Pharmaceutical agent comprising a benzamide derivative as...

A - Human Necessities – 61 – K

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A61K 31/4406 (2006.01) A61K 47/02 (2006.01) A61K 47/06 (2006.01)

Patent

CA 2380757

Stable pharmaceutical formulations can be obtained by mixing a pharmaceutically useful benzamide derivative or a pharmaceutically acceptable salt thereof with additives that do not easily produce degradation products, blending an organic acid salt, an amine compound, and an inorganic basic substance, producing solid formulations by the dry granulation method, and further adjusting the pH of the liquid formulations to 4 to 12. Pharmaceutical formulations that produce little degradation products and that are stable enough to be used as medical drugs can be obtained.

La présente invention concerne des formulations pharmaceutiques stables qui obtenues au moyen d'un procédé qui consiste à mélanger un dérivé benzamide, intéressant sur le plan pharmaceutique, ou un de ses sels acceptable sur le plan pharmaceutique, avec des additifs qui ne donnent pas facilement de produits de dégradation, à introduire par mélange un sel d'acide organique, un composé aminé et une substance basique inorganique, à produire des formulations solides au moyen du procédé de granulation en voie sèche, puis à ajuster le pH de formulations liquides entre 4 et 12. On obtient ainsi des formulations pharmaceutiques donnant peu de produits de dégradation et suffisamment stables pour être utilisées comme médicaments.

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