KIM, HYUN UK,金贤煜,金賢煜,LIM, HYUNG KYU,林亨奎,HONG, SUNG HEE,洪性熙,KIM, DAE JIN,金大振,BAE, SUNG MIN,裵城敏,KWON, SE CHANG,权世昌,權世昌
申请号：
TW102126621
公开号：
TW201408337A
申请日:
2013.07.25
申请国别(地区):
TW
年份:
2014
代理人:
摘要：
The present invention relates to a liquid formulation of long-acting insulinotropic peptide conjugate, comprising a pharmaceutically effective amount of long-acting insulinotropic peptide conjugate consisting of a physiologically active peptide, insulinotropic peptide, and an immunoglobulin Fc region； and an albumin-free stabilizer, wherein the stabilizer comprises a buffer, a sugar alcohol, a non-ionic surfactant, and an isotonic agent, and a method for preparing the formulation. For the purpose of preventing microbial contamination, a preservative may be added. The liquid formulation of the present invention is free of human serum albumin and other potentially hazardous factors to body, having no risk of viral contamination, and thus can provide excellent storage stability for insulinotropic peptide conjugates at high concentration.本發明係有關一種長效胰促泌素肽接合物之液體製劑及製備該製劑之方法，該製劑包括：醫藥上有效量之由生理活性肽、胰促泌素肽及免疫球蛋白Fc區組成之長效胰促泌素肽接合物；及不含白蛋白的安定劑，其中該安定劑包括緩衝劑、糖醇、非離子性界面活性劑、及等張劑。為了防止微生物污染可添加保藏劑。本發明之液體製劑係不含人血清白蛋白及其他對身體具潛在危險的因子，無病毒污染風險，因而可對高濃度胰促泌素肽接合物提供優異儲存安定性。
