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Claims for Patent: 5,545,628

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Claims for Patent: 5,545,628

Title: Pharmaceutical composition containing fenofibrate
Abstract:A pharmaceutical composition is provided for treating hyperlipidemia or hypercholesterolemia or both in a mammal, which contains an effective amount of each of fenofibrate and an excipient containing one or more polyglycolyzed glycerides.
Inventor(s): Deboeck; Arthur (Carolina, PR), Maes; Paul (Carolina, PR), Baudier; Phillipe R. (Carolina, PR)
Assignee: Galephar P.R. Inc. (Carolina, PR)
Application Number:08/370,883
Patent Claims: 1. A pharmaceutical composition for treating hyperlipidemia or hypercholesterolemia or both in a mammal, which comprises an effective amount of each of fenofibrate and an excipient comprising one or more polyglycolyzed glycerides.

2. The composition of claim 1, wherein said fenofibrate is present in an amount of 5% to 95% by weight based on the total weight of the composition.

3. The composition of claim 1, wherein the polyglycolyzed glycerides have a HLB value of at least 10.

4. The composition of claim 3, wherein the polylglycolyzed glycerides have a HLB value of from 12 to 15.

5. The composition of claim 1, which further comprises polyalkylene glycols to adjust the HLB value or melting point or both to the desired value.

6. The composition of claim 1, wherein a suspension stabilizer is added.

7. The composition of claim 6, wherein said suspension stabilizer is selected from the group and consisting of cellulose, povidone, poloxamers, .alpha., .OMEGA.-hydroxy-poly(oxyethylene) poly(oxypropylene)-poly(oxyethylene)bloc polymers.

8. The composition of claim 1, in which said fenofibrate and said excipient are in unit dosage form and are contained in a hard gelatin capsule.

9. The composition of claim 8, wherein said hard gelatin capsule contains from about 67 mg to about 200 mg of fenofibrate.

10. A method of making a solid oral dosage form of a pharmaceutical composition, comprising an effective amount of each of fenofibrate and an excipient comprising one or more polyglycolyzed glycerides, which method comprises adding said molten fenofibrate and said excipient to hard gelatin capsules, and allowing said said molten fenofibrate and said excipient to cool therein.

11. A method of treating hyperlipidemia or hypercholesterolemia or both in a mammal in need threof, which comprises administering to said mammal an effective amount of a pharmaceutical composition, comprising fenofibrate and an excipient containing one or more polyglycolyzed glycerides.

12. The method of claim 11, wherein said mammal is human, and said effective amount of fenofibrate in said composition is from about 100 mg to 600 mg per day.

13. The method of claim 12, wherein said effective amount of fenofibrate in said composition is from about 100 mg to 300 mg per day.

14. The method of claim 11, wherein said composition is administered orally.

15. The method of claim 10, which is with the proviso that the fenofibrate used is not co-micronized.
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