DOSAGE FORMS FOR ORAL ADMINISTRATION OF ZOLEDRONIC ACID OR RELATED COMPOUNDS FOR TREATING DISEASE
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, such as arthritis.
1 . A method of treating pain associated with arthritis comprising orally administering zoledronic acid to a human being in need thereof, wherein the amount of the zoledronic acid orally administered to the human being within a period of about one week is about 30 mg to about 100 mg.
2 . The method of claim 1 , wherein the total amount of the zoledronic acid that is orally administered to the human being within a period of one month is about 100 mg to about 500 mg.
3 . The method of claim 1 , wherein the zoledronic acid is in an acid form.
4 . The method of claim 1 , wherein the zoledronic acid is in a salt form.
5 . The method of claim 1 , wherein the zoledronic acid is in a disodium salt form.
6 . The method of claim 1 , wherein the zoledronic acid is orally administered for at least two consecutive weeks.
7 . The method of claim 1 , wherein the zoledronic acid is orally administered in a dosage form that further comprises magnesium stearate.
8 . The method of claim 1 , wherein the zoledronic acid is orally administered in a dosage form that further comprises microcrystalline cellulose.
9 . The method of claim 1 , wherein the zoledronic acid is orally administered in a dosage form that further comprises a crosslinked polyvinylpyrrolidone.
10 . The method of claim 1 , wherein the zoledronic acid is orally administered in a dosage form that further comprises fumed silica.
11 . A method of treating pain associated with arthritis comprising orally administering zoledronic acid, in an acid or a salt form, to a human being in need thereof, wherein, in order to improve bioavailability, the human being fasts for at least one hour prior to oral administration of the zoledronic acid and for at least one hour after oral administration of the zoledronic acid, wherein the zoledronic acid is orally administered in a dosage form having a mean bioavailability of 1.4% to 3%.
12 . The method of claim 11 , wherein the zoledronic acid in the dosage form has a mean bioavailability of 1.4% to 2%.
13 . The method of claim 11 , wherein the dosage form contains about 40 mg to about 150 mg of the zoledronic acid.
14 . The method of claim 13 , wherein the dosage form is orally administered weekly.
15 . The method of claim 11 , wherein the dosage form contains about 0.5 mg to about 10 mg of the zoledronic acid.
16 . The method of claim 15 , wherein the dosage form is orally administered daily.
17 . The method of claim 11 , wherein the dosage form contains about 100 mg to about 300 mg of the zoledronic acid.
18 . The method of claim 17 , wherein the dosage form is orally administered monthly.
19 . The method of claim 11 , wherein 50 mg/m 2 to 200 mg/m 2 of the zoledronic acid is orally administered to the human being within a period of 1 month.
20 . The method of claim 11 , wherein 30 mg to 100 mg of the zoledronic acid is orally administered to the human being within a period of 1 week.
21 . The method of claim 11 , wherein the zoledronic acid is in an acid form.
22 . The method of claim 11 , wherein the zoledronic acid is in a salt form.
23 . The method of claim 11 , wherein the zoledronic acid is in a disodium salt form.
24 . The method of claim 11 , wherein the human being fasts for at least one hour prior to oral administration of the zoledronic acid and for at least one hour after oral administration of the zoledronic acid.
25 . The method of claim 11 , wherein the dosage form further comprises magnesium stearate.
26 . The method of claim 11 , wherein the dosage form further comprises microcrystalline cellulose.
27 . The method of claim 11 , wherein the dosage form further comprises a crosslinked polyvinylpyrrolidone.
28 . The method of claim 11 , wherein the dosage form further comprises fumed silica.
29 . The method of claim 11 , wherein the human being remains upright for at least 30 minutes after oral administration of the zoledronic acid.
30 . The method of claim 11 , wherein the human being remains upright for at least 1 hour after oral administration of the zoledronic acid.