Solid-state form of celecoxib having enhanced bioavailability

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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Details

C548S356100, C548S373100, C548S375100, C548S376100

Reexamination Certificate

active

06964978

ABSTRACT:
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.

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patent: WO 00/42021 (2000-07-01), None
patent: WO 00/66562 (2000-11-01), None
patent: WO 01/15664 (2001-03-01), None
Stavchansky et al: Bioavailability in Tablet Technology. In Pharmaceutical dosage forms, by Marcel Dekker, Inc. p 349-472, 1990.

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