Process for the preparation of pharmaceutically acceptable...

C - Chemistry – Metallurgy – 07 – D

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C07D 503/18 (2006.01) C07D 503/00 (2006.01) C12P 17/18 (2006.01)

Patent

CA 2215038

A process for preparation of a pharmaceutically acceptable salt of clavulanic acid comprising the steps of: removing solids from a clavulanic acid containing fermentation broth by microfiltration; acidifying the filtrate to a pH between 1 and 3; extracting the acidified filtrate with a water immiscible solvent and separating the clavulanic acid containing extract; mixing the extract with a metal donor and at least one additional solvent; and separating the metal clavulanate salt from the solution.

Ce procédé de préparation d'un sel d'acide clavulanique, acceptable sur le plan pharmacologique, qui consiste à enlever les solides, par microfiltration, de l'acide clavulanique contenant le bouillon de fermentation; à acidifier le filtrat afin d'obtenir un pH compris entre 1 et 3; à extraire le filtrat acidifié à l'aide d'un solvant non miscible dans l'eau et à séparer l'acide clavulanique contenant l'extrait; à mélanger l'extrait avec un donneur de métal ainsi qu'avec au moins un solvant additionnel; et à séparer de la solution le clavulanate de métal.

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