UNIT-I
Reformulation Studies: Introduction to preformulation, goals, and objectives, the 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, racemization, polymerization. BCS classification of drugs and 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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