Solid compositions comprising compounds unstable to oxygen...

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/403 (2006.01) A61K 9/00 (2006.01) A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 9/36 (2006.01) A61K 31/375 (2006.01) A61K 31/397 (2006.01) A61K 31/4035 (2006.01) A61K 31/4353 (2006.01) A61K 31/55 (2006.01) A61K 47/22 (2006.01) A61P 25/00 (2006.01) A61P 25/16 (2006.01) A61P 25/18 (2006.01) A61P 25/28 (2006.01)

Patent

CA 2469940

The invention aims at stabilizing a solid composition containing a nitrogenous fused-heterocycle compound unstable to oxygen to provide a stable pharmaceutical preparation. The stabilization can be attained by keeping the equilibrium moisture content at 10 % or above and/or adding ascorbic acid or a salt thereof, by preliminarily applying a film coating free from light screens, or by applying one or more packaging selected from among oxygen- barrier packaging, inert gas replacement packaging, vacuum packaging and sealing packaging with an oxygen absorber.

L'objet de cette invention est de stabiliser une composition solide renfermant un composé azoté à hétérocycle fusionné instable à l'oxygène dans le but d'obtenir une préparation pharmaceutique stable. A cette fin, on peut maintenir l'humidité d'équilibre à 10 % ou plus et/ou ajouter de l'acide ascorbique ou un sel de cet acide, procéder à une application préliminaire d'un revêtement en film exempt d'écrans lumineux, ou bien appliquer un ou plusieurs emballages pris parmi des emballages imperméables à l'oxygène, des emballages de rechange à gaz inerte, des emballages sous vide et des emballages d'étanchéité avec absorbeur d'oxygène.

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