Crystalline parecoxib sodium

Details Crystalline parecoxib sodium Crystalline parecoxib sodium

C - Chemistry, Metallurgy

07

D

C07D 261/08 (2006.01) A61K 31/42 (2006.01) A61P 29/00 (2006.01) C07D 457/06 (2006.01)

Patent

CA 2478500

Parecoxib sodium is provided in a crystalline form that is substantially anhydrous and substantially nonsolvated. Various such anhydrous, nonsolvated crystal forms have been identified, including Forms A, B and E as described herein. Also provided is a parecoxib sodium drug substance wherein at least about 90% of the parecoxib sodium is in one or more anhydrous, nonsolvated crystal forms. Such a drug substance is a storage-stable intermediate that can be further processed, for example by dissolution or slurrying in an aqueous medium together with one or more parenterally acceptable excipients, followed by lyophilization of the resulting solution or slurry to provide a reconstitutable injectable composition suitable for therapeutic use.

La présente invention concerne du parécoxib sodium sous forme cristalline sensiblement anhydre et non solvatée. Diverses formes anhydres de cristaux non solvatés ont été identifiées, y-compris les Formes A, B et E de l'invention. L'invention concerne également une substance médicamenteuse à base de parécoxib sodium dans laquelle un minimum d'environ 90 % du parécoxib sodium est sous l'une au moins des formes anhydres de cristaux non solvatés. Une telle substance médicamenteuse constitue un intermédiaire stable au stockage se prêtant au traitement ultérieur, notamment par dissolution ou réduction en coulis dans un milieu aqueux accompagné d'au moins un excipient utilisable par voie parentérale, puis par lyophilisation de la solution ou du coulis de façon à obtenir une composition injectable reconstituable convenant à l'utilisation thérapeutique.

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