JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

Students will know the preformulation studies, methodology, different excipients

used in solid dosage forms and their evaluation with references to production technologies. The students also know the optimization techniques and their applications in pharmaceutical industries.

Course Outcome

Students shall explain the preformulation parameters, apply ICH guidelines and

evaluate drug, drug excipients compatibility. Students also explain about formulation and development, use of excipients in tablets, powders, capsules, micro-encapsules and coating techniques. They also learn and apply the statistical design in different formulations.

UNIT - I

Preformulation studies: Goals of Preformulation, preformulation parameters, Polymorphs and Amorphous forms, selection of drugs- solubility, partition coefficient, salt forms, humidity, solid state properties, Particle Size Analysis (Laser Diffraction and Dynamic Light Scattering) drug-excipient compatibility, flow properties, format and content of reports of preformulation, preformulation stability studies as per ICH.

UNIT - II

Formulation development of solid dosage forms – I: New materials, excipient science - diluents, disintegrants, superdisintegrants, etc, evaluation of functional properties of excipient, co-processed materials, methods of preparation and evaluation.

UNIT - III

Formulation development of solid dosage forms– II: Coating, coating machines, coating techniques in tablet technology for product development, computerization, inprocess control of tablets, formulation development and manufacture of powder dosage forms for internal use. Microencapsulation- types, methodology, problems encountered.

UNIT - IV

Formulation development of soft and hard gelatin capsules:Introduction, production and methods of manufacture, filling equipment and filling operations, formulations, finishing, special techniques, advances in capsule manufacture, machines, processing and control including pharmaceutical aspects, physical stability and packaging.

UNIT - V

Optimization techniques in pharmaceutical formulation and processing: Introduction, optimization parameters, statistical design, response surface method, contour diagrams, factorial design, partial factorial design, simplex methods, mixture designs, Placket Burhan method, Box Benken method, applications in pharmaceutical formulation.

TEXT BOOKS

• 1. Pharmaceutics - The Science of Dosage form design by ME Aulton.
• 2. Pharmaceutical Dosage forms - Tablets (Vol I, II and III) by Lieberman, Lachman and Schwartz.
• 3. Pharmaceutical Dosage forms - Capsules (Vol I, II and III) by Avis, Lieberman and Lachman.
• 4. Pharmaceutical Dosage forms – Disperse systems (Vol I, II and III) by Avis, Lieberman and Lachman.
• 5. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes. R22M.PHARM PHARMACEUTICS/PHARMACEUTICAL TECH. JNTUH
• 6. Pharmaceutical statistics by Bolton

REFERENCE BOOKS:

• 1. The Theory and Practice of industrial Pharmacy by Leon Lachman, Herbert A. Lieberman.
• 2. Remington’s Science and Practice of Pharmacy by A. Gennaro.
• 3. Ansel’s Pharmaceutical Dosage form and Drug delivery system by Loyd V. Allen, Jr. Nicholas G. Popovich, Howard C. Ansel.
• 4. Generic Drug Product Development by Leon Shargel and IsadoreKanfer.
• 5. Dispensing for Pharmaceutical Students by SJ Carter.
• 6. Industrial Pharmacy - Selected Topics, CVS Subramanyam and J Thimmasetty, Vallabh Prakashan Delhi – 2013 R22M.PHARM PHARMACEUTICS/PHARMACEUTICAL TECH. JNTUH M.Pharm I Year I Sem (Pharmaceutics/Pharmaceutical Technology)