TREATMENT OF PAIN WITH ORAL DOSAGE FORMS COMPRISING ZOLEDRONIC ACID AND AN ENHANCER
Disclosed herein are methods of treating or preventing pain. Typically, a pharmaceutical composition having a therapeutically effective amount of the zoledronic acid is administered to a mammal suffering from pain. The pharmaceutical composition may further comprise an enhancer, which can be a medium chain fatty acid salt, an ester, an ether, or a derivative of a medium chain fatty acid and can have a carbon chain length of from about 4 to about 20 carbon atoms.
1 . A method of treating or preventing pain caused by a medical condition in a subject, the method comprising:
administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of zoledronic acid or a salt thereof;
wherein the pharmaceutical composition further comprises an enhancer selected from the group consisting of a medium chain fatty acid salt, an ester, an ether, or a derivative of a medium chain fatty acid.
2 . The method of claim 1 , wherein the enhancer has a carbon chain length of from about 8 to about 12 carbon atoms.
3 . The method of claim 1 , wherein the pharmaceutical composition is in a solid oral dosage form.
4 . The method of claim 1 , wherein the enhancer is sodium decanoate.
5 . The method of claim 1 , wherein the ratio of the zoledronic acid to the enhancer is from about 1:5 to about 1:10.
6 . The method of claim 1 , wherein the composition is in the form of a delayed release enteric coated tablet.
7 . The method of claim 1 , wherein the composition is in the form of an immediate release enteric coated tablet.
8 . The method claim 1 , wherein the composition comprises about 10 mg to about 20 mg of zoledronic acid and about 500 mg to about 600 mg of sodium decanoate.
9 . The method of claim 8 , wherein the pain is associated with arthritis.
10 . The method of claim 8 , wherein the pain is inflammatory pain.
11 . The method of claim 8 , wherein the pain is musculoskeletal pain.
12 . The method of claim 8 , wherein the pain is associated with complex regional pain syndrome.
13 . The method of claim 8 , wherein the pain is neuropathic pain.
14 . The method of claim 8 , wherein the pain is low back pain.
15 . The method of claim 1 , wherein the composition comprises about 20 mg of zoledronic acid, about 550 mg of sodium decanoate, about 275 mg of sorbitol, about 4.5 mg of colloidal silicon dioxide, about 45 mg of crospovidone, about 4.5 mg of stearic acid, about 54 mg of Opadry 1 yellow, about 81 mg of Acryl-EZE II, and about 1.3 mg of talc.
16 . The method of claim 15 , wherein the pain is associated with arthritis.
17 . The method of claim 15 , wherein the pain is inflammatory pain.
18 . The method of claim 15 , wherein the pain is musculoskeletal pain.
19 . The method of claim 15 , wherein the pain is associated with complex regional pain syndrome.
20 . The method of claim 15 , wherein the pain is low back pain.
21 . A method of treating pain, comprising administering a pharmaceutical composition for oral administration to a mammal in need thereof, wherein the pharmaceutical composition is effective in delivering therapeutically effective amounts of a drug and an enhancer to an intestine, said composition comprising zoledronic acid and an enhancer, wherein the composition is in a dosage form comprising about 1 mg to about 25 mg zoledronic acid, and wherein the enhancer is a medium chain fatty acid or a salt of a medium chain fatty acid having a carbon chain length of from 6 to 20 carbon atoms, is solid at room temperature, and is the only enhancer present in the composition.
22 . A method of treating pain, comprising administering solid oral dosage form to a mammal in need thereof, wherein the solid oral dosage form is effective in delivering therapeutically effective amounts of zoledronic acid and an enhancer to an intestine, said composition comprising zoledronic acid and an enhancer, wherein the enhancer is a medium chain fatty acid or a salt of a medium chain fatty acid having a carbon chain length of from 6 to 20 carbon atoms, is solid at room temperature, and is the only enhancer present in the composition, and wherein upon oral delivery of the composition to a human subject.