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