Polymorph screening helps to identify all relevant forms of an API, investigate its properties and choose the optimal crystalline form. Conducting these screens can also help prevent the appearance of new forms in the latter stages of development. Our scientists focus on establishing the interconversions between forms, relative stability of forms and understanding the monotropic or enantiotropic relationship between polymorphs as per the requirement. About 90% of drug substances have the ability to exist in different crystal forms, therefore, understanding and controlling polymorphism is essential to successful pre-clinical development. Understanding polymorphism is key to eliminating batch-to-batch inconsistency and ensuring consistent in-vivo performance. With polymorphs differing in properties such as stability, hygroscopicity, and dissolution rate, some compounds can prove challenging to develop. Polymorph screening is a regulatory requirement whether a salt, cocrystal or free form compound is chosen for development. We recommend performing drug polymorphism screening as part of the process of selecting a pre-clinical candidate. This allows any challenges to be identified and overcome before causing any delays to the pre-clinical program.
Compiled from https://www.jubilantbiosys.com
