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Course Title PHARMACEUTICAL TECHNOLOGY II

Course Code PH601

Course Credit

Lecture : 3

Practical : 3

Tutorial : 0

Total : 6

Course Objectives

On the completion of the course, students will be able to:

Understand the basic concepts of formulation, labeling, packing of different types of

pharmaceutical dosage forms.

To understand theory, preparation and evaluation of oral solid Formulation.

Students should be able to formulate and evaluate tablet, capsule and microsphere like

preparation.

Detailed Syllabus

Sr. No.

Name of Chapter & Details Hours Allotted

Section-I

1 Tablet: 06

Definition, Advantages and disadvantages, Introduction to types of

tablets.

Pharmaceutical Tablet Compression Tooling: Terminology, tablet design,

specification and information required, use and care of the tooling.

Compaction and Compression:

Objectives, theory, process of compression, effect of compressional force

on powders/granules. Heckel and Kawakita equations.

2 Formulation of different types of tablets: excipients, granulation

techniques, machinery for large scale granulation and compression, In

process controls, processing problems and remedies.

Evaluation (Pharmacopoeial and nonpharmacopoeial test) and

equipments. Standard regulatory criteria for weight uniformity test,

content uniformity test, hardness test, friability test, disintegration test

and disolution test.

08

3 Coating of Tablets: objectives, types of coating, film forming materials,

formulations of coating solution, equipments for coating, coating

process, evaluation of coated tablets, coating defects, specialized coating

processes.

04

4 Pharmaceutical Packaging and Labeling:

Definition, Packaging components, types, specifications and methods of

evaluation, stability aspects of packing. Primary and secondary

packaging, packaging materials, containers and closures; and tamper-

evident packaging, packaging equipments. Regulatory requirements in

05

pharmaceutical packaging.

Section-II

5 Hard Gelatin Capsules:

Definitions, Advantages, disadvantages, Ideal requirements, Production

of Hard capsules (Gelatin and nongelatin e.g. vegetable), Capsule

storage, size of capsules, formulation and methods of capsule filling,

problems and remeadies, quality control, climatic control in capsule

department, I.P capsules.



content uniformity test, disintegration test and disolution test.

07

6 Soft Gelatin Capsules:

Formulation of shell and capsule coat, quality control with special

emphasis on current dissolution testing.



content uniformity test, disintegration test and disolution test.

07

7 Microcapsules/Microspheres:

Importance of microcapsule and microsphere in pharmacy, methods of

preparation: Phase separation, coacervation, multiorifice centrifugal

methods, spray congelling, polymerisation, complex emulsion, Air

suspension technique, coating pan and other techniques, evaluation of

microcapsules, Applications of biodegradable and nonbiodegradable

polymers in Microcapsules/Microspheres.

04

8 Extrusion and Pelletization : 04

Factgors affecting pellet properties, Cold extrusion, Melt extrusion,

Applications of extrusion in pharmacy (including preparation of solid

solution), selective equipments used for extrusion and pelletization, Use

of polyethylene oxide and Eudragit in melt extrusion, Use of MCC in

pelletization, evaluation of pellet.

Pharmaceutical Technology II (Practical)

1. Filling of powder/ granules/ pellets in hard gelatin capsule and its evaluation.

2. Preparation of microcapsules by simple coacervation method.

3. Preparation and evaluation of microsphere.

4. Prepare and evaluate granule ready for directly compression.

5. Prepare and evaluate granule by wet granulation method using different binder solution.

6. Preparation and evaluation of effervescent tablet.

7. Preparation and evaluation of ferrous sulphate tablet.

8. Preparation and evaluation of paracetamol tablet.

9. Preparation and evaluation of tablets employing direct compression.

10. Preparation and evaluation of tablets employing wet granulation.

11. Preparation and evaluation of tablets employing compression coating.

12. Preparation and evaluation of pellet.

13. Preparation and evaluation of coated tablet by dip coating process.

14. Other practicals covering syllabus aspects.

Instructional Method and Pedagogy:

Lectures will be conducted with the aid of multi-media projector, black board, OHP etc.

Assignments based on course content will be given to the students at the end of each

unit/topic and will be evaluated at regular interval.

