H.N.B. GARHWAL UNIVERSITY SRINAGAR (GARHWAL)

A CENTRAL UNIVERSITY

Third year examination for the degree of bachelor in pharmaceutical sciences

(Four year integrated course)

Sr.

No.

Code

No Subjects

Maximum Marks

Total

Minimum Passing MarksSessional

ExamsAnnual Exams

THEORY PAPERS

1.

2.

3.

4.

5.

6.

7.

3T1

3T2

3T3

3T4

3T5

3T6

3T7

Pharmaceutical Technology I

Medicinal Chemistry I

Pharmaceutical Microbiology

Pharmacognosy II

Pharmaceutical Biochemistry

Pharmacology II

Clinical Principles & Drug Interaction

20

20

20

20

20

20

20

80

80

80

80

80

80

80

100

100

100

100

100

100

100

40

40

40

40

40

40

40

PRACTICALS

1.

2.

3.

4.

5.

6.

3P1

3P2

3P3

3P4

3P5

3P6

Pharmaceutical Technology I

Medicinal Chemistry I

Pharmaceutical Microbiology

Pharmacognosy II

Pharmaceutical Biochemistry

Pharmacology II

20

20

20

20

20

20

80

80

80

80

80

80

100

100

100

100

100

100

40

40

40

40

40

40

Pharmaceutical Technology I

(3T1)

1. Preformulation Studies:(a) Study of physical properties of drug like physical form, particle size, shape, density, wetting, dielectric constant,

solubility, dissolution, and organoleptic properties and their effect on formulation, stability, and bioavailability.(b)Study of chemical characters of drug molecule like Hydrolysis, Oxidation, Reduction, Racemisation,

Polymerization, etc. and their influence on stability of products.2. Liquid Dosage Forms:

Introduction, types, additives used in formulations, vehicles, stabilizers, preservatives, suspending agents, emulsifying agents, solubilizers, colours, flavours, etc. Manufacturing, packaging and evaluation of clear liquid of suspensions and emulsions.

3. Semisolid Dosage forms:Definitions, types, mechanism of drug penetration through skin, factor influencing penetration, semisolid bases and their selection, general formulation of semisolids, manufacturing procedure, evaluation and packaging.

4. Tablets:(a) Formulation of different types of tablets, granulation methods, technology of production of granules on large scale

by various techniques, physics of tablet making, manufacturing, packaging, and evaluation of tablets.(b)Coating of tablets: Types of coating, film forming materials, formulation of coating solution, equipments for

coating process, evaluation of coating tablets.5. Capsules:

Advantages and disadvantages, of capsule dosage form, material for production of hard gelatine capsule shell, size of capsule, method of capsule production, soft gelatine capsule shell and capsule content, importance of base adsorption and minim per gram (M/g) factor in soft capsule, quality control, stability testing, and storage of capsule dosage form.

6. Microencapsulation:Types of microcapsules, importance of microcapsules in pharmacy, microencapsulation by coacervation phase separation, multiorifice centrifugal process, spray drying, spray congealing, or suspension technique, coating pan and other techniques.

7. Quality Control And Quality Assurance (including e-GMP) and Pharmaceutical Process Validation.8. Packaging of Pharmaceutical Products:

Packaging components, types of specifications and method of evaluation, stability aspect of packaging, packaging equipments, factor influencing choice of containers, legal and other official requirements for containers, package testing.

PRACTICALS (3P1)

Experiments based on preparation and evaluation of dosage forms described in the syllabus.

BOOKS RECOMMENDED1. Handbook of Basic Pharmacokinetics- Ritschel W.A., Drug Intelligence Publication, M. Hamilton, 1977.2. Fundamental of Clinical Pharmacokinetics- Wagner J.C., Drug Intelligence Publication, M. Hamilton, 1975. 3. Remington’s Pharmaceutical science- Gennaro A.R., 19th Edition, Mack Publishing kco., Easton PA. 1995.4. Clinical Pharmacokinetics- Rowland M. & Tozer N., 2nd Edition Lea & Febiger, Philadelphia, 1989.5. Pharmacokinetics- Gibaldi M. Perrier D., 2nd Edition Marcel Dekker New York, 1982.

6. Pharmacokinetics for the pharmaceutical scientist- Wagner J.C., Technomic Publishing AG, Switzerland, 1993.7. Biopharmaceutics and Pharmacokinetics- Bramhankar & Jaiswal.

