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Claims for Patent: 9,399,012

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Claims for Patent: 9,399,012

Title:Reduced dose intravenous acetaminophen
Abstract: Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.
Inventor(s): Royal; Mike Allan (San Diego, CA), Breitmeyer; James Bradley (Rancho Santa Fe, CA)
Assignee: MALLINCKRODT IP (Dublin, IE)
Application Number:12/270,796
Patent Claims: 1. A method for the treatment of pain or fever in an adult human or an adolescent human subject weighing at least 50 kg, in need thereof, comprising administering to the subject, by an intravenous route of administration, a therapeutically effective amount of a pharmaceutical composition comprising about 550 mg to about 800 mg of acetaminophen; and repeating said administration at least once at an interval of about 3 to about 5 hours.

2. The method of claim 1, wherein the subject receives a total of about 3 to about 5 grams of acetaminophen in a period of twenty four hours.

3. The method of claim 2, wherein the pharmaceutical composition is administered at least six times in a period of twenty four hours.

4. The method of claim 1, wherein the pharmaceutical composition comprises at least one antioxidant.

5. The method of claim 4, wherein the at least one antioxidant is selected from the group consisting of cysteine hydrochloride monohydrate, thiolyglycolic acid, thiolacetic acid, dithiothreitol, reduced glutathione, thiourea, a-thioglycerol, cysteine, aceticysteine, mercaptoethane sulfonic acid, ascorbic acid, ascorbic acid derivatives, an organic compound having at least one thiol, an alkyl polyhydroxylated compound, a cycloalkyl polyhydroxylated compound, and mixtures thereof.

6. The method of claim 5, wherein the at least one antioxidant comprises cysteine hydrochloride monohydrate.

7. The method of claim 1, further comprising a buffering agent.

8. The method of claim 7, wherein the buffering agent comprises disodium phosphate dehydrate.

9. The method of claim 1, wherein the pharmaceutical composition has a pH between about 4 to about 8.

10. The method of claim 9, wherein the pharmaceutical composition has a pH of between about 5 and about 6.

11. The method of claim 1, wherein the pharmaceutical composition has an osmolality of between about 200 mOsm/L to about 400 mOsm/L.

12. The pharmaceutical composition of claim 11, wherein the acetaminophen is present in the composition in an amount of about 600 mg to about 700 mg.

13. The method of claim 1, wherein the pharmaceutical composition further comprises an isotonicity agent.

14. The method of claim 13, wherein the isotonicity agent is dextrose, mannitol, or lactose.

15. The method of claim 14, wherein the isotonicity agent is mannitol.

16. The method of claim 1, further comprising EDTA.

17. The method of claim 1, wherein the pharmaceutical composition further comprises at least one analgesic agent other than acetaminophen.

18. The method of claim 17, wherein the at least one analgesic agent other than acetaminophen comprises an anilide, an opioid, an NSAID, a cannabinoid, a pyrazalone, or a barbiturate.

19. The method of claim 18, wherein the at least one analgesic agent other than acetaminophen comprises an opioid.

20. The method of claim 1, wherein the subject is suffering from a fever.

21. The method of claim 1, wherein the subject is unconscious, sedated, fasting, nauseous, or unable to be administered a pharmaceutical composition by an oral route.

22. The method of claim 1, wherein the pharmaceutical composition is administered after a surgical intervention on the subject.

23. The method of claim 1, wherein the pharmaceutical composition is administered within 3 hours of a surgical intervention on the subject.

24. The method of claim 23, wherein the pharmaceutical composition is administered within 1 hour of a surgical intervention on the subject.

25. The method of claim 1, wherein the pharmaceutical composition is administered postoperatively.

26. The method of claim 1, further comprising administering to the subject at least one analgesic agent other than acetaminophen.

27. The method of claim 26, wherein the at least one analgesic agent other than acetaminophen comprises an anilide, an opioid, an NSAID, a cannabinoid, a pyrazalone, or a barbiturate.

28. The method of claim 1, wherein the subject is suffering from an infection.

29. A method for reducing pain or fever in an adult human or an adolescent human subject weighing at least 50 kg, in need thereof, comprising administering to the subject, by an intravenous route of administration, a therapeutically effective amount of a pharmaceutical composition in solution comprising: about 600 mg to about 700 mg of acetaminophen, cysteine hydrochloride monohydrate, disodium phosphate dehydrate, and mannitol, wherein the solution has a pH of about 5 to about 6, and an osmolality of about 200-400 mOsm/L; and repeating said administration at least once at an interval of about 3 to about 5 hours.

30. The method of claim 29, wherein the pharmaceutical composition has an acetaminophen concentration of about 0.5% (w/v) to about 10% (w/v).

