SK CHEMICALS CO., LTD.; LTD.;SK CHEMICALS CO.;에스케이케미칼 주식회사
发明人:
PARK, Jun-sung,박준성,SHIN, DongChul,신동철,RYU, Keun-Ho,류근호,SHIN, Ho Chul,신호철,HWANG, Sang-wook,황상욱,KIM, Gwan-young,김관영,KIM, Hun-Taek,김훈택
申请号：
KRKR2015/004021
公开号：
WO2015/163689A1
申请日:
2015.04.22
申请国别(地区):
KR
年份:
2015
代理人:
摘要：
The present invention relates to a composition, prepared by a melt extrusion method, comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl]-2-thiophene carboxamide as an active ingredient. The composition according to the present invention has a wide variety of advantages, such as securing an elution rate and bioavailability of an active ingredient, improving an absorption deviation according to whether a patient has a meal or not, securing stability during the preparation process, etc. Also, the present invention provides a method for preparing such a composition.La présente invention concerne une composition, préparée par un procédé d'extrusion par fusion, comprenant comme principe actif le 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phényl]-1,3-oxazolidin-5-yl}-méthyl]-2-thiophène carboxamide. La composition selon la présente invention présente un grand nombre d'avantages, tels que d'assurer le débit d'élution et la biodisponibilité du principe actif, d'améliorer les différences d'absorption selon que le patient est à jeun ou pas, garantir la stabilité au cours du procédé de préparation, etc. En outre, la présente invention concerne un procédé de préparation d'une telle composition.본 발명은 5-클로로-N-({(5S)-2-옥소-3-[4-(3-옥소-4-모르폴리닐)-페닐]-1,3-옥사졸리딘-5-일}-메틸]-2-티오펜카르복스아미드를 유효 성분으로 포함하는, 용융 압출법으로 제조된 조성물에 관한 것이다. 본 발명에 따른 조성물은 유효 성분의 용출률 및 생체이용률이 확보되고, 환자의 식사 여부에 따른 흡수 편차가 개선되며, 제조 과정에서의 안정성이 확보되는 등 매우 다양한 장점을 가진다. 본 발명은 또한 이러한 조성물을 제조할 수 있는 제조 방법을 제공한다.
