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|Title:||Pharmaceutical composition containing fenofibrate and method for the preparation thereof|
|Abstract:||Pharmaceutical compositions comprising micronized fenofibrate, a surfactant and a binding cellulose derivative as a solubilization adjuvant, wherein said compositions contain an amount of fenofibrate greater than or equal to 60% by weight and methods of producing fenofibrate compositions.|
|Inventor(s):||Criere; Bruno (Gravigny, FR), Suplie; Pascal (Montaure, FR), Chenevier; Philippe (Montreal, CA), Oury; Pascal (Le Chesnay, FR), Rotenberg; Keith S. (Denville, NJ), Bobotas; George (Tarpon Springs, FL)|
|Assignee:||Ethypharm (Saint Cloud, FR)|
1. A method of reducing food effect when treating hypertriglyceridemias and/or hypercholesterolemias and/or hyperlipidemias in a patient in need thereof comprising
administering to said patient a therapeutically effective amount of a pharmaceutical composition comprising micronized fenofibrate, a surfactant and hydroxypropylmethylcellulose, wherein said composition is in the form of granules comprising: (a) a
neutral core; and (b) an active layer, surrounding the neutral core; wherein said neutral core comprises a sugar or a sugar mixed with starch; said active layer comprises the micronized fenofibrate, the surfactant, and the binding cellulose
derivative; and wherein the mass ratio of said fenofibrate to said hydroxypropylmethylcellulose is between 5/1 and 15/1, and said hydroxypropylmethylcellulose represents between 5 and 12% by weight of the composition.
2. The method of claim 1, wherein said patient is fed a high fat containing meal and the bioavailability of fenofibrate administered to said patient is equivalent to when said patient has fasted.
3. The method of claim 1, wherein said patient is fed at least 800-1000 calories, 50% of which are from fat, and the bioavailability of fenofibrate administered to said patient is equivalent to when said patient has fasted.
4. The method of claim 1, wherein said patient is fed a therapeutic lifestyle change diet and the bioavailability of fenofibrate administered to said patient is equivalent to when said patient has fasted.
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