectives: Upon completion of the course the student shall be able to

1. Understand the chemistry of drugs with respect to their pharmacological activity

2. Understand the drug metabolic pathways, adverse effect and therapeutic value of drugs

3. Know the Structural Activity Relationship of different class of drugs

4. Study the chemical synthesis of selected drugs

Sr.

No.

Content:

Study of the development of the following classes of drugs, Classification,

mechanism of action, uses of drugs mentioned in the course, Structure

activity relationship of selective class of drugs as specified in the course and

synthesis of drugs superscripted (*)

Hours

1 UNIT I 10

1.1 Antihistaminic agents: Histamine, receptors and their distribution in

thehumanbody

H1–antagonists: Diphenhydramine hydrochloride*,

Dimenhydrinate,Doxylamines cuccinate, Clemastine fumarate,

Diphenylphyraline hydrochloride, Tripelenamine hydrochloride,

Chlorcyclizine hydrochloride, Meclizine hydrochloride, Buclizine

hydrochloride, Chlorpheniramine maleate, Triprolidine hydrochloride*,

Phenidamine tartarate, Promethazine hydrochloride*, Trimeprazine tartrate,

Cyproheptadine hydrochloride, Azatidine maleate, Astemizole, Loratadine,

Cetirizine, Levocetrazine Cromolyn sodium

H2-antagonists: Cimetidine*, Famotidine, Ranitidin.

4

1.2 Gastric Proton pump inhibitors: Omeprazole, Lansoprazole,

Rabeprazole,Pantoprazole

1

1.3 Anti-neoplastic agents:

Alkylatingagents:Meclorethamine* Cyclophosphamide, Melphalan,

Chlorambucil, Busulfan, Thiotepa

Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil,

Floxuridine,Cytarabine, Methotrexate*, Azathioprine

Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin

5

377

98

Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate

Miscellaneous: Cisplatin, Mitotane.

2 UNIT II 10

2.1 Anti-anginal:

Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate,

Isosorbidedinitrite*, Dipyridamole.

Calcium channel blockers: Verapamil, Bepridil hydrochloride,

Diltiazemhydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine,

Nimodipine.

Diuretics:

Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide,

Dichlorphenamide.

Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide,

Cyclothiazide

Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid.

Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride.

Osmotic Diuretics: Mannitol

7

2.2 Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril,

Benazeprilhydrochloride, Quinapril hydrochloride, Methyldopate

hydrochloride,* Clonidine hydrochloride, Guanethidine monosulphate,

Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine,

Hydralazine hydrochloride.

3

3 UNIT III 10

3.1 Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide

hydrochloride,Disopyramide phosphate*, Phenytoin sodium, Lidocaine

hydrochloride, Tocainide hydrochloride, Mexiletine hydrochloride,

Lorcainide hydrochloride, Amiodarone, Sotalol.

4

3.2 Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine

andCholestipol

2

3.3 Coagulant & Anticoagulants: Menadione, Acetomenadione,

Warfarin*,Anisindione, clopidogrel

2

3.4 Drugs used in Congestive Heart Failure: Digoxin

Digitoxin,Nesiritide, Bosentan, Tezosentan.

2

4 UNIT IV 08

4.1 Drugs acting on Endocrine system

Nomenclature, Stereochemistry and metabolism of steroids

2

4.2 Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol,

Oestradiol,Oestrione, Diethyl stilbestrol.

1

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99

4.3 Drugs for erectile dysfunction: Sildenafil, Tadalafil 1

4.4 Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol 1

4.5 Corticosteroids: Cortisone, Hydrocortisone, Prednisolone,

Betamethasone,Dexamethasone

2

4.6 Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine,

Propylthiouracil,Methimazole.

1

5 UNIT V 07

5.1

Antidiabetic agents:

Insulin and its preparations

Sulfonyl ureas: Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride.

Biguanides: Metformin.

Thiazolidinediones: Pioglitazone, Rosiglitazone.

Meglitinides: Repaglinide, Nateglinide.

Glucosidase inhibitors: Acrabose, Voglibose.

2

5.2 Local Anesthetics: SAR of Local anesthetics

Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine,

Cyclomethycaine,Piperocaine.

Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*,

Butacaine,Propoxycaine, Tetracaine, Benoxinate.

Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine,

Etidocaine.

Miscellaneous: Phenacaine, Diperodon, Dibucaine.*

5

Total 45

Reference Books (Latest Editions to be adopted)

1. Wilson and Giswold‘s Organic medicinal and Pharmaceutical Chemistry.

2. Foye‘s Principles of Medicinal Chemistry.

3. Burger‘s Medicinal Chemistry, Vol I to IV.

4. Introduction to principles of drug design- Smith and Williams.

5. Remington‘s Pharmaceutical Sciences.

6. Martindale‘s extra pharmacopoeia.

7. Organic Chemistry by I.L. Finar, Vol. II.

8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1to 5.

9. Indian Pharmacopoeia.

10. Text book of practical organic chemistry- A.I.Vogel.

379

100

BP502T INDUSTRIAL PHARMACY I (Theory) 3 L + 1T / Week

Scope: Course enables the student to understand and appreciate the influence

ofpharmaceutical additives and various pharmaceutical dosage forms on the performance of

the drug product.

Objectives: Upon completion of the course the student shall be able to

1. Know the various pharmaceutical dosage forms and their manufacturing techniques.

2. Know various considerations in development of pharmaceutical dosage forms

3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality

Sr.

No.

Content Hours

1 UNIT I - Preformulation Studies 7

1.1 Introduction to preformulation, goals and objectives, study

ofphysicochemical characteristics of drug substances

1

1.2 Physical properties: Physical form (crystal & amorphous), particle size,

shape, flowproperties, solubility profile (pKa, pH, partition coefficient),

polymorphism

2

1.3 Chemical Properties: Hydrolysis, oxidation, reduction, racemisation,

polymerizationBCS classification of drugs

2

1.4 Application of preformulation considerations in the development of solid,

liquid oral and parenteral dosage forms and its impact on stability of dosage

forms.

2

2 UNIT II 10

2.1 Tablets

a.Introduction, ideal characteristics of tablets, classification of tablets.

Excipients, Formulation of tablets, granulation methods, compression and

processing problems. Equipments and tablet tooling.

b.Tablet coating: Types of coating, coating materials, formulation of coating

composition, methods of coating, equipment employed and defects in

coating.

c.Quality control tests: In process and finished product tests

8

2.2 Liquid orals: Formulation and manufacturing consideration of solutions,

suspensions and emulsions; Filling and packaging; evaluation of liquid orals

official in pharmacopoeia

2

3 UNIT III 8

3.1 Hard gelatin capsules: Introduction, Extraction of gelatin and production of 3

380

101

hardgelatin capsule shells. size of capsules, Filling, finishing and special

techniques of formulation of hard gelatin capsules. In process and final

product quality control tests for capsules.

3.2 Soft gelatin capsules: Nature of shell and capsule content,size

ofcapsules,importance of base adsorption and minimum/gram factors,

production, in process and final product quality control tests. Packing,

storage and stability testing of soft gelatin capsules

3

3.3 Pellets: Introduction, formulation requirements, pelletization process,

equipments formanufacture of pellets

2

4 UNIT IV 10

4.1 Definition, types, advantages and limitations. Preformulation factors and

essential requirements, vehicles, additives, importance of isotonicity

2

4.2 Production procedure, production facilities and controls. 1

4.3 Formulation of injections, sterile powders, emulsions, suspensions, large

volume parenterals and lyophilized products, Sterilization.

3

4.4 Containers and closures selection, filling and sealing of ampoules, vials and

infusion fluids. Quality control tests

1

4.5 Ophthalmic Preparations: Introduction, formulation considerations;

formulation of eyedrops, eye ointments and eye lotions; methods of

preparation; labeling, containers; evaluation of ophthalmic preparations

3

5 UNIT V 10

5.1

Cosmetics: Formulation and preparation of the following cosmetic

preparations:lipsticks, shampoos, cold cream and vanishing cream, tooth

pastes, hair dyes and sunscreens.

3

5.2 Pharmaceutical Aerosols: Definition, propellants, containers, valves, types

of aerosolsystems; formulation and manufacture of aerosols; Evaluation of

aerosols; Quality control and stability studies.

3

5.3 Packaging Materials Science: Materials used for packaging of

pharmaceutical products,factors influencing choice of containers, legal and

official requirements for containers, stability aspects of packaging materials,

quality control tests

4

Total 45

Reference Books (Latest Editions to be adopted)

1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman

&J.B.Schwartz

2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman

3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman

4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition

381

102

5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science

(RPS)

6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman

7. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill livingstone,

Latest edition

8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger, Philadelphia,

5th

edition, 2005

9. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel

Dekker Series, Vol 107.

382

103

BP503T PHARMACOLOGY-II (Theory) 3 L + 1T / Week

Scope: This subject is intended to impart the fundamental knowledge on various

aspects(classification, mechanism of action, therapeutic effects, clinical uses, side effects and

contraindications) of drugs acting on different systems of body and in addition, emphasis on

the basic concepts of bioassay.

Objectives: Upon completion of this course the student should be able to:

1. Understand the mechanism of drug action and its relevance in the treatment of

different diseases

2. Demonstrate isolation of different organs/tissues from the laboratory animals by

simulated experiments

3. Demonstrate the various receptor actions using isolated tissue preparation

4. Appreciate correlation of pharmacology with related medical sciences

Sr.

No.

Content Hours

1 UNIT I 10

Pharmacology of drugs acting on cardio vascular system

a. Introduction to hemodynamic and electrophysiology of heart.

b. Drugs used in congestive heart failure

c. Anti-hypertensive drugs.

d. Anti-anginal drugs.

e. Anti-arrhythmic drugs.

f. Anti-hyperlipidemic drugs.

2 UNIT II 10

2.1 Pharmacology of drugs acting on cardio vascular system

a Drug used in the therapy of shock.

b Hematinics, coagulants and anticoagulants.

c Fibrinolytics and anti-platelet drugs

d Plasma volume expanders

6

2.2 Pharmacology of drugs acting on urinary system

a Diuretics

b Anti-diuretics

4

3 UNIT III 10

Autocoids and related drugs

a Introduction to autacoids and classification

b Histamine, 5-HT and their antagonists.

c Prostaglandins, Thromboxanes and Leukotrienes.

d Angiotensin, Bradykinin and Substance P.

383

104

e Non-steroidal anti-inflammatory agents

f Anti-gout drugs

g Antirheumatic drugs

h Histamine, 5-HT and their antagonists.

i Prostaglandins, Thromboxanes and Leukotrienes.

j Angiotensin, Bradykinin and Substance P.

k Non-steroidal anti-inflammatory agents

l Anti-gout drugs

m Antirheumatic drugs

4 UNIT IV 08

Pharmacology of drugs acting on endocrine system

a Basic concepts in endocrine pharmacology.

b Anterior Pituitary hormones- analogues and their inhibitors.

c Thyroid hormones- analogues and their inhibitors.

d Hormones regulating plasma calcium level-Parathormone, calcitonin

and Vitamin-D.

e Insulin, Oral Hypoglycemic agents and glucagon.

f ACTH and corticosteroids.

5 UNIT V 07

5.1

Pharmacology of drugs acting on endocrine system

a. Androgens and Anabolic steroids.

b. Estrogens, progesterone and oral contraceptives.

c. Drugs acting on the uterus.

4

5.2 Bioassays

a. Principles and applications of bioassay.

b. Types of bioassay

c. Bioassay of insulin, oxytocin, vasopressin, ACTH, d-

tubocurarine,digitalis, histamine and 5-HT

3

Total 45

Reference Books (Latest Editions to be adopted)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale‘s Pharmacology,

Churchil Livingstone Elsevier

2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc

Graw-Hill.

3. Goodman and Gilman‘s, The Pharmacological Basis of Therapeutics

4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K.,

Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott

Williams & Wilkins.

384

105

5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott‘s Illustrated Reviews-Pharmacology.

6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical

Publishers (P) Ltd, New Delhi.

7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher

8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert.

9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.

10. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan

385

106

BP504T PHARMACOGNOSY AND PHYTOCHEMISTRY II (Theory)

3 L + 1T / Week

Scope: The main purpose of subject is to impart the students the knowledge of how

thesecondary metabolites are produced in the crude drugs, how to isolate and identify and

produce them industrially. Also this subject involves the study of producing the plants and

phytochemicals through plant tissue culture, drug interactions and basic principles of

traditional system of medicine

Objectives: Upon completion of the course, the student shall be able:

1. to know the modern extraction techniques, characterization and identification of the

herbal drugs and phytoconstituents

2. to understand the preparation and development of herbal formulation.

3. to understand the herbal drug interactions

4. to carryout isolation and identification of phytoconstituents

Sr.

No.

Content Hour

s

1 UNIT I - Metabolic pathways in higher plants and their determination 7

1.1 Brief study of basic metabolic pathways and formation of different

secondary metabolites through these pathways- Shikimic acid pathway,

Acetate pathways and Amino acid pathway.

4

1.2 Study of utilization of radioactive isotopes in the investigation of Biogenetic

studies.

