CHUNG IN HWA,정인화,LEE IN KYU,이인규,MO KIL WOONG,모길웅,SHIN JAE WON,신재원,KIM HYEON JEONG,김현정,KIM A REUM,김아름,JUNG KI WON,정기원,AN JI HUN,안지훈
申请号：
KR1020180101416
公开号：
KR1019289870000B1
申请日:
2018.08.28
申请国别(地区):
KR
年份:
2018
代理人:
摘要：
The present invention provides a pharmaceutical composition comprising a new monohydrate crystal form. As a new crystalline monohydrate of Mirabegron, the composition has low hygroscopicity and is easy to be stored for a long time. The solubility is enhanced so that a polyethylene 8000, which is a hydrophilic base damaging a mucous membrane in the body, does not need to be used. The flow rate, uniformity, and electrostatic force of the particles are enhanced, so that tableting becomes very easy during a preparation process. The composition also contains 4.3±；1% of water molecules.COPYRIGHT KIPO 2019본 발명자들은 미라베그론의 새로운 결정질 일수화물로서 흡습성이 낮아 장기보관에 용이하고, 용해도가 개선되어 체내 점막을 손상시키는 친수성 기제인 폴리에틸렌글리콜 8000을 사용하지 않아도 되며, 입자의 흐름도, 균일성, 정전기력이 향상 되어 제제과정에서 타정에 매우 용이하고 물분자를 4.3% ±1% 함유하는 새로운 일수화물 결정형을 포함한 약제학적 조성물을 제공한다.
