LARGE DOSE RIBAVIRIN FORMULATIONS
The present invention is related to pharmaceutical dosage forms of ribavirin which are designed to increase patient compliance to a ribavirin therapy. Examples of such dosage forms include 400 mg to 600 mg tablets. These dosage forms are bioequivalent to multiple doses of tablets containing small amounts of ribavirin.
1 . A method for increasing patient compliance of a therapy comprising ribavirin, the method comprising administering a single pharmaceutical dosage form comprising 400 mg to 600 mg of ribavirin.
2 . The method of claim 1 , wherein the dosage form is a tablet which comprises 400 mg of ribavirin.
3 . The method of claim 1 , wherein the dosage form is a tablet which comprises 600 mg of ribavirin.
4 . The method of claim 1 , wherein the method is conducted two times per day.
5 . The method of claim 4 , wherein the method provides a daily dose of 800 mg, 1000 mg or 1200 mg of ribavirin.
6 . A method for increasing patient compliance of a therapy comprising ribavirin, the method comprising administering, twice a day to a subject, exactly one dosage form comprising 400 mg to 600 mg of ribavirin.
7 . The method of claim 6 , wherein the dosage form is a tablet which comprises 400 mg of ribavirin.
8 . The method of claim 7 , wherein the dosage form has at least one of the following characteristics:
a tablet hardness of from about 10.27 kp to about 12.88 kp;
a tablet weight of from about 0.5470 g to about 0.5535 g;
a tablet thickness of from about 4.86 mm to about 4.91 mm; and
a tablet friability of from about 0.23% to about 0.26%.
9 . The method of claim 6 , wherein the dosage form is a tablet which comprises 600 mg of ribavirin.
10 . The method of claim 9 , wherein the dosage form has at least one of the following characteristics:
a tablet hardness of from about 10.64 kp to about 12.58 kp;
a tablet weight of from about 0.8174 g to about 0.8357 g;
a tablet thickness of from about 6.38 mm to about 6.41 mm; and
a tablet friability of from about 0.23% to about 0.33%.
11 . The method of claim 6 , wherein the method provides a daily dose of 800 mg, 1000 mg or 1200 mg of ribavirin.
12 . The method according to claim 6 , wherein the dosage form is a tablet which is dispensed in HDPE bottles.
13 . The method according to claim 6 , wherein the dosage form is a tablet which is dispensed in a unit dose package.
14 . The method according to claim 13 , wherein the unit dose package is a blister pack containing 2, 4, 6, 8, 10, 12, 16, 20, 24, 48 or 56 tablets.
15 . A daily dosage regimen of ribavirin treatment comprising administering to a patient in need thereof exactly one dosage form of ribavirin and 8 hours to 16 hours later administering another one dosage form of ribavirin.
16 . The daily dosage regimen of claim 15 , wherein the dosage form comprises 400 mg to 600 mg of ribavirin.
17 . The daily dosage regimen of claim 16 , wherein the dosage form is a tablet which comprises 400 mg of ribavirin.
18 . The daily dosage regimen of claim 16 , wherein the dosage form is a tablet which comprises 600 mg of ribavirin.
19 . The daily dose regimen of claim 15 , wherein the regimen provides a daily dose of 800 mg, 1000 mg or 1200 mg of ribavirin.