b. pharm. course : fourth year (vii sem. & viii sem

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Please crosscheck and verify with the duly signed hard copy available with the concerned departmental office / library to be aware about any upgradation or

correction in the syllabus /scheme taken place time to time, as and when needed.

Dr. H. S. Gour Central University Sagar (MP)

Proposed Curriculum for B. Pharm. Course

(Structure of courses)

B. Pharm. Course : Fourth Year (VII Sem. & VIII Sem.)


Department

Dept. of

Pharmaceutical

Sciences

Course B.Pharm. Code

Subject Pharmaceutical

Sciences

Subject

Code PHS-54 School EAT 50

B.PHARM. – VII SEMESTER (Theory & Tutorials)

Course

S. No

Course

Code Course Name L* T* Credits

01 PHSC 7101 Medicinal Chemistry III 3 0 3

02 PHSC 7102 Pharmaceutical Analysis III 4 0 4

03 PHSC 7103 Pharmacology III 3 0 3

04 PHSC 7104 Drug Legislation and

Regulatory Affairs 4 0 4

05 PHSC 7105 Clinical & Hospital

Pharmacy 4 0 4

Total= 18 0 18

B.PHARM. – VII SEMESTER (Practicals)

Course

S. No

Course

Code Course Name P* Credits

01 PHSC 7106 Medicinal Chemistry III 3 1

02 PHSC 7107 Pharmaceutical Analysis III 3 1

03 PHSC 7108 Pharmacology III 6 2

04 PHSC 7109 Clinical & Hospital

Pharmacy 3 1

Total= 15 5

Note: * - L - Lecture T – Tutorial P – Practical C- Total Credit




Dr. H. S. Gour Central University Sagar (MP)

Proposed Curriculum for B. Pharm. Course


Department

Dept. of

Pharmaceutical

Sciences

Course B.Pharm. Code

Subject Pharmaceutical

Sciences

Subject

Code PHS-54 School EAT 50

B.PHARM. – VIII SEMESTER (Theory & Tutorials)

Course

S. No

Course


01 PHSC 8101 Novel and Controlled

Drug Delivery Systems 4 0 4

02 PHSC 8102 Biopharmaceutics &

Pharmacokinetics 4 0 4

03 PHSC 8103 Pharmacognosy and

Phytochemistry -IV 3 0 3

04 PHSC 8104 Elective 4 0 4

Total 15 0 15

B.PHARM. – VIII SEMESTER (Practicals)

Course

S. No

Course


01 PHSC 8105 Novel and Controlled Drug

Delivery Systems 3 1

02 PHSC 8106 Biopharmaceutics &

Pharmacokinetics 3 1

03 PHSC 8107 Pharmacognosy and

Phytochemistry -IV 3 1

04 PHSC 8108 Project on elective 6 2

Total 15 05

Note: * - L - Lecture T – Tutorial P – Practical C- Total Credit

PHSC 8104 Electives (T)

1. GMP, Quality Assurance

2. Packaging Technology

3. Drug Design

4. Drug Interactions

5. Neutraceuticals

6. Herbal Drug Technology




B.PHARM. VII SEMESTER (Theory & Tutorials)

Course Code Course L T Credits

PHSC 7101 Medicinal Chemistry-III 3 0 3

Hours Per Week

Medicinal Chemistry-III

Theory: 4h/week

1. Principles of drug design: Traditional analogue, quantitative structure activity relationship (QSAR)

and mechanism based approaches. A brief introduction to graph theory, application of mechanism

based approaches. Application of quantum mechanics, computer aided drug designing (CADD) and

molecular modelling. Introduction to QSAR

2. Prodrug design

1. Vitamins excluding detailed study of constitution.

1. Metabolite antagonism-basic concepts, active site directed irreversible enzyme inhibitors,

mechanism based enzyme inhibitors, dihydrofolate synthetase inhibitors, dihydrofolate reductase

inhibitors, amino acid antagonists, antagonists directed against nucleic acids, β-lactamase

inhibitors.

2. The following topics shall be treated covering chemical naming, structure activity relationship,

physicochemical and stero aspects, mode of action and uses. The emphasis would be only on BP

and IP compounds. Synthesis of only those drugs given in parentheses under each topic would be

covered.

3. Sulphonamides, development, nomenclature and classification, antimicrobial spectrum, drug

resistance, synergism with dihydrofolate reductaste inhibitors, toxicity and side effects, reduction

of crystal urea, physicochemical properties and biological activity, protein binding and distribution,

metabolism, sulphonamides and trimethoprim combination (sulphanilamide, sulphacetamide,

sulphadiazine, sulphadimethoxine, sulphamethazole and sulphamethoxazole)

4. Antibiotics- classification, cycloserine, chloramphenicol, penicillins, cephalosporins,

aminoglycosides, tetracyclines, polypeptides (chloramphenicol)

5. Antimycobacterial agents- Introduction to mycobacterium, development of antimycobacterium

agents and their use in therapeutics (dapsone, sulfoxone sodium, solapsone, isonicotinic acid

hydrazide, para aminosalicylic acid, pyrazinamide and ethionamide)

