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Claims for Patent: 9,198,888

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Claims for Patent: 9,198,888

Title:Pharmaceutical compositions for the coordinated delivery of NSAIDs
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.
Inventor(s): Plachetka; John R. (Chapel Hill, NC)
Assignee: POZEN INC. (Chapel Hill, SC)
Application Number:14/753,195
Patent Claims: 1. A method of reducing the incidence of NSAID-associated gastric ulcers in a patient requiring NSAID treatment for osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis, and who is at risk of developing an NSAID-associated ulcer, wherein the method comprises administering to said patient a therapeutically effective amount of a pharmaceutical composition in unit dosage form comprising: (a) esomeprazole or a pharmaceutically acceptable salt thereof wherein, upon introduction of said unit dosage form into a medium, said esomeprazole or a pharmaceutically acceptable salt thereof is released regardless of the pH of the medium; and (b) naproxen surrounded by coating that does not dissolve until the surrounding medium is at a pH of at least 3.5.

2. The method of claim 1, wherein naproxen is surrounded by coating that does not dissolve until the surrounding medium is at a pH of at least 4.0.

3. The method of claim 1, wherein naproxen is surrounded by coating that does not dissolve until the surrounding medium is at a pH of at least 5.0.

4. The method of claim 1, wherein naproxen is present in said unit dosage form in an amount of 200-600 mg.

5. The method of claim 1, wherein naproxen is present in said unit dosage form in an amount of 500 mg.

6. The method of claim 1, wherein esomeprazole or a pharmaceutically acceptable salt thereof is present in said unit dosage form in an amount of from 5 to 100 mg.

7. The method of claim 1, wherein naproxen is present in said unit dosage form in an amount of between 200-600 mg and esomeprazole or a pharmaceutically acceptable salt thereof in an amount of from 5 to 100 mg per unit dosage form.

8. The method of claim 1, wherein said coating is a time-release coating.

9. The method of claim 1, wherein said coating is a pH-responsive coating.
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