3

2 UNIT II – General introduction, composition, chemistry & chemical

classes, general methods of extraction & analysis, biosources, therapeutic

uses and commercial applications of following secondary metabolites:

14

2.1 Alkaloids: Vinca, Rauwolfia, Belladonna, Opium, 2

2.2 Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta 2

2.3 Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea,

Digitalis

2

2.4 Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander, 2

2.5 Tannins: Catechu, Pterocarpus 1

2.6 Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony 2

2.7 Glycosides: Senna, Aloes, Bitter Almond 1

2.8 Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia,

taxus, carotenoids

2

3 UNIT III 6

386

107

Isolation ,identifaction and analysis of phytoconstituents

1. Terpenoids: Menthol, Citral, Artemisin

2. Glycosides: Glycyrhetinic Acid and Rutin

3. Alkaloids: Atropine, Quinene, reserpine, Caffeine

4. Resins: Phodophyllatoxin, curcumin

4 UNIT IV 6

Industrial production, estimation and utilization of the following

phytoconstituents: Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin,

Atropine, Podophyllotoxin, Caffeine, Taxol, Vincristine and Vinblastine

5 UNIT V 10

Basics of Phytochemistry

Modern methods of extraction, application of latest techniques like

Spectroscopy, chromatography and electrophoresis in the isolation,

purification and identification of crude drugs

Total 45

Reference Books (Latest Editions to be adopted)

1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,

London, 2009.

2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution,

New Delhi.

3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,

Nirali Prakashan, New Delhi.

4. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.

5. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi,

2007

6. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.

7. A.N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi, 2005.

8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.

9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VE Tylor.

10. The formulation and preparation of cosmetic, fragrances and flavours.

11. Remington‘s Pharmaceutical sciences.

12. Text Book of Biotechnology by Vyas and Dixit.

13. Text Book of Biotechnology by R.C. Dubey.

387

108

BP505T PHARMACEUTICAL JURISPRUDENCE (Theory) 3 L + 1T / Week

Scope: This course is designed to impart basic knowledge on importantlegislations related to

the profession of pharmacy in India.

Objectives: Upon completion of the course, the student shall be able to understand:

1. The Pharmaceutical legislations and their implications in the development and marketing

of pharmaceuticals.

2. Various Indian pharmaceutical Acts and Laws

3. The regulatory authorities and agencies governing the manufacture and sale of

pharmaceuticals

4. The code of ethics during the pharmaceutical practice

Sr. No. Content Hours

1 UNIT I - Drugs and Cosmetics Act, 1940 and its rules 1945 10

1.1 Objectives, Definitions, Legal definitions of schedules to the act and rules 3

1.2 Import of drugs – Classes of drugs and cosmetics prohibited from import,

Import under license or permit. Offences and penalties.

2

1.3 Manufacture of drugs – Prohibition of manufacture and sale of certain drugs 2

1.4 Conditions for grant of license and conditions of license for manufacture of

drugs, Manufacture of drugs for test, examination and analysis, manufacture

of new drug, loan license and repacking license

3

2 UNIT II - Drugs and Cosmetics Act, 1940 and its rules 1945. 10

2.1 Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F &

DMR (OA)

4

2.2 Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and

penalties

1

2.3 Labeling & Packing of drugs- General labeling requirements and specimen

labels for drugs and cosmetics, List of permitted colors. Offences and

penalties.

2

2.4 Administration of the act and rules – Drugs Technical Advisory Board,

Central drugs Laboratory, Drugs Consultative Committee, Government drug

analysts, Licensing authorities, controlling authorities, Drugs Inspectors

3

3 UNIT III 10

3.1 Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India;

its constitution and functions, Education Regulations, State and Joint state

pharmacy councils; constitution and functions, Registration of Pharmacists,

Offences and Penalties

3

3.2 Medicinal and Toilet Preparation Act –1955: Objectives, Definitions,

Licensing,Manufacture In bond and Outside bond, Export of alcoholic

3

388

109

preparations, Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary

Preparations. Offences and Penalties

3.3 Narcotic Drugs and Psychotropic substances Act-1985 and Rules:

Objectives,Definitions, Authorities and Officers, Constitution and Functions

of narcotic & Psychotropic Consultative Committee, National Fund for

Controlling the Drug Abuse, Prohibition, Control and Regulation, opium

poppy cultivation and production of poppy straw, manufacture, sale and

export of opium, Offences and Penalties

4

4 UNIT IV 08

4.1 Study of Salient Features of Drugs and magic remedies Act and its

rules: Objectives, Definitions, Prohibition of certain advertisements, Classes

of Exempted advertisements, Offences and Penalties

2

4.2 Prevention of Cruelty to animals Act-1960: Objectives, Definitions,

InstitutionalAnimal Ethics Committee, Breeding and Stocking of Animals,

Performance of Experiments, Transfer and acquisition of animals for

experiment, Records, Power to suspend or revoke registration, Offences and

Penalties

3

4.3 National Pharmaceutical Pricing Authority: Drugs Price Control Order

(DPCO)-2013. Objectives, Definitions, Sale prices of bulk drugs, Retail

price of formulations, Retail price and ceiling price of scheduled

formulations, National List of Essential Medicines (NLEM)

3

5 UNIT V 07

5.1

Pharmaceutical Legislations – A brief review, Introduction, Study of drugs

enquirycommittee, Health survey and development committee, Hathi

committee and Mudaliar committee

1

5.2 Code of Pharmaceutical ethics D efinition, Pharmacist in relation to his

job, trade,medical profession and his profession, Pharmacist‘s oath

1

5.3 Medical Termination of pregnancy act 1

5.4 Right to information Act 1

5.5 Introduction to Intellectual Property Rights (IPR) 3

Total 45

Reference Books (Latest Editions to be adopted)

1. Forensic Pharmacy by B. Suresh

2. Text book of Forensic Pharmacy by B.M. Mithal

3. Hand book of drug law-by M.L. Mehra

4. A text book of Forensic Pharmacy by N.K. Jain

5. Drugs and Cosmetics Act/Rules by Govt. of India publications.

6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.

7. Narcotic drugs and psychotropic substances act by Govt. of India publications

389

110

8. Drugs and Magic Remedies act by Govt. of India publication

9. Bare Acts of the said laws published by Government. Reference books (Theory)

390

111

BP506P INDUSTRIAL PHARMACY(Practical)4 Hours/week

1. Preformulation studies on paracetamol/aspirin/or any other drug

2. Preparation and evaluation of Paracetamol tablets

3. Preparation and evaluation of Aspirin tablets

4. Coating of tablets- film coating of tables/granules

5. Preparation and evaluation of Tetracycline capsules

6. Preparation of Calcium Gluconate injection

7. Preparation of Ascorbic Acid injection

8. Quality control test of (as per IP) marketed tablets and capsules

9. Preparation of Eye drops/ and Eye ointments

10. Preparation of Creams (cold / vanishing cream)

11. Evaluation of Glass containers (as per IP)

Recommended Books: (Latest Editions)

1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman

&J.B.Schwartz

2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman

3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman

4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition

5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science

(RPS)

6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman

7. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill livingstone,

Latest edition

8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger, Philadelphia,

5th

edition, 2005

9. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel

Dekker Series, Vol 107.

391

112

BP507P PHARMACOLOGY-II (Practical) 4Hours/Week

1. Introduction to in-vitro pharmacology and physiological salt solutions.

2. Effect of drugs on isolated frog heart.

3. Effect of drugs on blood pressure and heart rate of dog.

4. Study of diuretic activity of drugs using rats/mice.

5. DRC of acetylcholine using frog rectus abdominis muscle.

6. Effect of physostigmine and atropine on DRC of acetylcholine using frog rectus

abdominis muscle and rat ileum respectively.

7. Bioassay of histamine using guinea pig ileum by matching method.

8. Bioassay of oxytocin using rat uterine horn by interpolation method.

9. Bioassay of serotonin using rat fundus strip by three point bioassay.

10. Bioassay of acetylcholine using rat ileum/colon by four point bioassay.

11. Determination of PA2 value of prazosin using rat anococcygeus muscle (by Schilds plot

method).

12. Determination of PD2 value using guinea pig ileum.

13. Effect of spasmogens and spasmolytics using rabbit jejunum.

14. Anti-inflammatory activity of drugs using carrageenan induced paw-edema model.

15. Analgesic activity of drug using central and peripheral methods

Note: All laboratory techniques and animal experiments are demonstrated by simulated

experiments by softwares and videos

Recommended Books (Latest Editions)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale‘s Pharmacology,

Churchil Livingstone Elsevier

2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc

Graw-Hill.

3. Goodman and Gilman‘s, The Pharmacological Basis of Therapeutics

4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K.,

Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott

Williams & Wilkins.

5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott‘s Illustrated Reviews-Pharmacology.

6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical

Publishers (P) Ltd, New Delhi.

7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher

8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert.

9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.

10. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan.

392

113

BP508P PHARMACOGNOSY AND PHYTOCHEMISTRY II (Practical)

4 Hours/Week

1. Morphology, histology and powder characteristics & extraction & detection of: Cinchona,

Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander

2. Exercise involving isolation & detection of active principles

a. Caffeine - from tea dust.

b. Diosgenin from Dioscorea

c. Atropine from Belladonna

d. Sennosides from Senna

3. Separation of sugars by Paper chromatography

4. TLC of herbal extract

5. Distillation of volatile oils and detection of phytoconstitutents by TLC

6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii) Colophony (iv)

Aloes (v) Myrrh

Recommended Books: (Latest Editions)

1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,

London, 2009.

2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution,

New Delhi.

3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,

Nirali Prakashan, New Delhi.

4. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.

5. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi,

2007

6. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.

7. A.N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi, 2005.

8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.

9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VE Tylor.

10. The formulation and preparation of cosmetic, fragrances and flavours.

11. Remington‘s Pharmaceutical sciences.

12. Text Book of Biotechnology by Vyas and Dixit.

13. Text Book of Biotechnology by R.C. Dubey.

393

114

SEMESTER VI

394

115

BP601T MEDICINAL CHEMISTRY – III (Theory) 3 L + 1T / Week

Scope: This subject is designed to impart fundamental knowledge on the

structure,chemistry and therapeutic value of drugs. The subject emphasis on modern

techniques of rational drug design like quantitative structure activity relationship

(QSAR), Prodrug concept, combinatorial chemistry and Computer aided drug design

(CADD). The subject also emphasizes on the chemistry, mechanism of action,

metabolism, adverse effects, Structure Activity Relationships (SAR), therapeutic uses

and synthesis of important drugs.

Objectives: Upon completion of the course student shall be able to

1. Understand the importance of drug design and different techniques of drug

design.

2. Understand the chemistry of drugs with respect to their biological activity.

3. Know the metabolism, adverse effects and therapeutic value of drugs.

4. Know the importance of SAR of drugs.

Sr.

No.

Content

Study of the development of the following classes of drugs, Classification,

mechanism of action, uses of drugs mentioned in the course, Structure

activity relationship of selective class of drugs as specified in the course and

synthesis of drugs superscripted by (*)

Hours

1 UNIT I 10

Antibiotics

Historical background, Nomenclature, Stereochemistry, Structure activity

relationship, Chemical degradation classification and important products of

the following classes.

(a) β-Lactam antibiotics: Penicillin, Cepholosporins, β Lactamase

inhibitors,Monobactams

(b) Aminoglycosides: Streptomycin, Neomycin, Kanamycin

(c) Tetracyclines:Tetracycline,Oxytetracycline,Chlortetracycline,Minocycl

ine, Doxycycline

2 UNIT II 10

Antibiotics

Historical background, Nomenclature, Stereochemistry, Structure activity

relationship, Chemical degradation classification and important products of

the following classes.

(a) Macrolide: Erythromycin Clarithromycin, Azithromycin.

(b) Miscellaneous: Chloramphenicol*, Clindamycin.

395

116

(c) Prodrugs: Basic concepts and application of prodrugs design.

(d) Antimalarials: Etiology of malaria.

(e) Quinolines: SAR, Quinine sulphate, Chloroquine*,

Amodiaquine,Primaquine phosphate, Pamaquine*, Quinacrine

hydrochloride, Mefloquine.

(f) Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.

(g) Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone.

3 UNIT III 10

3.1 Anti-tubercular Agents :

(a) Synthetic anti tubercular agents: Isoniozid*, Ethionamide,

Ethambutol,Pyrazinamide, Para amino salicylic acid.*

(b) Anti-tubercular antibiotics: Rifampicin, Rifabutin,

CycloserineStreptomycine, Capreomycin sulphate.

3

3.2 Urinary tract anti-infective agents :

(a) Quinolones: SAR of quinolones, Nalidixic Acid,Norfloxacin,

Enoxacin,Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin,

Gatifloxacin, Moxifloxacin

(b) Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.

3

3.3 Antiviral agents:

Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine

trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine,

Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir,

Ritonavir.

4

4 UNIT IV 08

4.1 Antifungal agents:

(a) Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin,

Griseofulvin.

(b) Synthetic Antifungal agents: Clotrimazole, Econazole,

Butoconazole,Oxiconazole Tioconozole, Miconazole*, Ketoconazole,

Terconazole, Itraconazole, Fluconazole, Naftifine hydrochloride,

Tolnaftate*.

2

4.2 Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole,

Diloxanide,Iodoquinol, Pentamidine Isethionate, Atovaquone, Eflornithine.

1

4.3 Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole,

Mebendazole*, Albendazole, Niclosamide, Oxamniquine, Praziquinal,

Ivermectin

1

4.4 Sulphonamides and Sulfones:

Historical development, chemistry, classification and SAR of Sulfonamides:

Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*,

4

396

117

Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mefenide acetate,

Sulfasalazine.

Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole

Sulfones: Dapsone*.

5 UNIT V 07

5.1

Introduction to Drug Design

Various approaches used in drug design.

Physicochemical parameters used in quantitative structure activity

relationship (QSAR) such as partition coefficient, Hammet‘s electronic

parameter, Tafts steric parameter and Hansch analysis.

Pharmacophore modeling and docking techniques

5

5.2 Combinatorial Chemistry: Concept and applications of

combinatorialchemistry: solid phase and solution phase synthesis.

2

Total 45

Reference Books (Latest Editions to be adopted)

1. Wilson and Giswold‘s Organic medicinal and Pharmaceutical Chemistry.

2. Foye‘s Principles of Medicinal Chemistry.

3. Burger‘s Medicinal Chemistry, Vol I to IV.

4. Introduction to principles of drug design- Smith and Williams.

5. Remington‘s Pharmaceutical Sciences.

6. Martindale‘s extra pharmacopoeia.

7. Organic Chemistry by I.L. Finar, Vol. II.

8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.

9. Indian Pharmacopoeia.

10. Text book of practical organic chemistry- A.I.Vogel.

397

118

BP602T PHARMACOLOGY-III (Theory) 3 L + 1T / Week

Scope: This subject is intended to impart the fundamental knowledge on various

aspects(classification, mechanism of action, therapeutic effects, clinical uses, side effects and

contraindications) of drugs acting on respiratory and gastrointestinal system,

infectiousdiseases, immuno-pharmacology and in addition, emphasis on the principles of

toxicology and chronopharmacology.

Objectives: Upon completion of this course the student should be able to:

1. understand the mechanism of drug action and its relevance in the treatment of

different infectious diseases

2. comprehend the principles of toxicology and treatment of various poisonings and

3. appreciate correlation of pharmacology with related medical sciences

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Pharmacology of drugs acting on Respiratory system

a. Anti -asthmatic drugs

b. Drugs used in the management of COPD

c. Expectorants and antitussives

d. Nasal decongestants

e. Respiratory stimulants

5

1.2 Pharmacology of drugs acting on the Gastrointestinal Tract

a. Antiulcer agents.

b. Drugs for constipation and diarrhoea.

c. Appetite stimulants and suppressants.

d. Digestants and carminatives.

e. Emetics and anti-emetics.

5

2 UNIT II 10

Chemotherapy

a. General principles of chemotherapy.

b. Sulfonamides and cotrimoxazole.

c. Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides,

quinolones and fluoroquinolins, tetracycline and aminoglycosides

3 UNIT III 10

Chemotherapy

a. Antitubercular agents

b. Antileprotic agents

398

119

c. Antifungal agents

d. Antiviral drugs

e.Anthelmintics

f. Antimalarial drugs

g. Antiamoebic agents

4 UNIT IV 08

4.1 Chemotherapy

a. Urinary tract infections and sexually transmitted diseases.

b. Chemotherapy of malignancy

3

4.2 Immunopharmacology

a. Immunostimulants

b. Immunosuppressant

c. Protein drugs, monoclonal antibodies, target drugs to

d. antigen, biosimilars

5

5 UNIT V 07

5.1

Principles of toxicology

a. Definition and basic knowledge of acute, subacute and chronic toxicity.

b. Definition and basic knowledge of genotoxicity, carcinogenicity,

teratogenicity and mutagenicity

c. General principles of treatment of poisoning

d. Clinical symptoms and management of barbiturates, morphine,

organophosphosphorus compound and lead, mercury and arsenic

poisoning

6

5.2 Chronopharmacology

a. Definition of rhythm and cycles.

b. Biological clock and their significance leading to chronotherapy

1

Total 45

Reference Books (Latest Editions to be adopted)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale‘s

Pharmacology,Churchil Livingstone Elsevier

2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc

Graw-Hill

3. Goodman and Gilman‘s, The Pharmacological Basis of Therapeutics

4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K.,

Bradley R.W., Applied Therapeutics, The Clinical use of Drugs. The Point Lippincott

Williams & Wilkins

5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott‘s Illustrated Reviews-Pharmacology

399

120

6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical

Publishers (P) Ltd, New Delhi.

7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher

Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,

8. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata,

9. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,

10. N.Udupa and P.D. Gupta, Concepts in Chronopharmacology.

400

121

BP603T HERBAL DRUG TECHNOLOGY (Theory) 3 L + 1T / Week

Scope: This subject gives the student the knowledge of basic understanding of herbal

drugindustry, the quality of raw material, guidelines for quality of herbal drugs, herbal

cosmetics, natural sweeteners, nutraceutical etc. The subject also emphasizes on Good

Manufacturing Practices (GMP), patenting and regulatory issues of herbal drugs

Objectives: Upon completion of this course the student should be able to:

1. understand raw material as source of herbal drugs from cultivation to herbal drug product

2. know the WHO and ICH guidelines for evaluation of herbal drugs

3. know the herbal cosmetics, natural sweeteners, nutraceuticals

4. appreciate patenting of herbal drugs, GMP .

Sr. No. Content Hours

1 UNIT I 11

1.1 Herbs as raw materials

Definition of herb, herbal medicine, herbal medicinal product, herbal drug

preparation Source of Herbs Selection, identification and authentication of

herbal materials Processing of herbal raw material

3

1.2 Biodynamic Agriculture

Good agricultural practices in cultivation of medicinal plants including

Organic farming.

Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides

3

1.3 Indian Systems of Medicine

Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy

Preparation and standardization of Ayurvedic formulations viz Aristas and

Asawas, Gjutika, Churna, Lehya and Bhasma

5

2 UNIT II 07

2.1 Neutraceuticals

General aspects, Market, growth, scope and types of products available in

the market. Health benefits and role of Nutraceuticals in ailments like

Diabetes, CVS diseases, Cancer, Irritable bowel syndrome and various

Gastro intestinal diseases.

2

2.2 Study of following herbs as health food: Alfaalfa, Chicory, Ginger,

Fenugreek, Garlic, Honey, Amla, Ginseng, Ashwagandha, Spirulina

2

2.3 Herbal-Drug and Herb-Food Interactions: General introduction to

interaction andclassification. Study of following drugs and their possible side

effects and interactions: Hypercium, kava-kava, Ginkobiloba, Ginseng,

Garlic, Pepper & Ephedra

3

401

122

3 UNIT III 10

3.1 Herbal Cosmetics

Sources and description of raw materials of herbal origin used via, fixed oils,

waxes, gums colours, perfumes, protective agents, bleaching agents,

antioxidants in products such as skin care, hair care and oral hygiene

products.

4

3.2 Herbal excipients:

Herbal Excipients – Significance of substances of natural origin as excipients

– colorants, sweeteners, binders, diluents, viscosity builders, disintegrants,

flavors & perfumes.

3

3.3 Herbal formulations :

Conventional herbal formulations like syrups, mixtures and tablets and

Novel dosage forms like phytosomes

3

4 UNIT IV 10

4.1 Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal

drugsStability testing of herbal drugs.

2

4.2 Patenting and Regulatory requirements of natural products:

a. Definition of the terms: Patent, IPR, Farmers right, Breeder‘s right,

Bioprospecting and Biopiracy

b. Patenting aspects of Traditional Knowledge and Natural Products.

Case study of Curcuma & Neem.

5

4.3 Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC),

Regulation ofmanufacture of ASU drugs - Schedule Z of Drugs & Cosmetics

Act for ASU drugs

3

5 UNIT V 07

5.1

General Introduction to Herbal Industry

Herbal drugs industry: Present scope and future prospects.

A brief account of plant based industries and institutions involved in work on

medicinal and aromatic plants in India.

3

5.2 Schedule T–Good Manufacturing Practice of Indian systems of medicine

Components of GMP (Schedule – T) and its objectives

Infrastructural requirements, working space, storage area, machinery and

equipments, standard operating procedures, health and hygiene,

documentation and records.

4

Total 45

Reference Books (Latest Editions to be adopted)

1. Textbook of Pharmacognosy by Trease & Evans.

2. Textbook of Pharmacognosy by Tyler, Brady & Robber.

402

123

3. Pharmacognosy by Kokate, Purohit and Gokhale

4. Essential of Pharmacognosy by Dr.S.H.Ansari

5. Pharmacognosy & Phytochemistry by V.D.Rangari

6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian

Medicine & Homeopathy)

7. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of

Botanicals. Business Horizons Publishers, New Delhi, India, 2002.

403

124

BP604T BIOPHARMACEUTICS AND PHARMACOKINETICS (Theory)

3 L + 1T / Week

Scope:This subject is designed to impart knowledge and skills of Biopharmaceuticsand

pharmacokinetics and their applications in pharmaceutical development, design of dose and

dosage regimen and in solving the problems arised therein.

Objectives: Upon completion of the course student shall be ableto:

1. Understand the basic concepts in biopharmaceutics and pharmacokinetics and their

significance.

2. Use of plasma drug concentration-time data to calculate the pharmacokinetic parameters

to describe the kinetics of drug absorption, distribution, metabolism, excretion,

elimination.

3. To understand the concepts of bioavailability and bioequivalence of drug products and

their significance.

4. Understand various pharmacokinetic parameters, their significance & applications

Sr.

No.

Content Hour

s

1 UNIT I - 10

1.1 Introduction to Biopharmaceutics 1

1.2 Absorption; Mechanisms of drug absorption through GIT, factors

influencing drugabsorption though GIT, absorption of drug from Non per

oral extra-vascular routes

5

1.3 Distribution of Tissue permeability of drugs, binding of drugs, apparent,

volume of drug distribution, protein binding of drugs, factors affecting

protein-drug binding. Kinetics of protein binding, Clinical significance of

protein binding of drugs

4

2 UNIT II 10

2.1 Drug Elimination renal excretion of drugs, factors affecting renal excretion

of drugs,renal clearance, Non-renal routes of drug excretion of drugs

3

2.2 Bioavailability and Bioequivalence: Definition andObjectives of

bioavailability studies, absolute andrelative bioavailability, measurement of

bioavailability, in-vitro drug dissolution models, in-vitro, in-vivo

correlations, bioequivalence studies, methods to enhance the bioavailability

of poorly soluble drugs.

7

3 UNIT III 10

Pharmakokinetics: Definition and introduction of pharmacokinetics,

404

125

compartment models, Non-compartment models, physiological models, One

compartment open model. a. Intravenous Injection (Bolus) b. Intravenous

infusion, extra vascular administrations, calculations of Ka, KE, t1/2, Vd,

AUC Ka, Clt and CLr- definition methods of elimination, understanding of

their significance and application.

4 UNIT IV 08

Multicompartment models: Two compartment open model. IV bolus

kinetics of Multiple dosing, steady state drug level, calculation of loading

and maintenancedose and their significance in clinical setting

5 UNIT V 07

Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing

Non-linearity.c. Michaelis-menton method of estimating parameters,

Biotransformation of drugs

Total 45

Reference Books (Latest Editions to be adopted)

1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.

2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari

3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th

edition,Prentice-Hall Inernational edition.USA

4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil

B.Jaiswal,Vallabh Prakashan Pitampura, Delhi

5. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.

6. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS

Health Science Press.

7. Biopharmaceutics; By Swarbrick

8. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and

9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.

10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing

Company,Pennsylvania 1989.

11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and

expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.

12. Remington‘s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia

405

126

BP605T PHARMACEUTICAL BIOTECHNOLOGY (Theory) 3 L + 1T / Week

Scope:

Biotechnology has a long promise to revolutionize the biological sciences and

technology.

Scientific application of biotechnology in the field of genetic engineering, medicine

and fermentation technology makes the subject interesting.

Biotechnology is leading to new biological revolutions in diagnosis, prevention and

cure of diseases, new and cheaper pharmaceutical drugs.

Biotechnology has already produced transgenic crops and animals and the future

promises lot more.

It is basically a research-based subject.

Objectives: Upon completion of the subject student shall be able to;

1. Understanding the importance of Immobilized enzymes in Pharmaceutical

Industries

2. Genetic engineering applications in relation to production of pharmaceuticals

3. Importance of Monoclonal antibodies in Industries

4. Appreciate the use of microorganisms in fermentation technology

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Brief introduction to Biotechnology with reference to Pharmaceutical Sciences 1

1.2 Enzyme Biotechnology- Methods of enzyme immobilization and applications. 2

1.3 Biosensors- Working and applications of biosensors in Pharmaceutical

Industries.

1

1.4 Brief introduction to Protein Engineering. 2

1.5 Use of microbes in industry. Production of Enzymes- General consideration -

Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.

2

1.6 Basic principles of genetic engineering. 2

2 UNIT II 10

2.1 Study of cloning vectors, restriction endonucleases and DNA ligase. 2

2.2 Recombinant DNA technology. Application of genetic engineering in

medicine.

2

2.3 Application of r DNA technology and genetic engineering in the products: 2

2.4 Interferon b) Vaccines- hepatitis- B c) Hormones- Insulin. 2

2.5 Brief introduction to PCR 2

406

127

3 UNIT III 10

Types of immunity- humoral immunity, cellular immunity

a. Structure of Immunoglobulins

b. Structure and Function of MHC

c. Hypersensitivity reactions, Immune stimulation and Immune suppressions

d. General method of the preparation of bacterial vaccines, toxoids, viral

vaccine, antitoxins, serum-immune blood derivatives and other products

relative to immunity

e. Storage conditions and stability of official vaccines

f. Hybridoma technology- Production, Purification and Applications

g. Blood products and Plasma Substitutes

4 UNIT IV 08

4.1 Immuno blotting techniques- ELISA, Western blotting, Southern blotting. 2

4.2 Genetic organization of Eukaryotes and Prokaryotes 1

4.3 Microbial genetics including transformation, transduction, conjugation,

plasmids and transposons

2

4.4 Introduction to Microbial biotransformation and applications 2

4.5 Mutation.: Types of mutation/ mutants 1

5 UNIT V 07

5.1

Fermentation methods and general requirements, study of media, equipments,

sterilization methods, aeration process, stirring.

