Process for preparing ondansetron hydrochloride dihydrate...

C - Chemistry – Metallurgy – 07 – D

Patent

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C07D 233/54 (2006.01)

Patent

CA 2565854

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 ~m, 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.

La présente invention a trait à un procédé de préparation de particules de chlorhydrate dihydraté d'ondansetron où au moins environ 70 % des particules ont une granulométrie inférieure à 250 µm, comprenant les étapes suivantes: (a) la préparation d'une solution comportant du chlorhydrate d'ondansetron et de l'eau; et (b) l'ajout de la solution dans un milieu de précipitation comportant un non solvant miscible dans l'eau pour le chlorhydrate d'ondansetron, tout en maintenant le mélange obtenu à une température égale ou inférieure à environ 40 °C.

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