Novel preparation containing benzimidazole derivative

Abstract

The present invention relates to a novel formulation comprising a benzimidazole derivative. The formulation for oral administration comprising a compound of Formula 1 according to the present invention or a pharmaceutically acceptable salt thereof; and at least one disintegrant selected from the group consisting of croscarmellose sodium, sodium starch glycolate and low-substituted hydroxypropylcellulose, exhibits an excellent storage stability and has an effect on preventing a phenomenon of decline in dissolution rate, thus being usefully used as a formulation for oral administration.

1 .- 9 . (canceled) 
     
     
         10 . A tablet comprising a compound of Formula 1, or a pharmaceutically acceptable salt thereof, prepared by a process comprising:
 mixing the compound with an excipient and a disintegrant;   adding a binder solution comprising at least one binder and distilled water, thereby creating a mixture;   kneading and drying the mixture;   adding a lubricant to the mixture; and   pressing the mixture into a tablet   
       
         
           
           
               
               
           
         
       
     
     
         11 . The tablet of  claim 10 , wherein the excipient is mannitol, lactose, starch, microcrystalline cellulose, colloidal silicon dioxide, or a combination thereof. 
     
     
         12 . The tablet of  claim 11 , wherein the excipient is a combination of mannitol and microcrystalline cellulose. 
     
     
         13 . The tablet of  claim 11 , wherein the excipient is a combination of lactose and microcrystalline cellulose. 
     
     
         14 . The tablet of  claim 11 , wherein the excipient is a combination of starch and microcrystalline cellulose. 
     
     
         15 . The tablet of  claim 10 , wherein the disintegrant is croscarmellose sodium, sodium starch glycolate, or low-substituted hydroxypropylcellulose. 
     
     
         16 . The tablet of  claim 15 , wherein the disintegrant is croscarmellose sodium. 
     
     
         17 . The tablet of  claim 16 , wherein the croscarmellose sodium ranges from 6 mg to 30 mg and the tablet has a mass of 200 mg. 
     
     
         18 . The tablet of  claim 15 , wherein the disintegrant is sodium starch glycolate. 
     
     
         19 . The tablet of  claim 15 , wherein the disintegrant is low-substituted hydroxypropylcellulose having a substitution degree of a hydroxypropoxy group that amounts to 5 to 16 mass %. 
     
     
         20 . The tablet of  claim 10 , wherein the binder is hydroxypropylcellulose, polyvinylpyrrolidone, or copovidone. 
     
     
         21 . The tablet of  claim 20 , wherein the binder is hydroxypropylcellulose. 
     
     
         22 . The tablet of  claim 20 , wherein the binder is polyvinylpyrrolidone. 
     
     
         23 . The tablet of  claim 20 , wherein the binder is copovidone. 
     
     
         24 . The tablet of  claim 10 , wherein the lubricant is at least one selected from the group consisting of stearic acid, magnesium stearate, calcium stearate, sodium benzoate, sodium stearyl fumarate, glyceryl monooleate, glyceryl monostearate, glyceryl behenate, glyceryl palmitostearate, zinc stearate, paraffin group, and mixtures thereof. 
     
     
         25 . The tablet of  claim 24 , wherein the lubricant is magnesium stearate. 
     
     
         26 . The tablet of  claim 10 , wherein the process for preparing further comprises sizing the mixture to obtain granules of a certain size. 
     
     
         27 . The tablet of  claim 10 , further comprising adding a second excipient when adding the lubricant. 
     
     
         28 . The tablet of  claim 27 , wherein the second excipient is colloidal silicon dioxide. 
     
     
         29 . The tablet of  claim 10 , wherein the compound is in the amount of 50 mg or 100 mg.