KIM HYUN UK,LIM HYUNG KYU,JANG MYUNG HYUN,KIM SANG YUN,BAE SUNG MIN,KWON SE CHANG
申请号:
CL2015001206
公开号:
CL2015001206A1
申请日:
2015.05.06
申请国别(地区):
CL
年份:
2015
代理人:
摘要:
The present invention relates to an albumin-free liquid formulation comprising a long-lasting oxyntomodulin conjugate in which an oxyntomodulin peptide comprising a derivative, variant, precursor or fragment of oxyntomodulin is linked to an immunoglobulin Fc region, which can increase the duration of physiological activity of the long-lasting oxyntomodulin conjugate and maintain theinvivostability thereof for an extended period of time, as compared to native oxyntomodulin, as well as a method for preparing the liquid formulation. The liquid formulation comprises a buffer, a sugar alcohol and a nonionic surfactant and does not contain a human serum albumin and factors that are potentially harmful to the human body, and thus is not susceptible to viral infection. In addition, the oxyntomodulin conjugate of the invention comprises oxyntomodulin linked to an immunoglobulin Fc region, and thus has a large molecular weight, prolonged physiological activity, and excellent storage stability, compared to native oxyntomodulin.Una formulación líquida de un conjugado de oxintomodulina de larga duración que comprende una cantidad farmacológicamente activa de un conjugado de oxintomodulina de larga duración, en la que el conjugado de un derivado de oxintomodulina comprende un derivado de oxintomodulina que es un péptido fisiológicamente activo y una región de inmunoglobulina Fc y un polímero no peptidilo, donde el polímero no peptidilo se une covalentemente al derivado de oxintomodulina y la región Fc y un estabilizante libre de albumina, en la que el estabilizante contiene un tampón, un alcohol de azúcar y un tensioactivo no iónico.