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.