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Claims for Patent: 8,481,078

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Claims for Patent: 8,481,078

Title:Solid dosage form comprising a fibrate
Abstract: The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:13/315,030
Patent Claims: 1. A tablet comprising particles comprising (a) a solid carrier and (b) fenofibrate in a vehicle, the vehicle having a melting point of from about 30.degree. C. to about 100.degree. C., wherein the particles have a d.sub.gw of from about 20 .mu.m to about 2000 .mu.m, the particles comprise about 10% to about 70% by weight of fenofibrate, based upon 100% total weight of the fenofibrate and vehicle, and the tablet provides immediate release of the fenofibrate.

2. The tablet of claim 1, wherein the particles have a d.sub.gw of from about 100 to about 400 .mu.m.

3. The tablet of claim 1, wherein the vehicle has a melting point of from about 40.degree. C. to about 75.degree. C.

4. The tablet of claim 3, wherein the vehicle has a melting point of from about 40.degree. C. to about 70.degree. C.

5. The tablet of claim 1, wherein the vehicle is hydrophilic.

6. The tablet of claim 1, wherein the vehicle comprises one or more of polyethylene glycol, poloxamers, polyoxyethylene stearates, poly-epsilon-caprolactone, polyvinylpyrrolidone, polyvinylpyrrolidone-polyvinylacetate copolymer, polymethacrylic polymers, polyvinyl alcohol, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, and poly(ethylene oxide).

7. The tablet of claim 1, wherein the vehicle comprises one or more of polyvinylpyrrolidones, polyvinyl-polyvinylacetate copolymers, polyvinyl alcohol, polyvinylpyrrolidone polymers, acrylic polymers, polymethacrylic polymers, myristyl alcohol, hydroxypropyl methylcellulose, hydroxypropyl cellulose, methylcellulose, sodium carboxymethylcellulose, hydroxyethyl cellulose, pectins, cyclodextrins, galactomannans, alginates, carragenates, xanthan gums and mixtures thereof.

8. The tablet of claim 1, wherein the vehicle comprises polyoxyethylene oxide, polyoxyethylene stearate, poly-epsilon-caprolactone or any mixtures thereof.

9. The tablet of claim 1, wherein the vehicle comprises poloxamer.

10. The tablet of claim 9, wherein the poloxamer is poloxamer 188.

11. The tablet of claim 9, wherein the poloxamer is poloxamer 407.

12. The tablet of claim 9, wherein the weight ratio of fenofibrate to poloxamer is from about 3:1 to about 1:20.

13. The tablet of claim 1, wherein the tablet is a compressed tablet.

14. The tablet of claim 1, wherein at least 75% of the fenofibrate is released within about 45 minutes when tested according to Ph. Eur. Dissolution test (paddle) employing water with 0.75% sodium lauryl sulfate as the dissolution medium and at 50 rpm and a temperature of about 37.degree. C.

15. A solid dosage form comprising particles, the particles comprising a solid carrier sprayed with fenofibrate in a vehicle, the vehicle having a melting point of from about 30.degree. C. to about 100.degree. C., wherein the solid dosage form comprises about 10% to about 70% by weight of fenofibrate, based upon 100% total weight of the fenofibrate and vehicle, the particles have a d.sub.gw of from about 20 .mu.m to about 2000 .mu.m, and the solid dosage form provides immediate release of the fenofibrate.

16. The solid dosage form of claim 15, wherein the particles have a d.sub.gw of from about 100 .mu.m to about 400 .mu.m.

17. The solid dosage form of claim 15, wherein the vehicle has a melting point of from about 40.degree. C. to about 75.degree. C.

18. The solid dosage form of claim 15, wherein the vehicle comprises poloxamer.

19. A solid dosage form prepared by: (a) spraying a mixture of fenofibrate and a liquid vehicle onto a solid carrier to form particles, said solid carrier at a temperature below the melting point of the vehicle, wherein the vehicle has a melting point of from about 30.degree. C. to about 100.degree. C.; and (b) forming a solid dosage from the particles of step (a), wherein the particles have a d.sub.gw of from about 20 .mu.m to about 2000 .mu.m, the solid dosage form comprises from about 10% to about 70% by weight of fenofibrate, based upon 100% total weight of the fenofibrate and vehicle, and the solid dosage form provides immediate release of the fenofibrate.

20. The solid dosage form of claim 19, wherein the particles have a d.sub.gw of from about 100 .mu.m to about 400 .mu.m.

21. The solid dosage form of claim 19, wherein the vehicle having a melting point of from 40.degree. C. to about 75.degree. C.

22. A tablet comprising fenofibrate in a vehicle, the vehicle comprising poloxamer, wherein (i) the tablet comprises about 10% to about 35% by weight of fenofibrate, based upon 100% total weight of the fenofibrate and vehicle, (ii) the tablet is prepared by (a) spraying a mixture of fenofibrate and poloxamer onto a solid carrier, and (b) forming a tablet form the product of step (a), and (iii) the tablet provides immediate release of the fenofibrate.

23. A method of reducing total cholesterol (total-C), LDL-C, apo-lipoprotein B, or total triglycerides in a patient in need thereof, the method comprising orally administering a tablet of claim 1 to said patient.

24. The tablet of claim 1, wherein the vehicle comprises polyethylene glycol.

25. The solid dosage form of claim 15, wherein the vehicle comprises polyethylene glycol.

26. The solid dosage form of claim 19, wherein the vehicle comprises polyethylene glycol.

27. The tablet of claim 1, wherein the vehicle comprises hydrogenated castor oil.

28. The solid dosage form of claim 15, wherein the vehicle comprises hydrogenated castor oil.

29. The solid dosage form of claim 19, wherein the vehicle comprises hydrogenated castor oil.
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