General Considerations of Design and Development of Dosage Forms: Pre-formulation Review

Abstract

Goal of formulation development is to convert active drug moiety into suitable dosage forms. This can be achieved by investigating of physicochemical properties of a drug substance alone and along with excipients before the formulation. The main objective of pre-formulation testing is to collect the information useful to develop stable, bioavailable dosage forms with safety consideration. Pre-formulation investigations are designed to collect all necessary data, especially physicochemical, physico-mechanical, and biopharmaceutical properties of drug substances, excipients, and packaging materials. This review provides information about pre-formulation parameters such as physical, chemical, solubility, stability, storage, and precaution to be taken for ensure the quality of product.