Section B - DR

By Beth Cunningham,2014-06-17 15:32
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Section B - DR ...



    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,

    Stability Analysis.

    2. Solubility and Dissolution: - 10

    Methods of expressing solubility,

    Prediction of solubility

    Physicochemical prediction of solubility

    Solubility Parameters

    Factors affecting on solubility

    Dissolution mechanisms

    Factors affecting dissolution

    Intrinsic 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

    maintenance dose.

    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

    controlled dissolution.

    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

    Transdermal system

    Occular system

    Intravaginal and intrauterine system

    Injection and implant

    Biomucoadhesive system

    Iontophhoretic system

    Sonophoretic system

    Targeted drug delivery system: - Liposome, Nanoparticles, Prodrugs, Resealed

    erythrocytes, Antibody targeted systems

    6 Scale Up Techniques: - 06 Introduction

    Steps involved in scale up

    General consideration

    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