6. Antimalarials: Quinoline and analogues, 8-amino quinolines, 9- amino acridines, 4- amino

quinolines, diamino pyrimidine, biguanides (primaquin, mepacrine, chloroquin , pyrimethamine)




7. Antiamoebic agents: Emetine hydrochloride, quinoline derivatives, metal free substances,

diloxanide furoate, metronidazole, organometallic compounds, acetarsol (diodohydroxyquinoline,

diloxanide)

8. Drugs used for trypanosomiasis and other protozoal diseases

9. Anthelmintics drugs used in cestide infections, drugs used in trematode infections, drugs for

intestinal nematode infections, antifilarial agents (niclosamide , hexylresorcinol,

diethylcarbamazine citrate, thiabendazole)

10. Antifungal agents, antibiotics, griseofulvin, amphotericin, candicidine, nystatin, synthetic

antifungal agents, salicyclic acid, miconazole elcomazole, tolanflate, flucotosine, dithranol and

chlorphenesin

11. Urinary antiseptics quinolones, nalidixic acid, nitrofurantion

12. Disinfictants and antiseptics

13. Antineoplastic agent- Introduction, characteristic of cancer cell, cell growth cycle, causes of

cancer, antimetabolites, 6-thioguanine, methotrexate, 6-mercaptopurine, cytarabine, 5-flurouracil

and dacarbazine, alkylating agents, mechlorethamine, melphalan, busulphan, mitomycin, cisplatin,

thiotepa, chlorambucil, carmustine, lomustine, cyclophosphamide, DNA intercalating agents,

doxorubicin, daunorubicin, mitoxantrine, antibiotics, dactinomycin, bleomycin, mithramycin,

anthramycin, antimitotic agents, vincristine, vinblastine, miscellaneous agents, procarbazine,

asparaginase, interferones, hydroxyurea.

14. Antiviral agents- introduction to DNA, RNA and retroviruses, viral replication, amantidine

hydrochloride, interferones, acyclovir, idoxuridine, trifluorothymidine, vidarabine, cytarabine,

ribavirin, methisazone, zidovudine.

15. Diagnostic agents

BOOKS RECOMMENDED

1) Foye, W.C., Principles of Medicinal Chemistry, Lea and Febiger, Philadelphia.

2) Wolff , M.E. Ed., Burger’s Medicinal Chemistry, John Wiley and Sons, New York.

3) Hansch, C., Comprehensive Medicinal Chemistry, Pergarnon Press, Oxford.

4) Delagado, J.N. and Remers, W.A.R, Wilson and Giswold’s Text Book of Organic,Medicinal and

Pharmaceutical Chemistry, J.Lippincott Co., Philadelphia.

5) Kar, A., Medicinal Chemistry, Willey Eastern Ltd., New Delhi.

6) Patrick, G., An Introduction to Medicinal Chemistry, Scientific Distributors, Mumbai.

7) Malone, Dyson and Purey, May’s Chemistry of Synthetic Drugs.

8) Singh H.K., Kapoor, V. K., Medicinal and Pharmaceutical Chemistry, Vallabh Prakashan, New Delhi

9) Thomas, G., Introduction to Medicinal Chemistry, CBS Publishers and Distributors, New Delhi.






PHSC 7102 Pharmaceutical Analysis III 4 0 4

Hours Per Week

Pharmaceutical Analysis III

Theory: 4h/week

5. Electromagnetic radiations – Nature of electromagnetic radiations, the interaction between energy and

matter, applications of quatum mechanics theory, the absorption of energy by atoms and molecules, the

emission of radiant energy by atom and molecules: refraction and diffraction

6. Ultraviolet and Visible spectrophotometry- Electronic excitation, quantitative laws, deviation from beers

law, graphical presentation of data, chromophores, photometric errors, instrumentation (light sources,

prism, & grating, monochromators, photoemissive & photomultipliers tubes), single& double beam

instruments, steps in spectrophotometric measurements (sample handling; amplification and radiation of

detectors, selection of wavelengths & bandwidth), concentration and optimum absorbance value,

applications (direct & indirect methods, analysis of mixture).

7. Flourometric analysis- Theory, quantitative description, experimental factors effecting fluorescence

intensity, factors effecting I0 & f directly, relationship of fluorescence to molecular structure,

instrumentation (cells, light sources, wavelength selection, detectors), correction of spectra,

pharmaceutical applications.

8. Flame photometry- Origin of spectra, atomization and ionization, instrumentation (nebulizer, mirrors,

burners, slits, monochromators and detectors), background emission, interferences, qualitative

applications in pharmaceutical analysis.

9. Atomic absorption spectroscopy- Theory of absorption of radiant energy by atoms, equipment,

analytical applications.

