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).

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  A pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to acetaminophen is a weight ratio is  of 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  administering to the mammal an effective amount of the pharmaceutical composition of  claim 1    claim 6 . 
     
     
       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 . 
     
     
       17. The pharmaceutical composition of  claim 16  wherein the tramadol is racemic. 
     
     
       18. The pharmaceutical composition of  claim 16  wherein the tramadol is present as its hydrochloride salt. 
     
     
       19. The pharmaceutical composition of  claim 18  wherein the tramadol hydrochloride is racemic. 
     
     
       20. The pharmaceutical composition of  claim 16  wherein said active ingredient consists essentially of an admixture of said tramadol and said acetaminophen. 
     
     
       21. The pharmaceutical composition of  claim 16  wherein the weight ratio is about  1 : 1 . 
     
     
       22. The pharmaceutical composition of  claim 16  wherein the weight ratio is from about  1 : 5  to about  1 : 1600 . 
     
     
       23. The pharmaceutical composition of  claim 16  wherein the weight ratio is about  1 : 5 . 
     
     
       24. The pharmaceutical composition of  claim 16  comprising a pharmaceutically acceptable carrier. 
     
     
       25. The pharmaceutical composition of  claim 16  that is in the form of a powder. 
     
     
       26. The pharmaceutical composition of  claim 16  that is in the form of a capsule. 
     
     
       27. The pharmaceutical composition of  claim 16  that is in the form of a tablet. 
     
     
       28. The pharmaceutical composition of  claim 16  that is in the form of a suspension. 
     
     
       29. The pharmaceutical composition of  claim 16  that is in the form of a solution. 
     
     
       30. A method for treating pain in a mammal comprising administering to the mammal an effective amount of the pharmaceutical composition of  claim 16 . 
     
     
       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 . 
     
     
       32. The pharmaceutical composition of  claim 31  wherein the tramadol is racemic. 
     
     
       33. The pharmaceutical composition of  claim 31  wherein the tramadol is present as its hydrochloride salt. 
     
     
       34. The pharmaceutical composition of  claim 33  wherein the tramadol hydrochloride is racemic. 
     
     
       35. The pharmaceutical composition of  claim 31  wherein said active ingredient consists essentially of an admixture of said tramadol and said acetaminophen. 
     
     
       36. The pharmaceutical composition of  claim 31  comprising a pharmaceutically acceptable carrier. 
     
     
       37. The pharmaceutical composition of  claim 31  that is in the form of a powder. 
     
     
       38. The pharmaceutical composition of  claim 31  that is in the form of a capsule. 
     
     
       39. The pharmaceutical composition of  claim 31  that is in the form of a tablet. 
     
     
       40. The pharmaceutical composition of  claim 31  that is in the form of a suspension. 
     
     
       41. The pharmaceutical composition of  claim 31  that is in the form of a solution. 
     
     
       42. A method for treating pain in a mammal comprising administering to the mammal an effective amount of the pharmaceutical composition of  claim 31 . 
     
     
       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 . 
     
     
       44. The pharmaceutical composition of  claim 43  wherein the tramadol is racemic. 
     
     
       45. The pharmaceutical composition of  claim 43  wherein the tramadol is present as its hydrochloride salt. 
     
     
       46. The pharmaceutical composition of  claim 45  wherein the tramadol hydrochloride is racemic. 
     
     
       47. The pharmaceutical composition of  claim 43  wherein said active ingredient consists essentially of an admixture of said tramadol and said acetaminophen. 
     
     
       48. The pharmaceutical composition of  claim 43  comprising a pharmaceutically acceptable carrier. 
     
     
       49. The pharmaceutical composition of  claim 43  that is in the form of a powder. 
     
     
       50. The pharmaceutical composition of  claim 43  that is in the form of a capsule. 
     
     
       51. The pharmaceutical composition of  claim 43  that is in the form of a tablet. 
     
     
       52. The pharmaceutical composition of  claim 43  that is in the form of a suspension. 
     
     
       53. The pharmaceutical composition of  claim 43  that is in the form of a solution. 
     
     
       54. A method for treating pain in a mammal comprising administering to the mammal an effective amount of the pharmaceutical composition of  claim 43 . 
     
     
       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 . 
     
     
       56. The pharmaceutical composition of  claim 55  wherein the tramadol is racemic. 
     
     
       57. The pharmaceutical composition of  claim 55  wherein the tramadol is present as its hydrochloride salt. 
     
     
       58. The pharmaceutical composition of  claim 57  wherein the tramadol hydrochloride is racemic. 
     
     
       59. The pharmaceutical composition of  claim 55  wherein said active ingredient consists essentially of an admixture of said tramadol and said acetaminophen. 
     
     
       60. The pharmaceutical composition of  claim 55  comprising a pharmaceutically acceptable carrier. 
     
     
       61. The pharmaceutical composition of  claim 55  that is in the form of a powder. 
     
     
       62. The pharmaceutical composition of  claim 55  that is in the form of a capsule. 
     
     
       63. The pharmaceutical composition of  claim 55  that is in the form of a tablet. 
     
     
       64. The pharmaceutical composition of  claim 55  that is in the form of a suspension. 
     
     
       65. The pharmaceutical composition of  claim 55  that is in the form of a solution. 
     
     
       66. A method for treating pain in a mammal comprising administering to the mammal an effective amount of the pharmaceutical composition of  claim 55 . 
     
     
       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.     
     
     
       68. The pharmaceutical composition of  claim 67  that is in the form of a capsule. 
     
     
       69. The pharmaceutical composition of  claim 67  that is in the form of a tablet. 
     
     
       70. The pharmaceutical composition of  claim 67  that is in the form of a suspension. 
     
     
       71. The pharmaceutical composition of  claim 67  that is in the form of a solution. 
     
     
       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 . 
     
     
       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 . 
     
     
       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 . 
     
     
       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 . 
     
     
       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 .