Rajiv Gandhi Proudyogiki Vishwavidalaya, Bhopal (M.P.) B.Pharma- VII Semester

Rajiv Gandhi Proudyogiki Vishwavidalaya, Bhopal (M.P.)

B.Pharma- VII Semester

PY-701 PHARMACEUTICS VIII

(PHARMACEUTICAL TECHNOLOGY I)

Formulation considerations, technology involved, equipment (machine) employed, problems to be

encountered, packaging evaluation and CMP (India, WHO & USFDA) requirements of the following dosage

forms.

1. Solid Dosage Forms- Tablets, Tablet coatings and Capsules.

2. Liquid Dosage Forms- Liquid Orals, Dry Syrups.

3. Semisolid Dosage Forms- ointments, Creams, Suppositories, Gels.

4. Sterile Dosage Forms- Parenteral ( Small Volume Parenterals & Large Volume Parenterals ) and

ophthalmic Preparations.

5. Pharmaceutical Aerosols

Blood Products and Plasma Substitutes:

Collection, processing and storage of whole human blood, concentrated human RBC, dried human plasma,

human normal immunoglobulin, plasma substitutes, ideal requirements, PVP, Dextran, etc. for control of

blood pressure,

Surgical products:

Definition, surgical cotton, surgical gauzes, bandages, adhesive tapes, absorbable and non absorbable sutures,

ligatures and catguts, Medical prosthetics and organ replacement materials.

Books Recommended

1. Rawlins, E.A., Text Book Of Pharmaceutics, Bailliere Tindall.

2. Lachman, L. , Liberman, H.A. and Kanig, J.L., The Theory and Practice of Industrial Pharmacy,

Lea and Febiger, Philadelphia.

3. Liberman, H.A., lachman, L. and Ker Inc. New York.

4. Pharmacopoeia Of India, Ministry of Health and family Welfare, Govt. of India, New Delhi.

5. Avis, K.E., Lachman, L. and Liberman, H.A., Pharmaceutical Dosage Forms-Parenteral

Medication Vol.1-2, Marcel Decker Inc., New York.

6. Banker G.S. and Rhode C.T., Modern Pharmaceutics, Marcell Decker Inc., New York.

7. Bean, H.S., Beckett, A.H. and Carless, A.H., Advances in Pharmaceutical Sciences, Vol.1-4,

Academic Press, London.

B.Pharm. Semester VII

PY-701:Pharmaceutics-VIII Pharmaceutical Technology –I

List of Practicals

1. Prepare and evaluate Paracetamol Compressed Tablets.

2. Prepare and evaluate Effervescent Tablets of Aspirin.

3. Prepare and evaluate Dispersible tablets of Diclofenac Sodium.

4. Perform the Sugar Coating on the given sample of Tablets.

5. Perform the Film Coating on the given sample of Tablets.

6. Perform the Enteric Coating coating on the given sample of Tablets.

7. Prepare and evaluate Tetracycline HCL Capsules.

8. Prepare and evaluate Antacid Suspension.

9. Prepare and evaluate B-Complex Syrup.

10. Prepare and evaluate Amoxicillin Dry Syrup.

11. Prepare and evaluate Castor Oil Emulsion.

12. Prepare and evaluate Diclofenac Sodium Suppositories.

13. Prepare and evaluate Vaporizing Ointment.

14. Prepare and evaluate Non-Staining Iodine Ointment containing Methyl Salicylate.

15. Prepare and evaluate Antiseptic Cream.

16. Prepare and evaluate Diclofenac Gel.

17. Prepare and evaluate Ciprofloxacin Eye Drop.

18. Prepare and evaluate Water for Injection.

19. Prepare and evaluate Oxytetracycline Injection.

20. Perform the Sability Studies of given sample of Paracetamol Tablets.

21. Prepare and evaluate an aqueous injection of a poorly water – soluble drug using hydrotropic

solubilization technique.

Course Contents

PY702 : Pharmaceutics-X

(Biopharmaceutics and Pharmacokinetics)

Introduction to biopharmaceutics and pharmacokinetics development and their role in drug formulation.

Biopharmaceutics

Definition , passage of drugs across biological barrier , Physiochemical , Biological and Pharmacaceutical

factors influencing biopharmaceutical performance of drugs.

1. Gastrointestinal absorption of drugs: Passage of drugs across biological membranes, nature of

biological membranes, gastrointestinal absorption mechanisms.

2. Factors affecting drug absorption : Physiological factors, dietary factors,physiochemical factors, pH

partition hypothesis, dosage form factors.

3. Methods of studying gastrointestinal absorption: In vitro and in vivo methods.

4. Drug disposition: Distribution in blood, cellular distribution, plasma protein binding, tissue protein

binding.

Drug Excretion: Routes of drug excretion, renal excretion of drugs, factors affecting renal excretion,

biliary and salivary excretion of drugs.

Drug biotransformation: Pathways of drug metabolism, drug metabolizing enzymes, factors affecting

drug metabolism and drug response, inhibition and stimulation of drug metabolism.