10. IR spectrophotometry- Theory, characteristics, absorption bands of organic functional group,

interpretation of IR absorption spectra, frequency range, band width, and scan speed, concentration

range and absorbance value, preparation of samples, sample cell, IR instrumentation (light source,

monochromator detectors) qualitative and quantitative application in pharmaceutical analysis, analytical

shortcomings

11. X Ray-spectrometry - An introduction to the theory of X ray spectroscopy [miller, space lattice and unit

cell, bravais lattices]. Interplaner spacing in crystal system. Diffraction of X -ray by crystal, bracgg




equation, powder method, x- ray diffraction pattern of cubic system [NaCl], application on

pharmaceutical analysis.

12. Nuclear magnetic resonance spectroscopy- An introduction to theory of NMR, magnetic properties of

the nuclei, nuclear magnetic movements, absorption of energy, chemical shifts, shielding and

deshielding, spin-2 coupling, NMR instrumentation, typical spectra, analytical applications in

pharmaceutical analysis.

13. Mass spectrometry- Instrumentation, basic principles determination of molecular formula, recognition of

molecular ion peak, fragmentation, mass spectra of simple compounds [saturated hydrocarbon].

14. Use of electrophoresis method in drug analysis.

15. Polarography and its application- Theory, mass transport processes, current potential relationship,

polarization, choice of electrodes, instrumentation, effect of oxygen, calculation of concentration,

laboratory design and safety

16. Amperometric titration and its application.

BOOKS RECOMMENDED

1) Svehla, G. Vogel’s Text Book of Micro and Semi Micro Qualitative Inorganic Analysis, Orient

Longman, Hyderabad.

2) Beckett, A.H. and Stenlake, J.B., Practical Pharmaceutical Chemistry, The Athlone Press of the

University of London.

3) Chatten, L.G., Text Book of Pharmaceutical Chemistry, Marcel Dekker, New York.

4) Connors, K,.A., A Text Book of Pharmaceutical Analysis, Wiley Interscience, New York.

5) Higuchi, J. and Hansen E.B., Pharmaceutical Analysis, Interscience Publisher, John Willey and Sons,

New York, Sydney.

6) Silverstein,R.M., Bassier, G.C., and Morril,T.C., Spectrophotometric Identification of Organic

Compounds, John Wiley and Sons Inc.

7) Willard, Merritt and Settle, Instrumental Methods of Chemical Analysis,CBS

Publisher and Distributors, New Delhi.

8) Ewing, G.W., Instrumental Methods of Chemical Analysis.






PHSC 7103 Pharmacology-III 3 0 3

Hours Per Week

Pharmacology-III

Theory: 3h/week

1. Drugs acting on the Gastrointestinal Tract

a) Antacids, antisecretory and anti-ulcers drugs

b) Laxatives and antidiarrhoeal drugs

c) Appetite stimulants and suppressants

d) Emetics and anti-emetics

2. Pharmacolgy of Endocrine system.

a) Hypothalamic and pituitary hormones.

b) Thyroid hormones and anti thyroid drugs, parathormone, calcitonin and vitamin D.

c) Insulin, oral hypoglycaemic agents and glucagons.

d) ACTH and corticosteroids.

e) Androgens and anabolic steroids.

f) Estrogen, progesterone and oral contraceptive.

g) Drugs acting on the uterus.

3. Chemotherapy

a) General principles of chemotherapy.

b) Sulfonamides and cotrimoxazole.

c) Antibiotics – Penicillins, Cephalosporins, Chloramphenicol, Erythromycin, Quinolones and

miscellaneous antibiotics.

d) Chemotherapy of tuberculosis, leprosy, fungal diseases, urinary tract infections and sexually

transmitted diseases.

e) Chemotherapy of malignancy and immunosuppressive agents.

f) Definition of poison, general principles of treatment of poisoning with particular reference to

barbiturates, opioids, organophosphorous and atropine poisoning.

g) Heavy metals and heavy metal antagonists.




BOOKS RECOMMENDED

1) Barar F S K, Text Book of Pharmacology, Interprint, New Delhi.

2) Best and Taylor's Physiological Basis of Medical Practice, William & Wilkins, Baltimore.

3) Crossland J and Thomson J H., Essentials of Pharmacology, Harper and Row Publishers,

NewYork

4) Craig C R and Stitzel R R, Modern Pharmacology, Little Brown and Company, 1994.

5) Goodman and Gilman's, The Pharmacological basis of Therapeutics; Editors: J G Hardman, L E

6) Guyton A C, Hall JE., Textbook of Medical Physiology,WB Sannders Company.

7) Mycek M J, Gertner S Band Perper M M, Pharmacology Lippincott's Illustrated Reviews,

Lippincott Company, Philadelphia.

8) Paul L., Principles of Pharmacology, Chapman and Hall.

9) Rang MP, Dale MM, Riter lM., Pharmacology, Churchill Livingstone.

10) Tortora G J, and Anagnodokos N P, Principles of Anatomy and Physiology Harper & Row

Publishers N. Y.





S. No. Course


01 PHSC 7104 Drug Legislation and

Regulatory Affairs 4 0 4

DRUG LEGISLATION AND REGULATORY AFFAIRS

Theory: 4h/week

1. Historical background

a) Drug legislation in India.

b) Code of pharmaceutical ethics.

