JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

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: Goals of preformulation, solid state manipulation and characterization. pH dependent solubility of drug, equilibrium solubility, intrinsic dissolution of drug, particle size distribution. Flow of Powders: Physical properties and importance. Angle of repose, Cars index, compressibility, bulk density, tapped density.

UNIT - II

Excipients used in various dosage forms like tablets, capsules, emulsions, suspensions, semisolids and sterile products. Knowledge of packing materials. Drug- excipient compatibility- Drug stability, factors affecting stability, stabilization methods.

UNIT - III

Tablets: Types of tablets, granulation methods, highlighting operations such as mixing, drying, milling, blending, lubrication and compression. Tablet coating: Types of coating, steps involved in coating process- pan coating and fluid bed coating and problems associated with coating. Hard Gelatin Capsules: General principles and steps involved in the production of drug loaded hard gelatin capsules, filling operation, filling of powders, granules and pellets.

UNIT - IV

Dissolution: Principles of dissolution, factors influencing dissolution, official methods and apparatus. Dissolution of immediate release, controlled release and delayed release products.

UNIT - V

Stability testing: Chemical degradation and preventive measures. Various stability testing conditions and use of stabilizers in packing

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. R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS
• 6. Pharmaceutical statistics by Bolton Industrial Pharmacy - Selected Topics, CVS Subramanyam and J Thimmasetty, Vallabha Prakashan Delhi - 2013

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 Isadore Kanfer.
• 5. Dispensing for Pharmaceutical Students by SJ Carter. R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS M.Pharm I Year I Sem (Pharmaceutical Regulatory Affairs)