WHITEPAPER – Use of a Platform Formulation Technology to De-Risk Solid-State Variation in Drug Development

Active pharmaceutical ingredients (APIs) can exist in multiple crystal forms, known as polymorphs, that are chemically identical. Polymorphs of an API can appear over the course of development and lead to deviations across batches affecting stability, tableting properties, flowability, solubility, and release kinetics, and may ultimately result in a change in processability and drug (product) performance. These changes must be identified and addressed and as such, can have a significant impact on the success of the program, project timelines, and the investment of resources. While crystal structure prediction techniques can be used to identify possible polymorphs, their stability and morphological differences, especially the presence of unstable polymorphs, must be addressed to ensure product efficacy and safety.