2. Drug Laws: Study of the following (with latest amendments, wherever applicable)

a) Pharmacy Act, 1948.

b) Drugs and Cosmetics Act, 1940 and Rules.

c) Medicinal and Toilet Preparations (Excise Duties Act, 1955).

d) Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules.

e) Drug (Prices Control) Order.

f) Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and Rules.

g) Poisons Act.

h) Factories Act.

i) Prevention of Cruelty to Animals Act.

3. Introduction to IPR

(a) Patent Act and Rules

(b) Designs Act

(c) Trade and Merchandise Marks Act

(d) Monopolies and Restrictive Trade Practices Act.

BOOKS RECOMMENDED

1) N. K. Jain: Textbook of Forensic Pharmacy

2) Latest Editions of I.P., U.S.P and B.P.

3) Garfeild, Quality Assurance Principles of Analytical Laboratories

4) Mittal B.M. A Text Book of Forsenic Pharmacy, National Book Depot, Calcutta.

5) Bharati H K, Drugs and Pharmacy Laws in India, Sadhana Mandir, Indore.

6) KacChensney J C Packaging of Cosmetics and Toiletories, Newness Butterworth, London.





Course Code Course Name L* T* Credits

PHSE 7105 Clinical & Hospital Pharmacy 4 0 4

Clinical & Hospital Pharmacy

Theory: 4h/week

1. Organization and Structure: Organization of a hospital and hospital pharmacy, Responsibilities of a

hospital pharmacist, Pharmacy and therapeutic committee, Budget preparation and Implementation.

2. Hospital Formulary: Contents, preparation and revision of hospital formulary.

3. Drug Store Management and Inventory Control:

4. Organization of drug store, Types of materials stocked, storage conditions.

5. Purchase and Inventory Control principles, purchase procedures, Purchase order, Procurement and

stocking.

6. Drug distribution Systems in Hospitals:

7. Out-patient dispensing, methods adopted.

8. Dispensing of drugs to in-patients. Types of drug distribution systems. Charging policy, labeling.

9. Dispensing of drugs to ambulatory patients.

10. Dispensing of controlled drugs.

11. Central Sterile Supply Unit and their Management: Types of materials for sterilization, Packing of

materials prior to sterilization, sterilization equipments, Supply of sterile materials.

12. Manufacture of Sterile and Nonsterile Products: Policy making of manufacturable items, demand

and costing, personnel requirements, manufacturing practice, Master formula Card, production

control, Manufacturing records.

13. Drug Information Services: Sources' of Information on drugs, disease, treatment schedules,

procurement qf information, Computerized services (e.g., MEDLINE), Retrieval of information,

Medication error.

14. Records and Reports: Prescription filling, drug profile, patient medication profile, cases on drug

interaction and adverse reactions, idiosyncratic cases etc.

15. Introduction to clinical pharmacy practice, Definition and scope, common daily terminology used in

the practice of medicine.

16. Functioning and working of clinical pharmacy unit, manpower requirements.

17. Methodology and techniques of analysis of drug content and their metabolites blood and other

biological fluids and to correlates the therapeutics efficacy with drug concentrate in biological fluids.




18. Biological half lifes, pKa values, pH partition coefficient, stability with reference to clinical

application.

19. Pharmacists and patient counseling including specific examples.

BOOKS RECOMMENDED

1) Laurence, D R and Bennet P. N., Clinical Pharmacology, Churchill Livingstone.

2) Herfindal E T and Hirschman J L., Clinical Pharmacy and Therapeutics. Williams and Wilkins.

3) Remington’s Pharmaceutical Sciences.

4) W.E Hassan: Hospital Pharmacy.

5) Heifindal et al: Clinical Pharmacy & Therapeutics.

6) Allwood and Fell: Hospital Pharmacy.

7) Pratibha Nand and R.K. Khar: Hospital & Clinical Pharmacy.




B.PHARM. VII SEMESTER (Practicals)

Course


PHSC 7106 Medicinal Chemistry III 3 1

Medicinal Chemistry III

Practical: 3h/week

1. Introduction to the use of stereo-models

2. Synthesis of selected drugs and prodrugs from the course content

3. Workshop on molecular modeling including QSAR

4. An exercise involving stereo-selective synthesis of a compound

BOOKS RECOMMENDED

1) Vogel’s Text Book of practical Organic Chemistry, Longman, London. New York.

2) Mann F.G. and Saunders BC, Practical Organic Chemistry, Longman, London and New York.

3) Pharmacopoeia of India, Govt. of India, Ministry of Health, Delhi.

4) Siddiqui AA and Mohd. Ali, Practical Pharmaceutical Chemistry, New Delhi.





Course


PHSC 7107 Pharmaceutical Analysis III 3 1

Pharmaceutical Analysis III

Practical: 3h/week

1. Quantitative estimation of various drugs by UV-Visible spectrophotometer

2. Determination of the drug content in tablet formulations

3. Practicals involving flame photometer and specrofluorometer.

4. Interpretation of IR spectra.

BOOKS RECOMMENDED

1) Pharmacopoeia of India, Govt. of India, Ministry of Health, Delhi.

