РАСМУССЕН Гретэ Нерсков (DK),КИНДЕРМАНН Зузанне (CH),РАУ Харальд (DE),ВЕГГЕ Томас (DE)
申请号：
RU2012129674/15
公开号：
RU2012129674A
申请日:
2010.12.15
申请国别(地区):
RU
年份:
2014
代理人:
摘要：
1. A dry composition containing a therapeutically effective amount of a polymeric prodrug of rhGH and one or more lyoprotectors, where growth hormone is temporarily associated with a polymeric carrier. The composition according to claim 1, characterized in that the composition is dried by lyophilization. The dry composition according to claim 1 or 2, characterized in that the dry composition is stable for at least one year when stored at 2-25 ° C. The composition of claim 1, wherein the lyoprotector is trehalose. The composition according to claim 1, characterized in that the composition is provided in a single dose. The composition according to claim 1, characterized in that the composition is provided in the form of a multiple dose. The composition of claim 1, wherein the rhGH polymer prodrug has the chemical structure shown by formula (A), where HN-rhGH is the rhGH residue attached to a temporary linker； R1, R2, R3, R4 and R5 are independently selected from hydrogen, methyl, ethyl, propyl, isopropyl, butyl, isobutyl, tert-butyl； PEG is a pegylated residue attached to a temporary linker； n = 1 or 2； IX is selected from C1-C8 alkyl or C1-C12 heteroalkyl. 8. The composition of claim 7, wherein the constituent formula (A) has the following structure, wherein in each case, independently represents an integer from 250 to 750, preferably an integer from 300 to 400, and more preferably 500.9. The composition according to claim 1, characterized in that it contains one or more additional biologically active agents, either in their free form or as a prodrug, and in that one or more additional biologically active agents are selected from the group consisting of IGF- 1, ghrelin or ghrelin-like compounds, and1. Сухая композиция, содержащая терапевтически эффективное количество полимерного пролекарства rhGH и один или более лиопротекторов, где гормон роста временно связан с полимерным носителем.2. Композиция по п.1, отличающаяся тем, что композиция высушивается посредством лиоф