Pharmacokinetics

Absorbtion, distribution metabolism and excretion of drugs, fluid compartment and circulatory system,

protein binding, significance of plasma drug concentration measurement.

Compartment Models

Model selection criteria, alaika information criterian, one – compartment and two compartment models,

Wagner- Nelson and loo Riegelman methods for estimation of absorption constants. Curve fittings,regression

procedure and area under blood level curves.

Clinical Pharmacokinetics

Urinary excretions, computation of pharmacokinetic parameters from urine data, haepetic clearance,biliary

excretion,excretion ratio,dosage regimen adjustment in patients with and without renal failure,

pharmacokinetic drug interaction and their significance in combination therapy.

Biovailability and Bioequivalance

Biovailability and Bio-equivalance, Federal requirements, Methods of determination of bioavailability using

blood level and urinary excretion data, design and evaluations, bioavailability assessment.

Books recommended

1. Gibaldi, M.and Perrier d, Pharmacokinetics, 4th edn. Pharma mid press, Hydrabad

2. Notari, R.E., Biopharmaceutics and pharmacokinetics-An Introduction, marcel Decker New York.

3. Jaiswal , Brahmankar Biopharmaquality and pharmacokinetics.

4. Leepeter I.D., Pharmacokinetic analysis

5. Niazi Textbook of Biopharmacokinetics and clinical pharmacokinetics.

6. Venkaateshwaru v , Biopharmaceutics and pharmacokinetics, phared puss, Hydrabad.

7. Wagner-pharmacokinetics for the pharmastudies.

8. Dhachinamoorthi D: Biopharmaceutics and pharmacokinetics : A practical mannd

9. Shargel : pharmacokinetics & Biopharmacokinetics & Biopharmaceutics

B.Pharm. Sem – VII

PY 702 : Pharmaceutics – X

(Biopharmaceutics & pharmacokinetics ) practicals

List of Practicals

1. Determine the percentage protein binding of the given drug.

2. Determine oral bioavailability of the given drug/formulation by urinary excretion method using animal

model.

3. Perform bioequivalence study of two different brands of the marketed tablets of the given drug using

animal model.

4. Determine the rate of in-vitro absorption of the given drug using everted intestinal sack.

5. Determine the effect of different pH condition on solubility of a weekly acidic or basic drug and study

PH partition hypothesis.

6. Establish IVIVC for the given sample of drug.

7. Calculate elimination rate constant and elimination half life of given excretion data by sigma minus

method.

8. Calculate elimination rate constant and elimination half life of the given drug data administered by i.v.

bolus injection represented by one compartment model.

9. Calculate various pharmacokinetic parameters from the given data generated after single extra

vascular administration of drug represented by one compartment model.

10. Calculate various pharmacokinetic parameters from the given data obtained by using two compartment

open model.

Branch: Pharmacy-VII Semester

PY - 703 : PHARMACEUTICAL CHEMISTRY VIII

(MEDICINAL CHEMISTRY-III)

The synthesis of the selected drugs, mode of action, classification, uses, SAR of the following category of

drugs:

Drugs acting on Cardiovascular system :

* Cardiac Glycosides

* Antiarrythmic drugs

* Antianginal drugs

* Antihypertensive drugs

* Antihyperlipidimic drugs

Drugs acting on Urinary system :

* Diuretics

Chemotherapeutic Agents

* Anti metabolites(Including Sulpha durgs)

*Anti viral & Anti HIV,

* Anti neoplastic,

*Anti malarials,

* AntiProtozoal

* Anti tubercular,

* Anthelmintics,

* Antifungals

* B-lactum antibiotics

* Aminoglycosides

* Protein synthesis inhibitors (Tetracyclins,chloramphenicol,Macrolides)

* Miscellaneous antibiotics (Bacitracin, Glycopeptides, Polymyxins)

* Immuno- suppressive

Drugs affecting uterine motility

* Oxytocins (including prostaglandins and Ergot alkaloids).

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,Medicianl and

Pharmaceutical Chemistry, J.Lippincott Co., Philadelphia.

5. Nogrady, T., Medicinal Chemistry-A Biochemical Approach, Oxford University Press, New York,

Oxford.

6. Kar, A., Medicinal Chemistry, Willey Eastern Ltd., New Delhi.

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

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

9. Parimoo, P., Text Book of Medicinal Chemistry, CBS Publishers and Distributors, New Delhi.

10. Thomas, G., Introduction to medicinal Chemistry, CBS Publishers and Distributors, New Delhi.

11. Sten lake B.J. medicinal and pharm. Chemistry pharma mid press, Hyderabad

PY704 : Pharmaceutical Biotechnology Theory

Historical Development :

Immunology and Immunological Preparations :

Principles, Antigens and antibodies, Antigen-antibody reactions and their applications,

Immune system.Cellular humoral immunity, Immunological tolerance, Hypersensitibity,

Immunological and diagnostic preparations: Methods of their preparation, standardization and

storage.

