Compositions for oral administration of zoledronic acid or related compounds for treating disease
Oral dosage forms of osteoclast inhibitors, such as zoledronic acid, in an acid or a salt form can be used to treat or alleviate pain or related conditions.
1. A method of delivering zoledronic acid to the blood of a human being, comprising: fasting the human being for at least four hours, followed by orally administering a dosage form containing about 30 mg to about 800 mg of the zoledronic acid in a salt form to the human being, followed by fasting the human being for at least one hour, wherein orally administering the dosage form to the human being results in a bioavailability of zoledronic acid that is about 1.5% to 3%.
2. The method of claim 1 , wherein the dosage form contains about 30 mg to about 100 mg of the zoledronic acid in the salt form.
3. The method of claim 2 , wherein the dosage form is administered weekly.
4. The method of claim 1 , wherein about 50 mg/m 2 to about 200 mg/m 2 of the zoledronic acid in the salt form is administered within a period of about one month based upon the body surface area of the human being.
5. The method of claim 1 wherein orally administering the dosage form to the human being results in a bioavailability of zoledronic acid that is about 1.5% to about 2%.
6. The method of claim 1 wherein orally administering the dosage form to the human being results in a bioavailability of zoledronic acid that is about 2% to 3%.
7. The method of claim 1 , wherein the human being is fasted in a manner that maximizes the bioavailability of zoledronic acid resulting from orally administering the dosage form to the human being.
8. The method of claim 1 , wherein the dosage form is substantially non-toxic to the human being.
9. The method of claim 1 , wherein the dosage form contains about 0.18 millimoles of the zoledronic acid in the salt form.
10. A method of delivering zoledronic acid to the blood of a human being, comprising: fasting the human being for at least four hours, followed by orally administering a dosage form containing about 40 mg to about 150 mg of the zoledronic acid in a salt form to the human being, followed by fasting the human being for at least one hour, wherein orally administering the dosage form to the human being results in a bioavailability of zoledronic acid that is about 1.4% to about 1.5%, about 1.5% to about 1.6%, about 1.6% to about 1.8%, or about 1.8% to about 2%.
11. The method of claim 10 , wherein the dosage form is orally administered in a manner that maximizes the bioavailability of zoledronic acid resulting from orally administering the dosage form to the human being.
12. The method of claim 10 , wherein the dosage form contains about 0.2 millimoles of the zoledronic acid in the salt form.
13. The method of claim 10 , wherein the dosage form is well tolerated by the human being.
14. The method of claim 12 , wherein the dosage form is administered weekly.
15. A method of delivering zoledronic acid to the blood of a human being, comprising: fasting the human being for at least four hours, followed by orally administering a dosage form containing about 30 mg to about 100 mg of the zoledronic acid in a salt form to the human being, followed by fasting the human being for at least one hour, wherein orally administering the dosage form to the human being results in a bioavailability of zoledronic acid that is 2% to 3%.
16. The method of claim 15 , wherein the dosage form is orally administered in a manner that maximizes the bioavailability of zoledronic acid resulting from orally administering the dosage form to the human being.
17. The method of claim 15 , wherein the dosage form is well tolerated by the human being.
18. The method of claim 15 , wherein the dosage form contains about 0.18 millimoles of the zoledronic acid in the salt form.
19. The method of claim 18 , wherein the dosage form is administered about once weekly.
20. The method of claim 18 , wherein the zoledronic acid is in a disodium salt form.