31. The method of claim 30, wherein the acetaminophen concentration is about 1% (w/v).

32. The method of claim 29, wherein the pharmaceutical composition further comprises EDTA.

33. The method of claim 29, wherein the subject is suffering from postoperative pain.

34. The method of claim 1, wherein the level of pain the subject is suffering from is reduced.

35. The method of claim 1, wherein the pharmaceutical composition is administered as a pretreatment.

36. The method of claim 29, wherein the administered dose of acetaminophen is 650 mg, and further comprising repeating intravenous administration of 650 mg acetaminophen at least once at an interval of about 3 hours to about 5 hours.

37. The method of claim 36, wherein the interval is about 4 hours.

38. The method of claim 1, further comprising repeating intravenous administration of about 600 mg to about 700 mg acetaminophen at least once at an interval of about 3 hours to about 5 hours.

39. The method of claim 1, wherein the administered dose of acetaminophen is 650 mg, and further comprising repeating intravenous administration of 650 mg acetaminophen at least once at an interval of about 3 hours to about 5 hours.

40. The method of claim 29, wherein the interval is about 4 hours.

41. The method of claim 1, wherein the composition may be administered to the subject without dilution.

42. The method of claim 1, wherein the composition is a sterile solution that is ready for direct administration to the subject.

43. The method of claim 1, wherein the pharmaceutical composition is a lyophilized powder.

44. The method of claim 43, wherein the lyophilized powder must be reconstituted in solution prior to administration.

45. The method of claim 1, wherein the pharmaceutical composition is intravenously administered to the subject over about 5 minutes to about 30 minutes.

46. The method of claim 45, wherein the pharmaceutical composition is intravenously administered to the subject over about 15 minutes.

47. The method of claim 1, wherein the subject is administered less than 4 grams of acetaminophen over a twenty-four hour period.

48. A method of treating pain in a human subject weighing at least 50 kg comprising: administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising about 600 mg to about 700 mg of acetaminophen; and repeating said administration at least about once every 4 hours; wherein the composition is administered to the subject as a 15-minute intravenous infusion, and wherein the subject is administered less than 4 grams of acetaminophen over a 24-hour period.

49. The method of claim 48, wherein the composition comprises about 650 mg of acetaminophen.

50. The method of claim 48, wherein the composition is administered to the subject at least six times in a period of 24 hours.

51. The method of claim 48, wherein the composition is administered to the subject at least seven times in a period of 24 hours.

52. The method of claim 48, wherein the composition is administered to the subject at least eight times in a period of 24 hours.

53. The method of claim 48, wherein the composition may be administered to the subject without dilution.

54. The method of claim 48, wherein the composition is a sterile solution that is ready for subject administration.

55. The method of claim 48, wherein the composition is a lyophilized powder.

56. The method of claim 55, wherein the lyophilized powder must be reconstituted in solution prior to subject administration.

57. The method of claim 48, wherein the composition may be stored at ambient temperature for two years prior to use.

58. The method of claim 57, wherein the ambient temperature is less than 30 degrees Celsius.

59. The method of claim 48, wherein the composition further comprises a buffer in an amount of about 0.1% to about 0.7%.

60. The method of claim 48, wherein the composition further comprises a buffer in an amount of about 0.2% to about 0.3%.

61. The method of claim 48, wherein the composition further comprises a buffer in an amount of about 0.05% to about 2.0%.

62. The method of claim 48, wherein the composition further comprises at least one buffering agent.

63. The method of claim 62, wherein the at least one buffering agent is selected from the group consisting of a pharmaceutically acceptable salt or acid of citrate, phosphate, acetate, glutamate, tartrate, benzoate, lactate, histidine or other amino acids, gluconate, malate, succinate, formate, propionate, carbonate, or any combination thereof.

64. The method of claim 63, wherein the at least one buffering agent is disodium phosphate dehydrate.

65. The method of claim 48, wherein the pharmaceutical composition has a pH between about 4 to about 8.

66. The method of claim 48, wherein the pharmaceutical composition has a pH of between about 5 and about 6.

67. The method of claim 48, wherein the composition further comprises an antioxidant in an amount of about 0.3% to about 1.0%.

68. The method of claim 48, wherein the composition further comprises an antioxidant in an amount of about 0.5%.

69. The method of claim 48, wherein the composition further comprises at least one antioxidant.

70. The method of claim 69, wherein the at least one antioxidant is selected from the group consisting of cysteine hydrochloride monohydrate, thiolyglycolic acid, thiolacetic acid, dithiothreitol, reduced glutathione, thiourea, a-thioglycerol, cysteine, aceticysteine, mannitol, mercaptoethane sulfonic acid, ascorbic acid, ascorbic acid derivatives, an organic compound having at least one thiol, an alkyl polyhydroxylated compound, a cycloalkyl polyhydroxylated compound, and mixtures thereof.

71. The method of claim 70, wherein the at least one antioxidant is cysteine hydrochloride monohydrate.

72. The method of claim 70, wherein the at least one antioxidant is mannitol.

73. The method of claim 48, wherein the composition further comprises an isotonicity agent in an amount of about 65% to about 85%.

