Dosage forms for oral administration of zoledronic acid or related compounds
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: orally administering zoledronic acid in the disodium salt form to a human being in need of treatment with zoledronic acid, wherein a weekly dose of about 30 mg to about 100 mg of zoledronic acid in the disodium salt form is orally administered, wherein the weekly dose is orally administered as a single dose, or as 2, 3, 4, 5, 6, or 7 individual doses administered during the week, wherein the zoledronic acid in the disodium salt form is orally administered in a dosage form that does not contain a bioavailability enhancer, and wherein the zoledronic acid in the disodium salt form enhances bioavailability of zoledronic acid.
2. The method of claim 1 , wherein a single dose is orally administered approximately weekly for 6 weeks.
3. The method of claim 2 , wherein each single dose contains an amount of the disodium salt form of zoledronic acid that is equivalent to about 50 mg of the acid form of zoledronic acid.
4. The method of claim 3 , wherein orally administering each single dose results in an area under the plasma concentration curve of zoledronic acid in the human being, measured over a 48-hour period, of about 100 ng·hr/mL to about 200 ng·hr/mL.
5. The method of claim 3 , wherein orally administering the disodium salt form of zoledronic acid results in a 48-hour sustained plasma level factor in the human being that is at least about 2 times that of zoledronic acid administered intravenously.
6. The method of claim 3 , wherein the disodium salt form of zoledronic acid is orally administered to treat complex regional pain syndrome type I.
7. The method of claim 3 , wherein the disodium salt form of zoledronic acid is orally administered to treat complex regional pain syndrome type II.
8. The method of claim 7 , wherein the complex regional pain syndrome is associated with an inciting trauma.