Enzyme Immobilization –

Techniques of Immobilization of enzymes, Kinetics and factors affecting enzymes kinetics,

Enzymes based sensors, Study of enzymes such as Hyaluronidase, Penicillinase, Strepto-

Kinase, Amylases etc. Immobilization of bacteria and plant cells, Applications of

Immobilization.

Genetic Recombination :

Transformation, Conjugation, Transduction, Protoplast fusion, Gene cloning and their

applications, Monoclonal antibodies and hybridoma technology, Recombinant DNA

technology: Concepts, Methodology and Pharmaceutical applications. Study of drugs

produced by biotechnology such as Activase, Humulin, Humatrope, Introne A, Monoclate,

Orthoclone OKT3, Referon-A, Recombivax HB etc.Drug delivery systems in Gene therapy.

Microbiological Transformation –

Intoduction, Types of reactions mediated by micro organisms. Design of biotransformation

processes, Selection of organism, Biotransformation processes and its improvements with

special refrence to steroids.

Industrial Biotechnology –

Historical development, Fermenter and its design, Control of different parameters in

fermentation process, Isolation of mutants, Use of mutagenic agents, Factors in influencing

rate of mutation. Design of fermentation process, Fermentative, production of Alcohol, Acetic

acid, Penicillin, Streptomycin, Riboflavin, Vitamin B12.

B.Pharm. Semester- VII

PY 704 Pharmaceutical Biotechnology Practical

List of Practicals

1. Detect the presence of the amylase enzyme in saliva.

2. Isolate the DNA from cauliflower.

3. Perform VDRL test for the given sample of blood.

4. Isolate the phospholipid from egg yolk .

5. Perform WIDAL test for the given sample of blood.

6. Perform DOT ELISA test of the given sample of blood.

7. Isolate the total RNA from yeast tablet.

8. Immobilize the given enzyme by adsorption method using calcium alginate beads.

9. Perform titre value of antibody in given blood sample.

PY -705 : Pharmacology – IV

Chemotherapy of Microbial Diseases

General principles

Synthetic organic antimicrobials (Sulphonamides, quinolones etc.)

B-lactum antibiotics

Aminoglycosides

Protein synthesis inhibitors (Tetracyclins,chloramphenicol,Macrolides)

Antitubercular drugs, antileprotic drugs,antiprotozoals, anthelmintics, antifungals

Antiretroviral and antiviral drugs

Miscellaneous antibiotics (Bacitracin, Glycopeptides, Polymyxins)

Chemotherapy of cancer and immunosuppressive agents

Basic concepts of Pharmacotherapy

Individualization of drug therapy : Clinical pharmacokinetic and pharmacodynamics

Drug use during pregnancy, Pediatrics and Geriatrics

Adverse drug reactions and drug induced diseases

Drug interactions

Therapeutic drug monitoring

Clinical Toxicology

Definition of poison

General principles of treatment of poisoning

Treatment of opioid, barbiturate, organophosphorous, and atropine poisoning

Heavy metals and heavy metal antagonists

BOOKS RECOMMENDED

1) Herfindal, E.T., Gourley, D.R., (eds.) (2000) Textbook of therapeutics Drug and disease management.

7th ed.Baltimore : Lippincott Williams and Wilkins

2) Hardmen, J.G.Limbird, L.E. Gilman A., G., (eds.) (2001) Goodman and Gilman’s The

pharmacological basis of therapeutics. 10th ed. USA : The McGraw Hill Companies

3) Barar, F.S.K., (2000) Essential of therapeutics. New Delhi: S. Chand and Company (P) Ltd.

4) Satoskar, R.S. Bhandarkar, S.D., Rege, N.N., (2007) Pharmacology and Pharmacotherapeutics. 12th

ed. Mumbai: Popular Prakashan

5) Seth, S.D., (ed.) (2005) Textbook of Pharmacology. 2nd ed. New Delhi. Elsevier.

6) Tripathi, K.D. (1999) Essentials of Medical pharmacology. 4th ed. New Delhi : Jaypee Brothers

Medical Publishers (P) Ltd.

7) Rang, H.P., et. (eds.) (2003) Pharmacology. 5th ed. Philadelphia Elsevier.

8) Katzung , B.G., (2004) Basic and clinical pharmacology. 9th ed. USA : The Mcgraw Hill Companies.

9) Dipiro, J.T., et al. (eds.) (1997) Pharmacotherapy. A pathophysiologic approach. 3rd ed. Stanford,

Connecticut: Appleton and Longe.

10)Craig, C.R., Stitzel, R.E. (1999) Modern pharmacology with clinical applications. 5th ed. USA.

11) Guideliness for poison control. (1999) WHO, Geneva: AITBS Publisher, Delhi

12) Curry – Drug disposition and pharmacokinetics with a consideration of pharmacokinetics with a

consideration of pharmacological and elinical relationships, 3rd edn., pharmumed pre

13) Kenakin Terry P: A pharmacological Primer – theory applications & methods, pharma med prre