Spherical Agglomeration of Safinamide Mesylate: A Case Study of a Simultaneous Control of Crystalline Landscape and Micromeritic Properties

Safinamide mesylate (SAFIM) is a drug used in its anhydrous form as an add-on treatment for Parkinson′s disease. This work demonstrates the feasibility of a spherical agglomeration process on a molecule exhibiting an agglomeration′s unfavorable crystalline landscape, due to the high stability of SAFIM hydrate. After a comprehensive characterization of the crystalline landscape of SAFIM, conditions to obtain anhydrous SAFIM during the agglomeration process are presented. Temperature, stirring rate, the concentration of the slurry, and the amount of bridging liquid were studied to obtain spherical agglomerates with desirable micromeritic properties.