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Claims for Patent: 5,972,383

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Claims for Patent: 5,972,383

Title: Solid orally administerable raloxifene hydrochloride pharmaceutical formulation
Abstract:This invention provides orally administerable pharmaceutical formulations comprising raloxifene, its ethers or esters, or a pharmaceutically-acceptable salt thereof, in combination with a hydrophilic carrier composition.
Inventor(s): Gibson; Lowell L. (Greenwood, IN), Hartauer; Kerry J. (Indianapolis, IN), Stowers; Julian L. (Indianapolis, IN), Sweetana; Stephanie A. (Bloomington, IN), Thakkar; Arvind L. (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:09/088,695
Patent Claims: 1. A method of treating mammary tumors, prostatic tumors, or osteoporosis, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation comprising raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein:

the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and

the water soluble diluent is a polyol or sugar.

2. The method of claim 1, wherein the surfactant is a polyoxyethylene sorbitan fatty acid ester.

3. The method of claim 2, wherein the surfactant is polysorbate 80.

4. The method of claim 1, wherein the water soluble diluent is a sugar.

5. The method of claim 4, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

6. The method of claim 5, wherein the sugar is lactose.

7. The method of claim 6, wherein the surfactant is polysorbate 80.

8. The method of claim 7 further comprising a lubricant and a disintegrant.

9. The method of claim 1 further comprising a lubricant and a disintegrant.

10. The method of claim 9, wherein the lubricant is magnesium stearate or stearic acid, and the disintegrant is cross-linked polyvinylpyrrolidone.

11. The method of claim 10, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

12. The method of claim 11, wherein the diluent is a sugar.

13. A method of treating mammary tumors, prostatic tumors, or osteoporosis, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation consisting essentially of raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein:

the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and

the water soluble diluent is polyol or sugar.

14. The method of claim 12, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

15. The method of claim 14, wherein the diluent is a sugar.

16. A method of treating mammary tumors, prostatic tumors, or osteoporosis, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation consisting essentially of raloxifene hydrochloride in combination with polysorbate 80, lactose, polyvinylpyrrolidone, and magnesium stearate.

17. The method of claim 11, further comprising a film coating.

18. The method of claim 16, further comprising a film coating.

19. The method of claim 15, further comprising a film coating.

20. The method of claim 16, further comprising a film coating.

21. The method of claim 1 wherein said formulation is in the form of a tablet or capsule.

22. The method of claim 6 wherein said formulation is in the form of a tablet or capsule.

23. The method of claim 11 wherein said formulation is in the form of a tablet or capsule.

24. The method of claim 13 wherein said formulation is in the form of a tablet or capsule.

25. The method of claim 15 wherein said formulation is in the form of a tablet or capsule.

26. The method of claim 16 wherein said formulation is in the form of a tablet or capsule.

27. The method of claim 17 wherein said formulation is in the form of a tablet or capsule.

28. The method of claim 18 wherein said formulation is in the form of a tablet or capsule.

29. The method of claim 19 wherein said formulation is in the form of a tablet or capsule.

30. The method of claim 20 wherein said formulation is in the form of a tablet or capsule.

31. The method of claim 21 wherein said formulation is in the form of a tablet or capsule.

32. The method of claim 22 wherein said formulation is in the form of a tablet or capsule.

33. The method of claim 23 wherein said formulation is in the form of a tablet or capsule.

34. A method for the treatment or prophylaxis of mammary or prostatic fibrocystic disease, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation comprising raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein:

the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and

the water soluble diluent is a polyol or sugar.

35. The method of claim 17, wherein the surfactant is a polyoxyethylene sorbitan fatty acid ester.

36. The method of claim 18, wherein the surfactant is polysorbate 80.

37. The method of claim 17, wherein the water soluble diluent is a sugar.

38. The method of claim 20, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

39. The method of claim 21, wherein the sugar is lactose.

40. The method of claim 22, wherein the surfactant is polysorbate 80.

41. The method of claim 23 further comprising a lubricant and a disintegrant.

42. The method of claim 17 further comprising a lubricant and a disintegrant.

43. The method of claim 42, wherein the lubricant is magnesium stearate or stearic acid, and the disintegrant is cross-linked polyvinylpyrrolidone.

44. The method of claim 26, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

45. The method of claim 44, wherein the diluent is a sugar.

46. A method for the treatment or prophylaxis of mammary or prostatic fibrocystic disease, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation consisting essentially of raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein:

the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and

the water soluble diluent is polyol or sugar.

47. The method of claim 46, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

48. The method of claim 30, wherein the diluent is a sugar.

49. A method for the treatment or prophylaxis of mammary or prostatic fibrocystic disease, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation consisting essentially of raloxifene hydrochloride in combination with polysorbate 80, lactose, polyvinylpyrrolidone, and magnesium stearate.

50. The method of claim 24, further comprising a film coating.

51. The method of claim 28, further comprising a film coating.

52. The method of claim 31, further comprising a film coating.

53. The method of claim 32, further comprising a film coating.

54. The method of claim 17 wherein said formulation is in the form of a tablet or capsule.

55. The method of claim 19 wherein said formulation is in the form of a tablet or capsule.

56. The method of claim 24 wherein said formulation is in the form of a tablet or capsule.

57. The method of claim 26 wherein said formulation is in the form of a tablet or capsule.

58. The method of claim 26 wherein said formulation is in the form of a tablet or capsule.

59. The method of claim 27 wherein said formulation is in the form of a tablet or capsule.

60. The method of claim 40 wherein said formulation is in the form of a tablet or capsule.

61. The method of claim 31 wherein said formulation is in the form of a tablet or capsule.

62. The method of claim 61 wherein said formulation is in the form of a tablet or capsule.

63. The method of claim 62 wherein said formulation is in the form of a tablet or capsule.

64. The method of claim 63 wherein said formulation is in the form of a tablet or capsule.

65. The method of claim 64 wherein said formulation is in the form of a tablet or capsule.

66. The method of claim 65 wherein said formulation is in the form of a tablet or capsule.

67. A method for alleviating mammary cancer, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation comprising raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein:

the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and

the water soluble diluent is a polyol or sugar.

