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1. (WO2005108392) PROCESS FOR PREPARING ONDANSETRON HYDROCHLORIDE DIHYDRATE HAVING A DEFINED PARTICLE SIZE

Pub. No.:    WO/2005/108392    International Application No.:    PCT/IL2005/000473
Publication Date: Nov 17, 2005 International Filing Date: May 5, 2005
IPC: A61K 31/4178
C07D 403/02
C07D 233/54
Applicants: TARO PHARMACEUTICAL INDUSTRIES LTD.
GUTMAN, Daniella
CYJON, Rosa
Inventors: GUTMAN, Daniella
CYJON, Rosa
Title: PROCESS FOR PREPARING ONDANSETRON HYDROCHLORIDE DIHYDRATE HAVING A DEFINED PARTICLE SIZE
Abstract:
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 µm, 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.