BPH-305: PHARMACEUTICS –IX
(PHARMACEUTICAL TECHNOLOGY-I)
THEORY
Max. Marks: 80 Total Hours: 75 (3hrs/week)Note: Examiner to set eight questions and the candidates are required to attempt any five.
- Preformulation studies:Study of physical properties of drug like physical form, particle size, shape, density, wetting dielectric constant, solubility, dissolution and organoleptic properties and their effect on formulation, stability and bioavailability.
- Study of chemical properties of drug like hydrolysis, oxidation, reduction, recemization, polymerization etc., and their influence on formulation and stability of products. (10)
- Glandular, blood and related products: Introduction, extraction methods and preparation of thyroid, liver, pancreas, pituitary gland, Whole human blood, concentrated human RBC, dried human plasma, dried human serum, human plasma protein fraction, human fibrinogen, human thrombin, plasma substitute, ideal plasma substitute properties, products i.e. PVP, Dextran, absorbable gelatin, sponge, oxidized cellulose, calcium gluconate. (9)
- Design, development and process validation methods for pharmaceutical operations involved in the production of pharmaceutical products with special reference to liquid dosage forms. (7)
- ICH Guidelines for stability testing protocol for various pharmaceutical products. (7)
- GMP, Quality assurance, Quality audit. (5)
- Specifications of the international standards organization: (5)
- i) ISO 9001: Quality systems: Mode for quality assurance in design, development production installation and servicing.
- ii) ISO 9002: Quality systems: Model for quality assurance in production and installation.
- iii) ISO 9003: Quality systems: Model for quality assurance in final inspection and test.
- iv) ISO 9004: Quality management and quality system elements guidelines.
- v) Latest amendments of ISO.
- Skin: Structure and functions of skin, formulation, preparation and evaluation of cleansing creams, cold creams, cleansing lotions, foundation creams, moisturizing creams, skin tonics, handy and body lotion, sun preparations, face powders. (9)
- Hairs, structure and functions, formulation, preparation and evaluation of shampoos, dandruff preparation, hair creams, and fixers, hair colorants, hair remover (depilatories), shaving sticks and after shave lotion. (7)
- Nail, structure and functions, formulation, preparation and evaluation of nail lacquer . (5)
- Formulation, preparation and evaluation of other cosmetics like, anti-perspirants and deodorants, tooth powders and tooth paste, lipsticks. (8)
- Herbal Cosmetics.
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