Dosage forms for oral administration of zoledronic acid or related compounds for treating disease
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 repeatedly delivering zoledronic acid to the blood of a human being, comprising: requiring a human being in need of treatment with zoledronic acid to fast for at least 4 hours, administering an oral dosage form comprising zoledronic acid in an acid form or a salt form to the human being, and then requiring the human being to fast for an additional 2 hours, wherein the bioavailability of zoledronic acid in the dosage form is about 1.8% to about 2.3%, wherein the dosage form is administered more than once, and wherein about 100 mg/m 2 to about 200 mg/m 2 of the zoledronic acid in the acid form or the salt form is the average dose administered to the human being within a period of one month, and the zoledronic acid is administered for a total of 1 to 2 months.
2. The method of claim 1 , wherein the dosage form is administered approximately weekly in about equal doses.
3. The method of claim 2 , wherein the dosage form contains about 0.2 moles of the zoledronic acid in the acid form or the salt form.
4. The method of claim 1 , wherein the dosage form is administered approximately bi-weekly in about equal doses.
5. The method of claim 4 , wherein the dosage form contains about 0.4 moles of the zoledronic acid in the acid form or the salt form.
6. The method of claim 1 , wherein the dosage form is administered 2 or 3 times within the period of one month in about equal doses.
7. The method of claim 1 , wherein the dosage form is administered daily.
8. The method of claim 1 , wherein the dosage form is administered once during the period of one month.
9. The method of claim 1 , wherein the dosage form is administered 5 to 10 times during the period of one month in about equal doses.
10. The method of claim 1 , wherein the human being is required to fast to maximize bioavailability of zoledronic acid in the dosage form.
11. The method of claim 1 , wherein the dosage form is non-toxic.
12. The method of claim 1 , wherein the dosage form is well tolerated.
13. The method of claim 1 , wherein the dosage form contains about 0.6 moles of the zoledronic acid in the acid form or the salt form.
14. The method of claim 1 , wherein the dosage form contains about 50 mg to about 150 mg of the zoledronic acid in the acid form or the salt form.
15. The method of claim 1 , wherein the dosage form contains about 50 mg to about 100 mg of the zoledronic acid in the acid form or the salt form.
16. The method of claim 1 , wherein the dosage form contains about 100 mg to about 150 mg of the zoledronic acid in the acid form or the salt form.