Claims for Patent: RE39221

Summary for Patent: RE39221

Title:	Composition comprising a tramadol material and acetaminophen and its use
Abstract:	This invention relates to a composition comprising a tramadol material and acetaminophen, and its use. As used herein tramadol refers to various forms of tramadol. The compositions are pharmacologically useful in treating pain and tussive conditions. The compositions are also subject to less opioid side-effects such as abuse liability, tolerance, constipation and respiratory depression. Furthermore, where the components of the compositions are within certain ratios the pharmacological effects of the compositions are superadditive (synergistic).
Inventor(s):	Raffa; Robert B. (Norristown, PA), Vaught; Jeffrey L. (Glenmoore, PA)
Assignee:	Ortho-McNeil Pharmaceutical, Inc. (Raritan, NJ)
Application Number:	10/761,096
Patent Claims:	1. A pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to acetaminophen is a weight ratio from about 1:1 to about 1:1600..]. .[.2. The pharmaceutical composition of claim 1 wherein the tramadol material is tramadol hydrochloride..]. .[.3. The pharmaceutical composition of claim 2 wherein the tramadol hydrochloride is racemic..]. .[.4. The pharmaceutical composition of claim 1 wherein the weight ratio is about 1:1..]. .[.5. The pharmaceutical composition of claim 1 wherein the weight ratio is from about 1:5 to about 1:1600..]. 6. .[.The pharmaceutical composition of claim 5 wherein the.]. .Iadd.A pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to acetaminophen is a .Iaddend.weight ratio .[.is.]. .Iadd.of .Iaddend.about 1:5. .[.7. The pharmaceutical composition of claim 5 wherein the weight ratio is from about 1:19 to about 1:800..]. .[.8. The pharmaceutical composition of claim 7 wherein the weight ratio is from about 1:19 to about 1:50..]. .[.9. The pharmaceutical composition of claim 1 further comprising a pharmaceutically acceptable carrier..]. .[.10. The pharmaceutical composition of claim 1 further comprising a decongestant or bronchodilator..]. .[.11. The pharmaceutical composition of claim 1 further comprising an antitussive..]. .[.12. The pharmaceutical composition of claim 1 further comprising an antihistamine or a non-sedating antihistamine..]. .[.13. The pharmaceutical composition of claim 1 further comprising a muscle relaxant..]. .[.14. The pharmaceutical composition of claim 1 further comprising a sleep aid..]. 15. A method for treating .[.a.]. pain in a mammal comprising .[.an administration.]. .Iadd.administering .Iaddend.to the mammal an effective amount of the pharmaceutical composition of .[.claim 1.]. .Iadd.claim 6.Iaddend.. .Iadd.16. A pharmaceutical composition comprising an active ingredient that consists essentially of tramadol and acetaminophen, wherein the ratio of tramadol to acetaminophen is a weight ratio from about 1:1 to about 1:1600..Iaddend. .Iadd.17. The pharmaceutical composition of claim 16 wherein the tramadol is racemic..Iaddend. .Iadd.18. The pharmaceutical composition of claim 16 wherein the tramadol is present as its hydrochloride salt..Iaddend. .Iadd.19. The pharmaceutical composition of claim 18 wherein the tramadol hydrochloride is racemic..Iaddend. .Iadd.20. The pharmaceutical composition of claim 16 wherein said active ingredient consists essentially of an admixture of said tramadol and said acetaminophen..Iaddend. .Iadd.21. The pharmaceutical composition of claim 16 wherein the weight ratio is about 1:1..Iaddend. .Iadd.22. The pharmaceutical composition of claim 16 wherein the weight ratio is from about 1:5 to about 1:1600..Iaddend. .Iadd.23. The pharmaceutical composition of claim 16 wherein the weight ratio is about 1:5..Iaddend. .Iadd.24. The pharmaceutical composition of claim 16 comprising a pharmaceutically acceptable carrier..Iaddend. .Iadd.25. The pharmaceutical composition of claim 16 that is in the form of a powder..Iaddend. .Iadd.26. The pharmaceutical composition of claim 16 that is in the form of a capsule..Iaddend. .Iadd.27. The pharmaceutical composition of claim 16 that is in the form of a tablet..Iaddend. .Iadd.28. The pharmaceutical composition of claim 16 that is in the form of a suspension..Iaddend. .Iadd.29. The pharmaceutical composition of claim 16 that is in the form of a solution..Iaddend. .Iadd.30. A method for treating pain in a mammal comprising administering to the mammal an effective amount of the pharmaceutical composition of claim 16..Iaddend. .Iadd.31. A pharmaceutical composition comprising an active ingredient that consists essentially of tramadol and acetaminophen, wherein the ratio of tramadol to acetaminophen is a weight ratio from about 1:5 to about 1:50..Iaddend. .Iadd.32. The pharmaceutical composition of claim 31 wherein the tramadol is racemic..Iaddend. .Iadd.33. The pharmaceutical composition of claim 31 wherein the tramadol is present as its hydrochloride salt..Iaddend. .Iadd.34. The pharmaceutical composition of claim 33 wherein the tramadol hydrochloride is racemic..Iaddend. .Iadd.35. The pharmaceutical composition of claim 31 wherein said active ingredient consists essentially of an admixture of said tramadol and said acetaminophen..Iaddend. .Iadd.36. The pharmaceutical composition