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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:PARECOXIB钠以基本上无水且基本上未溶解的结晶形式提供。确定了各种非水,非溶剂化晶体形式,包括此处所述的形式A,B和E。还提供了一种PARECOXIB药物,其中至少90%的PARECOXIB钠存在于一种或多种无水的非晶体形式中。此类药物是可储存的中间体,可以进一步加工,例如,将一种或多种寄生性可接受的赋形剂溶解或冲刷到一起的水性介质中,然后对结果进行溶质化处理。适用于治疗用途。

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