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Claims for Patent: 6,652,881

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Claims for Patent: 6,652,881

Title: Fenofibrate pharmaceutical composition having high bioavailability
Abstract:The invention provides compositions comprising micronized fenofibrate, where the compositions have a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% 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 0.025 M sodium lauryl sulfate.
Inventor(s): Stamm; Andre (Griesheim, FR), Seth; Pawan (Irvine, CA)
Assignee: Laboratories Fournier, S.A. (Dijon, FR)
Application Number:10/288,425
Patent Claims: 1. A composition comprising micronized fenofibrate, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% 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 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, further comprising at least one polymer.

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

6. An orally administrable tablet comprising micronized fenofibrate, wherein the tablet has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopocia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium constituted by water with 0.025 M sodium lauryl sulfate.

7. The tablet of claim 6, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

8. The tablet of claim 6, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

9. The tablet of claim 6, further comprising at least one polymer.

10. The tablet of claim 6, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.

11. A composition comprising micronized fenofibrate and at least one polymer, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% 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 0.025 M sodium lauryl sulfate.

12. The composition of claim 11, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

13. The composition of claim 11, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

14. The composition of claim 11, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.

15. A composition comprising at least one inert carrier and one or more outer layers comprising micronized fenofibrate, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% 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 0.025 M sodium lauryl sulfate.

16. The composition of claim 15, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

17. The composition of claim 15, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

18. The composition of claim 15, further comprising at least one polymer.

19. The composition of claim 15, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.

20. The composition of claim 15 in the form of a tablet.

21. The composition of claim 15 in the form of a granulate.

22. A composition comprising granulates which comprise micronized fenofibrate; wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopocia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium constituted by water with 0.025 M sodium lauryl sulfate.

23. The composition of claim 22, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

24. The composition of claim 22, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

25. The composition of claim 22, wherein the granulates further comprise at least one polymer.

26. The composition of claim 22, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.

27. An orally administrable tablet comprising granulates, wherein the granulates comprise micronized fenofibrate, and wherein the tablet has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopocia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium constituted by water with 0.025 M sodium lauryl sulfate.

28. The tablet of claim 27, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

29. The tablet of claim 27, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

30. The tablet of claim 27, wherein the granulates further comprise at least one polymer.

31. The tablet of claim 27, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.

32. An orally administrable capsule comprising granulates, wherein the granulates comprise micronized fenofibrate, and wherein the capsule has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using a rotating blade method at 75 rpm according to the European Pharmacopocia, in a dissolution medium comprising water with 2% by weight polysorbate 80 or a dissolution medium comprising water with 0.025 M sodium lauryl sulfate.

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

34. The capsule of claim 32, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

35. The capsule of claim 32, wherein the granulates further comprise at least one polymer.

36. The capsule of claim 32, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.

37. A granulate comprising micronized fenofibrate, wherein the granulate has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% 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 constituted by water with 0.025 M sodium lauryl sulfate.

38. The granulate of claim 37, wherein the micronized fenofibrate has a size less than or equal to 20 microns.

39. The granulate of claim 37, wherein the micronized fenofibrate has a size less than or equal to 10 microns.

40. The granulate of claim 37, further comprising at least one polymer.

41. The granulate of claim 37, wherein the micronized fenofibrate is present in an amount of 20 to 45% by weight.
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