2) Vogel’s Text Book of Micro and Semi Micro Qualitative Inorganic Analysis, Orient Longman,

Hyderabad.

3) Beckett, A.H. and Stenlake, J.B., Practical Pharmaceutical Chemistry, The Athlone Press of the

University of London.




B. PHARM. VII SEMESTER (Practicals)

Course


PHSC 7108 Pharmacology III 6 2

Pharmacology III

Practical: 3h/week

1. Experiments on isolated preparations: To estimate the strength of the test sample of agonist/ drug

(e.g. acetylcholine, histamine, 5- HT, oxytocin, etc.) using a suitable isolated muscle preparation

employing matching bioassay, bracketing assay, three point assay and four point assay.

2. Pharmacology of Gastrointestinal Tract: To study the anti-ulcer and anti-secretary activity using

pylorus ligated rats.

BOOKS RECOMMENDED

1) Kulkarni S.K., Handbook of Experimentals Pharmacology, Vallabh Prakashan Delhi.

2) Ghosh M N., Fundamentals of Experimental Pharmacology, Scientific Book Agency, Calcutta.

3) Mycek M J, Gertner S Band Perper M M, Pharmacology Lippincott's Illustrated Reviews, Lippincott

Company, Philadelphia.





Course Code Course Name P* Credits

PHSE 7109 Clinical & Hospital Pharmacy 3 1

Clinical & Hospital Pharmacy

Practical: 3h/week

1. Experiments based on sterilization of various types of materials used in Hospitals.

2. Practicals designed on the use of computers in Drug Information Centre, prescription filling,

documentation of information on drug interaction.

BOOKS RECOMMENDED

1) Laurence, D R and Bennet P. N., Clinical Pharmacology, Churchill Livingstone.

2) Herfindal E T and Hirschman J L., Clinical Pharmacy and Therapeutics. Williams and Wilkins.

3) Remington’s Pharmaceutical Sciences.

4) W.E Hassan: Hospital Pharmacy.

5) Heifindal et al: Clinical Pharmacy & Therapeutics.

6) Allwood and Fell: Hospital Pharmacy.

7) Pratibha Nand and R.K. Khar: Hospital & Clinical Pharmacy.




B.PHARM. VIII SEMESTER (Theory & Tutorials)

Course


PHSC 8101 Novel and Controlled Drug

Delivery Systems 4 0 4

Novel and Controlled Drug Delivery Systems

Theory: 4h/week

1) Concepts and systems designed for rate controlled drug delivery. Mechanism of the drug release from

matrix systems and reservoir systems.

2) Concept of drug targeting

3) Sustained and Controlled Drug Delivery: Design and development, physico-chemical, biological and

pharmacokinetic properties influencing design and performance of controlled release products, materials

and methods used in their formulation, dose designing, In vitro and In vivo evaluation.

4) Micro-encapsulation: Types of microcapsules, importance of micro-encapsulation in pharmacy, micro-

encapsulation by phase separation, co-acervation, multi orifice, spray drying, spray congealing,

polymerization, complex emulsion, air suspension technique, coating pan and other techniques,

evaluation of micro capsules.

5) Transdermal drug delivery systems: types, design and fabrication.

6) Carrier/ vesicular based drug delivery systems i.e. Liposomes, niosomes, elastosomes, pharmacosomes.

7) General consideration and application of following drug delivery systems:

a) Bioadhesive and mucoadhesive drug delivery.

b) Nanopulmonary drug delivery.

c) Occular drug delivery.

d) Pro-drug.

BOOKS RECOMMENDED

1. Robinson, J.R. & Lee, V.H.I.,: Controlled and Novel Drug Delivery Marcel Dekker, New York and

Basel.

2. Jain, N.K.: Controlled and Novel Drug Delivery, CBS, New Delhi.

3. Jain, N.K. Advances in Novel and Controlled Drug Delivery.

4. Chien, Y.W.: Novel Drug Delivery Systems, Marcel Dekker, New York and Basel.

5. Roseman, T.J.: Controlled Release Drug Delivery Ssytems, Marcel Dekker New York

6. Goldberg : Targeted Drugs.

7. Bruck, S.D., Controlled Drug Delivery, Vol. I & II.

8. Juliano, R.L. Drug Delivery Systems.

9. Review articles published in various journals.





Course


PHSC 8102 Biopharmaceutics &

Pharmacokinetics 4 0 4

Biopharmaceutics & Pharmacokinetics

Theory: 4h/week

1) Introduction to biopharmaceutics & pharmacokinetics and their role in formulation development and

clinical setting. Distribution, metabolism and elimination of drugs, Biopharmaceutical study of drugs,

blood level concentration, biological half life and elimination rate constant. Apparent volume of

distribution.

2) Passage of drug across GIT membrane. Mechanism, physico-chemical, biological and pharmaceutical

factors affecting drug absorption through GIT- Physicochemical, biological and dosage from related

factors. Techniques for the GIT absorption assessment.

