发明名称 |
LIQUID FORMULATION OF LONG-ACTING INSULIN CONJUGATE |
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. |
申请公布号 |
US2015196643(A1) |
申请公布日期 |
2015.07.16 |
申请号 |
US201314415206 |
申请日期 |
2013.07.25 |
申请人 |
HANMI PHARM. CO., LTD. |
发明人 |
Lim Hyung Kyu;Kim Hyun Uk;Hong Sung Hee;Kim Min Young;Bae Sung Min;Kwon Se Chang |
分类号 |
A61K47/26;A61K47/10;A61K47/12;A61K47/02;A61K38/28;A61K47/48 |
主分类号 |
A61K47/26 |
代理机构 |
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代理人 |
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主权项 |
1. A liquid formulation of long-acting insulin conjugate, comprising a pharmaceutically effective amount of a long-acting insulin conjugate, wherein an insulin which is a physiologically active peptide, 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. |
地址 |
Hwaseong-si, Gyeonggi-do KR |