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Claims for Patent: 6,074,670

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Claims for Patent: 6,074,670

Title: Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Abstract:The invention provides an immediate-release fenofibrate composition comprising (a) an inert hydrosoluble carrier covered with at least one layer containing fenofibrate in a micronized form having a size less than 20 .mu.m, a hydrophilic polymer and, optionally, a surfactant, the polymer making up at least 20% by weight of (a); and (b) optionally one or several outer phase(s) or layers(s). The invention also provides a method for preparing said composition.
Inventor(s): Stamm; Andre (Griesheim, FR), Seth; Pawan (Irvine, CA)
Assignee: Laboratoires Fournier, S.A. (Dijon, FR)
Application Number:09/005,128
Patent Claims: 1. An immediate-release fenofibrate composition comprising:

(a) an inert hydrosoluble carrier covered with at least one layer containing fenofibrate in a micronized form having a size less than 20 .mu.m, a hydrophilic polymer and a surfactant; and

(b) optionally one or several outer phase(s) or layer(s),

wherein, based on the weight of (a), said inert hydrosoluble carrier makes up from 20 to 50% by weight, said fenofibrate makes up from 20 to 45% by weight, said hydrophilic polymer makes up from 20 to 45% by weight, and said surfactant makes up from 0.1 to 3% by weight.

2. The composition according to claim 1, 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 with 0.025M sodium lauryl sulfate.

3. The composition according to claim 1, in which the hydrophilic polymer is polyvinylpyrrolidone.

4. The composition according to claim 1, in which fenofibrate and the surfactant are co-micronized.

5. The composition according to claim 1, in which said surfactant is sodium lauryl sulfate.

6. The composition according to claim 5, in which fenofibrate and sodium lauryl sulfate are co-micronized.

7. The composition according to claim 1, in which the weight ratio fenofibrate/hydrophilic polymer is comprised between 1/10 and 4/1.

8. The composition according to claim 6, in which the weight ratio fenofibrate/hydrophilic polymer is comprised between 1/10 and 4/1.

9. The composition according to claim 1, in which the weight ratio fenofibrate/hydrophilic polymer is comprised between 1/2 and 2/1.

10. The composition according to claim 6, in which the weight ratio fenofibrate/hydrophilic polymer is comprised between 1/2 and 2/1.

11. The composition according to claim 1, in which the individual particle size of said inert hydrosoluble carrier is comprised between 50 and 500 microns.

12. An immediate-release fenofibrate composition comprising:

(a) an inert hydrosoluble carrier covered with at least one layer containing fenofibrate in a micronized form having a size less than 20 .mu.m, polyvinylpyrrolidone, and a surfactant; and

(b) optionally one or several outer phase(s) or layer(s),

wherein, based on the weight of (a), said inert hydrosoluble carrier makes up from 20 to 50% by weight, said fenofibrate makes up from 20 to 45% by weight, said polyvinylpyrrolidone makes up from 25 to 45% by weight, and said surfactant makes up from 0.1 to 3% by weight, and

wherein fenofibrate and the surfactant are co-micronized.

13. The composition according to claim 12, in which said surfactant is sodium laurylsulfate.

14. The composition according to claim 12, wherein said fenofibrate 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 with 0.025M sodium lauryl sulfate.

15. The composition according to claim 1, under the form of a tablet.

16. The composition according to claim 6, under the form of a tablet.

17. The composition according to claim 12, under the form of a tablet.

18. The composition according to claim 14, under the form of a tablet.

19. The composition according to claim 15 under the form of a tablet resulting from the compression of elements (a) together with an outer phase.

20. The composition according to claim 16 under the form of a tablet resulting from the compression of elements (a) together with an outer phase.

21. The composition according to claim 17 under the form of a tablet resulting from the compression of elements (a) together with an outer phase.

22. A method for preparing a composition according to claim 1, comprising the steps of:

(a) preparing a fenofibrate suspension in micronized form with a particle size below 20 .mu.m, in a solution of hydrophilic polymer and a surfactant;

(b) applying the suspension from step (a) to an inert hydrosoluble carrier;

(c) optionally, coating granules thus obtained with one or several phase(s)

or layer(s).

23. The method according to claim 22, in which step (b) is carried out in a fluidized-bed granulator.

24. The method according to claim 22, comprising a step in which products obtained from step (b) or (c) are compressed.

25. The composition according to claim 1, under the form of granules inside a capsule.

26. The composition according to claim 6, under the form of granules inside a capsule.

27. The composition according to claim 12, under the form of granules inside a capsule.

28. The composition according to claim 14, under the form of granules inside a capsule.

29. The composition according to claim 4, wherein the fenofibrate 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 with 0.025M sodium lauryl sulfate.

30. The composition according to claim 6, wherein the fenofibrate 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 with 0.025M sodium lauryl sulfate.

31. The composition according to claim 2, under the form of granules inside a capsule.

32. The composition according to claim 4, under the form of granules inside a capsule.

33. The composition according to claim 29 under the form of granules inside a capsule.

34. The composition according to claim 30, under the form of granules inside a capsule.

35. The composition according to claim 2, under the form of a tablet.

36. The composition according to claim 4, under the form of a tablet.

37. The composition according to claim 20, under the form of a tablet.

38. The composition according to claim 30, under the form of a tablet.
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