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Claims for Patent: 6,465,443

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Claims for Patent: 6,465,443

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:09/812,450
Patent Claims: 1. A pharmaceutical composition comprising about 35 mg, on an acid active basis, of a bisphosphonate selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

2. A pharmaceutical composition comprising about 40 mg, on an acid active basis, of a bisphosphonate selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

3. A pharmaceutical composition comprising about 45 mg, on an acid active basis, of a bisphosphonate selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

4. A pharmaceutical composition comprising about 50 mg, on an acid active basis, of a bisphosphonate selected from the group consisting of ibandronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

5. A pharmaceutical composition comprising about 35 mg, on an acid active basis, of a bisphosphonate selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

6. A pharmaceutical composition comprising about 40 mg, on an acid active basis, of a bisphosphonate selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

7. A pharmaceutical composition comprising about 45 mg, on an acid active basis, of a bisphosphonate selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

8. A pharmaceutical composition comprising about 50 mg, on an acid active basis, of a bisphosphonate selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

9. A pharmaceutical composition according to any one of claims 5-8 wherein said pharmaceutically acceptable salt is risedronate monosodium hemi-pentahydrate.

10. A kit comprising at least one pharmaceutically effective unit dosage of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof, for oral administration to a mammal in need thereof 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.

11. A kit according to claim 10 wherein said mammal is a human.

12. A kit according to claim 11 wherein said unit dosage comprises from about 1.5 to about 6000 .mu./kg body weight.

13. A kit according to claim 11 wherein said unit dosage comprises from about 10 to about 2000 .mu.g/kg body weight.

14. A kit according to claim 13 wherein said dosing interval is once-weekly.

15. A kit according to claim 14 wherein said unit dosage is in the form of a tablet.

16. A kit according to claim 15 wherein said kit is a blister pack.

17. A kit according to claim 16 which further comprises a memory aid for administering said unit dosages.

18. A kit according to claim 17 wherein said memory aid indicates that said unit dosages are administered once a week.

19. A kit according to claim 18 wherein said unit dosages are oriented in said pharmaceutical kit in the order of their intended use.

20. A kit according to claim 19 which further comprises a calcium supplement.

21. A kit according to claim 14 wherein said unit dosage is in the form of a capsule.

22. A kit according to claim 21 wherein said kit is a blister pack.

23. A kit according to claim 22 which further comprises a memory aid for administering said unit dosages.

24. A kit according to claim 23 wherein said memory aid indicates that said unit dosages are administered once a week.

25. A kit according to claim 24 wherein said unit dosages are oriented in said pharmaceutical kit in the order of their intended use.

26. A kit according to claim 25 which further comprises a calcium supplement.

27. A kit according to claim 14 wherein said unit dosage is in the form of a liquid.

28. A kit according to claim 27 which further comprises a memory aid for administering said unit dosages.

29. A kit according to claim 28 wherein said memory aid indicates that said unit dosages are administered once a week.

30. A kit according to claim 29 wherein said unit dosages are oriented in said pharmaceutical kit in the order of their intended use.

31. A kit according to claim 30 which further comprises a calcium supplement.

32. A kit comprising from about 7 mg to about 100 mg of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof, on an acid active basis, for oral administration to a human in need thereof, according to a continuous schedule having a once-weekly dosing interval.

33. A kit according to claim 32 wherein said unit dosage comprises about 35 mg of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof, on an acid active basis.

34. A kit according to claim 32 wherein said unit dosage comprises about 40 mg of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof, on an acid active basis.

35. A kit according to claim 32 wherein said unit dosage comprises about 45 mg of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof, on an acid active basis.

36. A kit according to claim 32 wherein said unit dosage comprises about 50 mg of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof, on an acid active basis.

37. A kit according to claim 33 wherein said unit dosage is in the form of a tablet.

38. A kit according to claim 37 wherein said kit is a blister pack.

39. A kit according to claim 38 which further comprises a memory aid for administering said unit dosages.

40. A kit according to claim 36 wherein said memory aid indicates that said unit dosages are administered once a week.

41. A kit according to claim 40 wherein said unit dosages are oriented in said pharmaceutical kit in the order of their intended use.

42. A kit according to claim 41 which further comprises a calcium supplement.

43. A kit according to claim 33 wherein said unit dosage is in the form of a capsule.

44. A kit according to claim 43 wherein said kit is a blister pack.

45. A kit according to claim 44 which further comprises a memory aid for administering said unit dosages.

46. A kit according to claim 45 wherein said memory aid indicates that said unit dosages are administered once a week.

47. A kit according to claim 46 wherein said unit dosages are oriented in said pharmaceutical kit in the order of their intended use.

48. A kit according to claim 47 which further comprises a calcium supplement.

49. A kit according to claim 33 wherein said unit dosage is in the form of a liquid.

50. A kit according to claim 49 which further comprises a memory aid for administering said unit dosages.

51. A kit according to claim 50 wherein said memory aid indicates that said unit dosages are administered once a week.

52. A kit according to claim 50 wherein said unit dosages are oriented in said pharmaceutical kit in the order of their intended use.

53. A kit according to claim 52 which further comprises a calcium supplement.

54. A kit according to any one of claims 10-53 wherein said pharmaceutically acceptable salt is risedronate monosodium hemi-pentahydrate.
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