| 发明名称 |
Dry Growth Hormone Composition Transiently Linked to a Polymer Carrier |
| 摘要 |
The present invention relates to dry compositions of rhGH polymer prodrug containing a lyoprotectant and, optionally, one or more than one excipient. Such compositions are stable for at least 1 year, when stored at 2-8° C. The invention further relates to methods of manufacturing said compositions, containers comprising such composition as well as a kit of parts. |
| 申请公布号 |
US2017056477(A1) |
申请公布日期 |
2017.03.02 |
| 申请号 |
US201615340595 |
申请日期 |
2016.11.01 |
| 申请人 |
Ascendis Pharma Growth Disorders Division A/S |
发明人 |
Rasmussen Grethe Nørskov;Kindermann Susanne;Rau Harald;Wegge Thomas |
| 分类号 |
A61K38/27;A61K45/06;A61K47/12;A61K47/18;A61M5/19;A61K47/10;A61K47/48;A61K9/00;A61K9/19;A61K47/26;A61K9/08 |
主分类号 |
A61K38/27 |
| 代理机构 |
|
代理人 |
|
| 主权项 |
1. A pen injector comprising:
a cartridge comprising:
a dry composition comprising:
a therapeutically effective amount of a recombinant human growth hormone (“rhGH”) polymer prodrug; anda lyoprotectant;wherein the rhGH is transiently linked via a reversible linker moiety to a polymer carrier, andwherein the composition is stable for at least 6 months when stored at temperatures ranging from 2 to 25° C., where during such storage less than 5% of the rhGH is released from the rhGH polymer prodrug as free rhGH. |
| 地址 |
Hellerup DK |
