System for release in lower gastrointestinal tract

Abstract

A system whereby a substance which is orally taken and to be delivered into the lower digestive tract is selectively delivered into the lower digestive tract. More particularly, a system which makes it possible to surely and quickly deliver the aimed substance to the lower digestive tract without being affected by pH change in the digestive tract due to change in bacterial flora. Compositions disintegrating in the lower digestive tract characterized by containing a compound <A>, which has a molecular weight of 1000 or less and has a disulfide bond, and a polymer <B>, which has a molecular weight exceeding 1000 and is digested by enteric bacteria and/or undergoes softening, swelling or dissolution due to a decrease in pH; molded products with the use of these compositions; and preparations with the use of these molded products.

1 . A formed product suitable for delivery of an active-ingredient for therapeutic use, comprising a matrix comprising chitosan and particles of cystine dispersed in said matrix.  
   
   
       2 . The formed product of  claim 1 , wherein cystine and chitosan are present in a ratio of 10/90 w/w to 90/10 W/W.  
   
   
       3 . The formed product of  claim 1 , wherein the matrix further comprises at least one substance selected from the group consisting of agar, pectin metal salt, carrageenin, gelatin, pectin, starch, cellulose, dimethylaminoethyl methacrylate/methylmethacrylate/butylmethacrylate copolymer and polyvinylacetal diethylaminoacetate that controls disintegration rate of the formed product in the large intestine of the gastrointestional tract.  
   
   
       4 . The formed product of  claim 1 , wherein the formed product is in the form of an empty hard capsule.  
   
   
       5 . The formed product of  claim 1 , wherein the formed product is in the form of a hard capsule, containing an active-ingredient for therapeutic use in the inside of said hard capsule.  
   
   
       6 . The formed product of  claim 5 , wherein the hard capsule further comprises an enteric coating on the outside of said hard capsule.  
   
   
       7 . The formed product of  claim 4 ,  5  or  6 , wherein the matrix containing chitosan further comprises at least one substance that controls disintegration rate in the large intestine of the lower gastrointestinal tract.  
   
   
       8 . The formed product of  claim 7 , wherein the at least one substance that controls the disintegration rate in the large intestine of the lower gastrointestinal tract is at least one substance selected from the group consisting of agar, pectin metal salt, carrageenin, gelatin, pectin, starch, cellulose, dimethylaminoethyl methacrylate/methylmethacrylate/butylmethacrylate copolymer and polyvinylacetal diethylaminoacetate.  
   
   
       9 . A method for delivering a material to a large intestine part of lower gastrointestinal tract of a patient, comprising the step of: 
 orally administering the formed product of  claim 6  to a patient.    
   
   
       10 . A formed product made of the matrix comprising chitosan and particles of cystine dispersed in said matrix; the said product is used for releasing a material selectively in a large intestine part of a lower gastrointestional tract.