EFFECT OF POLYMORPHISM ON THE DRUG PRODUCT DEVELOPMENT

Umamaheswari D.*, Abdul Hasan Shathali A., Senthil Prabhu R., Thangapriya A., Vanathi M., Vanitha P., Rajeshkumar B.

ABSTRACT

Polymorphism plays a significant role in various aspects of drug product development, such as chemical and physical stability, solubility, dissolution, bioavailability, bioequivalence, and manufacture. To ensure quality, safety, and efficacy of pharmaceuticals, careful consideration should be given during drug product development. In order to achieve consistent bioavailability over the shelf life of a drug substance and under diverse storage conditions, the most thermodynamically stable form of the drug substance must be selected. Getting a comprehensive understanding of low-solubility drug absorption requires studying polymorphism. Pharmaceutical formulation begins with investigating drug polymorphism. Pharma is increasingly focusing on polymorphism for formulations and regulatory considerations for solid pharmaceuticals. A comprehensive overview of polymorphism is provided here, including physical characteristics, classification, characterisation, synthesis methods, and strategies to enhance solubility.

Keywords: Polymorphism, Monotropes, Enatiotropes, Conformers, Solvates, Hydrates.