COMPOSITIONS CONTROLLING pH RANGE OF RELEASE AND/OR RELEASE RATE

Abstract

The present invention provides a composition controlling a pH range of release and/or a release rate, which contains (i) a thienotriazolodiazepine compound of the formula (I) and (ii) at least one kind of ingredient selected from the group consisting of a water-soluble polymer, an enteric polymer, a water-insoluble polymer and a porous polymer and/or a surfactant, as well as a production method thereof.

1 - 26 . (canceled) 
     
     
         27 . A composition comprising,
 (i) a thienotriazolodiazepine compound of the formula (I)   
       
         
           
           
               
               
           
         
         wherein X is a halogen, R 1  is C 1 -C 4  alkyl, R 2  is C 1 -C 4  alkyl, a is an integer of 1-4, R 3  is C 1 -C 4  alkyl, C 1 -C 4  hydroxyalkyl, C 1 -C 4  alkoxy, phenyl optionally having substituent(s), or heteroaryl optionally having substituent(s), a pharmaceutically acceptable salt thereof or a hydrate thereof and 
         (ii) at least one polymer selected from the group consisting of hydroxypropylmethylcellulose phthalate, methacrylic acid-methyl methacrylate copolymer, hydroxypropylmethylcellulose acetate succinate, and combinations thereof. 
       
     
     
         28 . The composition of  claim 27 , wherein the compound of the formula (I), a pharmaceutically acceptable salt thereof or a hydrate thereof is (S)-2-[4-(4-chlorophenyl)-2,3,9-trimethyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepin-6-yl]-N-(4-hydroxyphenyl)acetamide or a dihydrate thereof. 
     
     
         29 . The composition of  claim 27 , wherein the polymer is hydroxypropylmethylcellulose acetate succinate.