Surprise tests/Quizzes/Seminar/Tutorials will be conducted.

The course includes a laboratory, where students have an opportunity to build an

appreciation for the concepts being taught in lectures.

Students Learning Outcomes:

By the end of this course, the student should have a good understanding of basic process

which are used in different stage during preparation of pharmaceutical formulation.

Students should be able to know formulation, labeling, and packing of different types of

pharmaceutical products.

Text Books:

1. The Theory and Practice of Industrial Pharmacy by L Lachman, H Lieberman and J

Kanig.

2. Pharmaceutical Dosage Forms and Drug Delivery Systems by Ansel & others.

3. Advances In Controlled And Novel Drug Delivery, N.K. Jain, CBS publication New Delhi.

4. Handbook Of Pharmaceutical Technology by Ghosh Lk, Cbs Publishers & Distributors.

5. Pharmaceutical Technology by Sambamurthy, New Age publication.

Reference Books:

1. The Science & Practice of Pharmacy: A. G. Remington; Lippincott, Philadelphia.

2. Pharmaceutical Dosage Forms: Tablets: Vol.1, Vol. 2 and Vol.3, Ed. by Lieberman, Leon

Lachman and Joseph B. Schwartz, Marcel Dekker Inc., New York.

3. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes, Marcel

Dekker, Inc., New York.

4. Pharmaceutics: The Science of Dosage Form Design by Michael E. Aulton.

5. Pharmaceutical Product Development by N.K. Jain, CBS publication New Delhi.

Additional Resources

Soft copies of pharmaceutical technology books are available on

http://www.pharmatext.org, www.pharmacyebooks.com, and in

www.pharmamirror.com.

Latest information regarding pharmaceutical technology are available on

http://www.pharmainfo.net

Study material of pharmaceutical technology are available on mypharmaguide.com,

pharmatutor.com, authorstream.com, slideworld.com and in scribd.com .

Review articles published in international journal covering syllabus aspect.

Course Title BIOPHARMACEUTICS AND BIOSTATISTICS

Course Code PH612

Course Credit

Lecture : 3

Practical : 0

Tutorial : 0

Total : 3

Course Objectives


Understand basic aspects of Biopharmaceutics & Pharmacokinetics of the drugs.

Know absorption, distribution, metabolism & elimination (ADME) process of drugs occur

and various factors which influence on them in body.

Students should be able to learn Pharmacokinetics aspects of drugs and its significance.

Apply statastics in pharmaceutics, pharmacology, pharma chemistry and in pharma

cognosy field.

Detailed Syllabus

Sr. No.


Section-I

1 Biopharmaceutics:

Introduction to biopharmaceutics and its role in formulation

development, Passage of drugs across biological barriers (passive

diffusion, active transport, facilitated diffusion and pinocytosis), Factors

influencing absorption- physiochemical, physiological and

pharmaceutical, Drug distribution in the body, plasma protein binding and

drug excretion.

09

2 Bioavailability and Bioequivalence:

Measures of bioavailability, Cmax, tmax and area under the curve (AUC),

Design of single dose bio-equivalence study and relevant statistics, Review

of regulatory requirements for conduction of bio-equivalent studies.

05

3 Pharmacokinetics:

Definition and scope, significance of plasma drug concentration

measurement, Volume of distribution and distribution coefficient,

Determination of pharmacokinetic parameters from plasma and urine

data after drug administration by intra vascular and oral route, clearance

concept, mechanism of renal clearance, clearance ratio, determination of

renal clearance, hepatic elimination of drugs, first pass effect, extraction

ratio, hepatic clearance, biliary excretion, extrahepatic circulation.

Compartment model: Phamacokinetics of drug absorption, zero order

and first order absorption rate constant using Wagner- Nelson and Loo-

Riegelman method, compartment kinetics of one compartment and two

compartment models, curve fitting (Method of Residuals), regression

procedures, non-linear pharmacokinetics with special reference to one

compartment model after I.V. drug administration, michaeles menten

equation, detection of nonlinearity (saturation mechanism), numericals

08

related to pharmacokinetic parameters using one compartmental model.

