COMPOSITIONS FOR ORAL ADMINISTRATION OF ZOLEDRONIC ACID OR RELATED COMPOUNDS FOR TREATING COMPLEX REGIONAL PAIN SYNDROME
Oral dosage forms of osteoclast inhibitors, such as nitrogen-containing bisphosphonates, such as zoledronic acid in an acid or a salt form, or in a molecular complex can be used to treat or alleviate pain or related conditions, such as complex regional pain syndrome.
1 . A method of treating complex regional pain syndrome, comprising administering, to a human being in need thereof, a molecular complex comprising zoledronic acid and lysine, wherein about 400 mg to about 600 mg of zoledronic acid is administered within a period of about one month, wherein the molecular complex is a solid.
2 . The method of claim 1 , wherein the molecular complex is administered in a pharmaceutical composition further comprising a pharmaceutically acceptable excipient.
3 . The method of claim 2 , wherein the composition is an oral solid dosage form.
4 . The method of claim 3 , wherein the oral solid dosage form is a tablet or a capsule.
5 . The method of claim 2 wherein the pharmaceutical composition further comprises an excess amount of lysine.
6 . The method of claim 1 , wherein the molecular complex is crystalline.
7 . The method of claim 6 , wherein the molecular complex is in a pharmaceutical composition that further comprises a pharmaceutically acceptable excipient.
8 . The method of claim 7 , wherein the composition is an oral solid dosage form.
9 . The method of claim 8 , wherein the oral solid dosage form is a tablet or a capsule.
10 . The method of claim 6 , wherein the molecular complex is administered in a pharmaceutical composition that further comprises an excess amount of lysine.
11 . The method of claim 3 , wherein the oral dosage form contains 160 mg of zoledronic acid.
12 . The method of claim 11 , wherein the oral dosage form is administered about biweekly three times.
13 . The method of claim 1 , wherein about 5 to 10 individual doses are administered within the period of about one month.
14 . The method of claim 1 , wherein about 28 to 31 daily doses are administered within the period of about one month.
15 . A method of treating pain, comprising administering, to a mammal in need thereof, a molecular complex comprising zoledronic acid or a salt thereof and lysine, wherein about 200 mg/m 2 to about 400 mg/m 2 of zoledronic acid is administered within a period of about one month, wherein the molecular complex is a solid.
16 . The method of claim 15 , wherein the molecular complex is in a pharmaceutical composition that further comprises a pharmaceutically acceptable excipient.
17 . The method of claim 16 , wherein the composition is an oral solid dosage form.
18 . The method of claim 17 , wherein the oral solid dosage form is a tablet or a capsule.
19 . The method of claim 15 , wherein the molecular complex is in a composition that further comprises an excess amount of lysine.
20 . The method of claim 15 , wherein the molecular complex is crystalline.
21 . The method of claim 20 , wherein the molecular complex is in a composition that further comprises a pharmaceutically acceptable excipient.
22 . The method claim 21 , wherein the composition is an oral solid dosage form.
23 . The method of claim 22 , wherein the oral solid dosage form is a tablet or a capsule.
24 . The method of claim 20 , wherein the molecular complex is in a composition that further comprises an excess amount of lysine.
25 . The method of claim 17 , wherein the dosage form contains 160 mg of the zoledronic acid.
26 . The method of claim 17 , wherein the oral dosage form is administered about biweekly three times.
27 . The method of claim 15 , wherein the pain is low back pain.
28 . The method of claim 15 , wherein the pain is associated with complex regional pain syndrome.
29 . The method of claim 15 , wherein 4 or 5 weekly doses are administered within the period of about one month.
30 . The method of claim 15 , wherein 2 or 3 weekly doses are administered within the period of about one month.