Claims for Patent: 6,727,286

Summary for Patent: 6,727,286

Title:	Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid
Abstract:	The present invention provides a pharmaceutical composition comprising an aqueous solution of arginine and ibuprofen, wherein the molar ratio of arginine to ibuprofen is less than 1:1, as well as a method of making the same. The present invention also provides a method of treating a condition chosen from pain, inflammation, fever, and/or other conditions alleviated by ibuprofen comprising administering a pharmaceutical composition comprising an aqueous solution of arginine and ibuprofen, wherein the molar ratio of arginine to ibuprofen is less than 1:1.
Inventor(s):	Pavliv; Leo (Morrisville, NC)
Assignee:	Cumberland Pharmaceuticals Inc. (Nashville, TX)
Application Number:	09/985,246
Patent Claims:	1. A pharmaceutical composition comprising an aqueous solution of arginine and ibuprofen, wherein the molar ratio of arginine to ibuprofen is less than or equal to 0.97:1. 2. The pharmaceutical composition of claim 1, wherein the aqueous solution of arginine and ibuprofen has been terminally sterilized. 3. The pharmaceutical composition of claim 1, wherein the aqueous solution of arginine and ibuprofen has been lyophilized. 4. The pharmaceutical composition of claim 1, wherein the ibuprofen is (RS)-Ibuprofen. 5. The pharmaceutical composition of claim 1, wherein the ibuprofen is (S)-Ibuprofen. 6. The pharmaceutical composition of claim 1, wherein the arginine is L-arginine. 7. The pharmaceutical composition of claim 1, wherein the arginine is D-arginine. 8. The pharmaceutical composition of claim 1, wherein the molar ratio of arginine to ibuprofen is from about 0.10:1 to about 0.97:1. 9. The pharmaceutical composition of claim 8, wherein the molar ratio of arginine to ibuprofen is 0.92:1. 10. The pharmaceutical composition of claim 8, wherein the molar ratio of arginine to ibuprofen is 0.60:1. 11. The pharmaceutical composition of claim 8, wherein the molar ratio of arginine to ibuprofen is 0.97:1. 12. A method of making a pharmaceutical composition comprising an aqueous solution of arginine and ibuprofen, the method comprising dissolving arginine in water to form an arginine solution and dissolving ibuprofen in the arginine solution to form the aqueous solution of arginine and ibuprofen, wherein the molar ratio of arginine to ibuprofen is less than or equal to 0.97:1. 13. The method of claim 12, wherein the molar ratio of arginine to ibuprofen is from about 0.10:1 to about 0.97:1. 14. The method of claim 12, wherein the molar ratio of arginine to ibuprofen is 0.92:1. 15. The method of claim 12, wherein the molar ratio of arginine to ibuprofen is 0.60:1. 16. The method of claim 12, wherein the molar ratio of arginine to ibuprofen is 0.97:1. 17. The method of claim 12, further comprising terminally sterilizing the aqueous solution of arginine and ibuprofen. 18. The method of claim 12, further comprising lyophilizing the aqueous solution of arginine and ibuprofen. 19. The method of claim 12, wherein the ibuprofen is (RS)-Ibuprofen. 20. The method of claim 12, wherein the ibuprofen is (S)-Ibuprofen. 21. The method of claim 12, wherein the arginine is L-arginine. 22. The method of claim 12, wherein the arginine is D-arginine. 23. A method of treating one or more conditions chosen from pain, inflammation, fevers, and, patent ductus arteriosis comprising administering to a patient in need thereof an effective amount of an aqueous solution of arginine and ibuprofen, wherein the molar ratio of arginine to ibuprofen is less than or equal to 0.97:1. 24. The method of claim 23, wherein the molar ratio of arginine to ibuprofen is from about 0.10:1 to about 0.97:1. 25. The method of claim 23, wherein the molar ratio of arginine to ibuprofen is 0.92:1. 26. The method of claim 23, wherein the molar ratio of arginine to ibuprofen is 0.60:1. 27. The method of claim 23, wherein the molar ratio of arginine to ibuprofen is 0.97:1. 28. The method of claim 23, wherein the administration occurs via intravenous injection. 29. The method of claim 23, wherein the administration occurs via intramuscular injection. 30. The method of claim 23, wherein the administration occurs orally. 31. The method of claim 23, wherein the effective amount is from about 100 mg to about 800 mg of ibuprofen. 32. The method of claim 31, wherein the effective amount is about 400 mg of ibuprofen. 33. The method of claim 23, wherein the effective amount is about 7.5 mg/kg of ibuprofen. 34. The method of claim 23, wherein the condition is pain. 35. The method of claim 23, wherein the condition is inflammation. 36. The method of claim 23, wherein the condition is fever. 37. A pharmaceutical composition comprising an aqueous solution of arginine and ibuprofen prepared according to the method of claim 12. 38. The method of claim 23, wherein the condition is patent ductus arteriosis. 39. The pharmaceutical composition of claim 1, the molar ratio of arginine to ibuprofen is from about 0.60:1 to about 0.97:1. 40. The pharmaceutical composition of claim 39, wherein said molar ratio is from about 0.92:1 to about 0.97:1. 41. The method of claim 12, wherein the molar ratio of arginine to ibuprofen is from about 0.60:1 to about 0.97:1. 42. The method of claim 41, wherein the molar ratio of arginine to ibuprofen is from about 0.92:1 to about 0.97:1. 43. The method of claim 23, wherein the molar ratio of arginine to ibuprofen is from about 0.60:1 to about 0.97:1. 44. The method of claim 43, wherein the molar ratio of arginine to ibuprofen is from about 0.92:1 to about 0.97:1.