LEE, JOON WON,李晙源,HAN, WON YONG,韩元熔,韓元鎔,KIM, SU JUNG,金水晶,OH, JUN SEOK,吴俊锡,吳俊錫,KIM, SO YOUNG,金昭英,HONG, SU HYEON,洪秀贤,洪秀賢,SHIN, YEON KYEONG,申姸暻
申请号：
TW106121657
公开号：
TW201806617A
申请日:
2017.06.28
申请国别(地区):
TW
年份:
2018
代理人:
摘要：
The present invention provides a stable liquid pharmaceutical formulation containing: an antibody or its antigen-binding fragment； a surfactant； a sugar or its derivative； and a buffer. The stable liquid pharmaceutical formulation according to the present invention has low viscosity while containing a high content of the antibody, has excellent long-term storage stability based on excellent stability under accelerated conditions and severe conditions, and may be administered subcutaneously.本發明提供一種穩定之液體醫藥調配物，其含有：一抗體或其與抗原結合之片段；一表面活性劑；糖或其衍生物；一緩衝液。根據本發明的穩定液體醫藥調配物具有低黏度而含有高含量之抗體，依據其在加速條件與嚴苛條件下之優異穩定性質，其具優異的長期貯存穩定性，且可經皮下注射。