2

5.2 Large scale production fermenter design and its various controls. 1

5.3 Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic

acid, Griseofulvin

2

5.4 Blood product collection, Processing and storage of whole volume blood,

dries=d human plasma, plasma substituents

2

Total 45

Reference Books (Latest Editions to be adopted)

1. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applicationsof

RecombinantDNA: ASM Press Washington D.C.

2. RA Goldshy et. al., : Kuby Immunology.

3. J.W. Goding: Monoclonal Antibodies.

4. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal Society

of Chemistry.

5. Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.

6. S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific

Publication.

7. Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology, 2nd

edition, Aditya books Ltd., New Delhi

407

128

BP606T PHARMACEUTICAL QUALITY ASSURANCE (Theory)

3 L + 1T / Week

Scope: This course deals with the various aspects of quality control and qualityassurance

aspects of pharmaceutical industries. It deals with the important aspects like cGMP, QC tests,

documentation, quality certifications and regulatory affairs.

Objectives: Upon completion of the course student shall be able to:

1. understand the cGMP aspects in a pharmaceutical industry

2. appreciate the importance of documentation

3. understand the scope of quality certifications applicable to pharmaceutical industries

4. understand the responsibilities of QA & QC departments

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Quality Assurance and Quality Management concepts: Definition and

concept of Quality control, Quality assurance and GMP

4

1.2 Total Quality Management (TQM): Definition, elements, philosophies 2

1.3 ICH Guidelines: purpose, participants, process of harmonization, Brief

overview of QSEM,with special emphasis on Q-series guidelines, ICH

stability testing guidelines

2

1.4 QbD: Definition, overview, elements of QbD program, tools

ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for

registration

1

1.5 NABL accreditation : Principles and procedure 1

2 UNIT II 10

2.1 Organization and personnel: Personnel responsibilities, training, hygiene

and personal records. Premises: Design, construction and plant layout,

maintenance, sanitation, environmentalcontrol, utilities and maintenance of

sterile areas, control of contamination.

5

2.2 Equipments and raw materials: Equipments selection, purchase

specifications, maintenance,purchase specifications and maintenance of

stores for raw materials

5

3 UNIT III 10

3.1 Quality Control: Quality control test for containers, rubber closures and

secondary packing materials

5

3.2 Good Laboratory Practices: General Provisions, Organization and

Personnel, Facilities,Equipment, Testing Facilities Operation, Test and

5

408

129

Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study,

Records and Reports, Disqualification of Testing Facilities

4 UNIT IV 08

4.1 Complaints: Complaints and evaluation of complaints, Handling of return

good, recalling andwaste disposal.

2

4.2 Document maintenance in pharmaceutical industry: Batch Formula

Record, Master Formula

Record, SOP, Quality audit, Quality Review and Quality documentation,

Reports and documents, distribution records.

6

5 UNIT V 07

5.1

Calibration and Validation: Introduction, definition and general principles

of calibration,qualification and validation, importance and scope of

validation, types of validation, validation master plan. Calibration of pH

meter, Qualification of UV-Visible spectrophotometer, General principles

of Analytical method Validation.

6

5.2 Warehousing: Good warehousing practice, materials management 1

Total 45

Reference Books (Latest Editions to be adopted)

1. Quality Assurance Guide by organization of Pharmaceutical Products of India.

2. Good Laboratory Practice Regulations, 2nd

Edition, Sandy Weinberg Vol. 69.

3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related

materials Vol I WHO Publications.

4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh

5. How to Practice GMP‘s – P P Sharma.

6. ISO 9000 and Total Quality Management – Sadhank G Ghosh

7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and

Quality specification for Pharmaceutical Substances, Excipients and Dosage forms

8. Good laboratory Practices – Marcel Deckker Series

9. ICH guidelines, ISO 9000 and 14000 guidelines

409

130

BP607P MEDICINAL CHEMISTRY- III (Practical) 4 Hours / week

I Preparation of drugs and intermediates

1 Sulphanilamide

2 7-Hydroxy, 4-methyl coumarin

3 Chlorobutanol

4 Triphenyl imidazole

5 Tolbutamide

6 Hexamine

II Assay of drugs

1 Isonicotinic acid hydrazide

2 Chloroquine

3 Metronidazole

4 Dapsone

5 Chlorpheniramine maleate

6 Benzyl penicillin

III Preparation of medicinally important compounds or intermediates by Microwave

irradiation technique

IV Drawing structures and reactions using chem draw®

V Determination of physicochemical properties such as logP, clogP, MR, Molecular

weight, Hydrogen bond donors and acceptors for class of drugs course content

using drug design software Drug likeliness screening (Lipinskies RO5)

Recommended Books (Latest Editions)

1. Wilson and Giswold‘s Organic medicinal and Pharmaceutical Chemistry.

2. Foye‘s Principles of Medicinal Chemistry.

3. Burger‘s Medicinal Chemistry, Vol I to IV.

4. Introduction to principles of drug design- Smith and Williams.

5. Remington‘s Pharmaceutical Sciences.

6. Martindale‘s extra pharmacopoeia.

7. Organic Chemistry by I.L. Finar, Vol. II.

8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.

9. Indian Pharmacopoeia.

10. Text book of practical organic chemistry- A.I.Vogel.

410

131

BP608P PHARMACOLOGY-III (Practical) 4Hrs/Week

1. Dose calculation in pharmacological experiments

2. Antiallergic activity by mast cell stabilization assay

3. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and

NSAIDS induced ulcer model.

4. Study of effect of drugs on gastrointestinal motility

5. Effect of agonist and antagonists on guinea pig ileum

6. Estimation of serum biochemical parameters by using semi autoanalyser

7. Effect of saline purgative on frog intestine

8. Insulin hypoglycemic effect in rabbit

9. Test for pyrogens ( rabbit method)

10. Determination of acute oral toxicity (LD50) of a drug from a given data

11. Determination of acute skin irritation / corrosion of a test substance

12. Determination of acute eye irritation / corrosion of a test substance

13. Calculation of pharmacokinetic parameters from a given data

14. Biostatistics methods in experimental pharmacology( student‘s t test, ANOVA)

15. Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon

Signed Rank test)

*Experiments are demonstrated by simulated experiments/videos

Recommended Books (Latest Editions)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale‘s

Pharmacology,Churchil Livingstone Elsevier

2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc

Graw-Hill

3. Goodman and Gilman‘s, The Pharmacological Basis of Therapeutics

4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A.

K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs. The Point

Lippincott Williams & Wilkins

5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott‘s Illustrated Reviews-

Pharmacology

6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical

Publishers (P) Ltd, New Delhi.

7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher

Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,

8. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,

Kolkata,

411

132

9. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,

10. N.Udupa and P.D. Gupta, Concepts in Chronopharmacology.

BP609P HERBAL DRUG TECHNOLOGY (Practical) 4 hours/ week

1. To perform preliminary phytochemical screening of crude drugs.

2. Determination of the alcohol content of Asava and Arista

3. Evaluation of excipients of natural origin

4. Incorporation of prepared and standardized extract in cosmetic formulations like

creams, lotions and shampoos and their evaluation.

5. Incorporation of prepared and standardized extract in formulations like syrups,

mixtures and tablets and their evaluation as per Pharmacopoeial requirements.

6. Monograph analysis of herbal drugs from recent Pharmacopoeias

7. Determination of Aldehyde content

8. Determination of Phenol content

9. Determination of total alkaloids

Recommended Books: (Latest Editions)

1. Textbook of Pharmacognosy by Trease & Evans.

2. Textbook of Pharmacognosy by Tyler, Brady & Robber.

3. Pharmacognosy by Kokate, Purohit and Gokhale

4. Essential of Pharmacognosy by Dr.S.H.Ansari

5. Pharmacognosy & Phytochemistry by V.D.Rangari

6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian

Medicine & Homeopathy)

7. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of

Botanicals. Business Horizons Publishers, New Delhi, India, 2002.

412

133

SEMESTER VII

413

134

BP701T INSTRUMENTAL METHODS OF ANALYSIS (Theory) 3L + 1T / week

Scope: This subject deals with the application of instrumental methods in qualitative

andquantitative analysis of drugs. This subject is designed to impart a fundamental

knowledge on the principles and instrumentation of spectroscopic and chromatographic

technique. This also emphasizes on theoretical and practical knowledge on modern

analytical instruments that are used for drug testing.

Objectives: Upon completion of the course the student shall be able to:

1. Understand the interaction of matter with electromagnetic radiations and its

applications in drug analysis

2. Understand the chromatographic separation and analysis of drugs.

3. Perform quantitative & qualitative analysis of drugs using various analytical

instruments.

Sr.

No.

Content Hours

1. UNIT –I-UV Visible spectroscopy 10

1.1 Electronic transitions, chromophores, auxochromes, spectral shifts, solvent

effect on absorption spectra, Beer and Lambert‘s law, Derivation and

deviations.

3

1.2 Instrumentation - Sources of radiation, wavelength selectors, sample cells,

detectors-Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon

Photodiode.

2

1.3 Applications - Spectrophotometric titrations, Single component and multi

component analysis

2

1.4

Fluorimetry

Theory, Concepts of singlet, doublet and triplet electronic states, internal

and external conversions, factors affecting fluorescence, quenching,

instrumentation and applications

3

2 UNIT –II -IR spectroscopy 10

2.1 Introduction, fundamental modes of vibrations in poly atomic molecules,

sample handling, factors affecting vibrations

2

2.2 Instrumentation - Sources of radiation, wavelength selectors, detectors -

Golay cell, Bolometer, Thermocouple, Thermister, Pyroelectric detector

and applications

2

2.3 Flame Photometry-Principle, interferences, instrumentation and

applications

2

414

135

2.4 Atomic absorption spectroscopy- Principle, interferences,

instrumentation andapplications

2

2.5 Nepheloturbidometry- Principle, instrumentation and applications 2

3 UNIT –III Introduction to chromatography 10

3.1 Adsorption and partition column chromatography-

Methodology, advantages, disadvantages and applications.

4

3.2 Thin layer chromatography- Introduction, Principle, Methodology,

Rf values, advantages, disadvantages and applications.

2

3.3 Paper chromatography-Introduction, methodology, development techniques,

advantages, disadvantages and applications

2

3.4 Electrophoresis–Introduction, factors affecting electrophoretic mobility,

Techniques of paper, gel, capillary electrophoresis, applications

2

4 UNIT –IV 8

4.1 Gas chromatography - Introduction, theory, instrumentation,

derivatization,temperature programming, advantages, disadvantages and

applications

4

4.2 High performance liquid chromatography (HPLC)-Introduction,

theory,instrumentation, advantages and applications.

4

5 UNIT –V 7

5.1 Ion exchange chromatography- Introduction, classification, ion

exchange resins, properties, mechanism of ion exchange process,

factors affecting ion exchange, methodology and applications

3

5.2 Gel chromatography- Introduction, theory, instrumentation and

applications

2

5.3 Affinity chromatography- Introduction, theory, instrumentation and

applications

2

45

Reference Books:

1. Instrumental Methods of Chemical Analysis by B.K Sharma

2. Organic spectroscopy by Y.R Sharma

3. Text book of Pharmaceutical Analysis by Kenneth A. Connors

4. Vogel‘s Text book of Quantitative Chemical Analysis by A.I. Vogel

5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake

6. Organic Chemistry by I. L. Finar

7. Organic spectroscopy by William Kemp

8. Quantitative Analysis of Drugs by D. C. Garrett

9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi

10. Spectrophotometric identification of Organic Compounds by Silverstein

415

136

BP702T INDUSTRIAL PHARMACY II (Theory) 3L + 1T / week

Scope: This course is designed to impart fundamental knowledge on

pharmaceuticalproduct development and translation from laboratory to market

Objectives: Upon completion of the course, the student shall be able to:

1. Know the process of pilot plant and scale up of pharmaceutical dosage forms

2. Understand the process of technology transfer from lab scale to commercial batch

3. Know different Laws and Acts that regulate pharmaceutical industry

4. Understand the approval process and regulatory requirements for drug products

Sr.

No.