Medicinal Chemistry I

(3T2)

1. Basic Principles of Medicinal Chemistry:Structural features and pharmacologic activity (Optical isomerism, Geometric isomerism, Bio isomerism), Receptors(Receptors theories, Forces involved in drug interaction)

2. The following categories shall cover general study, IUPAC nomenclature of drugs, classification, structure activity relationship (SAR) (Chemical classes wherever applicable), Mode/Mechanism of action, therapeutic uses and syntheses of individually mentioned drugs.a) Anaesthetics: Syntheses of Thiopental sodium, Lidocaine, Benzocaine and Procaine.b) Hypnotics and Sedatives: Syntheses of Pintobarbitone, Amobarbiton and Nitrazepam.c) Anticonvulsants: Syntheses of Phenyloin, Peramethadone and Ethosuximide.d) Antipsychotics: Syntheses of Chlorpromazine and Haloperidol.e) Analgesics and Anti-inflammatory agents: Syntheses of Codeine, Nalorphine, Aminopyrine, Paracetamol,

Mofenamic acid, Indomethacin and Aspirin.f) Antihistaminics: Syntheses of Dimenhydrate, Antazoline, Pyrilamine maleate, Promethazine and

Diphenhydramine.g) Adrenergic and Cholinergic agents: Syntheses of Epinephrine, Isoproterinol, Salbutamol and Dicyclomine.h) Central Nervous System Stimulants: Syntheses of Nikethamide.i) Antihypertensive agents: Syntheses of Propenolol, Prazocin and Hydralazine hydrochloride.j) Diuretics: Syntheses of Acetazolamide, Hydrochlorthiazide, Chlorthiazide, Ethacrynic acid and Furosemide.k) Expectorants and Antitussive agents: Syntheses of Guaiphenesin.l) Gastrointestinal drugs.

PRACTICALS (3P2)

Syntheses involving some name reactions, heterocyclic nuclei and some simple drugs.

BOOKS RECOMMENDED1. William O. Foye, Principles of Medicinal Chemistry, 3rd Edition, Varghese Publishing House, Mumbai, 1989.2. Jaime N. Delgado & William A. Remers, Wilson and Gisvold’s Text Book of Organic Medicinal and Pharmaceutical

Chemistry, 9th Edition J.B. Lippincott Company, Philadelphia, 1991.3. Manfred E. Wolff, Burger’s Medicinal Chemistry & Drug Discovery 5th Edition Wiley Interscience New York 1995.4. H. Singh and V.K. Kapoor, Medicinal and Pharmaceutical Chemistry, 1st Edition Vallabh Prakashan, Delhi, 1996.5. Ashutosh Kar Medicinal Chemistry, New Age International (P) Limited, New Delhi, 1993.6. I. L. Finar Organic Chemistry, Vol. II, Stereo Chemistry and The Chemistry of Natural Products, 5 th Edition, ELBS,

Singapore, 1975.

Pharmaceutical Microbiology

(3T3)

1. Definition of microbiology & application of microbiology in pharmacy.2. Structure of bacterial cell.3. Classification of microbes and their taxonomy: Actinomycetes, bacteria, reickettsiae, spirochetes and viruses.4. General techniques: Preparation of media, sterilization, maintenance of cultures, stains and staining techniques.5. Control of microbes by physical and chemical methods:

a) Sterilization: Different methods, evaluation of sterilization methods, sterility testing of sterile pharmaceutical products.

b) Antiseptics & Disinfectants: Definition, factors influencing disinfectants, dynamics of disinfection, common disinfectants, antiseptics and their evaluation.

6. Microbial genetics and variation: a) Extra chromosomal genetic elements (plasmid).b) Genotypic and phenotypic variation.c) Mutation, gene transfer, colicinogenic factors, genetic mechanism of drug resistance in bacteria.

7. Microbial attack and host defence, virulence and pathogenicity, primary and specific defence, mechanism of body, infection and its transmission, interferones.

8. Microbial standardization antibiotics, vitamins and amino acids.9. Immunology and immunological preparations: Principles, antigens and haptens, immune system, cellular and

humoral immunity, immunological tolerance, antigen-antibody reactions and their applications, hypersensitivity, active and passive immunization products, their preparation, standardization and storage.

10. Genetic Engineering: Transformation, conjugation, transduction, protoplast fusion & gene cloning and their application, hybridomal and monoclonal antibiotics.

11. Biological products obtained by fermentation: General requirements, media, equipments and production of penicillin, streptomycin, tetracycline, vitamin C, riboflavin, citric acid.