3) Drug disposition: Distribution in blood, plasma -protein binding, application of drug protein binding.

4) Bioavailability and bioequivalence: Definitions, federal requirements, methods of determination of

bioavailability using blood and urinary excretion data. Protocol designs for bioavailability assessment.

Methods for bioequivalence determination.

5) Compartment Models: Definition, basis of classification, model selection criteria.

6) One-compartment open model with first order elimination kinetics, pharmacokinetics of single dose

administration as applied to intravenous (rapid/bolus) and oral administration, Intravenous transfusion,

superposition principle and multiple intravenous and oral administration, pharmacokinetic basis of

sustained release formulations.

7) Two compartment open model with first order elimination kinetics, pharmacokinetics of single and

multiple dose administration, as applied to intravenous (rapid/bolus) and oral administration intravenous

infusion, pharmacokinetic basis of sustained release formulations.

8) Absorption kinetics: Curve Fitting, Wagner-Nelson, Loo Riegelman methods and Deconvolution

methods for estimation of absorption rate constants.

9) Dosage regimen: Dosage regimen adjustment in patients with and without renal failure.

10) Non-Compartmental Analysis: Statistical moments, Application, bioavailability determination.

11) Non-Linear Pharmacokinetics: Michaelis-Menten's kinetics, pharmacokinetic characteristics, In-vivo

estimation of Km and Vm, Unit impulse response. Application in bioavailability determination.

BOOKS RECOMMENDED

1. Handbook of Basic Pharmacokinetics-Ritschel, W.A.,Drug Intelligence Publication, M Hamilton,

1977.

2. Fundamentals of Clinical Pharmacokinetics-Wagner,J.C.,Drug Intelligence Publication,

M.Hamilton, 1975.




3. Remington's Pharmaceutical Sciences - Gennaro A.R., ed., 19th Edition, Mack Publishing Co.,

Easton, PA. 1995.

4. Clinical Pharmacokinetics - Rowland, M. & Tozer,N., 2nd,edition, Lea and Febiger, Philadelphia,

1989.

5. Pharmacokinetics-Gibaldi M. & Perrier, D., 2nd ed., Marcel Dekker, New York, 1982.

6. Pharmacokinetics for the Pharmaceutical Scientist-Wagner, J.C., Technomic Publishing AG,

Switzerland, 1993.

7. Biopharmaceutics and Pharmacokinetics-Notari, R.E., 2nd ed., Marcel Dekker, New York, 1975.





Course


PHSC 8103 Pharmacognosy and

Phytochemistry -IV 3 0 3

Pharmacognosy and Phytochemistry -IV

Theory: 3h/week

(1) Study of indigenous traditional and emerging drugs with their source (includind alternative/

controversial) medicinal uses, pharmacological action/activity, chemical profile and authentication of

following:

Amla (Phyllanthus emblica), Harad (Myroblan-Treminalia chebula), Baheda (Terminalia belerca),

Guduchi (Tinospora cardifolia), Kalmegh (Andrographis paniculata), Guggal (Commiphora weightii),

Salai (boswellia serrata), Brahmi (Centell asiatica), Shankhpuspi (Convolvulus microphyllus), Bach

(Acorus calamus), Kantkari (Solanum xanthocarpum), Tulsi (Ocimum sanctum), Valerian (Valerian

wallchi), Jatamansi (Nardostacys jatamansi), Gokhru (Tribulus terrestris), Arjuna (Terminalia arjuna),

Ashok – (Saraca indica), Vidang (Embelia ribes), Lahsun (Garlic-Allium sativum), Malkangni

(Celastrus paniculata), Bhilwa (Semecarpus anacadium), Chirayata (Swertia chirata), Neem

(Azadirachta indica), satavar (Aspargus racemosus), Safed Musli (Chlorophytum borivalianum),

Artemisia (Artemica spp), Thylophora (Thylophora indica), Morinda (Morinda citrifolia), Chitrak

(Plumbago zeylanicum), Haldi (Curcuma domestica), Tephrosia (Tephrosia purpurea), Bhui Amla (

Phyllanthus amarus), Shilajeet

(2) Introduction to dosage forms in Indian system od medicine with preparation and standardization of some

important dosage forms such as Asavas Arishtas, Avalehas and Churnas.

(3) General method of extraction, isolation, identification and characterization of Phytoconstitutents of

Carbohydrates, Alkaloids Glycosides and Phenolic and Steroidal groups.

(4) An introduction to Tissue culture techniques with their scope as alternative sourse of Phyto-

Pharmaceuticals.

(5) An overview of plants as sourse of Bitters, Sweeteners, Colours, Flavoures, Carotinoids, Photosenstizing

agents and Vaccines

BOOKS RECOMMENDED

1. Trease, G.E. and Evans, W.C., Pharmacognosy, Bailliere Tindall, Eastbourne, U.K.

2. Tayler, V.C., Brady, L.R. and Robers, J.E., Pharmacognosy, Lea and Febiger, Philadelphia.

3. Shah, C.S. and Quadry, J.S., A text book of Pharmacognosy, B.S. Shah Publishers,

Ahmedabad.

