Process for the preparation of esomeprazole magnesium in a...

C - Chemistry – Metallurgy – 07 – D

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C07D 401/12 (2006.01) A61K 31/4439 (2006.01) A61P 1/04 (2006.01)

Patent

CA 2731254

There is provided a process for preparing purified esomeprazole magnesium, comprising the steps of: providing esomeprazole magnesium; contacting said esomeprazole magnesium with a non-solvent comprising an aqueous component up to a maximum content defined by water saturation in the non-solvent; and recovering purified esomeprazole magnesium formed from the contacting step. The process is particularly suitable to obtain esomeprazole magnesium dihydrate, expecially form A. The esomeprazole magnesium obtained is remarkably pure, stable and is resistant to form interchangeability.

Cette invention concerne un procédé de préparation désoméprazole magnésium purifié, ledit procédé comprenant les étapes consistant à fournir de lésoméprazole magnésium ; à mettre en contact ledit ésoméprazole magnésium avec un non-solvant comprenant un composant aqueux jusquà une teneur maximale définie par une saturation en eau dans le non-solvant ; et à récupérer lésoméprazole magnésium purifié formé à létape de mise en contact. Le processus est particulièrement approprié pour obtenir de lésoméprazole magnésium dihydraté, en particulier la forme A. Lésoméprazole magnésium obtenu est incroyablement pur, stable et résistant pour une interchangeabilité.

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