Section-II

4 Basics of statistics like mean, median, mode and standard deviation. 02

5 Sample and sampling methods:

Introduction, sample and population, importance of sampling, sample and

its characteristics. Sampling methods - Simple random sampling – lottery

method and random number tables; stratified random sampling;

systematic sampling; multistage sampling; cluster sampling. Sampling with

and without replacement, sampling distribution, standard error. Example

of – simple random sample and stratified random sampling.

02

6 Statistical inference – tests of hypothesis:

Introduction, testing of hypothesis – hypothesis, statistical hypothesis,

null hypothesis, alternative hypothesis, test of a hypothesis, critical

region, types of errors in testing of a hypothesis, level of significance, two-

tailed and one-tailed tests, degrees of freedom. Tests of significance

– large sample tests; small sample tests – t-test for testing the significance

of a single mean, t-test for testing the significance of difference between

two means, paired t-test. T-test for testing the significance of an observed

correlation coefficient, F-test for equality of two variances, Chi-square

test for goodness of fit, Chi-square test for testing independence of

attributes, Chi-square test for homogeneity. Example for all types of tests.

07

7 Correlation and Regression:

Introduction, types of correlation – positive or negative, simple, multiple

or partial. Coefficient of correlation, methods of studying correlation –

scatter diagram method, karl pearson’s product moment method,

04

spearman’s rank correlation method. Regression, lines of regression,

methods of finding regression lines - scatter diagram method, method of

least squares. Examples of all methods for correlation and regression.

8 Analysis of variance:

Introduction, assumptions of analysis of variance, analysis of variance for

oneway classification, analysis of variance for two-way classification.

Example of one-way and two-way classifications.

04

9 Non-parametric tests:

Introduction, advantages of non-parametric tests, the wilcoxon signed-

rank test, the wilcoxon rank-sum test, the kruskal-wallis test. Example of

all three non-parametric tests.

04






The course includes language practices such as Group Discussion, Interviews etc to

develop the communication skills of the students.


By the end of this course, the student should have a good understanding of basic process

which are used in different stage during preparation of pharmaceutical formulation.

Students should be able to know calculation of formulas, labeling, and packing of

different types of pharmaceutical products.

Text Books:

6. Texbook Biopharmaceutics and Pharmacokinetics by Ali Javed, birla publication.

7. Biopharmaceutics and Pharmacokinetics by Paradkar A, Nirali prakashan.

8. Business statistics - J K Sharma, PHI publication.

9. Statistical methods - S P Gupta, Sultan Chand & Sons.

Reference Books:

6. The Science & Practice of Pharmacy: A. G. Remington; Lippincott, Philadelphia.

7. Pharmaceutical Dosage Forms: Tablets: Vol.1, Vol. 2 and Vol.3, Ed. by Lieberman, Leon

Lachman and Joseph B. Schwartz, Marcel Dekker Inc., New York.

8. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes, Marcel

Dekker, Inc., New York.

9. Pharmaceutics: The Science of Dosage Form Design by Michael E. Aulton.

10. Pharmaceutical Product Development by N.K. Jain, CBS publication New Delhi.

11. Applied Biopharmaceutics and Pharmacokinetics by Leon Shargel, Susanna Wu-Pong

and Andrew B. C. Yu.

12. Pharmacokinetics by Milo Gibaldi and Donald Perrier.


Soft copies of biopharmaceutics and biostatastics books are available on

http://www.pharmatext.org, www.pharmacyebooks.com, and in

www.pharmamirror.com.

Latest information regarding biopharmaceutics and biostatastics are available on


Study material of biopharmaceutics and biostatastics are available on

mypharmaguide.com, pharmatutor.com, authorstream.com, slideworld.com and in

scribd.com .

Review articles published in international journal covering syllabus aspect.

Course Title MEDICINAL CHEMISTRY- II

Course Code PH603

Course Credit

Lecture : 3

Practical : 3

Tutorial : 0

Total : 6

Course Objectives

Medicinal chemistry-II will provide the sound knowledge about development of various

drugs on bases of metabolic aspect of drug and drug latentiation. Study about the organic

and inorganic compounds/drugs acting on gastro intestinal tract, types of viruses and

related viral diseases especially HIV and also development in other chemotherapeutic

agents including sulphonamides, quinolones, anthelmintic, anti-protozoal agents.

