COMPOSITIONS AND METHODS FOR TREATMENT OF PAIN

• US 20090110724A1
• Filed: 10/31/2007
• Published: 04/30/2009
• Est. Priority Date: 10/31/2007
• Status: Abandoned Application

• Current Assignee: Everett Laboratories Incorporated (Chemo Iberica, S.A.)
• Original Assignee: Everett Laboratories Incorporated (Chemo Iberica, S.A.)
• Inventors: Giordano, John A.
• Application Number:
  US11/932,237
• Publication Number:
  US 20090110724A1
• Time in Patent Office: Days
• US Class Current: 424/456
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/515 Barbituric acids; Derivatives thereof, e.g. sodium pentobarbital
• CPC Class Codes: A61K 31/522 having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to compositions and methods for treatment of various forms of pain. Specifically, the method involves administering to a patient a composition comprising butalbital, acetaminophen and caffeine in the gelcap dosage form, to treat and/or alleviate the occurrence or negative effects of various forms of headaches.

Claims

1. A composition comprising a barbiturate, an analgesic/antipyreffc and an analgesic adjunct, wherein said composition is in the fbrm of a gelcap and wherein said composition is free of other added active ingredients.

2. The composition of claim 1, wherein said barbiturate is selected from one or more of the group consisting of amobarbital, butalbital, aprobarbital, butabarbital, butethal, cyclobarbital. mephobarbital. methohexital, methylphenobarbitaL pentobarbital, phenobarbital, secobarbital, talbutal, thiobarbital, thiamylal. thiopental and thiopental sodium.

3. The composition of claim 1, wherein said analgesic/antipyretic is selected from one or more of the group consisting of acetaminophen, buprenorphine, butorphanol, codeine, dextropropoxyphene, dihydrocodeine, fentanyl, diamorphine (Heroin), hydrocodone, hydromorphone, ketobemidone, morphine, nalbuphine, oxycodone, oxymorphone. pentazocine, pethidine, tramadol, acetylsalicylic acid, diflunisal ethenzamide, aminophenazone, metamizole, phenazone, phenacetin, ziconotide, tetrahydrocannabinol, acetylsalicylic acid (aspirin), choline salicylate magnesium salicriate, sodium salicylate, ibuprofen, naproxen and ketoprofen.

4. The composition of claim 1, wherein said analgesic adjunct is selected from one or more of the group consisting of S (+)-ketamine, metoclopramide, ciramadol, sufentanil, caffeine and remifentanil.

5. The composition of claim 1 wherein said barbiturate is butalbital, said analgesic/antipyretic is acetaminophen and said analgesic adjunct is caffeine, and wherein said composition is administrable to a patient.

6. The composition of claim 5, wherein said composition is administrable to aid patient orally.

7. The composition of claim 1, wherein said composition comprises one or more of the group consisting of elixir, syrup and suspension.

8. The composition of claim 1, wherein said composition further comprises a flavorant.

16. The composition of claim 5, wherein said butalbital is present in the range of about 25 mg to about 75 mg.

17. The composition of claim 5, wherein said acetaminophen is present in the range of about 200 mg to about 600 mg.

18. The composition of claim 5, wherein said caffeine is present in the range of about 20 mg to about 60 mg.

19. The composition of claim 5, wherein said butalbital is present in the range of about 37.5 mg to about 62.5 mg.

20. The composition of claim 5, wherein said acetaminophen is present in the range of about 300 mg to about 500 mg.

21. The composition of claim 5, wherein said caffeine is present in the range of about 30 mg to about 50 mg.

22. The composition of claim 5, wherein said butalbital is present in the range of about 45 mg to about 55 mg.

23. The composition of claim 5, wherein said acetaminophen is present in the range of about 360 mg to about 440 mg.

24. The composition of claim 5, wherein said caffeine is present in the range of about 36 mg to about 44 mg.

25. The composition of claim 5, wherein said composition comprises about 25 mg to about 75 mg of butalbital;

about 200 mg to about 600 mg of acetaminophen; and

about 20 mg to about 60 mg of caffeine.

26. The composition of claim 5, wherein said composition comprises about 37.5 mg to about 62.5 mg of butalbital;

about 300 mg to about 500 mg of acetaminophen; and

about 30 mg to about 50 mg of caffeine.

27. The composition of claim 5, wherein said composition comprises about 45 mg to about 55 mg of butalbital:

about 360 mg to about 440 mg of acetaminophen; and

about 36 mg to about 44 mg of caffeine.

