Stable pharmaceutical compositions of...

A - Human Necessities – 61 – K

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A61K 31/47 (2006.01) A61K 47/04 (2006.01) A61P 9/00 (2006.01) A61P 35/00 (2006.01) A61P 43/00 (2006.01) C07D 215/48 (2006.01)

Patent

CA 2579810

A medicinal composition which comprises: a medicinal ingredient comprising, e.g., 4-(3-chloro-4-(cyclopropylamino-carbonyl)aminophenoxy)-7-methoxy-6- quinolinecarboxamide, a salt thereof, or a solvate of either; and (i) a compound whose 5% (w/w) aqueous solution or dispersion has a pH of 8 or higher and/or (ii) silicic acid, a salt thereof, or a solvate of either. It is a highly stable medicinal composition in which the decomposition of that compound under high-humidity high-temperature storage conditions or surface gelation of the medicinal composition has been reduced to a sufficient level.

Cette invention a pour objet une composition médicamenteuse contenant: un ingrédient médicamenteux contenant, par exemple, du 4-(3-chloro-4-(cyclopropylamino-carbonyl)aminophénoxy)-7-méthoxy-6-quinoléinecarboxamide, un sel de cette substance ou un solvate de l'une ou de l'autre ; et (i) un composé dont la solution ou dispersion aqueuse à 5 % (p/p) possède un pH de 8 ou plus et/ou (ii) un acide silicique, un sel de cette substance ou un solvate de l'une ou de l'autre. Il s'agit d'une composition médicamenteuse extrêmement stable qui permet de réduire la décomposition de ce composé dans des conditions de stockage à haute température et à forte humidité ou la gélification en surface de la composition médicamenteuse à un niveau satisfaisant.

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