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FORMULATION LIQUIDE À BASE D'UN CONJUGUÉ D'INSULINE À ACTION PROLONGÉE
专利权人:
Hanmi Pharm. Co.; Ltd.
发明人:
申请号:
EP13822348.2
公开号:
EP2877157B1
申请日:
2013.07.25
申请国别(地区):
EP
年份:
2018
代理人:
摘要:
The present invention relates to a liquid formulation of long-acting insulin conjugate, comprising a pharmaceutically effective amount of a long-acting insulin conjugate, wherein a physiologically active peptide, which is an insulin, is linked to 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 preventing microbial contamination in multiple uses, a preservative can be added to the formulation. The liquid formulation of the present invention does not comprise a human serum albumin and potentially hazardous factors to body, and thus it has excellent storage stability for insulin conjugate without a risk of viral infection.
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中国工程科技知识中心
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