DOSAGE FORMS FOR ORAL ADMINISTRATION OF ZOLEDRONIC ACID OR RELATED COMPOUNDS FOR TREATING DISEASE
Oral dosage forms of osteoclast inhibitors, such as nitrogen-containing bisphosphonates, can be used to treat or alleviate pain or related conditions such as complex regional pain syndrome.
1 . A method of treating pain associated with complex regional pain syndrome, comprising orally administering zoledronic acid in a disodium salt form to a human being in need thereof, wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in an AUC of zoledronic acid, over a four week period, that is about 400 ng·h/mL to about 1000 ng·h/mL.
2 . The method of claim 1 , wherein each orally administered dose contains about 50 mg to about 60 mg of the zoledronic acid in the disodium salt form.
3 . The method of claim 1 , wherein the zoledronic acid in the disodium salt form is orally administered at an interval of about 5 to 10 days.
4 . The method of claim 2 , wherein the zoledronic acid in the disodium salt form is orally administered about once a week.
5 . The method of claim 1 , wherein each orally administered dose of the zoledronic acid in the disodium salt form is orally administered in a manner that provides an AUC of zoledronic acid of about 140 ng·h/mL to about 150 ng·h/mL, measured over a 24 hour period.
6 . The method of claim 4 , wherein each orally administered dose of the zoledronic acid in the disodium salt form is orally administered in a manner that provides an AUC of zoledronic acid of about 130 ng·h/mL to about 150 ng·h/mL, measured over a 24 hour period.
7 . The method of claim 1 , wherein the complex regional pain syndrome is associated with an inciting traumatic event.
8 . The method of claim 6 , wherein the complex regional pain syndrome is associated with an inciting traumatic event.
9 . The method of claim 1 , wherein each orally administered dose contains about 55 mg to about 60 mg of the zoledronic acid in the disodium salt form.
10 . The method of claim 8 , wherein each orally administered dose contains about 55 mg to about 60 mg of the zoledronic acid in the disodium salt form.
11 . The method of claim 1 , wherein the zoledronic acid in the disodium salt form is orally administered about once a week for six weeks.
12 . The method of claim 1 , wherein the zoledronic acid in the disodium salt form is orally administered about once a week for three weeks.
13 . The method of claim 10 , wherein the zoledronic acid in the disodium salt form is orally administered about once a week for six weeks.
14 . The method of claim 10 , wherein the zoledronic acid in the disodium salt form is orally administered about once a week for three weeks.
15 . The method of claim 13 , wherein the zoledronic acid in the disodium salt form is orally administered in a dosage form that contains at least about 20% of the zoledronic acid in the disodium salt form by weight.
16 . The method of claim 14 , wherein the zoledronic acid in the disodium salt form is orally administered in a dosage form that contains at least about 20% of the zoledronic acid in the disodium salt form by weight.
17 . The method of claim 13 , wherein the zoledronic acid in the disodium salt form is orally administered in a dosage form that contains at least about 50% of the zoledronic acid in the disodium salt form by weight.
18 . The method of claim 14 , wherein the zoledronic acid in the disodium salt form is orally administered in a dosage form that contains at least about 50% of the zoledronic acid in the disodium salt form by weight.
19 . The method of claim 15 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 1.4% to about 1.8%.
20 . The method of claim 15 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 1.8% to about 2%.
21 . The method of claim 15 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 2% to about 2.2%.
22 . The method of claim 15 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 2.2% to about 2.4%.
23 . The method of claim 15 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 2.4% to about 2.8%.
24 . The method of claim 15 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 2.8% to about 3.2%.
25 . The method of claim 16 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 1.4% to about 1.8%.
26 . The method of claim 16 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 1.8% to about 2%.
27 . The method of claim 16 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 2% to about 2.2%.
28 . The method of claim 16 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 2.2% to about 2.4%.
29 . The method of claim 16 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 2.4% to about 2.8%.
30 . The method of claim 16 , wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 2.8% to about 3.2%.