PRACTICALS (3P3)

List of experiments:

Preparation sterilization of media (solid, liquid agar and broth). Isolation of pure colonies. Staining techniques (Gram’s staining, negative and simple staining). Aseptic transfer techniques. Antibiotic assays Sterility testing of water injection and normal saline and other sterile pharmaceutical products. Hanging drop techniques

BOOKS RECOMMENDED1. R. Anatnaryan & C.K. Panikar, Text Book of Microbiology, 6th Edition, Orient Longman, Hyderabad, 2001.2. S.J. Carter, Copper & Gunns, Tutorial Pharmacy, 6th Edition, CBS, Publishing House, New Delhi, 1999.3. W.B. Hugo & A.D. Russel, Pharmaceutical Microbiology, 4th Edition, Blackwell Scientific Publication, Oxford, 1987.4. B.D. Davies, R. Dulbecco, H.N. Eisen, H.S. Ginsberg, Microbiology, 4 th Edition, Harper and Raw, Publishers,

Singapore, 1990.5. Gennaro A.R., Remington’s Pharmaceutical Science 20th Edition, Lippincott Williams and Wilkin, Publications

Philadelphia, 2001.6. M.T. Madigan, J.M. Martinko, J. Parker, Brock Biology of Microorganisms, 9 th Edition, Prentice Hall International

Ind., London, 2000.7. P.B. Stanbury, A Whitaker, S.J. Hall, Principle of Fermentation Technology, 1 st Indian Edition, Aditya Books (P) Ltd.,

New Delhi, 1997.

Pharmacognosy II

(3T4)

1. Commerce in crude drugs: Collection, preparation, drying, and storage of drugs special emphasis on factors influencing quality of drugs, cultivation of medicinal plants.

2. Biogenesis of medicinally important glycosides and alkaloids, general techniques of biosynthetic studies.3. Systematic study of crude drugs:

Synonyms, biological / geographical sources, identification (microscopic characteristics of drugs in italic and bold), chemical constituents, chemical tests, uses, adulteration and evaluation of glycosidal, alkaloidal drugs belonging to following groups:-

Glycosidal Drugs:a) Anthraquinone glycosidal drugs: Senna, Aloe, Rhubarb, Cascara.b) Saponin glycosidal drugs: Dioscorea, Solanum, Liquorice, Senega, Ginseng.c) Cyanogenetic glycosidal drugs: Wild Cherry.d) Coumarins and Furanocoumarin glycosidal drugs: Psoralca.e) Miscellaneous glycosidal drugs: Gentian, Quassia, Saffron.

Alkaloidal Drugs:

a) Indole alkaloidal drugs: Nux-vomica, Rauwolfia, Catharanthus.b) Tropane alkaloidal drugs: Stramonium, Hyoscyamus, Datura, Belladonna, Duboisia.c) Isoquinoline alkaloidal drugs: Ipecac, Opium, Curare.d) Quinoline alkaloidal drugs: Cinchona.e) Pyridine alkaloidal drugs: Areca, Lobelia, Nicotiana.f) Imidazole alkaloidal drugs: Pilocarpus.g) Quinazoline alkaloidal drugs: Vasaka.h) Steroidal alkaloidal drugs: Ashwagandha, Kurchi, Veratrum.i) Proto- alkaloidal drugs: Ephedra, Colchium.j) Terpenoid alkaloidal drugs: Aconite.

4. Enzymes:Source, chemical nature and uses of Papain, Pancriatin, Urokinase, Diastase, Pepsin, Trypsin, Penicillinase, Hyaluronidase.

5. Study of drugs of marine origin.6. An overview of steroidal drug precursor from plants.

PRACTICALS (3P4) Evaluation of drugs (including in theory) in whole and powder form by macroscopic, microscopic, chemical and

chromatographic examination. Preparation of herbarium of plants from wild source. Quantitative microscopy of drugs.

BOOKS RECOMMENDED1. R.D. Chaudhary, Herbal Drug Industry, 1st Edition Publishers New Delhi, 1996.2. Ayurvedica Pharmacopoeia of India.3. V.D. Rangari, Pharmacognosy & Phytochemistry, Part I & II, 1st Edition, Career Publications, Nasik, 2002.4. W.C. Evans, Trease & Evans 15th Edition, Harcourt Publishers Ltd., London, 2002.5. C.K. Kokate, Pharmacognosy, 12th Edition, Nirali Prakashan Pune, 1999.6. Blumenthal, Herbal Medicine, 1st Edition, Integrative Medicine Communications, Newton, 2000.7. WHO Monographs on selected medicinal plants, Vol., I & II, 1st Edition, Word.8. Indian Materia Medica: Nadkarni

Pharmaceutical Biochemistry

(3T5)

1. Introduction: Biochemistry and its importance in pharmaceutical sciences.

2. Cell: Biochemical organization of the cell, production of cell energy, ATP and its biological significance, biochemical importance of colloidal systems, Donnan Effect.