Introduction about micro-organisms and effect and mechanism of antibiotics in various

diseases. Students will learn to know about chemistry, structure activity relationship and

metabolic aspect of all drugs in following category.

Detailed Syllabus - Theory

Sr. No.


Section-I

1 Prodrugs, softdrugs, harddrugs and Drug metabolism:

Utility and types of prodrugs, Introduction and importance of CYP450,

06

general pathways of Xenobiotics metabolism (functional group based

classification of both phases with examples), site of drug metabolism,

factors affecting drug metabolism.

2 To study history, development, structure activity relationship, mechanism

of action and synthesis of following classes of drugs

A. Drugs acting on respiratory tract

i. Anti-asthmatics

ii. Expectorants

iii. Anti-tussive agents

iv. Respiratory stimulants

v. Mucolytics

vi. Decongestants

B. Drugs acting on gastrointestinal tract

i. Antacids

ii. Anti-secretary (Ranitidine)

iii. Proton pump inhibitors (Omeprazole)

iv. Anti-emetics

v. Anti-diarrheals

vi. Laxatives

vii. Prokinetics

viii. Antispasmodics and drug modifying intestinal motility

ix. Drugs for irritable bowel syndrome

x. Local colorectal preparations

xi. Enzymes, carminatives and hepatobiliary preparations

11

3 A. Antiviral and Anti-HIV Agents:

Synthesis of Amantadine

08

B. Antineoplastic agents:

Synthesis of Chlorambucil, Cyclophosphamide, Thiotepa, Methotrexate,

Fluorouracil, Tamoxifen.

Section-II

4 Introduction, history, classification, nomenclature, mechanism of action,

adverse effects, therapeutic uses, structure activity relationship (SAR) and

synthetic procedures of selected drugs and recent developments of

following categories to be covered.

A. Chemotherapeutic Agents:

i. Synthetic Anti-bacterial Agents / Anti-microbial Agents:

SAR: Sulfonamides, Quinolones

Synthesis: Sulfacetamide, Sulfadoxin, Sulfamethoxazole,

Sulfasalazine, Trimethoprim, Norfloxacin, Ofloxacin, Ciprofloxacin.

ii. β-Lactam Antibiotics:

SAR: Cephalosporins, Penicillins

Synthesis of Penicillin-G

iii. Tetracyclines, Aminoglycosides, Macrolides and Miscellaneous

Antibiotics:

SAR: Aminoglycosides, Tetracyclines, Macrolides.

Synthesis of Chloramphenicol

iv. Anti-mycobacterial Agents:

Synthesis of Ethambutol, Isoniazid, Pyrazinamide, Clofazimine, PAS.

v. Anti-fungal Agents:

Synthesis of Clotrimazole, Ketoconazole, Fluconazole

vi. Anti-protozoal Agents:

vii. Anti-malarial and Anti-amoebic Agents

SAR: Quinolines

20

Synthesis of Metronidazole, Ornidazole, Chloroquine, Amodiaquine,

Primaquine, Pyrimethamine.

viii. Anthelmintics:

Synthesis of Albendazole, Mebendazole.

Medicinal chemistry- II (Practicals)

To study principles and reactions for identification of organic compounds

Systematic identification of organic compounds

1. To study about separation principles of various kinds of solid-liquid and liquid-liquid

binary organic mixture satisfying above all criteria.

2. To carryout identification, separation and spotting of given unknown binary organic

mixture (solid-liquid and liquid-liquid binary organic mixture)

To use TLC for matching Rf value of different components of mixture for identification

purpose


1. Know the basic concepts of chemotherapy.

2. Know the mechanism of action and effects of drugs on various organs of the body.

3. To study about chemistry of individual drug molecule.

4. To study about drug interactions and adverse effects.

5. To explore the role of metabolism in various pro-drugs, soft-drugs and hard-drugs

6. To study in detail about the SAR (structure activity relationship) of different classes of

drugs.

7. Know about the development of new drug.

8. To study separation techniques (physical and chemical) of mixture component in

different physical state and identification methods of the same.

