CHOI, SUK YOUNG,崔淑英,KO, YOUN KYUNG,高延庆,高延慶,SO, JIN EON,苏震彦,蘇震彥
申请号：
TW104108045
公开号：
TW201540322A
申请日:
2012.06.01
申请国别(地区):
TW
年份:
2015
代理人:
摘要：
The present invention relates to a stable liquid formulation of etanercept (recombinant p75 sTNFR:Fc fusion protein), and more particularly, to a liquid formulation comprising one or more stabilizers selected from the group consisting of methionine, lysine, histidine, and pharmaceutically acceptable salts thereof in an amount sufficient to reduce by-product formation of etanercept during storage. The liquid formulation according to the present invention effectively reduces production of etanercept by-products and to stably maintain its pharmaceutical efficacies for long-term storage. Therefore, the reconstitution procedure is not required before administration, and the sterile formulation can be administered to patients to ensure patient safety. Thus, it can be applied to the fields in need of etanercept treatment.本發明係關於依那西普(Etanercep)之安定的液體調配劑(重組體p75 sTNFR：Fc融合蛋白質)，且更具體係關於液體調配劑，其包含減少儲存期間依那西普副產物形成之足量的一種或多種選自下列所組成群組之安定劑：甲硫胺酸、離胺酸、組氨酸、和其藥學上可接受的鹽。根據本發明之液體調配劑，有效地減少依那西普之副產物之生成，且在長時間儲存下，安定地維持其藥學療效。因此在投藥前不需重建程序，且可將無菌的調配劑投藥病人以確保病人安全。於是，它能被應用於需要依那西普治療之領域。