3. Enzymes: Classification, nomenclature, factors affecting enzyme action, enzyme kinetics, mode and mechanism of enzyme action and inhibition, enzymes and their importance in diagnosis, enzyme immobilization.

4. Vitamins: Vitamins as co enzymes and their significance, metals as co- factors.

5. Carbohydrate Metabolism: Classification, glicolysis, citric acid cycle, glycogenesis, glycogenolysis, haxose monophosphate shunt (HMP), uronic acid pathway, blood sugar and its regulation, abnormalities of carbohydrate metabolism.

6. Lipid Metabolism: Oxidation of fatty acids, biosyntheses of fats, ketogenesis and ketosis, metabolism of cholesterol, essential fatty acids, eicosanoids, phospholipids, sphingolipids, abnormalities of lipid metabolism.

7. Bioenergetics: Biological oxidation and reduction, respiratory chain, oxidative phosphorilation, enzyme and co- enzyme of bio- redox system.

8. Metabolism of Amino Acids and Proteins: General biochemical reactions of amino acid like tansamination, deamination and decarboxylation, metabolism of sulphur containing amino acids, urea cycle, nitrogen balance, biosyntheses of bile salts and bile pigments.

9. Metabolism of Nuclic Acids and Protein Biosyntheses:a) Biosyntheses and catabolism of purines and pyrimidines containing nucleotide, abnormalities of nucleic acid

metabolism.b) Biosyntheses of DNA and its replication, mutation and repair mechanism, genetic diseases.c) An introduction to genetic engineering, biosyntheses of RNA, genetic code and protein synthesis.

10. Liver and Kidney function tests of biochemical importance.

PRACTICALS (3P5) Simple experiments on enzymes, proteins and amino acids, lipids, carbohydrates, nucleic acids. Urine analysis, blood analysis, food analysis, water analysis.

BOOKS RECOMMENDED1. Robert K. Murrey, Daryl K. Granner, Peter A. Mayes, Victor W. Rodwell, Harper’s Biochemistry, 25 th Edition,

McGraw Hill Health Profession Division, New York, USA, 1998.2. A.V.S.S. Rama Rao, Text Book of Biochemistry 6th Edition, L.K. & S. Publishers, Visakhapatnam, 1991.3. Melson Devid L. Lehninger Principles of Biochemistry, 3rd Edition, Macmillan Worth Publishers, New York, USA,

2001.4. Stryer Lubert, Berg Jeremy M., Tymoczko Johan L., Biochemistry, 5th Edition, W.H. Freeman & Company New

York, 2002.5. M.C. Pant, Essentials of Biochemistry, 8th Edition, Kedarnath Ramnath & Company Publishers, Meerut, 1996.

Pharmacology II

(3T6)

Pharmacology of the drugs of under mentioned categories will include classification, mechanism of action, doses, clinical uses, drug interactions and contraindications-

1. Drug Acting On Autonomic Nervous System:General considerations, cholinergic and anti-cholinergic agents, adrenergic agonists and antagonists, ganglionics blocking agents, skeletal muscle relaxants, local anaesthetic agents.

2. Drug Acting On Central Nervous System:General considerations, neurotransmitters in CNS, pre-anaesthetic medication, alcohol and disulfiram, general anaesthetics, sedatives and hypnotics, narcotic, analgesics, antipyretics, NSAID’S, anti-gout agents, anti-depressants, anti-psychotics, psychedelics, psychopharmacological agents, antiepileptics, CNS stimulants, antiparkinsonian agents, centrally acting muscle relaxants.

3. Drug Acting On Cardiovascular System:Digitalis and cardiac glycosides, antihypertensives, antianginals and vasodilators, antiarrythmics.

4. Toxicology:Principles of toxicology, manifestations of toxicity, immunotoxicity, toxic effects on genetic material cell replication, non therapeutic toxicants, air pollutions food additives and contaminations, animal toxins, metals, solvents, pesticides.

5. Drug Acting On Endocrine System:a) Hypothalamic and pituitary hormones.b) Thyroid hormones and antithyroid drugs, calcitonin, parathormones, vitamin D.c) Insulin, oral hypoglycaemic agents and glucagones.d) Adrenocorticoids, anabolics, antifertility agents.e) Drug acting on Uterus.

6. Drug Acting On Urinary System:Fluid electrolyte balance, diuretics.

7. Preclinical and Clinical Trials (Phase I, II, III & IV).8. Autacoids:

Histamine, antihistaminics, serotonin and its antagonists, prostaglandins, prostacyclines, thromboxanes, platelet activation factors, lipoxanes, leukotrienes.