Content Hours

1. UNIT –I 10

Pilot plant scale up techniques: General considerations - including

significance ofpersonnel requirements, space requirements, raw

materials, Pilot plant scale up considerations for solids, liquid orals,

semi solids and relevant documentation, SUPAC guidelines,

Introduction to Platform technology

2 UNIT –II 10

Technology development and transfer: WHO guidelines for

Technology Transfer: Terminologies, Technology transfer protocol,

Quality risk management, Transfer from R & D to production

(Process, packaging and cleaning), Granularity of TT Process (API,

excipients, finished products, packing materials) Documentation,

Premises and equipments, qualification and validation, quality control,

analytical method transfer, Approved regulatory bodies and agencies,

Commercialization - practical aspects and problems (case studies),

TOT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /

SIDBI; Technology of Transfer (TOT) related documentation -

confidentiality agreements, licensing, MoUs, legal issues

3 UNIT –III 10

3.1 Regulatory affairs: Introduction, Historical overview of Regulatory

Affairs, Regulatoryauthorities, Role of Regulatory affairs department,

Responsibility of Regulatory Affairs Professionals

2

3.2 Regulatory requirements for drug approval: Drug Development

Teams, Non-ClinicalDrug Development, Pharmacology, Drug

Metabolism and Toxicology, General considerations of Investigational

New Drug (IND) Application, Investigator‘s Brochure (IB) and New

8

416

137

Drug Application (NDA), Clinical research / BE studies, Clinical

Research Protocols, Biostatistics in Pharmaceutical Product

Development, Data Presentation for FDA Submissions, Management

of Clinical Studies.

4 UNIT –IV 8

Quality management systems: Quality management & Certifications:

Concept ofQuality, Total Quality Management, Quality by design, Six

Sigma concept, Out of Specifications (OOS), Change control,

Introduction to ISO 9000 series of quality systems standards, ISO

14000, NABL, GLP

5 UNIT –V 7

Indian Regulatory Requirements: Central Drug Standard Control

Organization(CDSCO) and State Licensing Authority: Organization,

Responsibilities, Common Technical Document (CTD), Certificate of

Pharmaceutical Product (COPP), Regulatory requirements and

approval procedures for New Drugs.

45

Recommended Books: (Latest Editions)

1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th

April available

at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.

2. International Regulatory Affairs Updates, 2005. available at

http://www.iraup.com/about.php

3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide

for Prescription Drugs, Medical Devices, and Biologics‘ Second Edition.

4. Regulatory Affairs brought by learning plus, inc. available at

http.//www.cgmp.com/ra.htm.

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BP703T PHARMACY PRACTICE (Theory) 3L + 1T / week

Scope: In the changing scenario of pharmacy practice in India, for successful practice

ofHospital Pharmacy, the students are required to learn various skills like drug distribution,

drug information, and therapeutic drug monitoring for improved patient care. In community

pharmacy, students will be learning various skills such as dispensing of drugs, responding to

minor ailments by providing suitable safe medication, patient counselling for improved

patient care in the community set up.

Objectives: Upon completion of the course, the student shall be able to

1. know various drug distribution methods in a hospital

2. appreciate the pharmacy stores management and inventory control

3. monitor drug therapy of patient through medication chart review and clinical review

4. obtain medication history interview and counsel the patients

5. identify drug related problems

6. detect and assess adverse drug reactions

7. interpret selected laboratory results (as monitoring parameters in therapeutics) of specific

disease states

8. know pharmaceutical care services

9. do patient counseling in community pharmacy;

10. appreciate the concept of Rational drug therapy.

Sr.

No.

Content Hours

1. UNIT –I 10

1.1 Hospital and it’s organization

Definition, Classification of hospital- Primary, Secondary and Tertiary

hospitals, Classification based on clinical and non- clinical basis,

Organization Structure of a Hospital, and Medical staffs involved in the

hospital and their functions.

2

1.2 Hospital pharmacy and its organization

Definition, functions of hospital pharmacy, Organization structure,

Location, Layout and staff requirements, and Responsibilities and

functions of hospital pharmacists.

2

1.3 Adverse drug reaction

Classifications - Excessive pharmacological effects, secondary

pharmacological effects, idiosyncrasy, allergic drug reactions, genetically

determined toxicity, toxicity following sudden withdrawal of drugs, Drug

interaction- beneficial interactions, adverse interactions, and

pharmacokinetic drug interactions, Methods for detecting drug interactions,

spontaneous case reports and record linkage studies, and Adverse drug

3

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reaction reporting and management.

1.4 Community Pharmacy

Organization and structure of retail and wholesale drug store, types and

design, Legal requirements for establishment and maintenance of a drug

store, Dispensing of proprietary products, maintenance of records of retail

and wholesale drug store

3

2 UNIT –II 10

2.1 Drug distribution system in a hospital

Dispensing of drugs to inpatients, types of drug distribution systems,

charging policy and labelling, Dispensing of drugs to ambulatory patients,

and Dispensing of controlled drugs.

2

2.2 Hospital formulary

Definition, contents of hospital formulary, Differentiation of hospital

formulary and Drug list, preparation and revision, and addition and

deletion of drug from hospital formulary.

2

2.3 Therapeutic drug monitoring

Need for Therapeutic Drug Monitoring, Factors to be considered during the

Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug

Monitoring.

2

2.4 Medication adherence

Causes of medication non-adherence, pharmacist role in the medication

adherence, and monitoring of patient medication adherence.

1

2.5 Patient medication history interview

Need for the patient medication history interview, medication interview

forms.

1

2.6 Community pharmacy management

Financial, materials, staff, and infrastructure requirements.

2

3 UNIT –III 10

3.1 Pharmacy and therapeutic committee

Organization, functions, Policies of the pharmacy and therapeutic

committee in including drugs into formulary, inpatient and outpatient

prescription, automatic stop order, and emergency drug list preparation.

2

3.2 Drug information services

Drug and Poison information centre, Sources of drug information,

Computerised services, and storage and retrieval of information

1

3.3 Patient counseling

Definition of patient counseling; steps involved in patient

counseling, and Special cases that require the pharmacist

2

3.4 Education and training program in the hospital 3

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Role of pharmacist in the education and training program, Internal and

external training program, Services to the nursing homes/clinics, Code

of ethics for community pharmacy, and Role of pharmacist in the

interdepartmental communication and community health education

3.5 Prescribed medication order and communication skills

Prescribed medication order- interpretation and legal requirements, and

Communication skills- communication with prescribers and patients.

2

4 UNIT –IV 8

4.1 Budget preparation and implementation

Budget preparation and implementation

2

4.2 Clinical Pharmacy

Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions

and responsibilities of clinical pharmacist, Drug therapy monitoring -

medication chart review, clinical review, pharmacist intervention, Ward

round participation, Medication history and Pharmaceutical care

5

4.3 Over the counter (OTC) sales

Introduction and sale of over the counter, and Rational use of common

over the counter medications.

1

5 UNIT –V 7

5.1 Drug store management and inventory control

Organisation of drug store, types of materials stocked and storage

conditions, Purchase and inventory control: principles, purchase procedure,

purchase order, procurement and stocking, Economic order quantity,

Reorder quantity level, and Methods used for the analysis of the drug

expenditure

3

5.2 Investigational use of drugs

Description, principles involved, classification, control, identification, role

of hospital pharmacist, advisory committee

2

5.3 Interpretation of Clinical Laboratory Tests

Blood chemistry, hematology, and urinalysis

2

45

Recommended Books (Latest Edition):

1. Merchant S.H. and Dr. J.S.Quadry. A textbook of hospital pharmacy, 4th ed. Ahmadabad:

B.S. Shah Prakakshan; 2001.

2. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of ClinicalPharmacy

Practice- essential concepts and skills, 1sted. Chennai: OrientLongman Private Limited;

2004.

3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger; 1986.

4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.

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141

5. Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society of Health

System Pharmacists Inc; 2009.

6. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS Publishers

& Distributers; 2008.

Journals:

1. Therapeutic drug monitoring. ISSN: 0163-4356

2. Journal of pharmacy practice. ISSN : 0974-8326

3. American journal of health system pharmacy. ISSN: 1535-2900 (online)

4. Pharmacy times (Monthly magazine)

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142

BP704T NOVEL DRUG DELIVERY SYSTEMS (Theory) 3L + 1T / week

Scope: This subject is designed to impart basic knowledge on the area of novel drugdelivery

systems.

Objectives: Upon completion of the course student shall be able

1. To understand various approaches for development of novel drug delivery systems.

2. To understand the criteria for selection of drugs and polymers for the development of Novel

drug delivery systems, their formulation and evaluation

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Controlled drug delivery systems: Introduction, terminology/definitions

and rationale,advantages, disadvantages, selection of drug candidates.

Approaches to design controlled release formulations based on diffusion,

dissolution and ion exchange principles. Physicochemical and biological

properties of drugs relevant to controlled release formulations

7

1.2 Polymers: Introduction, classification, properties, advantages and

application ofpolymers in formulation of controlled release drug delivery

systems

3

2 UNIT –II 10

2.1 Microencapsulation: Definition, advantages and disadvantages,

microspheres/microcapsules, microparticles, methods of

microencapsulation, applications

3

2.2 Mucosal Drug Delivery system: Introduction, Principles of bioadhesion

/mucoadhesion, concepts, advantages and disadvantages, transmucosal

permeability and formulation considerations of buccal delivery systems

4

2.3 Implantable Drug Delivery Systems:Introduction, advantages and

disadvantages,concept of implantsand osmotic pump

3

3 UNIT –III 10

3.1 Transdermal Drug Delivery Systems: Introduction, Permeation through

skin, factorsaffecting permeation, permeation enhancers, basic components

of TDDS, formulation approaches

3

3.2 Gastroretentive drug delivery systems: Introduction, advantages,

disadvantages,approaches for GRDDS – Floating, high density systems,

inflatable and gastroadhesive systems and their applications

3

3.3 Nasopulmonary drug delivery system: Introduction to Nasal and 4

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143

Pulmonary routes ofdrug delivery, Formulation of Inhalers (dry powder and

metered dose), nasal sprays, nebulizers

4 UNIT –IV 8

Nanotechnology and its Concepts: Concepts and approaches for targeted

drug deliverysystems, advantages and disadvantages, introduction to

liposomes, niosomes, nanoparticles, monoclonal antibodies and their

applications

5 UNIT –V 7

5.1 Ocular Drug Delivery Systems: Introduction, intra ocular barriers and

methods toovercome –Preliminary study, ocular formulations and ocuserts

5

5.2 Intrauterine Drug Delivery Systems: Introduction, advantages and

disadvantages,development of intra uterine devices (IUDs) and

2

45

Recommended Books: (Latest Editions)

1. Y W. Chien, Novel Drug Delivery Systems, 2nd

edition, revised and expanded, Marcel

Dekker, Inc., New York, 1992.

2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker, Inc.,

New York, 1992.

3. Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley Interscience

Publication, John Wiley and Sons, Inc, New York. Chichester/Weinheim

4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New

Delhi, First edition 1997 (reprint in 2001).

5. S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances, Vallabh

Prakashan, New Delhi, First edition 2002.

Journals

1. Indian Journal of Pharmaceutical Sciences (IPA)

2. Indian Drugs (IDMA)

3. Journal of Controlled Release (Elsevier Sciences)

4. Drug Development and Industrial Pharmacy (Marcel & Decker)

5. International Journal of Pharmaceutics (Elsevier Sciences)

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144

BP705P INSTRUMENTAL METHODS OF ANALYSIS (Practical) 4 Hours/Week

1 Determination of absorption maxima and effect of solvents on absorption

maxima of organic compounds

2 Estimation of dextrose by colorimetry

3 Estimation of sulfanilamide by colorimetry

4 Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy

5 Assay of paracetamol by UV- Spectrophotometry

6 Estimation of quinine sulfate by fluorimetry

7 Study of quenching of fluorescence

8 Determination of sodium by flame photometry

9 Determination of potassium by flame photometry

10 Determination of chlorides and sulphates by nephelo turbidometry

11 Separation of amino acids by paper chromatography

12 Separation of sugars by thin layer chromatography

13 Separation of plant pigments by column chromatography

14 Demonstration experiment on HPLC

15 Demonstration experiment on Gas Chromatography

Recommended Books (Latest Editions)

1. Instrumental Methods of Chemical Analysis by B.K Sharma

2. Organic spectroscopy by Y.R Sharma

3. Text book of Pharmaceutical Analysis by Kenneth A. Connors

4. Vogel‘s Text book of Quantitative Chemical Analysis by A.I. Vogel

5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake

6. Organic Chemistry by I. L. Finar

7. Organic spectroscopy by William Kemp

8. Quantitative Analysis of Drugs by D. C. Garrett

9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi

10. Spectrophotometric identification of Organic Compounds by Silverstein

BP706PS PRACTICE SCHOOL 12 Hours/Week

Every candidate shall undergo practice school for a period of 150hours evenly distributed

throughout the semester. The student shall opt any one of thedomains for practice school

declared by the program committee from time to time.At the end of the practice school, every

student shall submit a printed report (in triplicate)on the practice school he/she attended (not

more than 25 pages). Along with the exams ofsemester VII, the report submitted by the student,

knowledge and skills acquired by thestudent through practice school shall be evaluated by the

subject experts at collegeleveland grade point shall be awarded.

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SEMESTER VIII

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146

BP801T BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)

3L + 1T / week

Scope: To understand the applications of Biostatics in Pharmacy. This subject deals

withdescriptive statistics, Graphics, Correlation, Regression, logistic regression Probability

theory, Sampling technique, Parametric tests, Non-Parametric tests, ANOVA, Introduction to

Design of Experiments, Phases of Clinical trials and Observational and Experimental studies,

SPSS, R and MINITAB statistical software‘s, analysing the statistical data using Excel.

