COMPOSITIONS CONTROLLING pH RANGE OF RELEASE AND/OR RELEASE RATE
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.