BP502T: Industrial Pharmacyi- Theory Syllabus for B.Pharm 5th Sem 2019 Pattern Mumbai University

Industrial Pharmacyi- Theory detailed Syllabus Scheme for Bachelor of Pharmacy (B.Pharm), 2019 regulation has been taken from the University of Mumbai official website and presented for the Pharmacy students. For Course Code, Subject Name, Continuous Mode, SE Marks, SE Duration, Total, Marks, Duration in Hours, Total Marks, and other information, do visit full semester subjects post given below.

For all other Mumbai University B.Pharm 5th Sem Syllabus 2019 Pattern, do visit B.Pharm 5th Sem 2019 Pattern Scheme. The detailed syllabus scheme for industrial pharmacyi- theory is as follows.

BP502T: Industrial Pharmacyi- Theory Syllabus for B.Pharm 5th Sem 2019 Pattern Mumbai University

Scope:

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Objectives

Upon completion of the course the student shall be able to

1. Know the various pharmaceutical dosage forms and their manufacturing techniques.
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality

UNIT I – Preformulation Studies 7

1. Introduction to preformulation, goals and objectives, study ofphysicochemical characteristics of drug substances 1
2. Physical properties: Physical form (crystal & amorphous), particle size, shape, flowproperties, solubility profile (pKa, pH, partition coefficient), polymorphism 2
3. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerizationBCS classification of drugs 2
4. Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms. 2

UNIT II 10

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UNIT III 8

1. Hard gelatin capsules: Introduction, Extraction of gelatin and production of hardgelatin capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules. In process and final product quality control tests for capsules.
2. Soft gelatin capsules: Nature of shell and capsule content,size ofcapsules,importance of base adsorption and minimum/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules 3
3. Pellets: Introduction, formulation requirements, pelletization process, equipments formanufacture of pellets 2

UNIT IV 10

1. Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity 2
2. Production procedure, production facilities and controls. 1
3. Formulation of injections, sterile powders, emulsions, suspensions, large volume parenterals and lyophilized products, Sterilization. 3
4. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests 1
5. Ophthalmic Preparations: Introduction, formulation considerations; formulation of eyedrops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations 3

UNIT V 10

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Reference Books (Latest Editions to be adopted)

1. Pharmaceutical dosage forms – Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman &J.B.Schwartz
2. Pharmaceutical dosage form – Parenteral medication vol- 1&2 by Liberman & Lachman
3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman
4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition
5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science (RPS)
6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
7. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill livingstone, Latest edition
8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger, Philadelphia, 5thedition, 2005
9. Drug stability – Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel Dekker Series, Vol 107.

For detail syllabus of all other subjects of Bachelor of Pharmacy (B.Pharm), 2019 regulation do visit B.Pharm 5th Sem Subjects syllabus for 2019 regulation.