Pharmaceutical preformulation: - Definition and scope, Establishment and importance of following physicochemical parameters :Solubility, pKa and selection of suitable salt, partition coefficient, dissolution, polymorphism, microscopy and powder properties, stability and drug-excipient compatibility Pharmaceutical factors influencing drug formulation.

Study of different types of formulation additives: Diluents, Binders, Disintegrating agents, Lubricants, Solvents, Co-solvents and Vehicles, Preservatives, Suspending agents, Emulsifying agents, Antioxidants, Preservatives, colouring, flavoring and sweetning agents, Viscosity enhancers, ointment and suppositories bases.

UNIT-III
Polymers and biodegradable polymers: Classification, Methods of synthesis, Properties, Characterization and evaluation. Brief introduction of biodegradable polymers, pharmaceutical applications of polymers..
Dissolution stability and degradation study: Chemical stability, pathways of degradation, physical and phase transformation, stability testing protocols for various pharmaceutical dosage forms, determination of expiry date (shelf life) and overage calculations, stabilization of pharmaceutical formulations.

UNIT-IV
Drug product design:Stages of drug discovery and development process, Importance of product design, considerations.

UNIT-V
Dissolution technology: Theories of dissolution, factors affecting dissolution, design of various dissolutionapparatus, dissolution media, dissolution testing of different types of dosage
formulations, data interpretation, mathematical models for predication of dissolution of profile.

• Establish the following preformulation parameters of the given drug sample.                     (a) Melting point  (b) solubility (c) intrinsic solubility (d) pKa (e) Partition coefficient

• Establish the following pre formulation parameters of the given drug sample.                     (a) Particle size distribution    (b) Flow proportion     (c) Bulk deurity     (d) Carr’s index         (e) Compression preparation.

• Study the drug excipient compatibility of given drug with commonly used excipent by TLC technique.

• Estimate the self life of the given drug

• Study the effect of mesture content on chemical stability of aspirin.

• Study the effect of temperation on stability of given photosensitive drug.

• Determine the molecular Mass of given polymer by viscometer.

• Perform the in-vitro dissolution study of given the sample of tablet.

• Study the effect of presence of surfactant in dissolution of tablet cantoning poorly soluble drug.

• Study the effect of solvent / co-solvent hydrotropic agents on solubility of given drug.

• Study the effect of pH of dissolution on in-vitro dissuasion study.

• Compare the dissolution profile of two marketed tablet products.

• Swarbrick J., Boylan J.C., Encydopedia of Pharmaceutical Technology, Second edition, Volume-1,2,3, Marcel Dekker, Inc. Newyork.

• Qice yihong, ChenY, Zhang G.G.Z., Developing solid Oral dosage forms- Pharmaceutical Theory and Practice charon Tech Ltd.

• Allen L.V., Popovich N.G., Ansel H.C., Ansel’s Pharmaceutics design and drug delivery systems, Eight edition, B.I. Publication Pvt. Ltd.

• Aulton M.E. Pharmaceutics-The science of dosage form design” second edition.,Churchill Livingstone Pvt. Ltd.

• Banker G.S., Rhodes C.T., Modern Pharmaceutics” second edition, Marcel Dekker, Inc., Newyork.

• Kanig J.J., Liebermen H.A., Lachman L. “The theory and Practics of Industrial Pharmacy, Varghese Publishing House, Bombay.

• Rowe RC, Sheskey P.J., Owen S.C., Handbook of Pharmaceutical Excipents, Fifth edition, Pharmaceutical Pr.

• Bugay D.E., Findlay W.P., Pharmaceutical Excipents, Marcel Dekker, Inc. Newyork.

• Kim C.J., Advanced Pharmaceutics- Physiochemical Principle CRC Press, Florida.

• Jan N.K.,Pharmaceutical Product Development,CBS Publishers and distributors, NewDelhi.

• Shah D.H., “SOP Guidelines”, Business Horizons Publishers, New Delhi.

• Wachter A.H., Nash R.A., “Pharmaceutical Process validation, Marcel Dekker, Inc. Newyork.

• Mazzo D.J., “International stability Testing” Interpha Press, Inc. Illinois.

• Gibaldi M., Perriner D., “Pharmacokinetics:, Marcel Dekker Newyork.