4. Kokate, C.K., Purohit, A.P. and Gokhale, S.B., Pharmacognosy, Nirali Prakashan, Pune.

5. Indian Pharmacopoeia, Ministry of Health and Family Welfare, Govt. of India, New Delhi.

6. Wallis, T.E., Text Book of Pharmacognosy, Jand A Churchill Limited, London





Course


PHSC 8104 Elective 4 0 4

Theory: 4h/week

List of Elective Subjects:

I. GMP, Quality Assurance and Validation

II. Packaging Technology

III. Drug Design

IV. Drug Interaction

V. Nutraceuticals

VI. Herbal Drug Technology

I. GMP, Quality Assurance and Validation

1. Concept of CGMP, Total Quality Management, GLPS, ISO 9000.

2. Premises, location design, plant layout, construction, maintenance of sterile areas, control of

contamination.

3. Equipment selection.

4. Raw material purchase specification.

5. In process quality controls.

II. Packaging Technology

1. Glass containers for pharmaceuticals: Glass types, their manufacture, chemical performance, testing

and quality control.

2. Plastic containers for pharmaceuticals: Classification of plastic, plastic polymers and their

physicochemical, mechanical and biological properties; Additives and fabrication processes. Plastic

containers for parenterals and transfusion sterile drip kits, quality control testing, biological toxicity.

3. Paper and paper board: Types of paper, folding cartons, quality control testing of paper and paper

board.

4. Metal containers: Aluminium and tin plate, drums. Collapsible tubes and aerosol containers,

lacquering, coating and lining.

5. Caps and closures: Types of caps, closure, liners, child resistant caps. Elastomeris closures for

parenterals, classification of elastomers, physical, chemical and biological properties and their

quality control.

6. Labels and labeling: Types of labels, adhesives, inkjet and bar coding.

7. Flexible packaging: types of films, Co-extruded films, foils, coating and laminates, shrink and

stretch films.




8. Corrugated and solid fiber boards and boxes: Types of corrugation methods.

9. Transit worthiness of package.

10. Packaging machinery including strip packaging, form, fill and seal machines, liquid and solid filling

machines, capping machines.

11. Product-package compatibility: Stability of product, packaging selection and development criteria.

12. Tamper evident packaging systems.

III. Drug Design

1. 2-D QSAR

a) Traditinal method of drug design

b) Physicochemical properties of compounds – Lipophilic, Electrophilic and steric. Their role in

drug action.

c) Physicochemical parameters – partition coefficient, chromatographyic parameters. pKa

values, chemical shift values, molar refractivity, Van der Waals radii, molecular connectivity,

simple valence and calculation thereof.

d) Substituent constants their significance and uses, correlation charts, spread over activity.

e) Hansch analysis and Free- Wilson method.

f) Multiple regression Analysis, cross correlation.

2. 3-D QSAR

a) Drawbacks of 2-D QSAR and need for 3-D QSAR, sources of hits, combitorial libraries,

selection of a lead, optimization of a lead, drug targets.

b) X-ray crystallography, NMR and drug design, homologous modeling.

c) Thermodynamic consideration of drug binding – free energy change, enthalpy change,

electrostatic interaction, ionic bond, charge – dipole & dipole, dipole interactions, dispersion

forces.

d) Entropic contributions – translational and rotational entropy, hydrophobic effect, salvation

effects.

e) Intermolecular interaction –free energy perturbation and partitioning method.

f) Ligand – receptor interaction- intrinsic binding energies.

g) Role of stereochemistry in drug design.

h) Structure based drug design and Pharmacophore based drug design.

i) Softwares of drug design.




IV. Drug Interactions

1. Definition and basis of drug interactions

2. Mechanism of drug interactions

3. Factors contributing to the occurrence of drug interactions

4. Drug-drug Interactions with reference to analgesics, anti-inflammatory drugs, diuretics,

cardiovascular drugs, gastro-intestinal agents, antibiotics, vitamins and hypoglycemic drugs.

5. Use of drug interactions information

a. Food and drug interactions

b. Nicotine and drug interactions

c. Alcohol and drug interactions

6. Adverse drug reactions

7. Patients variables

8. Legal aspects- drug interactions litigation

V. Nutraceuticals

1. Introduction to Nutraceuticals as Science: Historical perspective, classification, scope. Applied

aspects of the Nutraceutical Science. Sources of Nutraceuticals. Relation of Nutraceutical Science

with other Sciences: Medicine, Human physiology, genetics, food technology, chemistry and

nutrition.

2. Properties, structure and functions of various Nutraceuticals: Glucosamine, Octacosanol, Lycopene,

Carnitine, Melatonin and Ornithine alpha ketoglutarate. Use of proanthocyanidins, grape products,

flaxseed oil as Nutraceuticals.

3. Current global trends in nutraceuticals, their types, raw materials, quality control and assurance,

regulatory affairs and commerce in nutraceuticals.

