Reconstitutable parenteral composition containing a cox-2...

Details Reconstitutable parenteral composition containing a cox-2... Reconstitutable parenteral composition containing a cox-2...

A - Human Necessities

61

K

A61K 31/42 (2006.01) A61K 9/19 (2006.01) A61K 31/00 (2006.01) A61K 31/122 (2006.01) A61K 31/365 (2006.01) A61K 31/415 (2006.01) A61K 31/444 (2006.01) A61K 31/50 (2006.01) A61K 47/02 (2006.01) A61K 47/18 (2006.01) A61P 29/00 (2006.01)

Patent

CA 2442906

A pharmaceutical composition comprises, in powder form, (a) at least one water- soluble therapeutic agent selected from selective COX-2 inhibitory drugs and prodrugs and salts thereof, for example parecoxib sodium, in a therapeutically effective total amount constituting about 30% to about 90% by weight, (b) a parenterally acceptable buffering agent in an amount of about 5% to about 60% by weight, and optionally (c) other parenterally acceptable excipient ingredients in a total amount not greater than about 10% by weight, of the composition. The composition is reconstitutable in a parenterally acceptable solvent liquid to form an injectable solution. A lyophilization process is provided for preparation of such a composition.

L'invention concerne une composition pharmaceutique comprenant, sous forme de poudre, (a) au moins un agent thérapeutique hydrosoluble choisi dans le groupe comprenant des médicaments et des promédicaments inhibiteurs sélectifs de COX-2, et des sels de ceux-ci, par exemple, du sodium de parecoxib, en quantité totale pharmaceutiquement efficace représentant de 30 % environ à 90 % environ en poids, (b) entre 5 % environ et 60 % environ en poids d'un tampon parentéralement acceptable, et éventuellement, (c) d'autres constituants excipients représentant une quantité totale inférieure à environ 10 % en poids, de la composition. La composition peut être reconstituée dans un liquide solvant parentéralement acceptable pour former une solution injectable. La présente invention concerne également un procédé de lyophilisation pour préparer une telle composition.

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