Controlled release preparation

Abstract

A controlled release preparation wherein the release of active ingredient is controlled, which releases an active ingredient for an extended period of time by staying or slowly migrating in the gastrointestinal tract, is provided by means such as capsulating a tablet, granule or fine granule wherein the release of active ingredient is controlled and a gel-forming polymer. Said tablet, granule or fine granule has a release-controlled coating-layer formed on a core particle containing an active ingredient.

1 - 49 . (canceled) 
     
     
         50 . A pharmaceutical composition containing a tablet, granule, or fine granule, in which a release of an active ingredient is controlled,
 the pharmaceutical composition comprising: a first component; a second component; and the active ingredient, in one common structure,   wherein the first component and the second component each comprise one polymeric substance or two or more polymeric substances, which control release of the active ingredient,
 the first component and the second component have different properties of controlling the release of the active ingredient from each other, and 
 the elution rate of the active ingredient controlled by the first component is 10% or less for 5 hours in a solution of pH 6.0, and 5% or less for one hour and 60% or more for 8 hours in a solution of pH 6.8, and 
   wherein the active ingredient is R-isomer of lansoprazole or a salt thereof.   
     
     
         51 . The pharmaceutical composition according to  claim 50 ,
 wherein the first component comprises the active ingredient.   
     
     
         52 . The pharmaceutical composition according to  claim 50 ,
 wherein the first component and the second component are present in the one common structure, which comprises a core member containing the active ingredient, and   the first component and the second component are formed on the core member.   
     
     
         53 . The pharmaceutical composition according to  claim 50 ,
 wherein the elution rate of the active ingredient is determined in a Mcilvaine solution.   
     
     
         54 . The pharmaceutical composition according to  claim 50 ,
 wherein the elution rate of the active ingredient is determined in a Clark-Lubs solution.   
     
     
         55 . The pharmaceutical composition according to  claim 52 ,
 wherein the first component and the second component each comprise at least one layer that comprises the one polymeric substance or two or more polymeric substances that have different release properties from each other, and   the at least one layer has the property of controlling the release of active ingredient.   
     
     
         56 . The pharmaceutical composition according to  claim 52 ,
 wherein the at least one layer comprises a pH-dependently soluble polymer, which comprises the one polymeric substance or the two or more polymeric substances that have different release properties from each other.   
     
     
         57 . The pharmaceutical composition according to  claim 56 ,
 wherein the one polymeric substance or the two or more polymeric substances are selected from the group consisting of hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, carboxymethylethyl cellulose, methyl methacrylate-methacrylic acid copolymer, methacrylic acid-ethyl acrylate copolymer, methacrylic acid-methyl acrylate-methyl methacrylate copolymer, hydroxypropyl cellulose acetate succinate, polyvinyl acetate phthalate, and shellac.   
     
     
         58 . The pharmaceutical composition according to  claim 52 , wherein the one common structure further comprises one or more additional layers. 
     
     
         59 . The pharmaceutical composition according to  claim 58 ,
 wherein at least one layer of the at least one layer having the property of controlling the release of active ingredient in the second component and the one or more additional layers is an enteric coating layer.   
     
     
         60 . The pharmaceutical composition according to  claim 59 ,
 wherein the enteric coating layer comprises at least one polymeric substance selected from the group consisting of hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, carboxymethylethyl cellulose, methyl methacrylate-methacrylic acid copolymer, methacrylic acid-ethyl acrylate copolymer, methacrylic acid-methyl acrylate-methyl methacrylate copolymer, hydroxypropylcellulose acetate succinate, polyvinyl acetate phthalate, and shellac.   
     
     
         61 . The pharmaceutical composition according to  claim 58 ,
 wherein at least one layer of the one or more additional layers comprises the active ingredient.