Methods for the safe administration of imidazole or imidazolium compounds
Methods for the safe administration of imidazole or imidazolium compounds, and conditions that may be treated by these methods, are described herein.
1. A method of safely and effectively delivering zoledronic acid to the blood of a human being through repeated oral administration comprising:
mixing zoledronic acid with a diluent, binder, an excipient, a disintegrating agent, a flavoring agent, or a lubricant to form a pharmaceutical composition containing at least 20% zoledronic acid by weight;
wherein the pharmaceutical composition is in the form of a pill, tablet, or capsule, and containing about 0.15 millimoles to about 1.1 millimoles of zoledronic acid in the acid or a salt form; and
wherein the pill, tablet, or capsule is orally administered to a human being at least twice a month and no more frequently than once a day.
2. The method of claim 1 , wherein, about 0.15 millimoles to about 0.22 millimoles of zoledronic acid is orally administered weekly.
3. The method of claim 2 , wherein the pill, tablet, or capsule containing zoledronic acid is orally administered for about 6 weeks.
4. The method of claim 1 , wherein the pill, tablet, or capsule comprises more than about 30% zoledronic acid by weight.
5. The method of claim 2 , wherein the pill, tablet, or capsule comprises more than about 30% zoledronic acid by weight.
6. The method of claim 3 , wherein the pill, tablet, or capsule comprises more than about 30% zoledronic acid by weight.
7. The method of claim 1 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least 1.5 times that of 4 mg of zoledronic acid administered intravenously.
8. The method of claim 2 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least 1.5 times that of 4 mg of zoledronic acid administered intravenously.
9. The method of claim 3 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least 1.5 times that of 4 mg of zoledronic acid administered intravenously.
10. The method of claim 1 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
11. The method of claim 2 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
12. The method of claim 3 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
13. The method of claim 1 , wherein the zoledronic acid is orally administered in a manner that results in a 48 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
14. The method of claim 2 , wherein the zoledronic acid is orally administered in a manner that results in a 48 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
15. The method of claim 3 , wherein the zoledronic acid is orally administered in a manner that results in a 48 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
16. The method of claim 1 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.3% to 4%.
17. The method of claim 2 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.3% to 4%.
18. The method of claim 3 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.3% to 4%.
19. The method of claim 1 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.8% to 3%.
20. The method of claim 2 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.8% to 3%.
21. The method of claim 3 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.8% to 3%.
22. The method of claim 1 , wherein the zoledronic acid is orally administered in a dosage form that, other than a counter-ion to zoledronic acid, contains no agents which enhance the bioavailability of zoledronic acid.
23. The method of claim 2 , wherein the zoledronic acid is orally administered in a dosage form that, other than a counter-ion to zoledronic acid, contains no agents which enhance the bioavailability of zoledronic acid.
24. The method of claim 3 , wherein the zoledronic acid is orally administered in a dosage form that, other than a counter-ion to zoledronic acid, contains no agents which enhance the bioavailability of zoledronic acid.
25. The method of claim 1 , wherein the human being is not suffering from a blood cancer.
26. The method of claim 2 , wherein the human being is not suffering from a blood cancer.
27. The method of claim 3 , wherein the human being is not suffering from a blood cancer.
28. The method of claim 1 , wherein the zoledronic acid is orally administered in a solid dosage form having a binder.
29. The method of claim 2 , wherein the zoledronic acid is orally administered in a solid dosage form having a binder.
30. The method of claim 3 , wherein the zoledronic acid is orally administered in a solid dosage form having a binder.