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Claims for Patent: 8,668,929

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Claims for Patent: 8,668,929

Title:Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Abstract: Compositions and methods for the treatment of pain in a mammal are described. More specifically, a dosage form designed for release of acetaminophen and an opioid is described, wherein the dosage form provides delivery of the drugs to the upper gastrointestinal tract ("GI") of a mammal for an extended period of time.
Inventor(s): Han; Chien-Hsuan (Sunnyvale, CA), Hou; Sui Yuen Eddie (Foster City, CA), Reid; Monica L. (San Mateo, CA)
Assignee: Depomed, Inc. (Newark, CA)
Application Number:13/529,960
Patent Claims: 1. A method for treating pain, comprising: administering at least twice daily, a dosage form comprising an extended release polymer matrix comprising a dose of acetaminophen and a dose of an opioid, wherein the extended release matrix is comprised of a swellable polymer and imbibes fluid after administration to swell to a size sufficient to promote gastric retention of the matrix, wherein the swellable polymer is selected from the group consisting of a polyalkylene oxide, a cellulosic polymer, a poly(acrylamide), a poly(N-vinyl lactam), and a polyvinylamine, and wherein within about 1 hour in an in vitro disintegration test the dosage form releases more than about 50% of the dose of acetaminophen, and wherein by about 6 hours in an in vitro disintegration test, the percent of opioid released from the dosage form is greater than the percent of acetaminophen released from the dosage form, and wherein the in vitro disintegration test is at 37.degree. C. in 0.1N HCl.

2. The method of claim 1, wherein substantially all of the doses of acetaminophen and the opioid are released within about ten hours in an in vitro disintegration test.

3. The method of claim 1, wherein the dose of acetaminophen in the dosage form is between about 100-1300 mg.

4. The method of claim 1, wherein the dose of opioid in the dosage form is between about 5-40 mg.

5. The method of claim 4, wherein the dosage form comprises an opioid selected from the group consisting of oxycodone, hydrocodone, and pharmaceutically acceptable salts thereof.

6. The method of claim 3, wherein the dose of opioid in the dosage form is between about 5-40 mg.

7. The method of claim 6, wherein the dosage form comprises an opioid selected from the group consisting of oxycodone, hydrocodone, and pharmaceutically acceptable salts thereof.

8. The method of claim 1, wherein the dosage form comprises an immediate release portion.

9. The method of claim 7, wherein the dosage form comprises an immediate release portion.

10. The method of claim 9, wherein the dosage form comprises between about 20-50 weight percent of poly(ethylene oxide).

11. The method of claim 10, wherein the poly(ethylene oxide) has a molecular weight of between about 900,000 Daltons to about 4,000,000 Daltons.

12. The method of claim 1, wherein the dosage form comprises between about 20-50 weight percent of poly(ethylene oxide).

13. The method of claim 12, wherein the poly(ethylene oxide) has a molecular weight of between about 900,000 Daltons to about 2,000,000 Daltons.

14. A method for treating pain, comprising: administering at least twice daily, a dosage form comprising an extended release polymer matrix comprising a dose of acetaminophen and a dose of an opioid, wherein the extended release matrix (i) is comprised of a swellable polymer and (ii) imbibes fluid after administration to swell to a size sufficient to promote gastric retention of the matrix, wherein the swellable polymer is selected from the group consisting of a polyalkylene oxide, a cellulosic polymer, a poly(acrylamide), a poly(N-vinyl lactam), and a polyvinylamine, and wherein at about 1 hour in an in vitro disintegration test the percent of acetaminophen released by the dosage form is greater than the percent of opioid released, and wherein by about 4-6 hours in an in vitro disintegration test, the dosage form releases greater than 90% of the dose of acetaminophen and the cumulative percent of opioid released is within about 10% of the cumulative percent of acetaminophen released, and wherein the in vitro disintegration test is at 37.degree. C. in 0.1N HCl.

15. The method of claim 14, wherein substantially all of the doses of acetaminophen and the opioid are released within about ten hours in an in vitro disintegration test.

