Sandeep Nema

US Patent:

7695736, Apr 13, 2010

Filed:

Apr 1, 2002

Appl. No.:

10/113281

Inventors:

Tugrul T. Kararli - Skokie IL, US
Sandeep Nema - Grayslake IL, US
Aziz Karim - Skokie IL, US

Assignee:

Pfizer Inc. - New York NY

International Classification:

A61K 9/14

US Classification:

424489

Abstract:

A pharmaceutical composition comprises, in powder form, (a) at least one water-soluble therapeutic agent selected from selective COX-2 inhibitory drugs and prodrugs and salts thereof, for example parecoxib sodium, in a therapeutically effective total amount constituting about 30% to about 90% by weight, (b) a parenterally acceptable buffering agent in an amount of about 5% to about 60% by weight, and optionally (c) other parenterally acceptable excipient ingredients in a total amount not greater than about 10% by weight, of the composition. The composition is reconstitutable in a parenterally acceptable solvent liquid to form an injectable solution. A lyophilization process is provided for preparation of such a composition.

US Patent:

20030100595, May 29, 2003

Filed:

Nov 12, 2002

Appl. No.:

10/292682

Inventors:

Aziz Karim - Skokie IL, US
Sandeep Nema - Grayslake IL, US
Gary Ewing - Kalamazoo MI, US

International Classification:

A61K031/415
A61K031/365

US Classification:

514/406000, 514/471000

Abstract:

A pharmaceutical composition that is substantially free of water comprises at least one orally deliverable dosage unit comprising a therapeutically effective amount of a sulfonamide prodrug and, where the prodrug is readily degradable ex vivo, has means to inhibit such degradation prior to oral administration. Illustratively the prodrug is parecoxib or a water-soluble salt thereof, and the composition has means to inhibit conversion of the parecoxib to valdecoxib. A method of treating or preventing a COX-2 mediated disorder in a subject comprises (a) dissolving at least one dosage unit of such a composition in a pharmaceutically acceptable aqueous vehicle to form a solution, and (b) orally administering the solution to the subject before substantial precipitation of insoluble matter occurs in the solution.