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Claims for Patent: 6,277,405

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Claims for Patent: 6,277,405

Title: Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
Abstract:The invention provides a micronized fenofibrate composition. The micronized fenofibrate 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. The composition can further comprise hydrophilic polymers, surfactants, hydrosoluble carriers, outer phases or layers, or other pharmaceutically acceptable excipients. The immediate-release fenofibrate composition is preferably in the form of a tablet or in the form of granules inside a capsule.
Inventor(s): Stamm; Andre (Griesheim, FR), Seth; Pawan (Irvine, CA)
Assignee: Labaratoires Fournier, S.A. (Dijon, FR)
Application Number:09/572,330
Patent Claims: 1. A composition comprising a hydrosoluble carrier and micronized fenofibrate having 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.

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

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

4. The composition according to claim 1, wherein the micronized fenofibrate have a size less than or equal to 20 .mu.m.

5. The composition according to claim 4, wherein the micronized fenofibrate have a size less than or equal to 10 .mu.m.

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

7. The composition according to claim 1, further comprising a hydrophilic polymer.

8. The composition according to claim 7, wherein the hydrophilic polymer is polyvinylpyrrolidone, poly(vinyl alcohol), hydroxypropylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, gelatin, or a mixture thereof.

9. The composition according to claim 7, wherein the hydrophilic polymer is present in an amount of 20 to 45% by weight.

10. The composition according to claim 1, further comprising a surfactant.

11. The composition according to claim 10, wherein the surfactant is sodium lauryl sulfate, monooleate, monolaurate, monopalmitate, monostearate, polyoxyethylene sorbitane, sodium dioctylsulfosuccinate, lecithin, stearylic alcohol, cetostearylic alcohol, cholesterol, polyoxytheylene ricin oil, polyoxyethylene fatty acid glyceride, poloxamer, or a mixture thereof.

12. The composition according to claim 10, wherein the surfactant is present in an amount of 0.1 to 3% by weight.

13. The composition according to claim 1, wherein the hydrosoluble carrier is present in an amount of 20 to 50% by weight.
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