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Details for Patent: 6,596,317

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Details for Patent: 6,596,317

Title: Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Abstract:The invention provides suspensions of micronized fenofibrate. The suspensions can comprise micronized fenofibrate in a solution of hydrophilic polymers. The suspensions can further comprise one or more surfactants.
Inventor(s): Stamm; Andre (Griesheim, FR), Seth; Pawan (Irvine, CA)
Assignee: Laboratoires Fournier, SA (Dijon, FR)
Filing Date:Feb 21, 2002
Application Number:10/078,500
Claims:1. A suspension of micronized fenofibrate having a size less than 20 .mu.m in a solution of at least one hydrophilic polymer; wherein the hydrophilic polymer is present in an amount from 5 to 40% by weight; and wherein the hydrophilic polymer is a polyvinylpyrrolidone, a poly(vinyl alcohol), a hydroxypropylcellulose, a hydroxymethylcellulose, a hydroxypropylmethylcellulose, a gelatin, or a mixture of two or more thereof.

2. The suspension according to claim 1, wherein the fenofibrate has a size less than 10 .mu.m.

3. The suspension according to claim 1, wherein the fenofibrate is present in an amount from 1 to 40% by weight.

4. The suspension according to claim 3, wherein the fenofibrate is present in an amount from 10 to 25% by weight.

5. The suspension according to claim 1, wherein the hydrophilic polymer is present in an amount from 10 to 25% by weight.

6. The suspension according to claim 1, wherein the hydrophilic polymer is a polyvinylpyrrolidone.

7. The suspension according to claim 1, wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/10 and 4/1.

8. The suspension according to claim 7, wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1.

9. The suspension according to claim 1, further comprising at least one surfactant.

10. The suspension according to claim 9, wherein the surfactant is present in an amount up to 10% by weight.

11. The suspension according to claim 10, wherein the surfactant is present in an amount up to 5% by weight.

12. The suspension according to claim 9, wherein the weight ratio of surfactant/hydrophilic polymer is between 1/500 and 1/10.

13. The suspension according to claim 2, wherein the weight ratio of surfactant/hydrophilic polymer is between 1/100 and 5/100.

14. The suspension according to claim 9, wherein the surfactant is sodium lauryl sulfate, monooleate, monolaurate, monopalmitate, monostearate or another ester of polyoxyethylene sorbitane, sodium dioctylsulfosuccinate lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxyethylene ricin oil, polyoxyethylene fatty acid glycerides, poloxamer, or a mixture of two or more thereof.

15. The suspension according to claim 14, wherein the surfactant is sodium lauryl sulfate.

16. The suspension according to claim 9, wherein the fenofibrate and surfactant are co-micronized.

17. A suspension of micronized having a size less than 20 .mu.m in a solution of at least one hydrophilic polymer and at least one surfactant, wherein the fenofibrate is present in an amount of from 1 to 40% by weight, the hydrophilic polymer is present in an amount from 5 to 40% by weight, and the surfactant is present in an amount up to 10% by weight; and wherein the hydrophilic polymer is a polyvinyl pyrrolidone, a poly(vinyl alcohol), a hydroxypropylcellulose, a hydroxymethylcellulose, a hydroxypropylmethylcellulose, a gelatin, or a mixture of two or more thereof.

18. The suspension according to claim 7, wherein the fenofibrate has a size less than 10 .mu.m.

19. The suspension according to claim 7, wherein the hydrophilic polymer is polyvinylpyrrolidone.

20. The suspension according to claim 7, wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/10 and 4/1.

21. The suspension according to claim 19, wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1.

22. The suspension according to claim 17, wherein the weight ratio of surfactant/hydrophilic polymer is between 1/500 and 1/10.

23. The suspension according to claim 22, wherein the weight ratio of surfactant/hydrophilic polymer is between 1/100 and 5/100.

24. The suspension according to claim 17, wherein the surfactant is sodium lauryl sulfate.

25. A suspension of micronized fenofibrate having a size less than 20 .mu.m in a solution of polyvinylpyrrolidone and a surfactant, wherein the fenofibrate is present in an amount from 1 to 40% by weight, the hydrophilic polymer is present in an amount from 5 to 40% by weight and the surfactant is present in an amount up to 10% by weight.

26. The suspension according to claim 25, the fenofibrate has a size less than 10 .mu.m.

27. The suspension according to claim 25, wherein the fenofibrate is present in an from 10 to 25% by weight.

28. The suspension according to claim 25, wherein the hydrophilic polymer is present in an amount from 10 to 25% by weight.

29. The suspension according to claim 25, wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/10 and 4/1.

30. The suspension according to claim 29, wherein the weight ratio of fenofibrate/hydrophilic polymer is between 1/2 and 2/1.

31. The suspension according to claim 25, wherein the surfactant is present in an amount up to 5% by weight.

32. The suspension according to claim 25, wherein the weight ratio of surfactant/hydrophilic polymer is between 1/500 and 1/10.

33. The suspension according to claim 32, wherein the weight ratio of surfactant hydrophilic polymer is between 1/100 and 5/100.

34. The suspension according to claim 1, wherein the surfactant is sodium lauryl sulfate.

35. The suspension of claim 1, wherein the at least one hydrophilic polymer is a mixture of hydrophilic polymers.

36. The suspension of claim 17, wherein the at least one hydrophilic polymer is a mixture of hydrophilic polymers.

37. The suspension of claim 25, wherein the at least one hydrophilic polymer is a mixture of hydrophilic polymers.
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