Text Books:

1. Foe’s principles of medicinal chemistry. David A. Williams & Thomas L. Lemke. Lippincott

Williams & Wilkins.

2. Wilson and Griswold’s textbook of organic medicinal and Pharmaceutical Chemistry,

John H. Block and John M. Beale, Jr.. Lippincott Williams & Wilkins.

Reference Books:

1. Harkishan Singh and V.K Kapoor – text book of medicinal chemistry.

2. Medicinal chemistry by ashutoshkar

3. Principles of medicinal chemistry by kadam and bothara

4. Experimental organic and medicinal chemistry by biren n., shah. S. vikas.

5. Practical organic chemistry, Hitesh G. Raval, Sunil L. Baldania, Dimal A. Shah, Nirav and

Roopal Prakashan.

6. Burger’s Medicinal Chemistry and Drug Discovery, Donald j Abraham, Wiley interscience.

7. Vogel’s text book of practical organic chemistry.

8. Practical organic chemistry by F.G Mann and Saundars


Soft copies of medicinal and organic chemistry books that are available on websites.

Latest informations are available from scientific journals available in library and on websites.

Course Title INSTRUMENTAL ANALYSIS-I

Course Code PH604

Course Credit

Lecture : 3

Practical : 3

Tutorial : 0

Total : 6

Course Objectives


1. Understand the fundamental concepts of spectroscopy.

2. Understand the principle, instrument theory and practical, effect and application of

various spectroscopy method like UV, IR, NMR, Mass Fluorescence and atomic

absorption.

Detailed Syllabus

Sr. No.


Section-I

1 Fundamentals of Spectroscopy

Classification of spectra, Wave properties of electromagnetic radiation;

Particle/photon properties of electromagnetic radiation;

Electromagnetic spectrum.

04

2 UV-VIS spectroscopy

Theory; Beer and Lambert’s law - limitations and deviations from the law;

Terminologies associated with absorption measurements; Types of

transitions; Factors affecting spectral characteristics (structural and

nonstructural); Effect of conjugation; Wood ward Fieser rule;

Photometric titrations; Instrumentation, applications ( in analysis of

organic compounds and inorganic complexes ), advantages and

limitations of UV Visible spectroscopy; Quantitative analysis of binary

mixtures of absorbing substances by simultaneous equation method;

Calibration of UV Visible Spectrophotometer as per Pharmacopoeia.

10

3 IR spectroscopy

Theory of absorption of Infrared radiation by molecules; Molecular

vibrations; Factors influencing vibrational frequencies; Calculation of

vibrational frequencies ( Hooke’s law ); Sample handling techniques;

Instrumentation ( Dispersion and FTIR spectrometer ) and applications of

IR Spectroscopy; Calibration of IR Spectrophotometer as per

Pharmacopoeia

07

Section-II

4 Nuclear Magnetic Resonance spectroscopy

Fundamental Principles - nuclear spin, magnetic moment; Proton NMR

spectroscopy - theory, chemical shift and factors affecting chemical shift,

spin-spin coupling, coupling constant, relaxation process,

Instrumentation and applications of PMR; Brief overview of 13C NMR

09

5 Mass spectrometry

Theory; Ionization techniques, Ion separating techniques; Different types

of ions and their significance in mass spectra, Fragmentation rules and

07

rearrangements; Instrumentation and applications of mass

spectrometry.

6 Fluorescence spectroscopy

Introduction: luminescence, photoluminescence; Theory of Fluorescence

and Phosphorescence; Jablonski diagram; Factors affecting fluorescence

intensity (structural and nonstructural); Instrumentation, applications,

advantages and limitations of fluorescence spectroscopy.

03

7 Structure elucidation by joint application of UV, IR, NMR and Mass

spectrometry

03

Instrumental analysis I (Practical)

1. Calibration of UV spectrophotometer.

2. Determination of λmax, A(1cm 1%), Detection-Quantitation Limit and preparation of

calibration curve (Verification of Beer’s law) for any drug by UV-visible

spectrophotometer.

3. Determination of the dissociation constant of indicator/ stability constant of complex

(e.g. Ferric salicylate) using UV/visible - spectrophotometric method.

