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Details for Patent: 8,563,042

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Details for Patent: 8,563,042

Title:Pharmaceutical composition containing fenofibrate and method for the preparation thereof
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: Ethypharm (Sanit-Cloud, FR)
Filing Date:Jun 25, 2010
Application Number:12/823,900
Claims:1. A pharmaceutical composition comprising between 50 and 300 mg of micronized fenofibrate coated on neutral microgranules in a single active layer comprising said micronized fenofibrate, as surfactant and hydroxypropyl methyl cellulose (HPMC), wherein the fenofibrate/HPMC ratio is between 5/1 and 15/1 and the surfactant represents between 1 and 10% by weight relative to the weight of fenofibrate.

2. The composition of claim 1 in a capsule.

3. The composition of claim 1, wherein the dose of fenofibrate is 50 mg to 200 mg.

4. The composition of claim 1, wherein the neutral microgranules have a particle size between 200 and 1000 microns.

5. The composition of claim 4, wherein the neutral microgranules have a particle size between 400 and 600 microns.

6. The composition of claim 1, wherein the mean size of the fenofibrate micronized particles is less than 8 .mu.m.

7. The composition of claim 1, wherein the surfactant is sodium lauryl sulphate.

8. The composition of claim 1, wherein HPMC represents between 3 and 5% by weight relative to the weight of fenofibrate.

9. The pharmaceutical composition of claim 1, which, when administered to a patient in a fasting state at a dose of 200 mg fenofibrate, achieves a Cmax of at least 4 micrograms/ml.

10. The pharmaceutical composition of claim 1, which, when administered to a patient in a fasting state at to dose of 200 mg fenofibrate, achieves AUC of at least 119.

11. The pharmaceutical composition of claim 1, wherein at least 20% of said fenofibrate is dissolved at 5 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.

12. The pharmaceutical composition of claim 1, wherein at least 65% of said fenofibrate is dissolved at 15 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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