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,   wherein the first component and the second component each comprise one polymeric substance or two or more polymeric substances, which control the 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, 
 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 
 the second component comprises an enteric coating layer, and 
   wherein the active ingredient is R-isomer of lansoprazole or a salt thereof.   
     
     
         51 . The pharmaceutical composition according to  claim 50 ,
 wherein the elution rate of the active ingredient is determined in a Mcilvaine solution.   
     
     
         52 . The pharmaceutical composition according to  claim 50 ,
 wherein the elution rate of the active ingredient is determined in a Clark-Lubs solution.   
     
     
         53 . The pharmaceutical composition according to  claim 50 ,
 wherein each of the first and second components comprises a core member containing the active ingredient.   wherein the first component comprises a release-controlled coating layer that comprises a pH-dependently soluble polymer, which comprises the one polymeric substance or the two or more polymeric substances, which have the different release properties from each other, and   wherein the release of the active ingredient from the second component is controlled by the enteric coating layer.   
     
     
         54 . The pharmaceutical composition according to  claim 53 ,
 wherein the one polymeric substance or the two or more polymeric substances in the release-controlled coating layer are soluble in a pH range from 6.0 to 7.5.   
     
     
         55 . The pharmaceutical composition according to  claim 53 ,
 wherein the one polymeric substance or the two or more polymeric substances having the different release properties in the release-controlled coating layer 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.   
     
     
         56 . The pharmaceutical composition according to  claim 53 ,
 wherein the enteric coating layer comprises the one polymeric substance or the two or more polymeric substances selected from the group consisting of cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxymethylcellulose acetate succinate, ethyl acrylate-methyl methacrylate-trimethylammoniumethyl methacrylate chloride copolymer, methyl methacrylate-ethyl acrylate copolymer, carboxymethyl ethylcellulose, methacrylic acid-ethyl acrylate copolymer, and shellac.   
     
     
         57 . The pharmaceutical composition according to  claim 53 ,
 wherein the release-controlled coating layer covers at least about 80% of a surface of the core member in the first component.   
     
     
         58 . The pharmaceutical composition according to  claim 53 ,
 wherein the enteric coating layer is formed on an intermediate layer formed on the core member in the second component.