68. The method of claim 67, wherein the surfactant is a polyoxyethylene sorbitan fatty acid ester.

69. The method of claim 68, wherein the surfactant is polysorbate 80.

70. The method of claim 67, wherein the water soluble diluent is a sugar.

71. The method of claim 70, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

72. The method of claim 51, wherein the sugar is lactose.

73. The method of claim 72, wherein the surfactant is polysorbate 80.

74. The method of claim 73 further comprising a lubricant and a disintegrant.

75. The method of claim 70 further comprising a lubricant and a disintegrant.

76. The method of claim 58, wherein the lubricant is magnesium stearate or stearic acid, and the disintegrant is cross-linked polyvinylpyrrolidone.

77. The method of claim 59, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

78. The method of claim 77, wherein the diluent is a sugar.

79. A method for alleviating mammary cancers, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation consisting essentially of raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein:

the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and

the water soluble diluent is polyol or sugar.

80. The method of claim 79, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

81. The method of claim 80, wherein the diluent is a sugar.

82. A method for alleviating mammary cancer, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation consisting essentially of raloxifene hydrochloride in combination with polysorbate 80, lactose, polyvinylpyrrolidone, and magnesium stearate.

83. The method of claim 74, further comprising a film coating.

84. The method of claim 78, further comprising a film coating.

85. The method of claim 81, further comprising a film coating.

86. The method of claim 85, further comprising a film coating.

87. The method of claim 70 wherein said formulation is in the form of a tablet or capsule.

88. The method of claim 72 wherein said formulation is in the form of a tablet or capsule.

89. The method of claim 77 wherein said formulation is in the form of a tablet or capsule.

90. The method of claim 79 wherein said formulation is in the form of a tablet or capsule.

91. The method of claim 81 wherein said formulation is in the form of a tablet or capsule.

92. The method of claim 82 wherein said formulation is in the form of a tablet or capsule.

93. The method of claim 83 wherein said formulation is in the form of a tablet or capsule.

94. The method of claim 84 wherein said formulation is in the form of a tablet or capsule.

95. The method of claim 85 wherein said formulation is in the form of a tablet or capsule.

96. The method of claim 86 wherein said formulation is in the form of a tablet or capsule.

97. The method of claim 88 wherein said formulation is in the form of a tablet or capsule.

98. The method of claim 89 wherein said formulation is in the form of a tablet or capsule.

99. The method of claim 90 wherein said formulation is in the form of a tablet or capsule.

100. A method of alleviating benign prostatic hypertrophy, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation comprising raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein:

the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and

the water soluble diluent is a polyol or sugar.

101. The method of claim 100, wherein the surfactant is a polyoxyethylene sorbitan fatty acid ester.

102. The method of claim 101, wherein the surfactant is polysorbate 80.

103. The method of claim 100, wherein the water soluble diluent is a sugar.

104. The method of claim 103, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

105. The method of claim 104, wherein the sugar is lactose.

106. The method of claim 105, wherein the surfactant is polysorbate 80.

107. The method of claim 106 further comprising a lubricant and a disintegrant.

108. The method of claim 100 further comprising a lubricant and a disintegrant.

109. The method of claim 108, wherein the lubricant is magnesium stearate or stearic acid, and the disintegrant is cross-linked polyvinylpyrrolidone.

110. The method of claim 109, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

111. The method of claim 110, wherein the diluent is a sugar.

112. A method of alleviating benign prostatic hypertrophy, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation consisting essentially of raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein:

the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and

the water soluble diluent is polyol or sugar.

113. The method of claim 112, wherein the surfactant is polyoxyethylene sorbitan fatty acid ester.

114. The method of claim 113, wherein the diluent is a sugar.

115. A method of alleviating benign prostatic hypertrophy, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation consisting essentially of raloxifene hydrochloride in combination with polysorbate 80, lactose, polyvinylpyrrolidone, and magnesium stearate.

116. The method of claim 107, further comprising a film coating.

117. The method of claim 114, further comprising a film coating.

118. The method of claim 117, further comprising a film coating.

119. The method of claim 118, further comprising a film coating.

120. The method of claim 113 wherein said formulation is in the form of a tablet or capsule.

121. The method of claim 115 wherein said formulation is in the form of a tablet or capsule.

122. The method of claim 107 wherein said formulation is in the form of a tablet or capsule.

123. The method of claim 109 wherein said formulation is in the form of a tablet or capsule.

124. The method of claim 111 wherein said formulation is in the form of a tablet or capsule.

125. The method of claim 125 wherein said formulation is in the form of a tablet or capsule.

126. The method of claim 123 wherein said formulation is in the form of a tablet or capsule.

127. The method of claim 124 wherein said formulation is in the form of a tablet or capsule.

128. The method of claim 125 wherein said formulation is in the form of a tablet or capsule.

129. The method of claim 126 wherein said formulation is in the form of a tablet or capsule.

130. The method of claim 127 wherein said formulation is in the form of a tablet or capsule.

131. The method of claim 128 wherein said formulation is in the form of a tablet or capsule.

132. The method of claim 129 wherein said formulation is in the form of a tablet or capsule.
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