4. Determination of isosbestic point/pKa of indicator (e.g. Phenol red)

5. Two experiments on Spectrophotometric estimation of drugs in marketed formulations

(e.g. Paracetamol/Ibuprofen/sulphadiazine).

6. Two experiments- Fluorimetric estimation of drug (quinine sulphate/

riboflavin/Thiamine).

7. Two experiments: Colorimetric assay of colored drug (e.g. Vitamin B2) & non-colored

drug (e.g. Sulpha-BMR, Nitration of Paracetamol)

8. Identification of API by IR spectrum.

9. Content Uniformity of any drug as per Pharmacopoeia.

10. Workshop on structure elucidation of simple organic compounds using UV, IR, NMR, and

Mass spectra.









At the end of the course the students will be able to:

1. Operate the different sophisticated instrument which used in industry level at various

analytical purpose

2. Understand the basic principle of spectroscopy and their application

Text Books:

1. Principles of Instrumental Analysis by skoog, holler, Nieman, 5th edition.

2. Instrumental methods of Analysis, H.H. Willard, L.L. Meritt, J.A. Dean and F.A. Settle

Wadsworath, New York

Reference Books:

13. Pharmaceutical Analysis: Modern methods Part A, Part B, James W. Munson.

14. G. H. Jeffery, J. Basset, J. Mendham, R. C. Denny (Rev. by) Vogel’s Text Book of

Quantitative Chemical Analysis, Longman, London

15. A Textbook of Pharmaceutical Analysis. Connors K.A.

16. A.H. Beckett and J.B. Stenlake, Practical Pharmaceutical chemistry, part 1&2, the

athlone press, London.

17. Pharmacopoeia of India, Govt. of India, Ministry of Health.

18. British Pharmacopoeia, ministry of health and social welfare, UK.

19. The United States Pharmacopeia–National Formulary (USP–NF)


Soft copies pharmaceutical chemistry books are available on http://www.pharmatext.org

Latest information regarding to pharmaceutical chemistry are available on


Course Title PHARMACOLOGY- III

Course Code PH605

Course Credit

Lecture : 3

Practical : 3

Total : 6

Course Objectives

Pharmacology III will provide a detailed knowledge about the pharmacokinetics,

pharmacodynamics, receptor mechanisms and mechanism of resistance, drug

interactions, contraindications and adverse drug reactions of various drugs used for

chemotherapy. It will also provide thorough information about pharmacology of drugs

used in cardiovascular disorders as well as drugs acting on renal and hematopoietic

system. The subject also will give basic idea about pharmacogenomics and

pharmacogenetics.

Detailed Syllabus

Sr. No.


Section-I

1 Chemotherapy

a. General principles of chemotherapy

b. Sulfonamides, Cotrimoxazole, Quinolones and other agents used

in Urinary Tract Infections

23

c. Beta lactam antibiotics

d. Tetracycline and chloramphenicol

e. Aminoglycoside antibiotics

f. Macrolides

g. Antitubercular drugs

h. Antileprosy drugs

i. Antifungal drugs

j. Antiviral drugs

k. Antiparasitic drugs (Drugs used in Malaria, Helminthiasis,

Amoebiasis, Giardiasis, Trichomoniasis, Trypanosomiasis &

Leishmaniasis)

l. General principles of cancerous diseases and anticancer drugs

Section-II

2 Drugs acting on Cardiovascular and Renal System:

a. Cardiac Glycosides and other Cardiotonics

b. Diuretics and anti-Diuretics

c. Antihypertensive Drugs

d. Drugs used for coronary heart diseases (antianginal drugs and

drugs for myocardial infarction)

