(671g) Investigation of Compression Induced Amorphization of Crystalline API

Active Pharmaceutical Ingredient (API) often exists in several solid forms (crystalline or amorphous). The different solid forms are known to influence the physical, chemical and mechanical properties of the API. Despite of significant API form screening effort, the selected and thoroughly studied API form may still undergo phase transformations during typical pharmaceutical processing. Among the various pharmaceutical process induced phase transforms, crystalline to amorphous phase transformation and its underlying mechanism has been rarely reported. This study will discuss the recent findings on compression induced crystalline to amorphous phase transformation. The effect of axial and shear stresses as well as excipient and formulation will be discussed.