Objectives: Upon completion of the course the student shall be able to:

1. Know the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of

Experiment)

2. Know the various statistical techniques to solve statistical problems

3. Appreciate statistical techniques in solving the problems

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Introduction: Statistics, Biostatistics, Frequency distribution 2

1.2 Measures of central tendency: Mean, Median, Mode- Pharmaceutical

examples

3

1.3 Measures of dispersion: Dispersion, Range, standard deviation,

Pharmaceuticalproblems

2

1.4 Correlation: Definition, Karl Pearson‘s coefficient ofcorrelation, Multiple

correlation -Pharmaceuticals examples

3

2 UNIT –II 10

2.1 Regression: Curve fitting by the method of least squares, fitting the lines y=

a + bx and x= a + by, Multiple regression, standard error of regression–

Pharmaceutical Examples

3

2.2 Probability: Definition of probability, Binomial distribution, Normal

distribution,Poisson‘s distribution, properties – problems

Sample, Population, large sample, small sample, Null hypothesis,

alternative hypothesis, sampling, essence of sampling, types of sampling,

Error-I type, Error-II type, Standard error of mean (SEM) - Pharmaceutical

examples

4

2.3 Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA,

(One wayand Two way), Least Significance difference

3

3 UNIT –III 10

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147

3.1 Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test,

Kruskal-Wallistest, Friedman Test

2

3.2 Introduction to Research: Need for research, Need for design of

Experiments,Experiential Design Technique, plagiarism

3

3.3 Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter

Plot graph

2

3.4 Designing the methodology: Sample size determination and Power of a

study, Reportwriting and presentation of data, Protocol, Cohorts studies,

Observational studies, Experimental studies, Designing clinical trial, various

phases.

3

4 UNIT –IV 8

4.1 Blocking and confounding system for Two-level factorials 2

4.2 Regression modeling: Hypothesis testing in Simple and Multiple

regressionmodels

2

4.3 Introduction to Practical components of Industrial and Clinical Trials

problems:Statistical Analysis Using Excel, SPSS, MINITAB®, DESIGN

OF EXPERIMENTS, R - Online Statistical Software‘s to Industrial and

Clinical trial approach

4

5 UNIT –V 7

5.1 Design and Analysis of experiment- Factorial Design: Definition, 22,

23design. Advantage of factorial design

3

5.2 Response Surface methodology: Central composite design, Historical

design,Optimization Techniques

4

45

Recommended Books (Latest edition):

1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton, publisher

Marcel Dekker Inc. NewYork.

2. Fundamental of Statistics – Himalaya Publishing House- S.C.Guptha

3. Design and Analysis of Experiments –PHI Learning Private Limited, R. Pannerselvam,

4. Design and Analysis of Experiments – Wiley Students Edition, Douglas and C.

Montgomery

427

148

BP802T SOCIAL AND PREVENTIVE PHARMACY 3L + 1T / week

Scope: The purpose of this course is to introduce to students a number of health issues and their

challenges. This course also introduced a number of national health programmes. The roles of

the pharmacist in these contexts are also discussed.

Objectives:After the successful completion of this course, the student shall be able to:

1. Acquire high consciousness/realization of current issuesrelated to health and pharmaceutical

problems within the country and worldwide.

2. Have a critical way of thinking based on current healthcare development.

3. Evaluate alternative ways of solving problems related tohealth and pharmaceutical issues

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Concept of health and disease: Definition, concepts and evaluation of

public health.Understanding the concept of prevention and control of

disease, social causes of diseases and social problems of the sick.

1.2 Social and health education: Food in relation to nutrition and health,

Balanced diet,Nutritional deficiencies, Vitamin deficiencies, Malnutrition

and its prevention.

1.3 Sociology and health: Socio cultural factors related to health and disease,

Impact ofurbanization on health and disease, Poverty and health

1.4 Hygiene and health: personal hygiene and health care; avoidable habits

2 UNIT –II 10

2.1 Preventive medicine: General principles of prevention and control of

diseases such ascholera, SARS, Ebola virus, influenza, acute respiratory

infections, malaria, chicken guinea, dengue, lymphatic filariasis,

pneumonia, hypertension, diabetes mellitus, cancer, drug addiction-drug

substance abuse

3 UNIT –III 10

National health programs, its objectives, functioning and outcome of

the following: HIV AND AIDS control programme, TB, Integrated disease

surveillance program (IDSP), National leprosy control programme, National

mental health program, National programme for prevention and control of

deafness, Universal immunization programme, National programme for

control of blindness, Pulse polio programme

4 UNIT –IV 8

National health intervention programme for mother and child, National

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149

family welfare programme, National tobacco control programme, National

Malaria Prevention Program, National programme for the health care for the

elderly, Social health programme; role of WHO in Indian national program

5 UNIT –V 7

Community services in rural, urban and school health: Functions of PHC,

Improvement in rural sanitation, national urban health mission, Health

promotion and education in school.

45

Recommended Books (Latest edition):

1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd

Edition, 2010, ISBN:

9789380704104, JAYPEE Publications

2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Roy Rabindra

Nath, Saha Indranil, 4th

Edition, 2013, ISBN: 9789350901878, JAYPEE Publications

3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6th

Edition,

2014, ISBN: 9789351522331, JAYPEE Publications

4. Essentials of Community Medicine—A Practical Approach, Hiremath Lalita D, Hiremath

Dhananjaya A, 2nd

Edition, 2012, ISBN: 9789350250440, JAYPEE Publications

5. Park Textbook of Preventive and Social Medicine, K Park, 21st Edition, 2011, ISBN-14:

9788190128285, BANARSIDAS BHANOT PUBLISHERS.

6. Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad

Recommended Journals:

1. Research in Social and Administrative Pharmacy, Elsevier, Ireland

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150

BP803ET PHARMACEUTICAL MARKETING MANAGEMENT(Theory) -

ELECTIVE 3L + 1T Hours / week

Scope: The pharmaceutical industry not only needs highly qualified researchers, chemists and,

technical people, but also requires skilled managers who can take the industry forward by

managing and taking the complex decisions which are imperative for the growth of the industry.

The Knowledge and Know-how of marketing management groom the people for taking a

challenging role in Sales and Product management.

Objective: The course aims to provide an understanding of marketing conceptsand techniques

and their applications in the pharmaceutical industry.

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Marketing:

Definition, general concepts, and scope of marketing; Distinction between

marketing & selling; Marketing environment; Industry and competitive

analysis; Analyzing consumer buying behavior; industrial buying behavior

1.2 Pharmaceutical market:

Quantitative and qualitative aspects; size and composition of the market;

demographic descriptions and socio-psychological characteristics of the

consumer; market segmentation& targeting. Consumer profile; Motivation

and prescribing habits of the physician; patients' choice of physician and

retail pharmacist. Analyzing the Market; Role of market research.

2 UNIT –II 10

Product decision:

Meaning, Classification, product line and product mix decisions, product

life cycle, product portfolio analysis; product positioning; New product

decisions; Product branding, packaging and labeling decisions, Product

management in pharmaceutical industry.

3 UNIT –III 10

Promotion:

Meaning and methods, determinants of promotional mix, promotional

budget; An overview of personal selling, advertising, direct mail, journals,

sampling, retailing, medical exhibition, public relations, online promotional

techniques for OTC Products.

4 UNIT –IV 8

4.1 Pharmaceutical marketing channels:

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151

Designing channel, channel members, selecting the appropriate channel,

conflict in channels, physical distribution management: Strategic

importance, tasks in physical distribution management.

4.2 Professional sales representative (PSR):

Duties of PSR, purpose of detailing, selection and training, supervising,

norms for customer calls, motivating, evaluating, compensation and future

prospects of the PSR.

5 UNIT –V 7

5.1 Pricing:

Meaning, importance, objectives, determinants of price; pricing methods

and strategies, issues in price management in pharmaceutical industry. An

overview of DPCO (Drug Price Control Order) and NPPA (National

Pharmaceutical Pricing Authority).

5.2 Emerging concepts in marketing:

Vertical & Horizontal Marketing; Rural Marketing; Consumerism;

Industrial Marketing; Global Marketing.

45

Recommended Books: (Latest Editions)

1. Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India, New

Delhi

2. Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata MC

GrawHill, New Delhi.

3. Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill

4. Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India

5. Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition)

6. Ramaswamy, U.S & Nanakamari, S: Marketing Managemnt: Global Perspective,

IndianContext, Macmilan India, New Delhi.

7. Shanker, Ravi: Service Marketing, Excell Books, New Delhi

8. Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel

Publications.

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152

BP804ETPHARMACEUTICAL REGULATORY SCIENCE (Theory) - ELECTIVE

3L + 1T Hours / week

Scope: This course is designed to impart the fundamental knowledge on the

regulatoryrequirements for approval of new drugs, and drug products in regulated markets of

India & other countries like US, EU, Japan, Australia, UK etc. It prepares the students to learn in

detail on the regulatory requirements, documentation requirements, and registration procedures

for marketing the drug products.

Objectives: Upon completion of the subject student shall be able to;

1. Know about the process of drug discovery and development

2. Know the regulatory authorities and agencies governing the manufacture and sale of

pharmaceuticals

3. Know the regulatory approval process and their registration in Indian and international

markets

Sr.

No.

Content Hours

1 UNIT I 10

New Drug Discovery and development

Stages of drug discovery, Drug development process, pre-clinical

studies, non-clinical activities, clinical studies, Innovator and generics,

Concept of generics, Generic drug product development.

2 UNIT –II 10

2.1 Regulatory Approval Process

Approval processes and timelines involved in Investigational New

Drug (IND), New Drug Application (NDA), Abbreviated New Drug

Application (ANDA) in US. Changes to an approved NDA / ANDA.

6

2.2 Regulatory authorities and agencies

Overview of regulatory authorities of United States, European Union,

Australia, Japan, Canada (Organization structure and types of

applications)

4

3 UNIT –III 10

Registration of Indian drug product in overseas market

Procedure for export of pharmaceutical products, Technical

documentation, Drug Master Files (DMF), Common Technical

Document (CTD), electronic Common Technical Document (eCTD),

ASEAN Common Technical Document (ACTD)research

4 UNIT –IV 8

Clinical trials

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153

Developing clinical trial protocols, Institutional Review Board /

Independent Ethics committee - formation and working procedures,

Informed consent process and procedures, GCP obligations of

Investigators, sponsors & Monitors, Managing and Monitoring clinical

trials, Pharmacovigilance - safety monitoring in clinical trials

5 UNIT –V 7

Regulatory Concepts

Basic terminologies, guidance, guidelines, regulations, laws and acts,

Orange book, Federal Register, Code of Federal Regulatory, Purple

book

45

Recommended books (Latest edition):

1. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.

2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert

P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health care Publishers.

3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino,

MD, 5th

edition, Drugs and the Pharmaceutical Sciences,Vol.190.

4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons.

Inc.

5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and

biologics /edited by Douglas J. Pisano, David Mantus.

6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader

Kaufer, Marcel Dekker series, Vol.143

7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A.

Rozovsky and Rodney K. Adams

8. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and

Frederick P. Ognibene

9. Drugs: From Discovery to Approval, Second Edition By Rick Ng

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154

BP805ET PHARMACOVIGILANCE (Theory) - ELECTIVE 3L + 1T Hours / week

Scope: This paper will provide an opportunity for the student to learn about development

ofpharmacovigilance as a science, basic terminologies used in pharmacovigilance, global

scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme in

an organization, various methods that can be used to generate safety data and signal detection.

This paper also develops the skills of classifying drugs, diseases and adverse drug reactions.

Objectives:

At completion of this paper it is expected that students will be able to (know, do, and

appreciate):

1. Why drug safety monitoring is important?

2. History and development of pharmacovigilance

3. National and international scenario of pharmacovigilance

4. Dictionaries, coding and terminologies used in pharmacovigilance

5. Detection of new adverse drug reactions and their assessment

6. International standards for classification of diseases and drugs

7. Adverse drug reaction reporting systems and communication in pharmacovigilance

8. Methods to generate safety data during preclinical, clinical and post approval phases of

drugs‘ life cycle

9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation

10. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India

11. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning

12. CIOMS requirements for ADR reporting

13. Writing case narratives of adverse events and their quality.

Sr. No. Content Hours

1 UNIT I 10

1.1 Introduction to Pharmacovigilance

History and development of Pharmacovigilance

Importance of safety monitoring of Medicine

WHO international drug monitoring programme

Pharmacovigilance Program of India(PvPI)

4

1.2 Introduction to adverse drug reactions

Definitions and classification of ADRs

Detection and reporting

Methods in Causality assessment

Severity and seriousness assessment

Predictability and preventability assessment

4

434

155

Management of adverse drug reactions

1.3 Basic terminologies used in pharmacovigilance

Terminologies of adverse medication related events

Regulatory terminologies

2

2 UNIT –II 10

2.1 Drug and disease classification

Anatomical, therapeutic and chemical classification of drugs

International classification of diseases

Daily defined doses

International Non proprietary Names for drugs

3

2.2 Drug dictionaries and coding in pharmacovigilance

WHO adverse reaction terminologies

MedDRA and Standardised MedDRA queries

WHO drug dictionary

Eudravigilance medicinal product dictionary

3

2.3 Information resources in pharmacovigilance

Basic drug information resources

Specialised resources for ADRs

2

2.4 Establishing pharmacovigilance programme

Establishing in a hospital

Establishment & operation of drug safety department in industry

Contract Research Organisations (CROs)

Establishing a national programme

2

3 UNIT –III 10

3.1 Vaccine safety surveillance

Vaccine Pharmacovigilance

Vaccination failure

Adverse events following immunization

3

3.2 Pharmacovigilance methods

Passive surveillance – Spontaneous reports and case series

Stimulated reporting

Active surveillance – Sentinel sites, drug event monitoring and

registries

Comparative observational studies – Cross sectional study, case

control study and cohort study

Targeted clinical investigations

5

435

156

Recommended Books (Latest edition):

1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.

