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Claims for Patent: 7,041,319

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Claims for Patent: 7,041,319

Title:Fenofibrate pharmaceutical composition having high bioavailabilty
Abstract:The invention provides fenofibrate tablets comprising granulates, wherein the granulates can comprise carrier particles, micronized fenofibrate, and at least one hydrophilic polymer.
Inventor(s): Stamm; Andre (Griesheim, FR), Seth; Pawan (Irvine, CA)
Assignee: Laboratoires Fournier (Dijon, FR)
Application Number:10/290,333
Patent Claims: 1. A composition comprising micronized fenofibrate, wherein the composition has a dissolution of at least 95.9% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium which is 0.025 M sodium lauryl sulfate.

2. The composition of claim 1, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

3. The composition of claim 1, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

4. The composition of claim 1, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.

5. The composition of claim 1, further comprising at least one polymer.

6. The composition of claim 1, further comprising at least one pharmaceutical excipient.

7. The composition of claim 1 in the form of an orally administrable tablet.

8. The composition of claim 1 in the form of an orally administrable tablet comprising granulates.

9. The composition of claim 1 in the form of an orally administrable capsule.

10. The composition of claim 1 in the form of an orally administrable capsule comprising granulates.

11. The composition of claim 1 in the form of a granulate.

12. The composition of claim 1, further comprising at least one surfactant.

13. The composition of claim 6, wherein the pharmaceutical excipient is one or more compounds selected from the grouup consisting of a disintegration agent, a binder, a lubricating agent, and a flow enhancing agent.

14. The composition of claim 1, wherein the dissolution medium is constituted by water with 2% by weight polysorbate 80.

15. The composition of claim 1, wherein the dissolution medium is 0.025M sodium lauryl sulfate.

16. A composition comprising micronized fenofibrate, wherein the composition has a dissolution of at least 95.9%.+-.2.1% in b 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium which is 0.0.25 M sodium lauryl sulfate.

17. The composition of claim 16, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

18. The composition of claim 16, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

19. The composition of claim 16, wherein the micronized fenofibrate is present in an amount to 20 to 47% by weight.

20. The composition of claim 16, further comprising at least one polymer.

21. The composition of claim 16, further comprising at least one surfactant.

22. The composition of claim 16, further comprising at least one pharmaceutical excipient.

23. The composition of claim 22, wherein the pharmaceutical excipient is one or more compounds selected from the group consisting of a disintegration agent, a binder, a lubricating agent, and a flow enhancing agent.

24. The composition of claim 16 in the form of an orally administrable tablet.

25. The composition of claim 16 in the form of an orally administrable table comprising granulates.

26. The composition of claim 16 in the form of an orally administrable capsule.

27. The composition of claim 16 in the form of an orally administrable capsule comprising granulates.

28. The composition of claim 16 in the form of a granulate.

29. The composition of claim 16, wherein the dissolution medium is constituted by water with 2% by weight polysorbate 80.

30. The composition of claim 16, wherein the dissolution medium is 0.025 M sodium lauryl sulfate.

31. A composition comprising micronized fenofibrate, wherein the composition has a dissolution of at least 18.9% in 5 minutes; 67.1% in 10 minutes; 87.7% in 20 minutes; and 95.9% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium which is 0.025 M sodium lauryl sulfate.

32. The composition of claim 31, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

33. The composition of claim 31, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

34. The composition of claim 31, wherein the micronized fenolfbrate is present in an amount of 20 to 45% by weight.

35. The composition of claim 31, further comprising at least one polymer.

36. The composition of claim 31, further comprising at least one surfactant.

37. The composition of claim 31, further comprising at least one pharmaceutical excipient.

38. The composition of claim 37, wherein the pharmaceutical excipient is one or more compounds selected from the group consisting of a disintegration agent, a binder, a lubricating agent, and a flow enhancing agent.

39. The composition of claim 31 in the form of an orally administrable tablet.

40. The composition of claim 31 in the form of an orally administrable table comprising granulates.

41. The composition of claim 31 in the form of an orally administrable capsule.

42. The composition of claim 31 in the form of an orally administrable capsule comprising granulates.

43. The composition of claim 31 in the form of a granulate.

44. The composition of claim 31 wherein the dissolution medium is constituted by water with 2% by weight polysorbate 80.

45. The composition of claim 31, wherein the dissolution medium is 0.025 M sodium lauryl sulfate.

46. A composition comprising micronized fenofibrate, wherein the composition has a dissolution of at least 18.9% .+-. 0.1% in 5 minutes; 67.1% .+-. 3.7% in 10 minutes; 89.7% .+-. 2.3% in 20 minutes; and 95.9% .+-. 2.1% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium which is 0.025 M sodium lauryl sulfate.

47. The composition of claim 46, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

48. The composition of claim 46, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

49. The composition of claim 46, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.

50. The composition of claim 46, further comprising at least one polymer.

51. The composition of claim 46, further comprising at least one surfactant.

52. The composition of claim 46, further comprising at least one pharmaceutical excipient.

53. The composition of claim 52, wherein the pharmaceutical excipient is one or more compounds selected from the ground consisting of a disintegration agent, a binder, a lubricating agent, and a flow enhancing agent.

54. The composition of claim 46 in the form of an orally administrable table.

55. The composition of claim 46 in the form of an orally administrable table comprising granulates.

56. The composition of claim 46 in the form of an orally administrable capsule.

57. The composition of claim 46 in the form of an orally administrable capsule comprising granulates.

58. The composition of claim 46 in the form of a granulate.

59. The composition of claim 46, wherein the dissolution medium is constituted by water with 2% by weight polysorbate 80.

60. The composition of claim 46, wherein the dissolution medium is 0.025 M sodium lauryl sulfate.
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