28. The composition of claim 27, wherein said butalbital is present in the amount of about 50 mg.

29. The composition of claim 27, wherein said acetaminophen is present in the amount of about 400 mg.

30. The composition of claim 27, wherein said caffeine is present in the amount of about 40 mg.

31. The composition of claim 5, wherein said butalbital is present in the amount of about 50 mg;

said acetaminophen is present in the amount of about 400 mg; and

said caffeine is present in the amount of about 40 mg.

32. The composition of claim 5, wherein said composition is administrable to said patient to treat and/or alleviate the occurrence or negative effects of pain.

33. The composition of claim 32, wherein said pain is from one or more of the group consisting of chronic pain or acute pain.

34. The composition of claim 33, wherein said composition is administered to said patient to treat and/or alleviate the occurrence or negative effects of headaches.

35. The composition of claim 34, wherein said headaches is from one or more of the group consisting of tension type headache, migraine headache, cluster headache or chronic daily headache.

36. The composition of claim 35, wherein said tension type headaches is from one or more of the group consisting of episodic or chronic.

37. A method comprising administering to a patient the composition of claim 1.

38. A method comprising a patient taking the composition of claim 1,

39. The method of claim 37, wherein said barbiturate is selected from one or more of the group consisting of amobarbital, butalbital, aprobarbital, butabarbital, butethal, cyclobarbital mephobarbital, methohexital, methylphenobarbital, pentobarbital, phenobarbital, secobarbital, talbutal, thiobarbital, thiamylal, thiopental and thiopental sodium.

40. The method of claim 37, wherein said analgesic/antipyretic is selected from one or more of the group consisting of acetaminophen, buprenorphine, butorphanol, codeine, dextropropoxyphene, dihydrocodeine, fentanyl, diamorphine (Heroin), hydrocodone, hydromorphone, ketobemidone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, tramadol, acetylsalicylic acid, diflunisal, ethenzamide, aminophenazone, metamizole, phenazone, phenacetin, ziconotide, tetrahydrocannabinol, acetylsalicylic acid (aspirin), choline salicylate magnesium salicylate, sodium salicylate, ibuprofen, naproxen and ketoprofen.

41. The method of claim 37, wherein said analgesic adjunct is selected from one or more of the group consisting of S (+)-ketamine. metoclopramide, ciramadol, sufentanil, caffeine and remifentanil.

42. A method comprising administering to a patient the composition of claim 5.

43. A method comprising a patient taking the composition of claim 5.

44. The method of claim 37, wherein said composition is administered to th patient orally.

45. The method of claim 37, wherein said composition comprises one or more of the group consisting of elixir, syrup and suspension.

46. The method of claim 37, wherein said composition further comprises a flavorant.

47. The method of claim 37, wherein said composition is substantially free of other added active ingredients.

48. The method of claim 47, wherein said other active ingredient is another barbiturate.

49. The method of claim 47, wherein said other active ingredient is another analgesic/antipyretic.

50. The method of claim 47, wherein said other active ingredient is another analgesic adjunct.

51. The method of claim 48, wherein said barbiturate is selected from one or more of the group consisting of amobarbital, aprobarbital, butabarbital, butethal, cyclobarbital, mephobarbital, methohexital, methylphenobarbital, pentobarbital, phenobarbital, secobarbital, talbutal, thiobarbital, thiamylal thiopental and thiopental sodium.

52. The method of claim 49, wherein said analgesic/antipyretic is selected from one or more of the group consisting of buprenorphine, butorphanol, codeine, dextropropoxyphene, dihydrocodeine, fentanyl, diamorphine (Heroin), hydrocodone, hydromorphone, ketobemidone morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, tramadol, acetylsalicylic acid, diflunisal, ethenzamide, aminophenazone, metamizole, phenazone, phenacetin, ziconotide, tetrahydrocannabinol, acetylsalicylic acid (aspirin), choline salicylate magnesium salicylate, sodium salicylate, ibuprofen, naproxen and ketoprofen.

53. The method of claim 50, wherein said analgesic adjunct is selected from one or more of the group consisting of S (+)-ketamine, metoelopramide, ciramadol, sufentanil and remifentanil.