2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett

Publishers.

3.3 Communication in pharmacovigilance

Effective communication in Pharmacovigilance

Communication in Drug Safety Crisis management

Communicating with Regulatory Agencies, Business Partners,

Healthcare facilities & Media

2

4 UNIT –IV 8

4.1 Statistical methods for evaluating medication safety data Safety

data generation

Preclinical phase

Clinical phase

Post approval phase

3

4.2 ICH Guidelines for Pharmacovigilance

Organization and objectives of ICH

Expedited reporting

Individual case safety reports

Periodic safety update reports

Post approval expedited reporting

Pharmacovigilance planning

Good clinical practice in pharmacovigilance studies

5

5 Unit V 7

5.1 Pharmacogenomics of adverse drug reactions

Genetics related ADR with example focusing PK parameters

3

5.2 Drug safety evaluation in special population

Paediatrics

Pregnancy and lactation

Geriatrics

2

5.3 CIOMS

CIOMS Working Groups

CIOMS Form

1

5.4 CDSCO (India) and Pharmacovigilance

D&C Act and Schedule Y

Differences in Indian and global pharmacovigilance requirements

1

45

436

157

3. Mann's Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.

4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley

Publishers.

5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.

6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones& Bartlett

Publishers.

7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean

Hennessy,Wiley Publishers.

8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi,

Karin NyfortHansen,Milap C. Nahata

9. National Formulary of India

10. Text Book of Medicine by Yashpal Munjal

11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna

12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn3=7297

13. http://www.ich.org/

14. http://www.cioms.ch/

15. http://cdsco.nic.in/

16. http://www.who.int/vaccine_safety/en/

17. http://www.ipc.gov.in/PvPI/pv_home.html

437

158

BP806ETQUALITY CONTROL AND STANDARDIZATION OF HERBALS (Theory)–

ELECTIVE 3L + 1T Hours / week

Scope: In this subject the student learns about the various methods and guidelines forevaluation

and standardization of herbs and herbal drugs. The subject also provides anopportunity for the

student to learn cGMP, GAP and GLP in traditional system ofmedicines.

Objectives: Upon completion of the subject student shall be able to;

1. know WHO guidelines for quality control of herbal drugs

2. know Quality assurance in herbal drug industry

3. know the regulatory approval process and their registration in Indian and

international markets

4. appreciate EU and ICH guidelines for quality control of herbal drugs

Sr.

No.

Content Hours

1 UNIT I 10

Basic tests for drugs – Pharmaceutical substances, Medicinal plants

materials and dosage forms

WHO guidelines for quality control of herbal drugs.

Evaluation of commercial crude drugs intended for use

2 UNIT –II 10

2.1 Quality assurance in herbal drug industry of cGMP, GAP, GMP

and GLP intraditional system of medicine

6

2.2 WHO Guidelines on current good manufacturing Practices (cGMP) for

Herbal Medicines WHO Guidelines on GACP for Medicinal Plants.

4

3 UNIT –III 10

EU and ICH guidelines for quality control of herbal drugs.

Research Guidelines for Evaluating the Safety and Efficacy of Herbal

Medicines

4 UNIT –IV 8

Stability testing of herbal medicines. Application of various

chromatographic techniques in standardization of herbal products.

Preparation of documents for new drug application and export

registration

GMP requirements and Drugs & Cosmetics Act provisions.

5 UNIT –V 7

Regulatory requirements for herbal medicines.

438

159

WHO guidelines on safety monitoring of herbal medicines in

pharmacovigilance systems

Comparison of various Herbal Pharmacopoeias.

Role of chemical and biological markers in standardization of herbal

products

45

Recommended Books: (Latest Editions

1. Pharmacognosy by Trease and Evans

2. Pharmacognosy by Kokate, Purohit and Gokhale

3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub.,

2006.

4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.

5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal Products,

6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of

Botanicals. Business Horizons Publishers, New Delhi, India, 2002.

7. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles

to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8.

8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health Organization,

Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal Medicines. WHO

Regional Publications, Western Pacific Series No 3, WHO Regional office for the Western

Pacific, Manila, 1998.

9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn. World

Health Organization, Geneva, 1981.

10. WHO. Quality Control Methods for Medicinal Plant Materials. World Health

Organization, Geneva, 1999.

11. WHO. WHO Global Atlas of Traditional, Complementary and Alternative

Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health

Organization, Geneva, 2005.

12. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for

Medicinal Plants. World Health Organization, Geneva, 2004

439

160

BP807ET COMPUTER AIDED DRUG DESIGN (Theory)- ELECTIVE

3L + 1T / week

Scope: This subject is designed to provide detailed knowledge of rational drug designprocess

and various techniques used in rational drug design process.

Objectives: Upon completion of the course, the student shall be able to understand

1. Design and discovery of lead molecules

2. The role of drug design in drug discovery process

3. The concept of QSAR and docking

4. Various strategies to develop new drug like molecules.

5. The design of new drug molecules using molecular modelling software

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Introduction to Drug Discovery and Development

Stages of drug discovery and development

2

1.2 Lead discovery and Analog Based Drug Design

Rational approaches to lead discovery based on traditional medicine,

Random screening, Non-random screening, serendipitous drug

discovery, lead discovery based on drug metabolism, lead discovery

based on clinical observation.

4

1.3 Analog Based Drug Design:Bioisosterism, Classification,

Bioisostericreplacement. Any three case studies

4

2 UNIT –II 10

Quantitative Structure Activity Relationship (QSAR)

SAR versus QSAR, History and development of QSAR, Types of

physicochemical parameters, experimental and theoretical approaches

for the determination of physicochemical parameters such as Partition

coefficient, Hammet‘s substituent constant and Tafts steric constant.

Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like

COMFA and COMSIA.

3 UNIT –III - Molecular Modeling and virtual screening techniques 10

3.1 Virtual Screening techniques: Drug likeness screening, Concept

ofpharmacophore mapping and pharmacophore based Screening,

6

3.2 Molecular docking: Rigid docking, flexible docking, manual

docking,Docking based screening. De novo drug design.

4

4 UNIT –IV 8

Informatics & Methods in drug design

440

161

Introduction to Bioinformatics, chemoinformatics. ADME databases,

chemical, biochemical and pharmaceutical databases.

5 UNIT –V 7

Molecular Modeling: Introduction to molecular mechanics and

quantummechanics. Energy Minimization methods and

Conformational Analysis, global conformational minima

determination.

45

Recommended Books (Latest Editions)

1. Robert GCK, ed., ―Drug Action at the Molecular Level‖ University Prak Press

Baltimore.

2. Martin YC. ―Quantitative Drug Design‖ Dekker, New York.

3. Delgado JN, Remers WA eds ―Wilson & Gisvolds‘s Text Book of Organic

Medicinal & Pharmaceutical Chemistry‖ Lippincott, New York.

4. Foye WO ―Principles of Medicinal chemistry ‗Lea & Febiger.

5. Koro lkovas A, Burckhalter JH. ―Essentials of Medicinal Chemistry‖ Wiley

Interscience.

6. Wolf ME, ed ―The Basis of Medicinal Chemistry, Burger‘s Medicinal Chemistry‖

John Wiley & Sons, New York.

7. Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University

Press.

8. Smith HJ, Williams H, eds, ―Introduction to the principles of Drug Design‖

Wright Boston.

9. Silverman R.B. ―The organic Chemistry of Drug Design and Drug Action‖

Academic Press New York.

441

162

BP808ET CELL AND MOLECULAR BIOLOGY (Theory)- ELECTIVE

3L + 1T / week

Scope:

Cell biology is a branch of biology that studies cells – their physiological properties, their

structure, the organelles they contain, interactions with their environment, their life cycle,

division, death and cell function.

This is done both on a microscopic and molecular level.

Cell biology research encompasses both the great diversity of single-celled organisms like

bacteria and protozoa, as well as the many specialized cells in multi-cellular organismssuch

as humans, plants, and sponges.

Objectives: Upon completion of the subject student shall be able to;

1. Summarize cell and molecular biology history.

2. Summarize cellular functioning and composition.

3. Describe the chemical foundations of cell biology.

4. Summarize the DNA properties of cell biology.

5. Describe protein structure and function.

6. Describe cellular membrane structure and function.

7. Describe basic molecular genetic mechanisms.

8. Summarize the Cell Cycle

Sr.

No.

Content Hours

1 UNIT I 10

a) Cell and Molecular Biology: Definitions theory and basics and

Applications.

b) Cell and Molecular Biology: History and Summation.

c) Theory of the Cell? Properties of cells and cell membrane.

d) Prokaryotic versus Eukaryotic

e) Cellular Reproduction

f) Chemical Foundations – an Introduction and Reactions (Types)

2 UNIT –II 10

a) DNA and the Flow of Molecular Structure

b) DNA Functioning

c) DNA and RNA

d) Types of RNA

e) Transcription and Translation

442

163

3 UNIT –III 10

a) Proteins: Defined and Amino Acids

b) Protein Structure

c) Regularities in Protein Pathways

d) Cellular Processes

e) Positive Control and significance of Protein Synthesis

4 UNIT –IV 8

a) Science of Genetics

b) Transgenics and Genomic Analysis

c) Cell Cycle analysis

d) Mitosis and Meiosis

e) Cellular Activities and Checkpoints

5 UNIT –V 7

a) Cell Signals: Introduction

b) Receptors for Cell Signals

c) Signaling Pathways: Overview

d) Misregulation of Signaling Pathways

e) Protein-Kinases: Functioning

45

Recommended Books (latest edition):

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific

publications, Oxford London.

2. Prescott and Dunn., Industrial Microbiology, 4th

edition, CBS Publishers &

Distributors, Delhi.

3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.

4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.

5. Rose: Industrial Microbiology.

6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan

7. Cooper and Gunn‘s: Tutorial Pharmacy, CBS Publisher and Distribution.

8. Peppler: Microbial Technology.

9. Edward: Fundamentals of Microbiology.

10. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi

11. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly

company

12. B.R. Glickand J.J. Pasternak: Molecular Biotechnology: Principles and

Applications of RecombinantDNA: ASM Press Washington D.C.

13. R. A Goldshy et. al.,: Kuby Immunology

443

164

BP809ET COSMETIC SCIENCE (Theory) - ELECTIVE 3L + 1T / week

Sr.

No.

Content Hours

1 UNIT I 10

1.1 Classification of cosmetic and cosmeceutical products

Defination of cosmetics as per Indian and EU regulations, Evolution of

cosmoceuticals from cosmetics,cosmetics as quasi and OTC drugs

2

1.2 Cosmetic excipients: Surfactants, rheology modifiers, humectants,

emollients,preservatives. Classification and application

Skin: Basic structure and function of skin.

Hair: Basic structure of hair. Hair growth cycle

Oral Cavity: Common problem associated with teeth and gums.

8

2 UNIT –II 10

2.1 Principles of formulation and building blocks of skin care

products:

Face wash, Moisturizing cream, Cold Cream, Vanishing cream their

relative skin sensory, advantages and disadvantages. Application of

these products in formulation of cosmecuticals.

5

Principles of formulation and building blocks of Hair care

products:

Conditioning shampoo, Hair conditioners,antidandruff shampoo.

Hair oils.

Chemistry and formulation of Para-phylene diamine based hair dye.

Principles of formulation and building blocks of oral care products:

Toothpaste for bleeding gums, sensitive teeth. Teeth whitening,

Mouthwash

5

3 UNIT –III 10

3.1 Sun protection, Classification of Sunscreens and SPF 2

3.2 Role of herbs in cosmetics:

Skin Care: Aloe and turmeric

Hair care: Henna and amla.

Oral care: Neem and clove

6

3.3 Analytical cosmetics: BIS specification and analytical methods for

shampoo, skin-cream and toothpaste

2

4 UNIT –IV 8

Principles of Cosmetic Evaluation: Principles of sebumeter,

corneometer. Measurement of TEWL, Skin Color, Hair tensile strength,

444

165

Hair combing properties Soaps,and syndet bars. Evolution and skin

beneits.

5 UNIT –V 7

Oily and dry skin, causes leading to dry skin, skin moisturisation.

Basic understanding of the terms Comedogenic, dermatitis.

Cosmetic problems associated with Hair and scalp: Dandruff,

Hair fall causes

Cosmetic problems associated with skin: blemishes, wrinkles,

acne, prickly heat and body odor.

Antiperspirants and Deodorants- Actives and mechanism of action

45

References

1. Harry‘s Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin.

2. Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th

Edition,

Vandana Publications Pvt. Ltd., Delhi.

3. Text book of cosmelicology by Sanju Nanda & Roop K. Khar, Tata Publishers.

445

166

BP810ET EXPERIMENTAL PHARMACOLOGY- ELECTIVE 3L + 1T/ week

Scope:This subject is designed to impart the basic knowledge of preclinical studies

inexperimental animals including design, conduct and interpretations of results.

Objectives: Upon completion of the course the student shall be able to,

1. Appreciate the applications of various commonly used laboratory animals.

2. Appreciate and demonstrate the various screening methods used in preclinical research

3. Appreciate and demonstrate the importance of biostatistics and research methodology

4. Design and execute a research hypothesis independently

Sr.

No.

