Formulations of phenyl uracil compounds

Abstract

A pharmaceutical product comprising at least one phenyl uracil-based pharmaceutically active agent or an agent of related structural type and processes for obtaining such product.

1 - 20 . (canceled) 
     
     
         21 . A pharmaceutical product comprising an active agent compound having the structure of formula I, a salt thereof, or a crystal form thereof 
       
         
           
           
               
               
           
         
       
       copovidone, and at least one surfactant. 
     
     
         22 . The pharmaceutical product of  claim 21 , further comprising an amount of an alkalizing agent selected from the group consisting of sodium carbonate, sodium bicarbonate, and sodium arginine. 
     
     
         23 . The pharmaceutical product of  claim 22 , wherein the amount of alkalizing agent is about 2% to about 15% w/w. 
     
     
         24 . The pharmaceutical product of  claim 22 , wherein the alkalizing agent is sodium carbonate. 
     
     
         25 . The pharmaceutical product of  claim 21 , wherein the surfactant is selected from the group consisting of vitamin E d-alpha tocopheryl polyethylene glycol succinate, sorbitan laurate, and polyoxyethylene sorbitan monolaurate. 
     
     
         26 . The pharmaceutical product of  claim 21 , wherein the surfactant is vitamin E d-alpha tocopheryl polyethylene glycol succinate. 
     
     
         27 . The pharmaceutical product of  claim 21 , further comprising an amount of a disintigrant. 
     
     
         28 . The pharmaceutical product of  claim 27 , wherein the amount of disintegrant is about 2% to about 10% w/w. 
     
     
         29 . The pharmaceutical product of  claim 21 , further comprising about 5% sodium croscarmellose. 
     
     
         30 . The pharmaceutical product of  claim 21 , further comprising an amount of a lubricant selected from the group consisting of sodium stearyl fumarate and colloidal silicon dioxide. 
     
     
         31 . The pharmaceutical product of  claim 30 , wherein the amount of lubricant is about 0.1% to about 15% w/w. 
     
     
         32 . The pharmaceutical product of  claim 21 , further comprising about 2% sodium stearyl fumarate. 
     
     
         33 . A pharmaceutical product comprising a phenyl uracil active agent, copovidone, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, and a lubricant selected from the group consisting of sodium stearyl fumarate and colloidal silicon dioxide. 
     
     
         34 . The pharmaceutical product of  claim 33 , further comprising about 5% to about 15% w/w surfactant, wherein the surfactant is selected from the group consisting of vitamin E d-alpha tocopheryl polyethylene glycol succinate, sorbitan laurate, and polyoxyethylene sorbitan monolaurate. 
     
     
         35 . The pharmaceutical product of  claim 33 , wherein the product comprises about 5% w/w sodium croscarmellose. 
     
     
         36 . The pharmaceutical product of  claim 33 , wherein the lubricant is colloidal silicon dioxide and the product comprises about 0.5% to about 2% w/w colloidal silicon dioxide. 
     
     
         37 . The pharmaceutical product of  claim 33 , further comprising about 2% to about 15% w/w alkalizing agent, wherein the alkalizing agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, and sodium arginine. 
     
     
         38 . The pharmaceutical product of  claim 37 , wherein the alkalizing agent is sodium carbonate. 
     
     
         39 . The pharmaceutical product of  claim 33 , wherein the phenyl uracil compound is (E)-N-(4-(3-tert-butyl-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-2-methoxystyryl)phenyl)methanesulfonamide, a salt thereof, or a crystal form thereof. 
     
     
         40 . A method of treating hepatitis C comprising administering to a subject in need thereof an effective amount of the pharmaceutical product of  claim 33 .