Process for producing wet ribavirin pellets

Abstract

A process for producing wet ribavirin pellets is provided in order to make pharmaceutical dosages of ribavirin. The process is particularly useful as an alternative method for preparing pharmaceutical dosages of ribavirin that reduces the amount of ribavirin dust that is produced during the manufacturing process and allows for greater control of dissolution rates. According to the preferred embodiments, this method is accomplished through mixing ribavirin with at least one excipient into a uniform mixture, forming the mixture into a granulated mass by adding a wetting agent, shaping said granulated mass into soluble particles and drying the flowable particles. The process enables Ribavirin pharmaceutical pellets to be mixed with a binder and disintegrant to form a uniform mixture.

1 - 38 . (Canceled).  
     
     
         39 . A process of forming ribavirin particles, the process comprising: 
 mixing ribavirin with at least three excipients to form a mixture;    adding water to the mixture in the range of 15-79% of the total mixture; and    shaping the mixture into ribavirin particles.    
     
     
         40 . The process according to  claim 39 , further comprising filling a capsule with the particles resulting in a total weight ranging from 243 mg to 297 mg of particles in the capsule.  
     
     
         41 . The process according to  claim 40 , further comprising adding a lubricant to the particles before filling the capsule.  
     
     
         42 . The process according to  claim 41 , wherein one of the excipients is povidone.  
     
     
         43 . The process according to  claim 39 , wherein the at least three excipients are a binder, a filler, and a disintegrant.  
     
     
         44 . The process according to  claim 43 , wherein the binder, filler, and disintegrant are selected from the group consisting of: povidone, starch, lactose, polyethylene glycol, hydroxypropyl methylcellulose, croscarmellose sodium, cellulose, bentonite, cross-povidones, microcrystalline cellulose, and sucrose.  
     
     
         45 . The process according to  claim 39 , wherein the shaping step is accomplished by spheronization.  
     
     
         46 . The process according to  claim 39 , further comprising heating the mixture to a temperature ranging from about 35° C. to about 45° C., until the mixture contains a moisture content ranging from 0.5% to 5.0%.  
     
     
         47 . A process of forming a ribavirin mixture, the process comprising: 
 forming a mixture comprising about 35% to about 80% of ribavirin by weight, and at least two excipients;    adding water to the mixture; and    drying the mixture.    
     
     
         48 . The process according to  claim 47 , further comprising shaping the mixture into particles.  
     
     
         49 . A process of forming a ribavirin mixture, the process comprising: 
 combining ribavirin and at least three excipients to form a mixture;    adding water to the mixture; and    drying the mixture.    
     
     
         50 . The process according to  claim 49 , wherein water is added to the mixture in the range of 15-79% of the total mixture.  
     
     
         51 . A process of forming a ribavirin mixture, the process comprising: 
 combining ribavirin with a binder, disintegrant and wetting agent to form a granulated mixture; and    drying the granulated mixture.    
     
     
         52 . The process according to  claim 51 , wherein water is added as the wetting agent and in the range of 15-79% of the total mixture.  
     
     
         53 . The process according to  claim 51 , further comprising shaping the granulated mixture into particles and preparing a pharmaceutical dosage with the particles.  
     
     
         54 . Formulating a ribavirin composition by wet granulation.  
     
     
         55 . A ribavirin composition, wherein the composition consists essentially of free flowing ribavirin particles.  
     
     
         56 . The composition according to  claim 55 , further comprising at least three excipients.