DR. BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY, AURANGABAD
SYLLABUS FOR THE FINAL YEAR B. PHARM. COURSE
Sr. No. Subject Theory hours per week Practical hours per
week 4.1. Dosage form Design 3 3 4.2. Pharmacognosy and Phytochemistry 3 3 4.3. Medicinal Chemistry - II 3 3 4.4. Pharmacology and Bioassay 3 3 4.5. Pharmaceutical Management 3 -- 4.6. Quality Assurance Techniques 3 3 4.7. Pharmaceutical Jurisprudence and 3 --
Intellectual Property Rights
Total 21 15
4.1 : Dosage Form Design – Theory (Final B. Pharm.) - 3 HRS. / WEEK
Sr. Topics and contents Hours No.
SECTION - A
Preformulation: - 08
Concept of preformulation,
1. Organization of preformulation activity,
Essential information of new drug for preformulation, Principle areas of
preformulation: - Analytical preformulation, Bulk Characterization, Solubility,
2. Solubility and Dissolution: - 10
Methods of expressing solubility,
Prediction of solubility
Physicochemical prediction of solubility
Factors affecting on solubility
Factors affecting dissolution
Measurement of dissolution rates
3 Stability: - 10
Definition: - Expiry date, Shelf life, Order of reaction.
Environmental factors influencing stability: - pH, Solvent, Solubility, Additives, Light,
Temperature, Acid Base Catalysis, Ionic Strength
Modes of drug instability and methods to prevent them: - Chemical and Physical
Technique of stability prediction, Tentative expiry dating
Introduction to cGMP guidelines in stability testing and expiry dating(No details)
Effect of packaging material on stability of drug.
4 Package Development: - 10
Structure and composition
Glass- types, manufacture of glass, glass container, evaluation
Plastic- definition, material properties (mechanical, electrical and optical),
physicochemical properties (mass transfer, chemical attack), types-thermoplastic,
thermoset with example and applications.
Drug plastic interactions, evaluation of plastics
Collapsible tubes- metal, plastic, lamination
Closure: closure types (rubber, plastic), closure liners, tamper resistant packaging,
film wrappers, blister packing material, strip package, bubble pack, shrink banding,
pouches, bottle seal, taper seals, breakable caps, tape seals, seal cartons.
5 Oral Sustained Release and Introduction to NDDS: - 15 Introduction, Terminology
Biopharmaceutical aspects: - Steady state concepts, Calculation of loading and
Design of oral SRDF systems: - Biological factors, Physicochemical factors Diffusional systems: - Reservoir system, Lag time, Burst effect
Matrix system, Effect of porosity and tortuosity Dissolution controlled system, Cube route dissolution equation, Diffusion layer
Bioerodible and Combination of diffusion and dissolution systems Evaluation: - Official and unofficial methods of evaluation of SRDF/CRDF system Polymers used in SRDF system
Introduction to NDDS( Novel Drug Delivery System): -
Osmotically controlled system, osmotic pumps
Ion exchange system
Intravaginal and intrauterine system
Injection and implant
Targeted drug delivery system: - Liposome, Nanoparticles, Prodrugs, Resealed
erythrocytes, Antibody targeted systems
6 Scale Up Techniques: - 06 Introduction
Steps involved in scale up
Scale up examples of: Solid dosage form
Liquid dosage forms- Solution, Suspension, Emulsion.
Semi solid dosage forms- Suppository
7 Optimization and Experimental Design: - 07 Introduction
Concepts of optimized drug product
Various optimization parameters like problem types and variables Optimization techniques: - Classical optimization, Statistical design Optimization methods : Evolutionary, Simplex, Langarian, Search (Introduction only). Experimental design (Introduction to)
Designing strategy and purpose of experimental design along with pharmaceutical
Stages in experimental design
Starting of experimental design- Definition, Important concepts of experimental
design, Software for designing.
8 Design of Dosage Form:- 06 Principles of dosage form design (DFD)
Biopharmaceutical aspects of DFD
Drug related factors in DFD
Therapeutic considerations in DFD.
? Leon Lachmann, H. Liebermann, “Principles and Practice of Industrial Pharmacy
? Banker’s Modern Pharmaceutics ? Pharmaceutical Experimental Design, , M and D series by Lewis Vol-92
? Kim, Advanced Pharmaceutics
? Aulton, Pharmaceutics.
? Rawland, Pharmaceutics.
th? “Remington’s Science and Practice of Pharmacy”, 20 edition, Vol-I and II
? ICH guidelines for stability study
? Indian Pharmacopoeia – Current Editions ? British Pharmacopoeia – Current Editions ? United State Pharmacopoeia – Current Editions ? S.P.Vyas, R.K.Khar, Targeted and controlled drug delivery system, CBS Publication
? Chein, Controlled Drug Delivery Systems, Marcel Dekkers Publication.
4.1 : Dosage Form Design – Practical (Final B. Pharm.) - 3 HRS. / Batch / Week
1 Compare oxidative degradation of ascorbic acid at pH 2.0 and 8.0. 2 Compare the degradation rate constant of ascorbic acid in presence of cuppric ions. 3 Construction and analysis of Plaquette Burman design to a hypothetical system. 4 Demonstration of fluidised bed processing technique.
5 Demonstration of mixing performance evaluation of mixer (Sigma/ Planetary/ ribbon/ RMG) 6 Demonstration of Preparation of microcapsules of given sample of drug by extr