| abstract |
Parecoxib sodium in a crystalline form that is substantially anhydrous and substantially non-solvated. Different anhydrous crystalline forms not solvated with these characteristics have been identified, which include forms A, B and E as described herein. A parecoxib sodium drug substance is also provided where at least about 90% of said parecoxib sodium is in one or more non-solvated anhydrous crystalline forms. A drug substance with these characteristics is a stable intermediate during storage that can be further processed, for example by dissolution or by suspending it in an aqueous medium together with one or more acceptable excipients for parenteral use, followed by lyophilization of the solution or resulting suspension to provide a reconstitutable injectable composition suitable for therapeutic, anti-inflammatory, antipyretic, pain use. |