09 Jun 2021
During drug manufacturing, active pharmaceutical ingredients (APIs) are exposed to variable environmental conditions and encounter multiple stresses, which may lead to phase transformations. Similarly, during storage, solid-state changes can occur and possibly involve a polymorphic transition, solvate formation or desolvation, or interconversion to an amorphous form (Morris, Griesser et al. 2001).
The consequences of these changes can affect the performance of an API, and as a result, the quality, stability, and therapeutic effects of the final product may differ from what was expected. It is therefore essential to discover possible phase changes during pharmaceutical development processes, and if possible, take precautions to control them.