Unit 1: Preformulation and Optimization(10 Hrs)Drug Excipient interactions: different methods, kinetics of stability, Stability testing. Theories of dispersion and pharmaceutical Dispersion (Emulsion and Suspension, SMEDDS) preparation and stability Large and small volume parental physiological and formulation consideration, Manufacturing and evaluation.Optimization techniques in Pharmaceutical Formulation: Concept and parameters of optimization, Optimization techniques in pharmaceutical formulation and processing. Statistical design, Response surface method, Contour designs, Factorial designs and application in formulationUnit 2: Toxicity and Validation(8 Hrs)General concepts of toxicity, acute, sub-acute & chronic toxicity tests, teratogenicity & carcinogenicity, LD50, ED50, MIC- anti infectives, habituation & addiction. Introduction to Pharmaceutical Validation, Scope & merits of Validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipments, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.Study of consolidation parameters: Diffusion parameters, Dissolution parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors f2 and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard deviation, Chi square test, students T-test, ANOVA test.Unit 3: Modern Pharmaceutical Analytical Techniques (8 Hrs)Chromatographic methods: Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution and applications of the following: a) Paper chromatography b) Thin Layer chromatography c) Ion exchange chromatography d) Column chromatography e) Gas chromatography f) High Performance Liquid chromatography g) Affinity chromatography.Flame emission spectroscopy and Atomic absorption spectroscopy: Principle, Instrumentation, Interferences and Applications.Electrophoresis: Principle, Instrumentation, working conditions, factors affecting separation and applications of the following: a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis d) Zone electrophoresis e) Moving boundary electrophoresis f) Isoelectric focusing.Immunological Assays: Radioimmunology assay (RIA), ELISA (Theory & practical) and knowledge on Bioluminescence assays.Unit 4: Marketing the Drug(8 Hrs)Preclinical and clinical trials, Toxicity testing, Drug metabolism studies, Pharmacology, formulation, and stability tests, Clinical trials.Patenting and regulatory affairs, Patents, Regulatory affairs.Chemical and process development, Chemical development, Process development, Choice of drug candidate, Natural products.Unit 5: Specific Case Studies(6 Hrs)Case study 1: The design of angiotensin converting enzyme (ACE) inhibitorsCase study 2: The design of oxamniquineCase study 3: Discovery of Boceprevir: Treatment of Hepatitis C Virus Infection
