Abstract

PHARMACEUTICAL FORMULATION AND DEVELOPMENT: A REVIEW

Tanmay Dhamne*, Diksha Mhase and Pranita Shelke

ABSTRACT

The discusses the importance of preformulation studies, such ascharacterisation of physicochemical properties of potential new drugcandidates and the effect of these properties on drug performance anddosage form development. Such information is very critical informulation design and might even call for further molecular-levelmodifications. Therefore, the inherent chemical and physical propertiesof each drug must be considered before developing pharmaceuticalformulations, as they form the basis for combining them with otheringredients in dosage form production. The ultimate aims of thepreformulation studies are to produce elegant, stable, effective, andsafe dosage forms. This is done through kinetic rate profiles forestablishing, compatibility studies with other components, andphysicochemical parameters determination of the new drug substances.Drug characteristics that are considered crucial in preformulation studies include drugsolubility, partition coefficient, dissolution rate, polymorphic forms, and stability.Polymorphism refers to the ability of the same drug substance to crystallize in more than oneform; this can result in differences in chemical, physical, and therapeutic characteristics of thedrug molecule, which may include amorphous forms as well as crystalline forms. This articleprovides an overview of such properties and methods for assessing the preformulationparameters of drugs.

Keywords: Bulk characteristics, crystallization, flow properties, pKa, Hygroscopicity.