Pharmaceutical dosage form capable of maintaining stable...

Details Pharmaceutical dosage form capable of maintaining stable... Pharmaceutical dosage form capable of maintaining stable...

A - Human Necessities

61

K

A61K 9/48 (2006.01) A61K 31/18 (2006.01) A61K 31/635 (2006.01) A61K 9/107 (2006.01)

Patent

CA 2494358

The present invention provides a pharmaceutical dosage form comprising a fill material sealed in a gelatin capsule; the fill material comprises (a) a selective COX-2 inhibitory drug of low water solubility, and (b) a primary or secondary amine compound in an amount sufficient to inhibit cross-linking of gelatin in said gelatin capsule upon storage of the dosage form in a closed container maintained at 40 ~C and 75 % relative humidity for a period of 6 months.

La présente invention concerne une forme posologique pharmaceutique comprenant une capsule de gélatine contenant une charge. La charge est composée (a) d'un inhibiteur sélectif de la COX-2 faiblement soluble dans l'eau et (b) d'une amine primaire ou secondaire en quantité suffisante pour inhiber la réticulation de la gélatine dans ladite capsule de gélatine lors du stockage de la forme posologique dans un réceptacle fermé conservé à une température de 40 ·C et à une humidité relative de 75 % pendant 6 mois.

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