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Claims for Patent: 7,101,574

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Claims for Patent: 7,101,574

Title:Pharmaceutical composition containing fenofibrate and the preparation method
Abstract:The invention concerns a pharmaceutical composition containing micronized fenofibrate, a surfactant and a binding cellulose derivative, as solubilizing adjuvant, preferably hydroxypropylmethylcellulose. The cellulose derivative represents less than 20 wt. % of the composition. The association of micronized fenofibrate with a binding cellulose derivative, as solubilizing adjuvant and a surfactant enables enhanced bioavailability of the active principle. The invention also concerns a method for preparing said composition without using any organic solvent.
Inventor(s): Criere; Bruno (Gravigny, FR), Suplie; Pascal (Montaure, FR), Chenevier; Philippe (Montreal, CA)
Assignee: Laboratoires des Produits Ethiques Ethypharm (Houdan, FR)
Application Number:10/030,262
Patent Claims: 1. A pharmaceutical composition in the form of granules, wherein each granule comprises a neutral microgranule on which is a composition comprising: micronized fenofibrate, a surfactant, and a binding cellulose derivative as a solubilization adjuvant, and wherein said fenofibrate is present in an amount greater than or equal to 60% by weight, relative to the weight of said pharmaceutical composition, and further wherein said binding cellulose derivative represents between 2 to 15% by weight, relative to the weight of said pharmaceutical composition.

2. The pharmaceutical composition of claim 1, wherein said binding cellulose derivative is hydroxypropylmethylcellulose (HPMC).

3. The pharmaceutical composition of claim 2, wherein said hydroxypropylmethylcellulose has an apparent viscosity of between 2.4 and 18 cP.

4. The pharmaceutical composition of claim 1, wherein said fenofibrate is present in an amount greater than or equal to 70% by weight, relative to the weight of said pharmaceutical composition.

5. The pharmaceutical composition of claim 1, wherein said surfactant is selected from the group consisting of polyoxyethylene 20 sorbitan monooleate, sorbitan monododecanoate, and sodium lauryl sulfate.

6. The pharmaceutical composition of claim 1, wherein said surfactant represents between 1 and 10% by weight, relative to the weight of said fenofibrate.

7. The pharmaceutical composition of claim 2, wherein said fenofibrate/HPMC mass ratio is between 5/1 and 15/1.

8. The pharmaceutical composition of claim 1, wherein said pharmaceutical composition further comprises at least one excipient.

9. The pharmaceutical composition of claim 1, wherein said micronized fenofibrate has a mean particle size less than 15 .mu.m.

10. The pharmaceutical composition of claim 1, wherein said composition is contained in gelatin capsules.

11. A method for preparing the pharmaceutical composition of claim 1, wherein said granules are prepared by spraying onto neutral microgranules an aqueous suspension of micronized fenofibrate containing surfactant and solubilized binding cellulose derivative.

12. The pharmaceutical composition of claim 3, wherein said hydroxypropylmethylcellulose has an apparent viscosity of between 2.4 and 3.6 cP.

13. The pharmaceutical composition of claim 1, wherein said fenofibrate is present in an amount greater than or equal to 75% by weight, relative to the weight of said pharmaceutical composition.

14. The pharmaceutical composition of claim 1, wherein said surfactant represents between 3 and 5% by weight, relative to the weight of said fenofibrate.

15. The pharmaceutical composition of claim 1, wherein said binding cellulose derivative represents between 5 and 12% by weight, relative to the weight of said pharmaceutical composition.

16. The pharmaceutical composition of claim 8, wherein said excipient is selected from the group consisting of a diluent, an antifoaming agent, a lubricant, and a mixture thereof.

17. The pharmaceutical composition of claim 8, wherein said excipient is selected from the group consisting of lactose, .alpha.-(trimethylsilyl)-.omega.-methylpoly[oxy-(dimethylsilylene)], a mixture of .alpha.-(trimethylsilyl)-.omega.-methylpoly[oxy-(dimethylsilylene)] with silicon dioxide, and talc.

18. The pharmaceutical composition of claim 1, wherein said micronized fenofibrate has a mean particle size less than 8 .mu.m.

19. A pharmaceutical composition in the form of granules, wherein each granule comprises a neutral microgranule on which is a composition comprising: micronized fenofibrate, a surfactant, and a binding cellulose derivative as a solubilization agent, wherein the mass ratio of said fenofibrate to said binding cellulose derivative is between 5/1 and 15/1.

20. The pharmaceutical composition according to claim 19, wherein said binding cellulose derivative is hydroxypropylmethylcellulose.

21. The pharmaceutical composition of claim 19, wherein said binding cellulose derivative has an apparent viscosity of between 2.4 and 18 cP.

22. The pharmaceutical composition of claim 19, wherein said binding cellulose derivative has an apparent viscosity of between 2.4 and 3.6 cP.

23. The pharmaceutical composition of claim 19, wherein said surfactant is selected from the group consisting of polyoxyethylene 20 sorbitan monooleate, sorbitan monododecanoate, and sodium lauryl sulfate.

24. The pharmaceutical composition of claim 19, wherein said surfactant represents between 1 and 10% by weight, relative to the weight of said fenofibrate.

25. The pharmaceutical composition of claim 19, wherein said surfactant represents between 3 and 5% by weight, relative to the weight of said fenofibrate.

26. The pharmaceutical composition of claim 19, wherein said pharmaceutical composition further comprises at least one excipient.

27. The pharmaceutical composition of claim 26, wherein said excipient is selected from the group consisting of a diluent, an antifoaming agent, a lubricant, and a mixture thereof.

28. The pharmaceutical composition of claim 27, wherein said diluent is lactose.

29. The pharmaceutical composition of claim 27, wherein said antifoaming agent is .alpha.-(trimethylsilyl)-.omega.-methylpoly[oxy-(dimethylsilylen- e)] or a mixture of .alpha.-(trimethylsilyl)-.omega.-methylpoly[oxy-(dimethylsilylene)] with silicon dioxide.

30. The pharmaceutical composition of claim 27, wherein said lubricant is talc.

31. The pharmaceutical composition of claim 19, wherein said micronized fenofibrate has a mean particle size less than 15 .mu.m.

32. The pharmaceutical composition of claim 19, wherein said micronized fenofibrate has a mean particle size less than 8 .mu.m.

33. The pharmaceutical composition of claim 19, wherein said composition is contained in gelatin capsules.

34. The pharmaceutical composition of claim 2, wherein at least 95% of said fenofibrate is dissolved at 30 minutes, as measured using a continuous flow cell method with a flow rate of 8 ml/min of sodium lauryl sulfate at 0.1 N.
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