abstract |
Amorphous Celecoxib A drug substance celecoxib where celecoxib is present, in at least a detectable amount, as amorphous celecoxib. A celecoxib crystallization inhibitor compound comprising amorphous celecoxib particles or a celecoxib drug substance of any one of Claims 2 to 4 in intimate association with one or more crystallization inhibitor (s) in an amount effective to reduce celecoxib transformation amorphous to crystalline celecoxib. 1 A process for preparing the drug substance celecoxib, the process comprising: (a) melting celecoxib; (b) rapidly cooling the resulting molten celecoxib to form a celecoxib drug substance where celecoxib is present, in at least a detectable amount, in amorphous form; and optionally (c) triumph the drug substance celecoxib to form a powder of drug substance celecoxib. |