ADVANCES IN PHARMACEUTICAL TECHNOLOGY- I Periods per week TRIMESTER II Evaluation system Theory Examination Term Work *Each lecture

of 1 hr duration Hours 3 Marks 80 20 Lecture* Practical Tutorial 4 4 hrs. 1

489 PCE

1. Objective: Course is designed to impart knowledge of formulation additives used in various dosage forms, product development and cosmetic technology. Upon completion of the course, student should be able to understand: Formulation additives used in various dosage form along with its incompatibility , product development and testing of drugs and cosmetics. 2. Prerequisite :

Knowledge of pharmaceutical technology and formulation techniques.

3. Detailed Syllabus: Unit Topics Product development and testing of liquid orals Solutions, Suspensions, Emulsions - Microemulsions Selection of additives Manufacturing Evaluation Stability considerations Drug excipient interaction and incompatibilities. Solid dosage forms with reference to high speed continuous operations Tablets: Design and formulation, desirable properties of raw materials, types of tablets, Manufacturing and evaluation, recent developments in tabletting. Capsules: Hard & Soft gelatin capsules, excipients, manufacturing, evaluation. Coating: Sugar, film, air suspension coating. Equipment, procedure and evaluation. Product Development and Testing of Sterile Dosage Forms with Reference to High Speed and Continuous Operations Duration (Hr.)

i) Parenterals : SVP, LVP Methods of preparation and production facilities Evaluation Stability Packaging ii) Ophthalmics Ocular toxicity and irritation Preservatives Method of preparation Delivery to anterior and posterior segments Cutaneous and topical drug delivery with reference to high speed and continuous operations: Percutaneous absorption Factors affecting drug absorption from skin Topically applied products and their formulation. Evaluation Stability Aerosol Technology Propellants Containers Formulation Evaluation Stability MDI Cosmetic preparations: Formulation, Stability, Safety and Performance of the Following Products such as Skin care : Moisturizers, cleansing products, Sunscreens Hair care : Shampoos, hair dyes Oral hygiene products Nail preparations: nail laquers Coloured cosmetics : lipsticks Process Analytical Technology (PAT) - A framework for Innovative Pharmaceutical Manufacturing and Quality Assurance

4. Prescribed Texts:

Pharmaceutical dosage forms: Tablets, Vol. I, II, III, Edited by Lieberman H., A., Lachman L., and Schwartz, J., B., Marcel Dekker, New York, 1990. Pharmaceutical Dosage Forms: Parenteral Medications, Vol. I, II, III, Edition: 2, illustrated, revised, Kenneth E., A., Lieberman H., A., Lachman, L., Marcel Dekker, New York 1993. Pharmaceutical dosage forms: Dispersed Systems, Vol. I, II, III, Edition: 2, Lieberman H., A., Martin, M., R., Banker, G., S., Marcel Dekker, New York 1996. Pharmaceutical Inhalation Aerosol Technology, Edition: 2, illustrated, revised, Hickey, A.,

J., informa Health Care,2003. Harry's cosmeticology, Edition: 8, illustrated, Harry, R., A., and Rieger, M., M., Chemical Pub. Co., 2000. Modern pharmaceutics, Edition: 4, illustrated, revised, Banker, G., S., Rhodes, C., T., Informa Health Care, 2002.

5. Reference Books:

Supercritical fluid technology for drug product development, Edition: illustrated, York, P., Kompella, U., B., and Shekunov, U., B., Informa Health Care, 2004. Pharmaceutical Extrusion Technology, Edition: illustrated, Ghebre-Sellassie,I., and Martin, C., Informa Health Care, 2003. Polymorphism in pharmaceutical solids, Edition: illustrated, Brittain, H., G., Informa Health Care, 1999. Pharmaceutical Process Engineering, Edition: illustrated, Hickey, A.,J., and Ganderton, D., Informa Health Care, 2001. Topical Drug Delivery Formulations, Edition: illustrated, Osborne, D., W., and Amann, A., H., Informa Health Care, 1990. Poucher's perfumes, cosmetics and soaps, Edition: 9, Poucher, W., A., Jouhar, A., J., and Butler, H., Springer, 1993. Handbook of Pharmaceutical Excipients, Edition: 3, illustrated, revised, Kibbe, A.,H., American Pharmaceutical Association, Weller, P., J., Pharmaceutical Press, 2006. Good manufacturing practices for pharmaceuticals: a plan for total quality control, Edition: 4, illustrated, Willig, S., H. and Stoker J.,R., Marcel Dekker, 1997. Parenteral quality control: sterility, pyrogen, particulate, and package integrity testing, Edition: 3, illustrated, Akers, M., J., Larrimore, D., S., Guazzo, D., M., Informa Health Care, 2002. Cosmetics: Science and Technology, Edition: 2, reprint, Balsam, M., S., Krieger Pub Co., 1974.

6. Internet Reference:

http://en.wikipedia.org/wiki/Main_Page http://www.aapspharmscitech.org/ http://www.usp.org/ http://www.sciencedirect.com/ http://www.fda.gov/ http://www.aerosol.org/about_FEA.html

7. Term work:

The term work shall comprise of at least ten laboratory experiments and assignments based on the whole syllabus, duly recorded and graded. Minimum two class tests.