TABLET INCLUDING 7-[4-(4-BENZO[BETA]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
申请人:Otsuka Pharmaceutical Co., Ltd.
公开号:EP2767285A1
公开(公告)日:2014-08-20
This invention relates to a tablet containing, as an active ingredient, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof, that has excellent disintegration ability, storage stability and photostability.
The tablet of the present invention comprising an uncoated tablet containing 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof as an active ingredient, excipients such as lactose, corn starch, and microcrystalline cellulose; disintegrants such as low-substituted hydroxypropylcellulose, croscarmellose sodium, and sodium carboxymethyl starch; binders such as hydroxypropylcellulose; lubricants such as stearate;
and further comprising a coating layer containing hypromellose; talc; titanium oxide; colorant; and the like, the coating layer being applied to the surface of the uncoated tablet.
本发明涉及一种含有 7-[4-(4-苯并[b]噻吩-4-基-哌嗪-1-基)丁氧基]-1H-喹啉-2-酮或其盐作为活性成分的片剂,该片剂具有良好的崩解能力、储存稳定性和光稳定性。
本发明的片剂包括含有 7-[4-(4-苯并[b]噻吩-4-基-哌嗪-1-基)丁氧基]-1H-喹啉-2-酮或其盐作为活性成分的无包衣片剂,辅料如乳糖、玉米淀粉和微晶纤维素;崩解剂,如低取代羟丙基纤维素、croscarmellose sodium 和羧甲基淀粉钠; 粘合剂,如羟丙基纤维素; 润滑剂,如硬脂酸盐;
还包括一层包衣,包衣层含有低聚果糖、滑石粉、氧化钛、着色剂等,包衣层涂在未包衣片剂的表面。