Pharmaceutical dosage form comprising a sulfite compound

Details Pharmaceutical dosage form comprising a sulfite compound Pharmaceutical dosage form comprising a sulfite compound

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 2493974

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 sulfite 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.

L'invention a pour objet une forme posologique pharmaceutique comprenant une capsule de gélatine contenant une charge ; ladite charge comprend : (a) un médicament inhibiteur de COX-2 sélectif, peu soluble dans l'eau, et (b) un composé de sulfite présent en une quantité suffisante pour inhiber la réticulation de la gélatine dans ladite capsule de gélatine, lors du stockage de la forme posologique, pour une durée de 6 mois, dans un récipient fermé, maintenu à 40 ·C et comprenant 75 % d'humidité relative.

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