Unit-I: Preformulation Studies (07 Hrs.)

Syllabus:

Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances. a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism b. 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.

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