Method for isolating pharmaceutically exploitable etidronate...

C - Chemistry – Metallurgy – 07 – F

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C07F 9/38 (2006.01) A61K 31/663 (2006.01)

Patent

CA 2434790

The invention relates to a method for isolating etidronate disodium. According to said method, a liquid-liquid dispersion consisting of an aqueous-organic phase and an aqueous phase containing the etidronate disodium salt is set to a temperature of between 0 ~C and 30 ~C and is intensively mixed; a coarse- grained fraction is subsequently precipitated out of the liquid-liquid dispersion and in a second, delayed step, a fine-grained fraction is precipitated out of the organic phase. The invention also relates to a novel solid form of etidronate disodium that can be obtained using this method. The invention provides a method for producing etidronate disodium with a particle size in the region of 0.2 to 1.0 mm, good flowability and a high bulk density, coupled with properties that can be pharmaceutically exploited to advantage.

L'invention concerne un procédé pour l'isolation d'étidronate disodique. Selon ce procédé, on amène une dispersion liquide-liquide constituée d'une phase organique aqueuse et d'une phase aqueuse contenant le sel disodique d'étidronate à une température comprise entre 0 ·C et 30 ·C et on la mélange intimement, puis on précipite une fraction à gros grains de la dispersion liquide-liquide ; lors d'une deuxième étape retardée, on précipite une fraction à grains fins de la phase organique. L'invention concerne également une nouvelle forme solide d'étidronate disodique obtenue à l'aide de ce procédé. L'invention concerne un procédé pour la production d'étidronate disodique ayant une grosseur de grains comprise dans la plage allant de 0,2 à 1,0 mm, présentant une bonne faculté d'écoulement ou une densité apparente élevée et, en liaison avec cela, pouvant être avantageusement utilisé en pharmacie.

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