Syllabus (MICROBIOLOGY)

Course Type: MAJ-18

Semester: 8

Course Code: BMCBMAJ08T

Course Title: PHARMACEUTICAL MICROBIOLOGY

(L-P-Tu): 4-2-0

Credit: 6

Practical/Theory: Combined

Course Objective: 1. To understand the basics of pharmaceutical microbiology and microbial roles in pharmaceuticals. 2. To appraise the different products of microbial origin and their role in pharmacology. 3. To appreciate the role of secondary metabolites in pharmaceutical industry.

Learning Outcome: Upon successful completion of the course the candidate will be able to- 1. Understand the concept of antibiotics and their mode of action. 2. Learn about the sterilization and preservation of pharmaceutical products. 3. Gain idea about different chemotherapeutic agents. 4. Understand the importance of gene therapy and different types of vaccines.

MAJOR COURSE- 02

COURSE TITLE: PHARMACEUTICAL MICROBIOLOGY(THEORY)

TOTAL HOURS: 60 CREDITS:4

Unit 1. Introduction to chemotherapeutic agentsNo. of hours:12

History and development of chemotherapeutic agent, properties of anti-microbial agents, types of chemotherapeutic agents- synthetic, semi-synthetic and natural antibiotics.Types of antibiotics and their classification; non-medical uses of antibiotics. Sanitizers, chemical disinfectants and antiseptics.

Unit 2. Mode of action of antibioticsand antibiotic resistance No of hours: 14

Chemical nature and mode of action of antibiotics (inhibitors of cell wall synthesis, membrane, nucleic acid and protein synthesis), anti- fungal antibiotics, anti- viralantibiotics and interferons.Development of antibiotic resistance, Mechanism of antibiotic resistance. Concept of pharmacokinetics.

Unit 3. Microbial spoilage, sterilization and preservation of pharma products No. of hours:10

Microbial contamination spoilage and hazard: Sources of contamination, factors affecting survival and growth, breakdownof active ingredient and general formulations.

Principles of sterilizations with respect to pharmaceuticalindustries. Methods of sterilizations: steam, dry heat, radiation, gaseous and filtration, sterility testing of pharmaceutical products.

Principles of preservation, antimicrobial preservatives and their properties, preservative stability and efficacy.

Unit 4. Gene therapy and vaccine designNo. of hours: 14

Gene therapy: general introduction, ex vivo and in vivo gene therapy, potential targets for gene therapy, inherited disorders.

Vaccine design and production, classification, genetically recombinant vaccines, advantages and disadvantages – examples – hepatitis B vaccines, edible vaccines, DNA vaccines – principles and mechanism, vaccine clinical trials.

Unit. 5. Regulatory aspects in pharmaceutical industriesNo. of hours: 10

Introduction to pharmacopoeia: Food and Drug Administration (FDA) regulation and India Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP) Good Laboratory Practices (GLP) Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP).

SUGGESTED READINGS

1. “Pharmaceutical Biotechnology”, by S.S. Purohit, H.N. Kakarni and A.K. Saluja, Agrobios (India).
2. “Basic Biotechnology”, edited by Colin Ratledge and Bjorn Kristiansen, 2001, Cambridge University, Press, New York.
3. “Biotechnology: A Text Book of Industrial Microbiology”, 2nd edition by Wulf Crueger and Anneliese Crueger (Third Indian reprint 2005), Panima Publishing Corporation New Delhi / Bangalore.
4. Pharmaceutical Microbiology – Edt. by W.B.Hugo & A.D.Russell Sixth edition. Blackwell scientific Publications.
5. Quality control in the Pharmaceutical Industry - Edt. by Murray S.Cooper Vol.2. Academic Press New York.
6. Pharmaceutical Biotechnology by S.P.Vyas & V.K.Dixit. CBS Publishers & Distributors, New Delhi.
7. Good Manufacturing Practices for Pharmaceuticals Second Edition, by Sydney H.Willig, Murray M.Tuckerman, William S.Hitchings IV. Merkel Dekker NC New York.
8. Quality Assurance in Microbiology by Rajesh Bhatia, Rattan LalIchhpujani. CBS Publishers & Distributors, New Delhi.

COURSE TITLE: PHARMACEUTICAL MICROBIOLOGY(PRACTICAL)

TOTAL HOURS: 60 CREDITS:2

1. Sterility testing of pharmaceutical products.
2. Staining and biochemical test.
3. Determination of phenol coefficient.
4. Determination of.MICof antimicrobials.
5. Microbial assay of antibiotic by cup plate method and disc diffusion method.