4. Nutraceuticals and their significance in the prevention and treatment of diseases.

5. New technologies in development of Nutraceuticals and functional foods and chemoprevention and

Nutraceuticals.

6. Nutraceuticals and the future of medical science and consumer’s views on nutraceuticals.

VI. Herbal Drug Technology

1. Chemical and spectral approaches to simple molecules of natural origin.

2. Concepts of stereoisomerism taking examples of natural products.

3. Chemistry, biogenesis and pharmacological activity of medicinally important monoterpenes,

sesquiterpenes, diterpenes and triterpenoids.

4. Carotenoids: α- carotenes, β- carotenes, vitamin A, xanthophylls of medicinal impotance.

5. Glycosides: Chemistry and biogenesis of digitoxin, digoxin, hecogenin, sennosides and diosgenin.

6. Alkaloids: Chemistry, biogenesis and pharmacological activity of atropine and related compounds,

quinine, reserpine, morphine, papaverine, ephedrine, ergot and vinca alkaloids.

7. Chemistry and biogenesis of medicinally important lignans and quassanoids, flavonoids.

8. Natural allergens, photosensitizing agents and fungal toxins.

9. An introduction to plant vaccines, plant bitters and sweeteners.

10. Herbal constituents in cosmetics.

11. Marine Pharmacognosy: Novel medicinal agents from marine sources.




B.PHARM. VIII SEMESTER (Practicals)

Course


PHSC 8105 Novel and Controlled Drug

Delivery Systems 3 1

Novel and Controlled Drug Delivery Systems

Practical: 3h/week

Practicals related to theory.

BOOKS RECOMMENDED

1) Robinson, J.R. & Lee, V.H.I.: Controlled and Novel Drug Delivery Marcel Dekker, New York and

Basel.

2) Jain, N.K.: Controlled and Novel Drug Delivery,CBS, New Delhi.

3) Jain, N.K. Advances in Novel and Controlled Drug Delivery.

4) Chien, Y.W.: Novel Drug Delivery Systems, Marcel Dekker, New York and Basel.

5) Roseman, T.J.: Controlled Release Drug Delivery Ssytems, Marcel Dekker New, York

6) Goldberg : Targeted Drugs.

7) Bruck, S.D., Controlled Drug Delivery, Vol. I & II.

8) Juliano, R.L.: Drug Delivery Systems.




B.PHARM. VIII SEMESTER

BIOPHARMACEUTICS & PHARMACOKINETICS (Practicals)

Course


PHSC 8106 Biopharmaceutics &

Pharmacokinetics 3 1

Biopharmaceutics & Pharmacokinetics

Practical: 3h/week

Practicals based on ADME process, bioavailability, bioequivalance, protein binding, compartment models,

Non-linear pharmacokinetic analysis.

BOOKS RECOMMENDED

1. Handbook of Basic Pharmacokinetics-Ritschel, W.A. Drug Intelligence Publication, M Hamilton, 1977.

2. Fundamentals of Clinical Pharmacokinetics- Wagner, J.C., Drug Intelligence Publication, M. Hamilton,

1975.

3. Remington's Pharmaceutical Sciences - Gennaro A.R., ed., 19th Edition, Mack Publishing Co., Easton,

PA. 1995.

4. Clinical Pharmacokinetics - Rowland, M. & Tozer,N., 2nd,edition, Lea and Febiger, Philadelphia, 1989.

5. Pharmacokinetics-Gibaldi M. & Perrier, D., 2nd ed., Marcel Dekker, New York, 1982.

6. Pharmacokinetics for the Pharmaceutical Scientist-Wagner, J.C., Technomic Publishing AG,

Switzerland, 1993.

7. Biopharmaceutics and Pharmacokinetics-Notari, R.E., 2nd ed., Marcel Dekker, New York, 1975.




B.PHARM. VIII SEMESTER (Practicals)

Course


PHSC 8107 Pharmacognosy and

Phytochemistry -IV 3 1

Pharmacognosy and Phytochemistry -IV

Practical: 3h/week

1. Identification of drugs mentioned in theory (PHSC-8103) with microscopy of underlined drugs in entire

and powderded form.

2. Chemical evaluations of following through extractive values: Harad, Baheda, Amla, Kalmegh and Bach

3. Chromatographic evaluations of following: Harad, Baheda, Guduchi, Amla, Kalmegh, Guggul

4. Pharacognostic study of at least one commonly marketed herbal product

5. Excursion of Medicinal Plant Garden

BOOKS RECOMMENDED

1. Text Book of Pharmacognosy – C.S. Shah & J. S. Quadry 2. Text Book of Pharmacognosy – T. E. Wallis 3. Pharmacognosy – Trease & Evans 4. Pharmacognosy – Brady & Taylor 5. Text Book of Pharmacognosy – V. K. Kapoor & S.S. Handa 6. Pharmacognosy – C. K. Kokate, A.P. Purohit and S.B. Gokhale

B.PHARM. VIII SEMESTER (Project on elective)

Course


PHSC 8108 Project on elective 6 2

b. pharm. course : fourth year (vii sem. & viii sem

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