of claim 31 comprising a pharmaceutically acceptable carrier..Iaddend. .Iadd.37. The pharmaceutical composition of claim 31 that is in the form of a powder..Iaddend. .Iadd.38. The pharmaceutical composition of claim 31 that is in the form of a capsule..Iaddend. .Iadd.39. The pharmaceutical composition of claim 31 that is in the form of a tablet..Iaddend. .Iadd.40. The pharmaceutical composition of claim 31 that is in the form of a suspension..Iaddend. .Iadd.41. The pharmaceutical composition of claim 31 that is in the form of a solution..Iaddend. .Iadd.42. A method for treating pain in a mammal comprising administering to the mammal an effective amount of the pharmaceutical composition of claim 31..Iaddend. .Iadd.43. A pharmaceutical composition comprising an active ingredient that consists essentially of tramadol and acetaminophen, wherein the ratio of tramadol to acetaminophen is a weight ratio from about 1:5 to about 1:19..Iaddend. .Iadd.44. The pharmaceutical composition of claim 43 wherein the tramadol is racemic..Iaddend. .Iadd.45. The pharmaceutical composition of claim 43 wherein the tramadol is present as its hydrochloride salt..Iaddend. .Iadd.46. The pharmaceutical composition of claim 45 wherein the tramadol hydrochloride is racemic..Iaddend. .Iadd.47. The pharmaceutical composition of claim 43 wherein said active ingredient consists essentially of an admixture of said tramadol and said acetaminophen..Iaddend. .Iadd.48. The pharmaceutical composition of claim 43 comprising a pharmaceutically acceptable carrier..Iaddend. .Iadd.49. The pharmaceutical composition of claim 43 that is in the form of a powder..Iaddend. .Iadd.50. The pharmaceutical composition of claim 43 that is in the form of a capsule..Iaddend. .Iadd.51. The pharmaceutical composition of claim 43 that is in the form of a tablet..Iaddend. .Iadd.52. The pharmaceutical composition of claim 43 that is in the form of a suspension..Iaddend. .Iadd.53. The pharmaceutical composition of claim 43 that is in the form of a solution..Iaddend. .Iadd.54. A method for treating pain in a mammal comprising administering to the mammal an effective amount of the pharmaceutical composition of claim 43..Iaddend. .Iadd.55. A pharmaceutical composition comprising an active ingredient that consists essentially of tramadol and acetaminophen, wherein the ratio of tramadol to acetaminophen is a weight ratio from about 1:19 to about 1:50..Iaddend. .Iadd.56. The pharmaceutical composition of claim 55 wherein the tramadol is racemic..Iaddend. .Iadd.57. The pharmaceutical composition of claim 55 wherein the tramadol is present as its hydrochloride salt..Iaddend. .Iadd.58. The pharmaceutical composition of claim 57 wherein the tramadol hydrochloride is racemic..Iaddend. .Iadd.59. The pharmaceutical composition of claim 55 wherein said active ingredient consists essentially of an admixture of said tramadol and said acetaminophen..Iaddend. .Iadd.60. The pharmaceutical composition of claim 55 comprising a pharmaceutically acceptable carrier..Iaddend. .Iadd.61. The pharmaceutical composition of claim 55 that is in the form of a powder..Iaddend. .Iadd.62. The pharmaceutical composition of claim 55 that is in the form of a capsule..Iaddend. .Iadd.63. The pharmaceutical composition of claim 55 that is in the form of a tablet..Iaddend. .Iadd.64. The pharmaceutical composition of claim 55 that is in the form of a suspension..Iaddend. .Iadd.65. The pharmaceutical composition of claim 55 that is in the form of a solution..Iaddend. .Iadd.66. A method for treating pain in a mammal comprising administering to the mammal an effective amount of the pharmaceutical composition of claim 55..Iaddend. .Iadd.67. A pharmaceutical composition consisting essentially of: an active ingredient that consists of racemic tramadol hydrochloride and acetaminophen, wherein the ratio of racemic tramadol hydrochloride to acetaminophen is from about 1:5 to about 1:19; and a pharmaceutically acceptable carrier..Iaddend. .Iadd.68. The pharmaceutical composition of claim 67 that is in the form of a capsule..Iaddend. .Iadd.69. The pharmaceutical composition of claim 67 that is in the form of a tablet..Iaddend. .Iadd.70. The pharmaceutical composition of claim 67 that is in the form of a suspension..Iaddend. .Iadd.71. The pharmaceutical composition of claim 67 that is in the form of a solution..Iaddend. .Iadd.72. A method for treating pain in a mammal comprising orally administering to the mammal an effective amount of the pharmaceutical composition of claim 67..Iaddend. .Iadd.73. A method for treating pain in a mammal comprising orally administering to the mammal an effective amount of the pharmaceutical composition of claim 68..Iaddend. .Iadd.74. A method for treating pain in a mammal comprising orally administering to the mammal an effective amount of the pharmaceutical composition of claim 69..Iaddend. .Iadd.75. A method for treating pain in a mammal comprising orally administering to the mammal an effective amount of the pharmaceutical composition of claim 70..Iaddend. .Iadd.76. A method for treating pain in a mammal comprising orally administering to the mammal an effective amount of the pharmaceutical composition of claim 71..Iaddend.