JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

This subject is to make the student achieve different parameters and factors that

influence the dosage form design. This subject also impart the knowledge about unit operations, solid dosage forms and powders.

Course Outcomes:

• Different machinery used for various steps in manufacture of various dosage forms.
• Formulation and evaluation of hard and soft gelatin capsules and their advantages over other dosage forms.

UNIT - I

• a. Preformulation studies: Goals of preformulation, preformulation parameters, methodology, solid state manipulation and characterization, solubility and partition coefficient, drug- excipients compatibility, intrinsic dissolution.
• b. Advances in Pharmaceutical excipients. Excipients selection for capsules, tablets, suspensions and emulsions.
• c. Packaging development – selection of primary and secondary packaging materials and testing

UNIT - II

Pharmaceutical unit operations: A detail study involving machinery and theory of pharmaceutical unit operations like solid orals: Wet granulation- Rapid mixer granulator and Top spray granulation, Dry granulation- Slugging and roller compaction, drying, milling, blending, filtration and sterilization.

UNIT - III

Formulation development of solid and powder dosage forms: Improved production techniques for tablets, new materials, processes, equipment improvements, high shear mixers, compression machines, coating machines, coating techniques in tablet technology for product development and computerization for in process quality control of tablets. Formulation development and manufacture of powder dosage form for internal and external use including inhalation dosage forms.

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, the nature of the capsule shell and capsule, advances in capsule manufacture, processing and control including pharmaceutical aspects, physical stability and packaging.

UNIT - V

Optimization techniques in pharmaceutical formulation and processing: Quality by Design: Concept and application to formulation development. Design of experiments (DOE): Formula and process optimization 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.
• 6. Hand book of Pharmaceutical excipients
• 7. CVS Subhramanyam& J Thimmasethy, Industrial Pharmacy, Vallabh Prakasham, Delhi, 2014

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.
• 6. Pharmaceutical Packaging Technology by UK Jain, DC Goupale S Nayak. M.Pharm I Year I Sem (Industrial Pharmacy)