JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

The students shall know about the pilot plant scale up techniques for

manufacturing of tablets capsules, suspensions, emulsions and semisolids. The students also know about the filling of capsules, compression machines, sterilizers for formulation of parenterals and also know about the propellants, DPI, MDI and their quality control. The students also know about the cosmetics and neutraceuticals.

Course Outcomes

Students will know about the scale up and pilot plant techniques used for all

pharmaceutical dosage forms like tablets, capsules, parenterals, aerosols, cosmetics and neutraceuticals.

UNIT - I

Pilot plant Scale-up techniques used in pharmaceutical manufacturing

• a. Pilot plant: Technology transfer from R&D to pilot plant to pilot scale considerations of steps involved with manufacture, layout design, facility, equipment selection of tablets, capsules, suspensions, emulsions & semisolids.
• b. Scale up: Importance, Scale up process-size reduction, mixing, blending, granulation, compression, coating involved in tablets, capsules & liquid-liquid mixing.

UNIT - II

Formulation development of parenteral dosage forms: Advances in materials and production techniques, filling machines, sterilization methods (Moist heat, dry heat, filtration, radiation, gaseous sterilization), product layout.

UNIT - III

Pharmaceutical Aerosols: Advances in propellants, metered dose inhaler designs, dry powder inhalers, selection of containers and formulation aspects in aerosols formulation, manufacture and quality control.

UNIT - IV

• a. Cosmetics: Formulation approaches, preparation & method of manufacturing labeling& Q.C. of anti ageing products, sun screen lotion and fairness creams.
• b. Nutraceuticals:
• 1. Introduction, source, manufacture and analysis of glucosamine and cartinine.
• 2. Monographs: General and specific properties of glucosamine & cartinine.
• 3. A brief overview of role of nutraceuticals in cancer prevention & cardio vascular disorders.

UNIT - V

Aseptic processing operation

• a. Introduction, contamination control, microbial environmental monitoring, microbiological testing of water, microbiological air testing, characterization of aseptic process, media and incubation condition, theoretical evaluation of aseptic operations.
• b. Air handling systems: Study of AHUs, humidity & temperature control.

TEXT BOOKS:

• 1. Pharmaceutics - The Science of Dosage form design by ME Aulton.
• 2. The Theory and Practice of industrial Pharmacy by Leon Lachman, Herbert A. Lieberman.
• 3. Remington’s Science and Practice of Pharmacy by A. Gennaro.
• 4. Ansel’s Pharmaceutical Dosage form and Drug delivery system by Loyd V. Allen, Jr. Nicholas G. Popovich, Howard C. Ansel.
• 5. Pharmaceutical Dosage forms - Parenterals (Vol I, II and III) by Avis, Lieberman and Lachman.
• 6. Scale up techniques – Pharmaceutical process by Michael Levin, Marcel Dekker

REFERENCEBOOKS:

• 1. Bentley`s Text Book of Pharmaceutics by EA Rawlins.
• 2. Generic Drug Product Development by Leon Shargel.
• 3. Dispensing for Pharmaceutical Students by SJ Carter.
• 4. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes.
• 5. Nutraceuticals, 2nd edition by Brian lock wood M.Pharm I Year II Sem (Industrial Pharmacy)