Pharmaceutical compositions for the coordinated delivery of nsaids
AssigneePozen Inc.
InventorJohn R. PLACHETKA
Life of this patent
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Abstract
The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.
Claims20
1-56. (canceled)
A pharmaceutical composition in unit dosage form in the form of a tablet, said composition comprising:
- naproxen in an amount of 200-600 mg per unit dosage form;
- and
- esomeprazole in an amount of from 5 to 100 mg per unit dosage form,
- wherein upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium, and release of at least a portion of said naproxen is inhibited unless the pH of said medium is 3.5 or higher.
A pharmaceutical composition in unit dosage form in the form of a tablet, said composition comprising:
- a core layer comprising naproxen, wherein said core layer has a coating that inhibits release of said naproxen from said core layer unless said dosage form is in a medium with a pH of 3.5 or higher;
- and
- a layer comprising esomeprazole, wherein said layer is has a non-enteric film coating that, upon ingestion by a patient, releases said esomeprazole into the stomach of said patient.
Dependencies are inferred from the claim text.