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Claims for Patent: 6,251,426

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Claims for Patent: 6,251,426

Title: Ibuprofen-containing softgels
Abstract:Liquid softgel fill formulations containing ibuprofen in free acid form, and softgel capsules comprised of a gelatin sheath enclosing such fill formulations, are prepared by dissolving more than 30% of ibuprofen in free acid form in polyethylene glycol and at least 10% by weight of a polyvinylpyrrolidone having an average molecular weight of from about 2,000 to about 54,000. The formulations may also include a surfactant to increase the bioavailability of the ibuprofen.
Inventor(s): Gullapalli; Rampurna Prasad (Greensboro, NC)
Assignee: Banner Pharmacaps, Inc. (High Point, NC)
Application Number:09/389,003
Patent Claims: 1. A liquid softgel fill formulation consisting essentially of:

a) greater than 30% by weight ibuprofen in free acid form in solution;

b) from about 30 to about 60% by weight polyethylene glycol;

c) from about 10 to about 30% by weight of polyvinylpyrrolidone; and

d) from about 1 to about 10% by weight of a surfactant.

2. The softgel fill formulation of claim 1, wherein said ibuprofen is present in an amount of at least about 35% by weight.

3. The softgel formulation of claim 1, wherein said polyethylene glycol has an average molecular weight of from about 200 to about 1,000.

4. The softgel formulation of claim 1, wherein said polyvinylpyrrolidone has an average molecular weight of from about 2,000 to about 54,000.

5. The softgel fill formulation of claim 1, further including up to about 6% of a nasal decongestant or up to about 10% of an antihistaminic.

6. The softgel fill formulation of claim 1, further including up to about 10% by weight of a surfactant to increase the bioavailability of said ibuprofen.

7. The softgel formulation of claim 1, wherein said surfactant is selected from the group consisting of esters of d-alpha-tocopheryl, polyoxyethylene castor oil derivatives, and polyglycolyzed glycerides.

8. A liquid softgel fill formulation consisting essentially of:

a) greater than 30% by weight ibuprofen in free acid form in solution;

b) from about 30 to about 60% by weight of polyethylene glycol having an average molecular weight of from about 200 to about 1,000;

c) from about 10 to about 30% by weight of polyvinylpyrrolidone having an average molecular weight of from about 2,000 to about 54,000; and

d) from about 1 to about 10% by weight of a surfactant to increase the bioavailability of said ibuprofen.

9. The softgel fill formulation of claim 8, wherein said polyethylene glycol is has an average molecular weight of about 600.

10. The softgel formulation of claim 8, wherein said surfactant is selected from esters of d-alpha tocopheryl, polyoxyethylene castor oil derivatives, and polyglycolyzed glycerides.

11. A softgel capsule comprised of a sheath enclosing a liquid fill, said fill consisting essentially of:

a) greater than 30% by weight ibuprofen in free acid form in solution;

b) from about 30 to about 60% by weight polyethylene glycol;

c) from about 10 to about 30% by weight polyvinylpyrrolidone; and

d) from about 1 to about 10% by weight of a surfactant.

12. The softgel capsule of claim 11, wherein said ibuprofen is present in an amount of from about 35% to about 40% by weight of said fill.

13. The softgel capsule of claim 11, wherein said polyethylene glycol has an average molecular weight of from about 200 to about 1,000.

14. The softgel capsule of claim 11, wherein said surfactant is selected from esters of d-alpha tocopheryl, polyoxyethylene castor oil derivatives, and polyglycolyzed glycerides.

15. The softgel capsule of claim 11, wherein said polyvinylpyrrolidone has an average molecular weight of from about 2,000 to about 11,000.

16. The softgel capsule of claim 11, wherein said sheath is comprised of from about 45 to about 75% by weight gelatin, from about 20 to about 40% by weight of a plasticizer, and from about 5 to about 15% by weight water.

17. The softgel capsule of claim 11, further including up to about 6% of a nasal decongestant or up to about 10% of an antihistaminic.

18. A softgel capsule comprised of a sheath enclosing a liquid fill, said fill consisting essentially of:

a) at least 35% by weight ibuprofen in free acid form in solution;

b) from about 30 to about 50% by weight polyethylene glycol having an average molecular weight of from about 200 to about 1,000;

c) from about 15 to about 30% by weight of polyvinylpyrrolidone having an average molecular weight of from about 2,000 to about 11,000; and

d) a surfactant to increase the bioavailability of said ibuprofen.

19. The softgel capsule of claim 18, wherein said surfactant is selected from esters of d-alpha tocopheryl, polyoxyethylene castor oil derivatives, and polyglycolyzed glycerides.

20. The softgel capsule of claim 18, wherein said sheath is comprised of from about 45 to about 75% by weight gelatin, from about 20 to about 40% by weight plasticizer, and from about 5 to about 15% by weight water.

21. The capsule of claim 20, wherein said sheath plasticizer is selected from the group consisting of sorbitol, sorbitol special, maltitol, and mixtures thereof.

22. The capsule of claim 18, wherein the total weight of said capsule fill is less than 600 mg., and the weight of said ibuprofen is at least 200 mg.

23. A liquid softgel fill formulation consisting essentially of:

a) greater than 30% by weight ibuprofen in free acid form in solution;

b) from about 30 to about 60% by weight polyethylene glycol;

d) from about 10 to about 30% by weight of polyvinylpyrrolidone, wherein the ratio of polyethylene glycol to polyvinylpyrrolidone less than about 2.5:1; and

d) a surfactant to increase the bioavailability of said ibuprofen.

24. The liquid softgel fill formulation of claim 23 wherein the ratio of polyethylene glycol to polyvinylpyrrolidone is between about 1.6:1 and about 1.8:1.

25. A softgel capsule comprised of a sheath enclosing a liquid fill, said fill consisting essentially of:

a) greater than 30% by weight ibuprofen in free acid form in solution;

b) from about 30 to about 60% by weight polyethylene glycol;

c) from about 10 to about 30% by weight polyvinylpyrrolidone, wherein the ratio of polyethylene glycol to polyvinylpyrrolidone is less than about 2.5:1; and

d) a surfactant to increase the bioavailability of said ibuprofen.

26. The softgel capsule of claim 25 wherein the ratio of polyethylene glycol to polyvinylpyrrolidone is between about 1.6:1 and about 1.8:1.
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