Large dose ribavirin formulations

Abstract

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 comprises 400 mg of ribavirin and further comprises at least one excipient selected from the group consisting of microcrystalline cellulose, lactose monohydrate, crosscarmellose sodium, povidone and magnesium stearate. 
     
     
         3 . The method of  claim 1 , wherein the dosage form comprises 600 mg of ribavirin and further comprises at least one excipient selected from the group consisting of microcrystalline cellulose, lactose monohydrate, crosscarmellose sodium, povidone and magnesium stearate. 
     
     
         4 . 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. 
     
     
         5 . The method of  claim 4 , wherein the dosage form comprises 400 mg of ribavirin and further comprises at least one excipient selected from the group consisting of microcrystalline cellulose, lactose monohydrate, crosscarmellose sodium, povidone and magnesium stearate. 
     
     
         6 . The method of  claim 4 , wherein the dosage form is a 400 mg tablet which 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%.   
     
     
         7 . The method of  claim 4 , wherein the dosage form comprises 600 mg of ribavirin and further comprises at least one excipient selected from the group consisting of microcrystalline cellulose, lactose monohydrate, crosscarmellose sodium, povidone and magnesium stearate. 
     
     
         8 . The method of  claim 4 , wherein the dosage form is a 600 mg tablet which 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%.   
     
     
         9 . The method according to  claim 4 , wherein the dosage form is a tablet which is dispensed in HDPE bottles. 
     
     
         10 . The method according to  claim 4 , wherein the dosage form is a tablet which is dispensed in a unit dose package. 
     
     
         11 . The method according to  claim 10 , wherein the unit dose package is a blister pack containing 2, 4, 6, 8, 10, 12, 16, 20, 24, 48 or 56 tablets. 
     
     
         12 . 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. 
     
     
         13 . The daily dosage regimen of  claim 12 , wherein the dosage form comprises 400 mg to 600 mg of ribavirin. 
     
     
         14 . The daily dosage regimen of  claim 13 , wherein the dosage form is a tablet which comprises 400 mg of ribavirin. 
     
     
         15 . The daily dosage regimen of  claim 13 , wherein the dosage form is a tablet which comprises 600 mg of ribavirin.