e. Anti-arrhythmic Drugs

f. Drug therapy for hypercholesterolemia and Dyslipidemias

18

3 Drugs Acting on the Hemopoietic System:

a. Hematinics and Erythropoietin

b. Drugs Affecting Coagulation, Bleeding and Thrombosis

c. Plasma Expanders

03

4 Pharmacogenomics and Pharmacogenetics 02

Pharmacology-III Practical

I. Bioassays and cell based assays

1. Introduction to general principles of bioassay, pharmacopoeial bioassays and

biostandardization of various drugs

2. Introduction to cell based assay: Definition, Types, Advantages, limitations of cell

based assay, and application to High throughput screening

3. Bioassay of Acetylcholine using Rat ileum by Graphical method

4. Bioassay of Acetylcholine using Rat ileum by matching method

5. Bioassay of Acetylcholine using Rat ileum by three point method

6. Bioassay of Acetylcholine using Rat ileum by four point method

7. Bioassay of Histamine using Guinea pig ileum by matching method

8. Bioassay of Atropine using Rat ileum by Graphical method

9. Bioassay of Mepyramine using Guinea pig by Graphical method

II. Demonstration Experiments

1. Simulation Experiments on Cardiovascular System : Effects of Various Drugs

on Isolated Frog Heart.

2. Demonstration on the Effects of Various Drugs on the Rat blood Pressure









9. Know about the basic concepts for chemotherapy including problems encountered

with chemotherapy and applications of combination chemotherapy.

10. Know the selection and proper use of chemotherapeutic agents to prevent and treat

respective infectious diseases.

11. Know the mechanism of action and effects of drugs on various organs of the body.

12. Know the detailed pharmacokinetics of each drug covered under each section.

13. Know the importance of proper selection of drug otherwise resulting in drug

interactions and adverse drug reactions.

Text Books:

3. Essentials of medical pharmacology --K. D. Tripathi

4. Goodman Gilman A., Rall T.W., Nies A.I.S. and Taylor, P. Goodman and Gilman’s The

pharmacological basis of therapeutics, 12th edition, 2011. McGraw Hill< Pergamon

Press.

5. Handbook of Experimental Pharmacology- Goyal R.K.

6. Handbook of Experimental Pharmacology- Kulkarni S.K.

Reference Books:

9. Lewis’s Pharmacology – James Crossland – Churchil Livingstone

10. Lippincott’s illustrated reviews of Pharmacology- Mycek Mary J.

11. Katzung, B.G. basic and Clinical Pharmacology, 8th edition, McGraw Hill New York, 11th

Edn, 2009.

12. Satoskar R.S. et al – Pharmacolog and Pharmacotherapeutics. Popular Prakashan,

Mumbai.

13. Pharmacology and Toxicology- Kale S.R.

14. Ghosh M.N. Essentials of Experimental Pharmacology. Scientific book Agency,

Calcutta.


Soft copies of pharmacology and pathophysiology books are available on websites.

Latest informations are available from scientific journals available in library and on

websites.

Course Title QUALITY ASSURANCE AND INTELLECTUAL PROPERTY RIGHTS

Course Code PH606

Course Credit

Lecture : 3

Practical : 0

Tutorial : 0

Total : 3

Course Objectives

This subject gives basic knowledge about Intellectual Property Rights, various concepts of

copyrights, trade mark and geographical limitations.

To explain the students about various concepts of validation, designing of validation

protocol and validation documents. This course will provide students insight into validation

of various equipments, methods, formulations and building, quality management system,

quality audits, concept of total quality management etc.

Detailed Syllabus

Sr. No.

Name of Chapter & Details Hours

Allotted

SECTION I

1 Intellectual Property Rights: - Introduction, types, Scope and objectives of IPR in

Pharmacy. Concept of property with respect to intellectual creativity. Tangible

and Intangible property.

03

2 Definition, introduction, process of registration, term of registration and

infringement of following IPR: copyrights, trade mark, geographical indication,

industrial design.

06

3 Introduction: An understanding of the concepts of quality assurance, Good

Manufacturing Practice and quality control as applied to the pharmaceutical

industry.

Organization and personnel, responsibilities, training, hygiene, personnel,

records.

Manufacturing Premises: Location, Design, plant layout, construction

maintenance and sanitation, environmental control, utility services like gas,

water, maintenance of sterile areas & control of contamination.

Equipment, selection, purchase specifications, maintenance, clean-in place and

sterilize- in place methods (TP and STP). Raw materials; purchase, specifications,

stores, selection of venders & control of raw materials.

10

4 Good Laboratory Practices (GLP) 03

SECTION II

5 Good Clinical Practices (GCP) 03

6 Introduction to Pharmaceutical Validation:

Definition, Approaches to validation and scope of validation, Advantage of

Validation, importance of Validation, Limitation of Validation, Organization for

Validation, calibration & verification.

