Pharmacia Corporation

Pharmacia Corporation (of Pfizer, Inc.)

Michael J Hageman

Tugrul T Kararli

Patricia J Miyake

Lesley A MacKin

Xiaorong He

Brian R Rohrs

Kevin J Stefanski

Subhash Desai

Mark Kontny

Royal J Haskell

The selective cyclooxygenase-2 inhibitory drug celecoxib is provided in amorphous form. Also provided is a celecoxib drug substance wherein the celecoxib is present, in at least a detectable amount, as amorphous celecoxib. Also provided is a celecoxib-crystallization inhibitor composite comprising particles of amorphous celecoxib or a celecoxib drug substance of the invention in intimate association with one or more crystallization inhibitors, for example polymers. Also provided is a pharmaceutical composition comprising such a celecoxib-crystallization inhibitor composite and one or more excipients. Also provided are processes for preparing amorphous celecoxib, a celecoxib drug substance of the invention, a celecoxib-crystallization inhibitor composite of the invention, and a pharmaceutical composition of the invention. Also provided is a method of treating a medical condition or disorder in a subject where treatment with a cyclooxygenase-2 inhibitor is indicated, comprising administering, for example orally, a composition of the invention in a therapeutically effective amount.

Solid-state form of celecoxib having enhanced bioavailability

Pharmaceutical compositions are provided comprising one or more orally deliverable dose units, each comprising a selective cyclooxygenase-2 inhibitory drug of low water solubility in a therapeutically effective amount, wherein the drug is present in the form of solid particle, about 25% to 100% by weight of which are smaller than 1 &#x3bc;m. The compositions are useful in treatment or prophylaxis of cyclooxygenase-2 mediated conditions and disorders and have particular advantages where rapid onset of therapeutic effect is desired.

Cyclooxygenase-2 inhibitor compositions having rapid onset of therapeutic effect

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Portage, MI, United States of America

Michael J Hageman