Purification of tramadol

C - Chemistry – Metallurgy – 07 – C

Patent

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C07C 213/10 (2006.01) C07C 215/42 (2006.01)

Patent

CA 2316991

A process for the preparation of Tramadol according to a Grignard reaction of 2(dimethylaminomethyl)cyclo-hexanone with the reagent 3-methoxyphenylMgX, where X is a halogen, to obtain the crude base which is then introduced to a solvent, comprises contacting the crude base with hydrobromic or hydriodic acid to form a salt thereof, and subjecting the salt to a re-crystallisation step to obtain the product Tramadol hydrobromide or Tramadol hydriodide respectively, from which purified Tramadol base is obtainable for optional conversion to a pharmaceutically preferred form e.g. Tramadol hydrochloride.

L'invention concerne un procédé pour la purification du tramadol selon une réaction de Grignard entre du 2-(diméthylaminométhyl)cyclo-hexanone et le réactif 3-méthoxyphénylMgX, où X est un halogène, de manière à obtenir la base brute destinée à être introduite dans un solvant. On met en contact ladite base avec un acide bromhydrique ou iodhydrique pour former un sel correspondant. Ensuite, on soumet ledit sel à une phase de recristallisation donnant respectivement un bromhydrate de tramadol ou un iodhydrate de tramadol, produits à partir desquels il est possible d'obtenir une base de tramadol purifiée aux fins de conversion éventuelle sous forme de produit pharmaceutique préféré (par exemple, chlorhydrate de tramadol).

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