PRACTICALS (3P6) Experiments on CNS:

Recording of spontaneous motor activity, stereotype, analgesia, anticonvulsant activity and muscle relaxant activity of drugs using simple experiment.

CVS Pharmacology: To study the ionotropic and chrontropic effects of drugs on isolated frog heart. To study the effects of drugs on normal and hypo-dynamic frog heart.

To calculate the PA2 value of atropine and chlorpheniramine. Bioassay of acetylcholine, histamine, oxytocin, on suitable isolated preparation using matching assay, bracketing

assay, three point and four point assay.

BOOKS RECOMMENDED1. Goodman & Gillman, the Pharmaceutical Basis of Therapeutics, 9 th Edition, McGraw Hill Companies, New York,

USA, 1996.2. Katzung G. Bertram, Basic and Clinical Pharmacology, 8th edition, McGraw Hill Companies, N.Y., USA, 2001.3. Rang H.P., Dale M.M., Ritter J.M., Pharmacology, 4th Edition, Churchill Livingston, New York, USA, 1999.4. R.S. Satoshkar, Pharmacology and Pharmacotherapeutics, Vol. I & II, 16th Ed., Popular Prakashan, Mumbai, 1999.5. Monsoon D. Paul, Principles of Pharmacology, Chapman and Hill, New York, 1995.6. Laurence & Bennett, Clinical Pharmacology, 8th Edition, Churchill Livingston, New York, USA, 1997.7. S.D. Seth, Text Book of Pharmacology, 2nd Edition, Churchill Livingston Pvt. Ltd. New Delhi.

Clinical Principles & Drug Interaction(3T7)

1. Introduction: Development and scope of clinical Pharmacy, concept of health care team, role of clinical pharmacist as-a member of health care team and his/her important functions.

2. Basic Concepts of Pharmacotherapy:a) Clinical pharmacokinetics and individualization of Drug Therapy.b) Recording of medication history, self medication, and non-prescription drug usage, improving patient

compliance and providing patient counselling.c) Drug delivery systems and their biopharmaceutic and therapeutic consideration, general vs. patent drugs,

principles of pharmacoeconomics.d) Drug used in infancy and elderly (Paediatrics and Geriatrics).e) Drug use during pregnancy.f) Drug induced diseases.g) Drug interactions: Prescription monitoring, documentation and other methods for minimizing clinically relevant

drug interactions.h) General principles of clinical toxicology.i) Interpretation of Clinical Laboratory Test: Haematological, pathological and biochemical investigations as

marker of major organ damage and their effect on drug therapy decision.j) Adverse drug reactions (ADR) and the role of clinical pharmacist in their monitoring and prevention (concepts of

pharmacoepidemiology and pharmacovigilance).k) Drug information centre in a hospital, its need, component and activities, innovations in information retrieval

systems.l) Communication skills: Behavioural and interpersonal with patients and other professionals.

3. Important Disorder of Organs, Systems and Their Management:a) Cardiovascular Disorders: Hypertension, congestive heart failure (CHF), angina, acute myocardial infection,

cardiac arrhythmias.b) CNS Disorders: Epilepsy, Parkinsonism, schizophrenia, depression and migraine.c) Respiratory Diseases: Asthma.d) Gastrointestinal Disorders: Peptic ulcer, ulcerative colitis, hepatitis, cirrhosis.e) Endocrine Disorders: Diabetes mellitus and thyroid disorders.f) Infectious Diseases: Tuberculosis, urinary tract infections, enteric infections, upper respiratory infections,

sexually transmitted diseases (STD) & AIDS.g) Haematopoietic Disorders: Anemias.h) Joint and Connective Tissue Disorders: Rheumatic diseases, Gout and hyperuricemia.i) Neoplastic Diseases: Acute leukaemias, Hodgkin’s disease and carcinoma of breasts.

4. Therapeutic drug monitoring.5. Concept of essential drugs rational drug use.

BOOKS RECOMMENDED1. R. Walker, Clinical Pharmacy & Therapeutics, 2nd Edition, 2. D.H. Lawson, Clinical Pharmacy and Hospital Management, 1st Edition, Chapmen Hall, New York, USA, 1980.3. A.J. Winfield & R.M.E.R. Chards, Pharmaceutical Practice, 2nd Ed., Churchill Livingstone, New York, USA, 1999.4. W.E. Hassan, Hospital Pharmacy, 3rd Edition, Lea and Fiegiber, Philadelphia, New York, USA, 1974.5. A.R. Gennaro, Remington’s The Science and Practice of Pharmacy, Vol. I & II 20 th Edition, Lippincott, William and

Wilkins, Philadelphia, New York, USA, 2000.