05

7 Validation of Building and facilities: (DQ, IQ, OQ, PQ) 03

8 Types of Process Validation (prospective, retrospective & concurrent) 02

9 Analytical Method Validation:

General principles of analytical method validation for dosage forms. (accuracy,

precision, specificity, linearity, range, robustness etc.)

03

10 Concept of Total Quality Management, Six Sigma methodology, ISO 9000.

Controls on four M responsible for Quality variation in Pharmaceutical products.

05

11 Quality Audits 02





Surprise tests/Quizzes/Tutorials will be conducted.


At the end of the course the students will be able to:

Know about Intellectual Property Rights, various concepts of copyrights, trade mark and

geographical limitations.

Know details about basic concepts of quality, quality assurance and validation.

Text books:

1. P. P .Sharma “How to practice GMPs”, 3rd edition, Vandana Publication

2. CGMP :Current Good Manufacturing Practices For Pharmaceuticals By Potdar Manohar A.,

CBS Publishers

3. P. P. Sharma “How to practice GLP” Vandana Publication.

4. Pharmaceutical Quality Assurance, M.A. Potdar, Nirali Prakashan, Pune.

5. Current Good Manufacturing Practices, M.A. Potdar, Pharma-Med Press, Hyderabad.

6. Good laboratory practice and regulations by Mohanan P.V.

7. J. R. Berry and R.A. Nash, Pharmaceutical process validation. 3rd Ed Marcel Dekker, 2003.

8. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and Pharm Sci. Series,

Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y.

9. ISO 9000 and Total Quality Management – Sadhank G Ghosh

10. Total quality management, principles, implementation and Cases, Sharma D. D., Sulatan

Chand and Sons, New Delhi, 2000.

11. Fundamentals of Total Quality Managemnt, process analysis and improvement by Jens. J

Daulgard, Kai Kriestensen and Gopal K. Kanji. Taylor and Francis

Reference Books:

1. Intellectual property rights and biodiversity by Swansan T.

2. P. Warayan, Intellectual Property Laws, Eastern Law House.

3. Ira R. Bery, “Introduction to the Pharmaceutical Regulatory Process”, Drugs and Pharm Sci.

Series, Vol. 144, Marcel Dekker Inc., N.Y.

4. Indian Pharmacopoeia, Vol. 1-3, 2007.The Indian Pharmacopoeia commission, Ghaziabad,

Govt. of India.

5. The International Pharmacopoeia Vol 1,2,3,4,5 3rd Edition

6. A. C. Cartwright and Brian Mathews, “International Pharmaceutical Registration” Taylor and

Francis Ltd. UK, 2002.

7. P. Warayan, Intellectual Property Laws, Eastern Law House.

8. Patents for Medicine, by N. B. Zareri, Indian Drug Manufacturers Association (IDMA)

9. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman, Herbert A.

Lieberman, Joseph. L. Karig, Varghese Publishing House, Bombay

10. Pharmaceutical Master Validation plan by S. Haiden, CRC press.

11. Validation of pharmaceutical process by Conleton F.

12. Sidney H. Willig, "Good Manufacturing Practices for Pharmaceuticals", Drugs and Pharm. Sci.

Series, Vol. 109, Marcel Dekker Inc., N.Y.

13. GLP quality audit manual, Milton A. Anderson, Third edition, Informa Healthcare

14. Laboratory auditing for quality and regulatory compliance, by Donald C. Singer, Stefan and

Stedan, Drugs and pharmaceutical sciences, Vol. 150

15. Laboratory auditing for quality and regulatory compliance, by Donald C. Singer, Taylor and

Francis.

16. Total quality management, Dale H. Besterfield, Pearson Education, 3rd edn., 2003.


Soft copies of quality assurance and intellectual property right books are available on

http://www.pharmatext.org, www.pharmacyebooks.com, and in www.pharmamirror.com.

Latest information regarding quality assurance and intellectual property right are available on


Study material of quality assurance and intellectual property right are available on

mypharmaguide.com, pharmatutor.com, authorstream.com, slideworld.com and in

scribd.com.

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