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Details for Patent: 8,206,741

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Details for Patent: 8,206,741

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, NC)
Filing Date:May 16, 2005
Application Number:11/129,320
Claims:1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of: (a) a proton pump inhibitor selected from the group consisting of omeprazole, esomeprazole, lansoprazole, pantoprazole and rabeprazole, wherein at least a portion of said proton pump inhibitor is not surrounded by an enteric coating; and (b) aspirin, wherein said aspirin is surrounded by a coating that inhibits its release from said dosage form unless said dosage form is in a medium with a pH of 3.5 or higher; wherein said unit dosage form provides for release of said proton pump inhibitor and said aspirin such that: i) upon introduction of said unit dosage form into a medium, at least a portion of said proton pump inhibitor is released regardless of the pH of the medium; and ii) said aspirin is released when the pH of said medium is 3.5 or higher.

2. The pharmaceutical composition of claim 1, wherein said aspirin is present in said unit dosage form in an amount of 20-200 mg.

3. The pharmaceutical composition of claim 1, wherein said proton pump inhibitor is omeprazole in an amount of from 5 to 50 mg per unit dosage form.

4. A method of treating a patient to reduce inflammation, comprising administering to said patient the pharmaceutical composition of claim 1.

5. The method of claim 4, wherein said pharmaceutical composition is administered to reduce the risk of stroke or heart attack.

6. The pharmaceutical composition of claim 1, wherein said proton pump inhibitor is omeprazole.

7. The pharmaceutical composition of claim 6, wherein said omeprazole is in an amount of 10 or 20 mg per unit dosage form.

8. The pharmaceutical composition of claim 1, wherein said aspirin is present in said unit dosage form in an amount of 40-100 mg.

9. The pharmaceutical composition of claim 1, wherein said aspirin is present in said unit dosage form in an amount of 250-1000 mg.

10. The pharmaceutical composition of claim 1, wherein said aspirin is present in said unit dosage form in an amount of 250-1000 mg and said proton pump inhibitor is omeprazole in an amount of 10 or 20 mg per unit dosage form.

11. The pharmaceutical composition of claim 1, wherein said aspirin is present in said unit dosage form in an amount of 20-200 mg and said proton pump inhibitor is omeprazole in an amount of 5-50 mg per unit dosage form.

12. The pharmaceutical composition of claim 1, wherein said aspirin is present in said unit dosage form in an amount of 20-200 mg and said proton pump inhibitor is omeprazole in an amount of 10 or 20 mg per unit dosage form.

13. The pharmaceutical composition of claim 6, wherein said unit dosage form is a tablet comprising an inner core of said aspirin surrounded by a barrier coating that does not dissolve unless the pH of the surrounding medium is 3.5 or greater.

14. The pharmaceutical composition of claim 6, wherein said unit dosage form is a tablet comprising an inner core of said aspirin surrounded by a barrier coating that does not dissolve unless the pH of the surrounding medium is 4 or greater.

15. The pharmaceutical composition of claim 6, wherein said unit dosage form is a tablet comprising an inner core of said aspirin surrounded by a barrier coating that does not dissolve unless the pH of the surrounding medium is 5 or greater.

16. The pharmaceutical composition of claim 6 wherein said unit dosage form is a multilayer tablet comprising a single core and one or more layers outside of said single core, wherein: i) said aspirin is present in said core and is surrounded by a coating that does not release said aspirin unless the pH of the surrounding medium is 3.5 or higher; and ii) said omeprazole is in said one or more layers outside said core.

17. The pharmaceutical composition of claim 16, wherein said one or more layers outside of said core do not contain aspirin and are not surrounded by an enteric coating.

18. The pharmaceutical composition of claim 6, wherein said unit dosage form is a bilayer tablet having an outer layer of said omeprazole and an inner core of said aspirin and wherein said outer layer of said tablet is surrounded by a non-enteric film coating, wherein said tablet releases said omeprazole upon ingestion by a patient.

19. The pharmaceutical composition of claim 1, wherein said unit dosage form is a capsule.

20. A method of treating a patient to reduce inflammation, comprising administering to said patient the pharmaceutical composition of claim 6.

21. The method of claim 20, wherein said pharmaceutical composition is administered to reduce the risk of stroke or heart attack.

22. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of: (a) omeprazole, wherein at least a portion of said omeprazole is not surrounded by an enteric coating; and (b) aspirin, wherein said aspirin is surrounded by a coating that inhibits its release from said dosage form unless said dosage form is in a medium with a pH of 3.5 or higher; wherein said unit dosage form provides for release of said omeprazole and said aspirin such that: i) upon introduction of said unit dosage form into a medium, at least a portion of said omeprazole is released regardless of the pH of the medium; ii) said aspirin is released when the pH of said medium is 3.5 or higher; and iii) said aspirin is present in said unit dosage form in an amount of 40-100 mg and said omeprazole is present in said unit dosage form in an amount of 5-50 mg per unit dosage form.

23. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of: (a) omeprazole, wherein at least a portion of said omeprazole is not surrounded by an enteric coating; and (b) aspirin, wherein said aspirin is surrounded by a coating that inhibits its release from said dosage form unless said dosage form is in a medium with a pH of 3.5 or higher; wherein said unit dosage form provides for release of said omeprazole and said aspirin such that: i) upon introduction of said unit dosage form into a medium, at least a portion of said omeprazole is released regardless of the pH of the medium; ii) said aspirin is released when the pH of said medium is 3.5 or higher; and iii) said aspirin is present in said unit dosage form in an amount of 250-1000 mg and said omeprazole is present in said unit dosage form in an amount of 5-50 mg per unit dosage form.
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