Process for preparing ondansetron hydrochloride dihydrate having a defined particle size

摘要

The invention provides a process for preparing ondansetron hydrochloride dihydrate particles in which at least about 70% of the particles have a particle size of less than 250 mum, comprising the steps of: (a) preparing a solution comprising ondansetron hydrochloride and water; and (b) adding the solution into a precipitation medium which comprises a water-miscible nonsolvent for ondansetron hydrochloride, while maintaining the resulting mixture at a temperature of about 40° C. or less.