Enteric coated formulation of a benzimidazole derivative and method for preparation thereof

Abstract

Disclosed are an enteric coated formulation of a benzimidazole derivative comprising a core and a film of an enteric coating agent on the surface thereof, the core containing a complex of the benzimidazole derivative and an ion-exchange resin, and the enteric coating agent having the degree of substitution by an acidic group of less than 30%, and a method for preparation thereof.

What is claimed is:  
     
         1 . An enteric coated formulation of a benzimidazole derivative comprising a core and a film of an enteric coating agent on the surface thereof, the core containing a complex of the benzimidazole derivative and an ion-exchange resin, and the enteric coating agent having the degree of substitution by an acidic group of less than 30%.  
     
     
         2 . The enteric coated formulation according to  claim 1 , wherein the benzimidazole derivative is selected from the group consisting of omeprazole, lansoprazole, pantoprazole, timoprazole and picoprazole.  
     
     
         3 . The enteric coated formulation according to  claim 1 , wherein the ion-exchange resin is an anion-exchange resin.  
     
     
         4 . The enteric coated formulation according to  claim 3 , wherein the anion-exchange resin is cholestyramine resin or Dowex resin.  
     
     
         5 . The enteric coated formulation according to  claim 1 , wherein the enteric coating agent has the degree of substitution by the acidic group of 27% or less.  
     
     
         6 . The enteric coated formulation according to  claim 5 , wherein the enteric coating agent is hydroxypropyl methylcellulose phthalate.  
     
     
         7 . The enteric coated formulation according to  claim 6 , wherein the enteric coating agent is hydroxypropyl methylcellulose phthalate having the degree of substitution by phthalic acid of 20 to 27%.  
     
     
         8 . A method for preparation of an enteric coated formulation of a benzimidazole derivative, comprising the step of coating a core containing a complex of a benzimidazole derivative and an ion-exchange resin with an enteric coating agent having the degree of substitution by an acidic group of less than 30%.