Methods for the safe administration of imidazole or imidazolium compounds
View Patent ↗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.