54. The method of claim 42, wherein said butalbital is present in the range of about 25 mg to about 75 mg.

55. The method of claim 42, wherein said acetaminophen is present in the range of about 200 mg to about 600 mg.

56. The method of claim 42, wherein said caffeine is present in the range of about 20 mg to about 60 mg.

57. The method of claim 42, wherein said butalbital is present in the range of about 37.5 mg to about 62.5 mg.

58. The method of claim 42, wherein said acetaminophen is present in the range of about 300 mg to about 500 mg.

59. The method of claim 42, wherein said caffeine is present in the range of about 30 mg to about 50 mg.

60. The method of claim 42, wherein said butalbital is present in the range of about 45 mg to about 55 mg.

61. The method of claim 42, wherein said acetaminophen is present in the range of about 360 mg to about 440 mg.

62. The method of claim 42, wherein said caffeine is present in the range of about 36 mg to about 44 mg.

63. The method of claim 42, wherein said butalbital is about 50 mg.

64. The method of claim 42, wherein said acetaminophen is about 400 mg.

65. The method of claim 42, wherein said caffeine is about 40 mg.

66. The method of claim 42, wherein said composition is present in the range of about 25 mg to about 75 mg of said butalbital;

about 200 mg to about 600 mg of said acetaminophen; and

about 20 mg to about 60 mg of said caffeine.

67. The method of claim 42, wherein said composition is present in the range of about 37.5 mg to about 62.5 mg of said butalbital;

about 300 mg to about 500 mg of said acetaminophen; and

about 30 mg to about 50 mg of said caffeine.

68. The method of claim 42, wherein said composition is present in the range of about 45 mg to about 55 mg of said butalbital;

about 360 mg to about 440 mg of said acetaminophen; and

about 36 mg to about 44 mg of said caffeine.

69. The method of claim 42, wherein said butalbital is present in the amount of about 50 mg;

said acetaminophen is present in the amount of about 400 mg; and

s id caffeine is present in the amount of about 40 mg.

70. The method of claim 42, wherein said composition is administered to said patient to treat and/or alleviate the occurrence or negative effects of pain.

71. The method of claim 42, wherein said composition is administered to said patient to treat and/or alleviate the occurrence or negative effects from one or more of the group consisting of chronic pain or acute pain.

72. The method of claim 42, wherein said composition is administered to said patient to treat and/or alleviate the occurrence or negative effects of headaches.

73. The method of claim 42, wherein said composition is administered to said patient to treat and/or alleviate the occurrence or negative effects from one or more of the group consisting of tension type headache, migraine headache, cluster headache or chronic daily headache.

74. The method of claim 42, wherein said composition is administered to said patient to treat and/or alleviate the occurrence or negative effects from one or more of the group consisting of episodic tension type headache or chronic tension type headache.

75. The method of claim 42, wherein said composition is administered to said patient at a frequency selected from the group consisting of once a day, twice a day, three times a day, four times a day, five times a day, six times a day, seven times a day, eight times a day, nine times a day, ten times a day, eleven times a day and twelve times a day.

76. The method of claim 42, wherein said patient takes said composition at a frequency selected from the group consisting of once a day, twice a day, three times a day. four times a day, five times a day, six times a day, seven times a day, eight times a day, nine times a day, ten times a day, eleven times a day and twelve times a day.

77. The method of claim 42, wherein said composition is administered to said patient at a frequency selected from the group consisting of once every hour, once every two hours, once every three hours, once every four hours, once every five hours, once every six hours, once every seven hours, once every eight hours, once every nine hours, once every ten hours, once every eleven hours, once every twelve hours, once every thirteen hours, once every fourteen hours, once even fifteen hours, once every sixteen hours, once every seventeen hours, once every eighteen hours, once every nineteen hours, once every twenty hours, once every twenty one hours, once every twenty two hours, once every twenty three hours and once every twenty four hours.

78. The method of claim 42, wherein said patient takes said composition at a frequency selected from the group consisting of once every hour, once every two hours, once every three hours, once every four hours, once every five hours, once every six hours, once every seven hours, once every eight hours, once every nine hours, once every ten hours, once every eleven hours, once every twelve hours, once every thirteen hours, once every fourteen hours, once every fifteen hours, once every sixteen hours once every seventeen hours, once every eighteen hours once every nineteen hours, once every twenty hours, once every twenty one hours, once every twenty two hours, once every twenty three hours and once every twenty four hours.

79. The method of claim 42, wherein said composition is administered to said patient in a dose selected from the group consisting of 0.5, 1, 1.5,2,2.5,3, 3.5 and 4 dosage forms.

9. (canceled)

10. (canceled)

11. (canceled)

12. (canceled)

13. (canceled)

14. (canceled)

15. (canceled)

80. A composition consisting of butalbital, acetaminophen, caffeine and one or more inactive ingredients. wherein said composition is in the form of a gelcap.

81. The composition of claim 80, wherein said composition has about 25 mg to about 75 mg butalbital, about 200 mg to about 600 mg acetaminophen and about 20 mg to about 60 mg caffeine.

82. The composition of claim 81, wherein said composition has about 50 mg butalbital, about 400 mg acetaminophen, and about 40 mg caffeine.