Anti-histamine compositions and use thereof

Details Anti-histamine compositions and use thereof Anti-histamine compositions and use thereof

A - Human Necessities

61

K

A61K 31/19 (2006.01) A61K 31/135 (2006.01)

Patent

CA 2637726

The present invention provides for a storage stable pharmaceutical liquid solution for oral administration having a pharmaceutically effective amount of an antihistamine and having a purity equal to or greater than about 99% by weight-based HPLC assay, residual solvents of less than about 0.5%, and a total impurity of less than about 0.2%. The storage stable solution preferably contains cetirizine. The present invention further provides a process of preparing the storage stable pharmaceutical liquid solution as well as a method of treating a mammal with a therapeutically effective amount of cetirizine in the stable pharmaceutical liquid solution.

La présente invention concerne une solution liquide pharmaceutique stable au stockage destinée à être administrée par voie orale renfermant une quantité pharmaceutiquement efficace d'un antihistaminique et présentant une pureté égale ou supérieure à environ 99 % par dosage HPLC fondé sur le poids, une quantité de solvants résiduels inférieure à environ 0,5 % et une quantité totale d'impuretés inférieure à environ 0,2 %. La solution stable au stockage contient de préférence de la cétirizine. Cette invention concerne également un procédé de préparation de la solution liquide pharmaceutique stable au stockage ainsi qu'une méthode de traitement d'un mammifère faisant appel à une quantité thérapeutiquement efficace de cétirizine dans la solution liquide pharmaceutique stable.

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