16. The method of claim 14, wherein the dose of acetaminophen in the dosage form is between about 100-1300 mg.

17. The method of claim 14, wherein the dose of opioid in the dosage form is between about 5-40 mg.

18. The method of claim 17, wherein the dosage form comprises an opioid selected from the group consisting of oxycodone, hydrocodone, and pharmaceutically acceptable salts thereof.

19. The method of claim 16, wherein the dose of opioid in the dosage form is between about 5-40 mg.

20. The method of claim 19, wherein the dosage form comprises an opioid selected from the group consisting of oxycodone, hydrocodone, and pharmaceutically acceptable salts thereof.

21. The method of claim 14, wherein the dosage form comprises an immediate release portion.

22. The method of claim 20, wherein the dosage form comprises an immediate release portion.

23. The method of claim 22, wherein the dosage form comprises between about 20-50 weight percent of poly(ethylene oxide).

24. The method of claim 23, wherein the poly(ethylene oxide) has a molecular weight of between about 900,000 Daltons to about 4,000,000 Daltons.

25. The method of claim 14, wherein the dosage form comprises between about 20-50 weight percent of poly(ethylene oxide).

26. The method of claim 25, wherein the poly(ethylene oxide) has a molecular weight of between about 900,000 Daltons to about 2,000,000 Daltons.

27. A method for treating pain, comprising: administering at least twice daily, a dosage form comprising an extended release polymer matrix comprising a dose of acetaminophen and a dose of an opioid, wherein the extended release matrix (i) is comprised of a swellable polymer and (ii) imbibes fluid after administration to swell to a size sufficient to promote gastric retention of the matrix, wherein the swellable polymer is selected from the group consisting of a polyalkylene oxide, a cellulosic polymer, a poly(acrylamide), a poly(N-vinyl lactam), and a polyvinylamine, and wherein in an in vitro disintegration test the percent of acetaminophen released is greater than the percent of opioid released at times of 3 hours or less, at times greater than about 6 hours, the percent of opioid released is greater than the percent of acetaminophen released, and wherein the in vitro disintegration test is at 37.degree. C. in 0.1N HCl.

28. The method of claim 27, wherein substantially all of the doses of acetaminophen and the opioid are released within about ten hours in an in vitro disintegration test.

29. The method of claim 27, wherein the dose of acetaminophen in the dosage form is between about 100-1300 mg.

30. The method of claim 27, wherein the dose of opioid in the dosage form is between about 5-40 mg.

31. The method of claim 30, wherein the dosage form comprises an opioid selected from the group consisting of oxycodone, hydrocodone, and pharmaceutically acceptable salts thereof.

32. The method of claim 29, wherein the dose of opioid in the dosage form is between about 5-40 mg.

33. The method of claim 32, wherein the dosage form comprises an opioid selected from the group consisting of oxycodone, hydrocodone, and pharmaceutically acceptable salts thereof.

34. The method of claim 27, wherein the dosage form comprises an immediate release portion.

35. The method of claim 33, wherein the dosage form comprises an immediate release portion.

36. The method of claim 35, wherein the dosage form comprises between about 20-50 weight percent of poly(ethylene oxide).

37. The method of claim 36, wherein the poly(ethylene oxide) has a molecular weight of between about 900,000 Daltons to about 4,000,000 Daltons.

38. The method of claim 27, wherein the dosage form comprises between about 20-50 weight percent of poly(ethylene oxide).

39. The method of claim 38, wherein the poly(ethylene oxide) has a molecular weight of between about 900,000 Daltons to about 2,000,000 Daltons.

40. The method of claim 1, wherein the swellable polymer is an alkyl-substituted cellulosic polymer or a polyalkylene oxide.

41. The method of claim 14, wherein the swellable polymer is an alkyl-substituted cellulosic polymer or a polyalkylene oxide.

42. The method of claim 27, wherein the swellable polymer is an alkyl-substituted cellulosic polymer or a polyalkylene oxide.
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