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Details for Patent: 8,658,212

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Details for Patent: 8,658,212

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 to enhance the 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 (Houdan, FR) Sunfone Electronics Co. (TW) Ethypharm (Saint-Cloud, FR)
Filing Date:Aug 25, 2006
Application Number:11/509,806
Claims:1. A pharmaceutical composition comprising granules in a capsule, wherein each granule comprises: (a) a neutral microgranule; (b) an active layer surrounding the neutral microgranule; wherein said neutral microgranule comprises a sugar or a sugar mixed with starch; and said active layer comprises: micronized particles consisting of fenofibrate; a surfactant; and a binding cellulose derivative, and wherein the dose of fenofibrate is 50-200 mg, and said binding cellulose derivative is 2 to 15% by weight of said pharmaceutical composition; and wherein at least about 65% of the fenofibrate is dissolved at 15 minutes in a continuous flow cell method at a flow rate of 8 ml/min of sodium lauryl sulfate at 0.1 N.

2. The composition of claim 1, wherein the mean size of the micronized particles are 6.2-7.6 microns.

3. 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 C.sub.max of at least 4 micrograms/ml.

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

5. 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 0.1N.

6. The pharmaceutical composition of claim 1, wherein about 100% of the 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 0.1N.

7. A pharmaceutical composition in the form of granules in a capsule, wherein each granule comprises a neutral microgranule; micronized fenofibrate of mean particle size 6.2 .mu.m to 15 .mu.m; a surfactant; and a binding cellulose derivative, and wherein the dose of fenofibrate is 50-200 mg, and said binding cellulose derivative is 2 to 15% by weight of said pharmaceutical composition, and wherein the composition achieves a C.sub.max of fenofibric acid corresponding to about 4.5 .mu.g/ml when administered to a fasting patient at a dose of about 200 mg fenofibrate.

8. The composition of claim 7, wherein the mean size of the micronized particles is 6.2 .mu.m-10 .mu.m.

9. The composition of claim 7, wherein the mean size of the micronized particles is 6.2 .mu.m-8 .mu.m.

10. The pharmaceutical composition of claim 7, which, when administered to a patient in a fasting state at a dose of 200 mg fenofibrate, achieves AUC of at least 119.

11. The pharmaceutical composition of claim 7, 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 0.1N.

12. The pharmaceutical composition of claim 7, 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 0.1N.

13. The pharmaceutical composition of claim 7, wherein about 100% 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 0.1N.

14. A pharmaceutical composition in the form of granules in a capsule, wherein each granule comprises a neutral microgranule; micronized particles consisting of fenofibrate; a surfactant; and hydroxypropylmethylcellulose, and wherein the dose of fenofibrate is 50-200 mg, and said hydroxypropylmethylcellulose is 5 to 12% by weight of said pharmaceutical composition; and wherein the mean size of the micronized particles is less than 10 microns, and the composition achieves a C.sub.max corresponding to at least about 4.5 .mu.g/ml when administered at a dose of 200 mg fenofibrate to patient under fasting conditions.
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