74. The method of claim 48, wherein the composition further comprises at least one isotonicity agent.

75. The method of claim 74, wherein the at least one isotonicity agent is selected from the group consisting of mannitol, sorbitol, glycerol, sucrose, glucose, dextrose, levulose, fructose, lactose, polyethylene glycols 400 to 4000, phosphates, sodium chloride, potassium chloride, calcium chloride, calcium gluconoglucoheptonate, dimethyl sulfone, and combinations thereof.

76. The method of claim 75, wherein the at least one isotonicity agent is mannitol.

77. The method of claim 48, wherein the composition has an osmolality of between about 200 mOsm/L to about 400 mOsm/L.

78. The method of claim 48, wherein the composition comprises 650 mg of acetaminophen, and wherein the subject is administered the composition every four hours in a twenty-four hour period.

79. A method of reducing fever in a human subject weighing at least 50 kg comprising: administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising about 600 mg to about 700 mg of acetaminophen; and repeating said administration at least about once every 4 hours; wherein the composition is administered to the subject as a 15-minute intravenous infusion, and wherein the subject is administered less than 4 grams of acetaminophen over a twenty-four hour period.

80. The method of claim 79, wherein the composition comprises about 650 mg of acetaminophen.

81. The method of claim 79, wherein the composition is administered to the subject at least six times in a period of 24 hours.

82. The method of claim 79, wherein the composition is administered to the subject at least seven times in a period of 24 hours.

83. The method of claim 79, wherein the composition is administered to the subject at least eight times in a period of 24 hours.

84. The method of claim 79, wherein the composition may be administered to the subject without dilution.

85. The method of claim 79, wherein the composition is a sterile solution that is ready for subject administration.

86. The method of claim 79, wherein the composition is a lyophilized powder.

87. The method of claim 86, wherein the lyophilized powder must be reconstituted in solution prior to administration.

88. The method of claim 79, wherein the composition may be stored at ambient temperature for two years prior to use.

89. The method of claim 88, wherein the ambient temperature is less than 30 degrees Celsius.

90. The method of claim 79, wherein the composition further comprises a buffer in an amount of about 0.1% to about 0.7%.

91. The method of claim 79, wherein the composition further comprises a buffer in an amount of about 0.2% to about 0.3%.

92. The method of claim 79, wherein the composition further comprises a buffer in an amount of about 0.05% to about 2.0%.

93. The method of claim 79, wherein the composition further comprises at least one buffering agent.

94. The method of claim 93, wherein the at least one buffering agent is selected from the group consisting of a pharmaceutically acceptable salt or acid of citrate, phosphate, acetate, glutamate, tartrate, benzoate, lactate, histidine or other amino acids, gluconate, malate, succinate, formate, propionate, carbonate, or any combination thereof.

95. The method of claim 94, wherein the at least one buffering agent is disodium phosphate dehydrate.

96. The method of claim 79, wherein the pharmaceutical composition has a pH between about 4 to about 8.

97. The method of claim 79, wherein the pharmaceutical composition has a pH of between about 5 and about 6.

98. The method of claim 79, wherein the composition further comprises an antioxidant in an amount of about 0.3% to about 1.0%.

99. The method of claim 79, wherein the composition further comprises an antioxidant in an amount of about 0.5%.

100. The method of claim 79, wherein the composition further comprises at least one antioxidant.

101. The method of claim 100, wherein the at least one antioxidant is selected from the group consisting of cysteine hydrochloride monohydrate, thiolyglycolic acid, thiolacetic acid, dithiothreitol, reduced glutathione, thiourea, a-thioglycerol, cysteine, aceticysteine, mannitol, mercaptoethane sulfonic acid, ascorbic acid, ascorbic acid derivatives, an organic compound having at least one thiol, an alkyl polyhydroxylated compound, a cycloalkyl polyhydroxylated compound, and mixtures thereof.

102. The method of claim 101, wherein the at least one antioxidant is cysteine hydrochloride monohydrate.

103. The method of claim 101, wherein the at least one antioxidant is mannitol.

104. The method of claim 79, wherein the composition further comprises an isotonicity agent in an amount of about 65% to about 85%.

105. The method of claim 79, wherein the composition further comprises at least one isotonicity agent.

106. The method of claim 105, wherein the at least one isotonicity agent is selected from the group consisting of mannitol, sorbitol, glycerol, sucrose, glucose, dextrose, levulose, fructose, lactose, polyethylene glycols 400 to 4000, phosphates, sodium chloride, potassium chloride, calcium chloride, calcium gluconoglucoheptonate, dimethyl sulfone, and combinations thereof.

107. The method of claim 106, wherein the at least one isotonicity agent is mannitol.

108. The method of claim 79, wherein the composition has an osmolality of between about 200 mOsm/L to about 400 mOsm/L.

109. The method of claim 79, wherein the pharmaceutical composition comprises 650 mg of acetaminophen, and wherein the subject is administered the composition every four hours in a twenty-four hour period.
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