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CRYSTALLINE PARECOXIB SODIUM

机译:结晶PARECOXIB钠

摘要

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.
机译:帕瑞昔布钠以基本上无水且基本上非溶剂化的结晶形式提供。已经鉴定出各种这种无水,非溶剂化的晶体形式,包括本文所述的形式A,B和E。还提供了帕瑞昔布钠药物物质,其中至少约90%的帕瑞昔布钠为一种或多种无水非溶剂化晶体形式。此类药物是储存稳定的中间体,可以进一步加工,例如通过与一种或多种肠胃外可接受的赋形剂一起在水性介质中溶解或制浆,然后冻干所得溶液或浆液以提供可重构的可注射组合物适合用于治疗。

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