Control of API Powder Properties Via Cake Washing Protocol and Agitated Drying

An API candidate has historically shown a propensity to form hard, fused aggregates during agitated drying. Prior work focused on minimizing aggregate formation through control of drying conditions, and investigated various milling strategies for management of the final powder properties. However, milling is a high-risk operation for this API. This work demonstrates how modifications to the cake-washing protocol mitigated the formation of aggregates and hard lumps during agitated drying. This process modification allowed for the elimination of API milling operations while retaining the desired formulation performance.