Process for the preparation of pantoprazole sodium

Details Process for the preparation of pantoprazole sodium Process for the preparation of pantoprazole sodium

C - Chemistry, Metallurgy

07

D

C07D 401/12 (2006.01) A61K 31/4439 (2006.01)

Patent

CA 2591405

A one-pot process for the preparation of pantoprazole sodium by reacting 2- chloro methyl 3, 4 - dimethoxy pyridine hydrochloride with 2-mercapto-5- difluoromethoxy benzimidazole in an organic solvent system in presence of a phase transfer catalyst and further treating with aqueous sodium hypohalite solution comprising sodium hydroxide to obtain pantoprazole sodium in high yield and purity. The process for conversion of pantoprazole sodium to pantoprazole sodium sesquihydrate and also pantoprazole sodium monohydrate are also disclosed herein.

L'invention concerne un procédé monotope pour la préparation de pantoprazole sodique par réaction d'hydrochlorure de 2-chlorométhyl 3, 4 - diméthoxypyridine avec du 2-mercapto-5-difluorométhoxy benzimidazole dans un système de solvant organique en présence d'un catalyseur de transfert de phase, puis par traitement avec une solution d'hypohalite de sodium aqueuse comprenant de l'hydroxyde de sodium afin d'obtenir du pantoprazole sodique à rendement élevé et de haute pureté. L'invention concerne également un procédé de conversion de pantoprazole sodique en sesquihydrate de pantoprazole sodique et en monohydrate de pantoprazole sodique.

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