PREFORMULATION STUDIES IN FORMULATION OF NEW DOSAGE FORMS

Preformulation studies are a crucial step in pharmaceutical development,
focusing on evaluating the physical, chemical, and biopharmaceutical
properties of a drug to design safe, stable, and effective dosage forms.
Emerging with advances in physical pharmacy, these studies transformed
drug formulation from an empirical practice to a scientific process. Key
parameters assessed include crystal structure, polymorphism, solubility,
partition coefficient, particle size, density, hydrolysis, oxidation,
racemization, and polymerization. The Biopharmaceutics Classification
System (BCS) classifies drugs based on solubility and permeability, guiding
bioequivalence and regulatory decisions. Preformulation data support
excipient selection, manufacturing methods, packaging, and stability
assessment. Overall, these studies form the foundation for developing
bioavailable, stable, and therapeutically effective pharmaceutical products
while ensuring quality, safety, and efficient large-scale production.