Content Hours

1 UNIT I 8

Laboratory Animals:

Study of CPCSEA and OECD guidelines for maintenance,

breeding and conduct of experiments on laboratory animals,

Common lab animals: Description and applications of different

species and strains of animals. Popular transgenic and mutant

animals.

Techniques for collection of blood and common routes of

drug administration in laboratory animals, Techniques of blood

collection and euthanasia

2 UNIT –II 13

2.1 Preclinical screening models

a. Introduction: Dose selection, calculation and conversions,

preparation of drug solution/suspensions, grouping of animals

and importance of sham negative and positive control groups.

Rationale for selection of animal species and sex for the study.

b. Study of screening animal models for

Diuretics, nootropics, anti-Parkinson‘s,antiasthmatics,

6

2.2 Preclinical screening models: for CNS activity- analgesic,antipyretic,

anti-inflammatory, general anaesthetics, sedative and hypnotics,

antipsychotic, antidepressant, antiepileptic, antiparkinsonism,

alzheimer‘s disease

7

3 UNIT –III 12

Preclinical screening models: for ANS activity, sympathomimetics,

sympatholytics, parasympathomimetics, parasympatholytics, skeletal

muscle relaxants, drugs acting on eye, local anaethetics

446

167

4 UNIT –IV 12

4.1 Preclinical screening models: for CVS activity- antihypertensives,

diuretics, antiarrhythmic, antidyslepidemic, anti aggregatory,

coagulants, and anticoagulants

Preclinical screening models for other important drugs like antiulcer,

antidiabetic, anticancer and antiasthmatics.

6

4.2 Research methodology and Bio-statistics

Selection of research topic, review of literature, research hypothesis

and study design

Pre-clinical data analysis and interpretation using Student‘s ‗t‘ test and

One-way ANOVA. Graphical representation of data

6

Recommended Books (latest edition):

1. Fundamentals of experimental Pharmacology-by M.N.Ghosh

2. Hand book of Experimental Pharmacology-S.K.Kulakarni

3. CPCSEA guidelines for laboratory animal facility.

4. Drug discovery and Evaluation by Vogel H.G.

5. Drug Screening Methods by Suresh Kumar Gupta and S. K. Gupta

6. Introduction to biostatistics and research methods by PSS Sundar Rao and J Richard

447

168

BP8011ETADVANCED INSTRUMENTATION TECHNIQUES (Theory) –

ELECTIVE3L + 1T / week

Scope: This subject deals with the application of instrumental methods in qualitative

andquantitative analysis of drugs. This subject is designed to impart advanced knowledge

on the principles and instrumentation of spectroscopic and chromatographic hyphenated

techniques. This also emphasizes on theoretical and practical knowledge on modern

analytical instruments that are used for drug testing.

Objectives: Upon completion of the course the student shall be able to

1. understand the advanced instruments used and its applications in drug analysis

2. understand the chromatographic separation and analysis of drugs.

3. understand the calibration of various analytical instruments

4. know analysis of drugs using various analytical instruments

Sr. No. Content Hours

1 UNIT I 10

1.1 Nuclear Magnetic Resonance spectroscopy

Principles of H-NMR and C-NMR, chemical shift, factors affecting

chemical shift, coupling constant, Spin - spin coupling, relaxation,

instrumentation and applications

1.2 Mass Spectrometry- Principles, Fragmentation, Ionization techniques–

Electron impact, chemical ionization, MALDI, FAB, Analyzers-Time of

flight and Quadrupole, instrumentation, applications

2 UNIT –II 10

2.1 Thermal Methods of Analysis: Principles, instrumentation and applications

of ThermogravimetricAnalysis (TGA), Differential Thermal Analysis

(DTA), Differential Scanning Calorimetry (DSC)

2.2 X-Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X-

ray Crystallography, rotating crystal technique, single crystal

diffraction,powder diffraction, structural elucidation and applications.

3 UNIT –III 10

3.1 Calibration and validation-as per ICH and USFDA guidelines

3.2 Calibration of following Instruments- Electronic balance,

UV-Visible spectrophotometer, IR spectrophotometer, Fluorimeter, Flame

Photometer, HPLC and GC

4 UNIT –IV 8

4.1 Radio immune assay:Importance, various components, Principle, different

methods, Limitation and Applications of Radio immuno assay

4.2 Extraction techniques:General principle and procedure involved in the

solid phase extraction and liquid-liquid extraction

5 UNIT-V 7

448

169

Hyphenated techniques-LC-MS/MS, GC-MS/MS, HPTLC-MS.

Total 45

Recommended Books (Latest Editions)

1. Instrumental Methods of Chemical Analysis by B.K Sharma

2. Organic spectroscopy by Y.R Sharma

3. 3. Text book of Pharmaceutical Analysis by Kenneth A. Connors

4. Vogel‘s Text book of Quantitative Chemical Analysis by A.I. Vogel

5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake

6. Organic Chemistry by I. L. Finar

7. Organic spectroscopy by William Kemp

8. Quantitative Analysis of Drugs by D. C. Garrett

9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi

10. Spectrophotometric identification of Organic Compounds by Silverstein

449

170

BP8012ET DIETARY SUPPLEMENTS AND NUTRACEUTICALS (Theory)

- ELECTIVE

3L + 1T/ Week

Scope: This subject covers foundational topic that are important for understanding the

need and requirements of dietary supplements among different groups in the population.

Objective: This module aims to provide an understanding of the concepts behind the

theoretical applications of dietary supplements. By the end of the course, students should

be able to:

1. Understand the need of supplements by the different group of people to

maintain healthy life.

2. Understand the outcome of deficiencies in dietary supplements.

3. Appreciate the components in dietary supplements and the application.

4. Appreciate the regulatory and commercial aspects of dietary supplements

including health claims.

Sr. No. Content Hours

1 UNIT I 10

a) Definitions of Functional foods, Nutraceuticals and Dietary supplements.

Classification of Nutraceuticals, Health problems and diseases that can be

prevented or cured by Nutraceuticals i.e. weight control, diabetes, cancer,

heart disease, stress, osteoarthritis,

hypertension etc.

b) Public health nutrition, maternal and child nutrition, nutrition and

ageing, nutrition education in community.

c) Source, Name of marker compounds and their chemical nature,

Medicinal uses and health benefitsof following used as

nutraceuticals/functional foods: Spirulina, Soyabean, Ginseng, Garlic,

Broccoli, Gingko, Flaxseeds.

2 UNIT –II 10

450

171

Phytochemicals as nutraceuticals: Occurrence and characteristic

features(chemical nature medicinal benefits) of following:

a) Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin

b) Sulfides: Diallyl sulfides, Allyl trisulfide.

c) Polyphenolics: Reservetrol

d) Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins,

Flavones

e) Prebiotics / Probiotics.: Fructo oligosaccharides, Lacto bacillum

f) Phyto estrogens : Isoflavones, daidzein, Geebustin, lignans

g) Tocopherols

h) Proteins, vitamins, minerals, cereal, vegetables and beverages as

functional foods: oats, wheat bran, rice bran, sea foods, coffee, tea and

the like.

3 UNIT –III 10

a) Introduction to free radicals: Free radicals, reactive oxygen species,

production of free radicals in cells, damaging reactions of free radicals on

lipids, proteins, Carbohydrates, nucleic acids.

b) Dietary fibres and complex carbohydrates as functional food

ingredients..

4 UNIT –IV 8

a) Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion

injury, Cancer, Atherosclerosis, Free radicals in brain metabolism and

pathology, kidney

damage, muscle damage. Free radicals involvement in other disorders. Free

radicals theory of ageing.

b) Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic

antioxidant defence, Superoxide dismutase, catalase, Glutathione

peroxidase, Glutathione Vitamin C, Vitamin E, α- Lipoic acid, melatonin

Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy

Anisole.

c) Functional foods for chronic disease prevention

5 UNIT-V 7

a) Effect of processing, storage and interactions of various environmental

factors on the potential of nutraceuticals.

b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and

GMPs on Food Safety. Adulteration of foods.

c) Pharmacopoeial Specifications for dietary supplements and

nutraceuticals.

References:

1. Dietetics by Sri Lakshmi

451

172

2. Role of dietary fibres and neutraceuticals in preventing diseases by K.T Agusti and

3. P.Faizal: BSPunblication.

4. Advanced Nutritional Therapies by Cooper. K.A., (1996).

5. The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988).

6. Prescription for Nutritional Healing by James F.Balch and Phyllis A.Balch 2 nd Edn.,

7. Avery Publishing Group, NY (1997).

8. G. Gibson and C.williams Editors 2000 Functional foods Woodhead Publ.Co.London.

9. Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.

10. Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety, Good

11. Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional

12. Foods M.K. Sachmidl and T.P. Labuza eds. Aspen Press.

13. Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)

14. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease.

15. Eighth edition. Lea and Febiger

452

173

BP803ETPHARMACEUTICAL PRODUCT DEVELOPMENT(Theory)ELECTIVE

3L + 1T/ WEEK

Sr.

No.

Topic Hours

1 UNIT I 10

1.1 Introduction to pharmaceutical product development, objectives,

regulations related to preformulation, formulation development,

stability assessment, manufacturing and quality control testing of

different types of dosage forms

2 UNIT –II 10

2.1 An advanced study of Pharmaceutical Excipients in pharmaceutical

product development with a special reference to the following

categories

i. Solvents and solubilizers

ii. Cyclodextrins and their applications

iii. Non - ionic surfactants and their applications

iv. Polyethylene glycols and sorbitols

v. Suspending and emulsifying agents

vi. Semi solid excipients

3 UNIT –III 10

3.1 An advanced study of Pharmaceutical Excipients in pharmaceutical

product development with a special reference to the following

categories

i. Tablet and capsule excipients

ii. Directly compressible vehicles

iii. Coat materials

iv. Excipients in parenteral and aerosols products

v. Excipients for formulation of NDDS

Selection and application of excipients in pharmaceutical formulations

with specific industrial applications

4 UNIT –IV 8

Optimization techniques in pharmaceutical product development.A

study of various optimization techniques for pharmaceutical product

development with specific examples.Optimization by factorial designs

and their applications.A study of QbD and its application in

pharmaceutical product development.

5 UNIT-V 7

Selection and quality control testing of packaging materials for

pharmaceutical product development- regulatory considerations.

Total 45

453

174

Recommended Books (Latest editions)

1. Pharmaceutical Statistics Practical and Clinical Applications by Stanford Bolton,

CharlesBon; Marcel Dekker Inc.

2. Encyclopedia of Pharmaceutical Technology, edited by James swarbrick, Third

Edition,Informa Healthcare publishers.

3. Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman

andLeon Lachman; Marcel Dekker, Inc.

4. The Theory and Practice of Industrial Pharmacy, Fourth Edition, edited by Roop

kKhar, S P Vyas, Farhan J Ahmad, Gaurav K Jain; CBS Publishers and Distributors

Pvt.Ltd. 2013.

5. Martin‘s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by

Patrick J. Sinko, BI Publications Pvt. Ltd.

6. Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and R.

K.Khar, CBS Publishers and Distributors Pvt. Ltd, First Edition 2012.

7. Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen Jr.,

Nicholas B.Popovich, Howard C. Ansel, 9th Ed. 40

8. Aulton‘s Pharmaceutics – The Design and Manufacture of Medicines, Michael E.

Aulton,3rd Ed.

9. Remington – The Science and Practice of Pharmacy, 20th Ed.

10. Pharmaceutical Dosage Forms – Tablets Vol 1 to 3, A. Liberman, Leon Lachman

andJoseph B. Schwartz

11. Pharmaceutical Dosage Forms – Disperse Systems Vol 1 to 3, H.A. Liberman, Martin,

M.R and Gilbert S. Banker.

12. Pharmaceutical Dosage Forms – Parenteral Medication Vol 1 & 2, Kenneth E. Avis

andH.A. Libermann.

13. Advanced Review Articles related to the topics.

BP814PW PROJECT WORK 12 Hours/Week

Project is a requirement for the B. Pharm. degree, wherein under the guidance of a faculty

member, a group of not more than five learners in the eighth semester, is required to do

some innovative work with the application of knowledge gained while learning various

courses in the earlier years. The area of the project shall directly relate any one of the

elective subject opted by the student in semester VIII. The learner/s is/are expected to do a

survey of literature in the subject, work out a Project plan and carry it out through survey,

experimentation and/or modeling / computation. Through the Project work the learner has

to exhibit skills for both analysis and critical thinking. The complete details of the project

have to submitted as a report of not less than 25 pages (A4, 1 inch margins, single line

space, font Times Roman, font size 12, excluding count of reference pages) to the College

before the prescribed date. The credits assigned for Project is 6 credits.

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Shri. Yashwantrao Bhonsale Education Society’s

YASHWANTRAO BHONSALE COLLEGE OF PHARMACY

Bldg. No. 02, BKC, A/ P: Charathe - Vazarwadi, Tal: Sawantwadi, Dist.: Sindhudurg, Maharashtra- 416 510

Approved by AICTE, PCI, New Delhi, Govt. of Maharashtra, DTE. Affiliated to Mumbai University (B. Pharm, M. Pharm)

and MSBTE (D. Pharm) DTE Code: 3480; University Code: 1027; MSBTE Code: 1878

www.sybespharmacy.com +912363-272233/272299 Email:ybpharmacy@gmail.com

Mr. Achyut K. Sawantbhonsale Dr. Vijay A. Jagtap

Executive Chairman Principal

Academic Year Wise list of

Courses

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