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Claims for Patent: 6,225,294

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Claims for Patent: 6,225,294

Title: Method for inhibiting bone resorption
Abstract:Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein.
Inventor(s): Daifotis; Anastasia G. (Westfield, NJ), Santora, II; Arthur C. (Watchung, NJ), Yates; A. John (Westfield, NJ)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:09/440,577
Patent Claims: 1. A kit comprising at least one pharmaceutically effective unit dosage of a bisphosphonate selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zoledronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof, for oral administration to a mammal according to a continuous schedule having a dosing interval selected from the group consisting of once-weekly dosing, twice-weekly dosing, biweekly dosing, and twice-monthly dosing.

2. A kit according to claim 1 wherein said mammal is a human.

3. A kit according to claim 2 wherein said unit dosage of said bisphosphonate comprises from about 1.5 to about 6000 ug/kg body weight.

4. A kit according to claim 2 wherein said unit dosage of said bisphosphonate comprises from about 10 to about 2000 ug/kg body weight.

5. A kit according to claim 2 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

6. A kit according to claim 5 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

7. A kit according to claim 6 wherein said pharmaceutically acceptable salt is a sodium salt.

8. A kit according to claim 7 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

9. A kit according to claim 3 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

10. A kit according to claim 9 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium , and ammonium salts.

11. A kit according to claim 10 wherein said pharmaceutically acceptable salt is a sodium salt.

12. A kit according to claim 11 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

13. A kit according to claim 14 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

14. A kit according to claim 13 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

15. A kit according to claim 14 wherein said pharmaceutically acceptable salt is a sodium salt.

16. A kit according to claim 15 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

17. A kit according to claim 5 wherein said unit dosage comprises from about 8.75 to about 140 mg of said bisphosphonate on an alendronic acid active basis.

18. A kit according to claim 17 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

19. A kit according to claim 18 wherein said pharmaceutically acceptable salt is a sodium salt.

20. A kit according to claim 19 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

21. A kit according to claim 2 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

22. A kit according to claim 21 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

23. A kit according to claim 22 wherein said pharmaceutically acceptable salt is a sodium salt.

24. A kit according to claim 3 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

25. A kit according to claim 24 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

26. A kit according to claim 25 wherein said pharmaceutically acceptable salt is a sodium salt.

27. A kit according to claim 4 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

28. A kit according to claim 27 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

29. A kit according to claim 28 wherein said pharmaceutically acceptable salt is a sodium salt.

30. A kit according to claim 2 wherein said bisphosphonate is selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

31. A kit according to claim 30 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

32. A kit according to claim 31 wherein said pharmaceutically acceptable salt is a sodium salt.

33. A kit according to claim 3 wherein said bisphosphonate is selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

34. A kit according to claim 33 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

35. A kit according to claim 34 wherein said pharmaceutically acceptable salt is a sodium salt.

36. A kit according to claim 4 wherein said bisphosphonate is selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

37. A kit according to claim 36 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

38. A kit according to claim 37 wherein said pharmaceutically acceptable salt is a sodium salt.

39. A kit comprising at least one pharmaceutically effective unit dosage of a bisphosphonate selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zoledronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof, for oral administration to a mammal according to a continuous schedule having a dosing interval of once-weekly dosing.

40. A kit according to claim 39 wherein said mammal is a human.

41. A kit according to claim 40 wherein said unit dosage of said bisphosphonate comprises from about 1.5 to about 6000 ug/kg body weight.

42. A kit according to claim 40 wherein said unit dosage of said bisphosphonate comprises from about 10 to about 2000 ug/kg body weight.

43. A kit according to claim 40 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

44. A kit according to claim 43 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

45. A kit according to claim 44 wherein said pharmaceutically acceptable salt is a sodium salt.

46. A kit according to claim 45 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

47. A kit according to claim 41 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

48. A kit according to claim 47 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

49. A kit according to claim 48 wherein said pharmaceutically acceptable salt is a sodium salt.

50. A kit according to claim 49 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

51. A kit according to claim 42 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

52. A kit according to claim 51 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

53. A kit according to claim 52 wherein said pharmaceutically acceptable salt is a sodium salt.

54. A kit according to claim 53 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

55. A kit according to claim 43 wherein said unit dosage comprises from about 8.75 to about 140 mg of said bisphosphonate on an alendronic acid active basis.

56. A kit according to claim 43 wherein said unit dosage comprises from about 17.5 to about 70 mg of said bisphosphonate on an alendronic acid active basis.

57. A kit according to claim 56 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

58. A kit according to claim 57 wherein said pharmaceutically acceptable salt is a sodium salt.

59. A kit according to claim 58 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

60. A kit according to claim 56 wherein said unit dosage comprises about 35 mg of said bisphosphonate on an alendronic acid active basis.

61. A kit according to claim 60 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

62. A kit according to claim 61 wherein said pharmaceutically acceptable salt is a sodium salt.

63. A kit according to claim 62 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

64. A kit according to claim 56 wherein said unit dosage comprises about 70 mg of said bisphosphonate on an alendronic acid active basis.

65. A kit according to claim 64 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

66. A kit according to claim 65 wherein said pharmaceutically acceptable salt is a sodium salt.

67. A kit according to claim 66 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

68. A kit according to claim 40 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

69. A kit according to claim 68 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

70. A kit according to claim 69 wherein said pharmaceutically acceptable salt is a sodium salt.

71. A kit according to claim 41 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

72. A kit according to claim 71 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

73. A kit according to claim 72 wherein said pharmaceutically acceptable salt is a sodium salt.

74. A kit according to claim 42 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

75. A kit according to claim 74 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

76. A kit according to claim 75 wherein said pharmaceutically acceptable salt is a sodium salt.

77. A kit according to claim 40 wherein said bisphosphonate is selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

78. A kit according to claim 77 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

79. A kit according to claim 78 wherein said pharmaceutically acceptable salt is a sodium salt.

80. A kit according to claim 41 wherein said bisphosphonate is selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

81. A kit according to claim 80 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

82. A kit according to claim 81 wherein said pharmaceutically acceptable salt is a sodium salt.

83. A kit according to claim 42 wherein said bisphosphonate is selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

84. A kit according to claim 83 wherein said pharmaceutically acceptable salt is selected from the group consisting of sodium, potassium, calcium, magnesium, and ammonium salts.

85. A kit according to claim 84 wherein said pharmaceutically acceptable salt is a sodium salt.

86. A kit according to any one of claims 1-85 wherein said unit dosage form is a tablet or capsule.

87. A kit according to claim 86 wherein said kit is a blister pack.

88. A kit according to any one of claims 1-85 wherein said unit dosages are oriented in the order of their intended use.

89. A kit according to claim 88 wherein said unit dosage form is a tablet or capsule.

90. A kit according to claim 89 wherein said kit is a blister pack.

91. A kit according to any one of claim 1-85 wherein said kit comprises a memory aid.

92. A kit according to claim 88 wherein said kit comprises a memory aid.

93. A kit according to claim 89 wherein said kit comprises a memory aid.

94. A kit according to claim 90 wherein said kit comprises a memory aid.
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