Anti-histaminic composition

Details Anti-histaminic composition Anti-histaminic composition

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 31/4545 (2006.01) A61P 37/08 (2006.01)

Patent

CA 2574188

A stable pharmaceutical composition comprises desloratadine or a pharmaceutically acceptable salt, solvate, derivative, polymorph, hydrate or enantiomer thereof, and a carrier comprising at least one polyol. Preferred compositions comprise, in addition to desloratadine, from 50 to 80% polyol, from 5 to 15% disintegrating agent, and from 0.01 to 0.5% antioxidant and/or a chelating agent, all by weight of the composition. There is also provided the use of a polyol to stabilise a pharmaceutical composition comprising desloratadine. A process for making a stable pharmaceutical composition comprising desloratadine and one or more polyols, optionally together with other pharmaceutically acceptable excipients comprises blending the ingredients and formulating them so as to form said composition.

L'invention concerne une composition pharmaceutique stable comprenant de la desloratadine ou un sel pharmaceutiquement acceptable, un solvate, un dérivé, un polymorphe, un hydrate ou un énantiomère de cette dernière, ainsi qu'un support comprenant au moins un polyol. Les compositions préférées comprennent, en plus de la desloratadine, entre 50 et 80 % de polyol, entre 5 et 15 % d'un délitant et entre 0,01 et 0,5 % d'un antioxydant et/ou d'un chélatant, toutes les valeurs étant données en pourcentage en poids de la composition. L'invention concerne également l'utilisation d'un polyol afin de stabiliser une composition pharmaceutique comprenant de la desloratadine. Le procédé de préparation d'une composition pharmaceutique stable comprenant de la desloratadine et un ou plusieurs polyols, éventuellement associés à d'autres excipients pharmaceutiquement acceptables consiste à mélanger les ingrédients et à les préparer de manière à former ladite composition.

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