Course enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product.
Upon completion of the course the student shall be able to
- Know the various pharmaceutical dosage forms and their manufacturing techniques.
- Know various considerations in development of pharmaceutical dosage forms
- Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality
UNIT I 07 Hours
Pre-formulation Studies: Introduction to pre-formulation, goals and objectives, study of physico-chemical characteristics of drug substances.
- Physical Properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
- Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
- BCS classification of drugs & its significant Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.
UNIT-II 10 Hours
- Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipments and tablet tooling.
- Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating.
- Quality control tests: In process and finished product tests
Liquid Orals: Formulation and manufacturing consideration of syrups and elixirs, suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia .
UNIT-III 08 Hours
- Hard Gelatin Capsules: Introduction, Production of hard gelatin capsule shells. Size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.
- Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance of base adsorption and minim/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.
- Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets
UNIT-IV 10 Hours
- Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity
- Production procedure, production facilities and controls, aseptic processing Formulation of injections, sterile powders, large volume parenterals and lyophilized products.
- Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations
UNIT-V 10 Hours
Cosmetics: Formulation and preparation of the following cosmetic preparations:
lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influencing choice of containers, legal and official requirements for containers, stability aspects of packaging materials, quality control tests.
Recommended Books: (Latest Editions)
- Pharmaceutical dosage forms – Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman &J.B.Schwartz
- Pharmaceutical dosage form – Parenteral medication vol- 1&2 by Liberman & Lachman
- Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition
- Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science (RPS)
- Theory and Practice of Industrial Pharmacy by Liberman & Lachman
- Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill livingstone, Latest edition
- Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea & Febiger, Philadelphia, 5th edition, 2005
- Drug stability – Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel Dekker Series, Vol 107.