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PHARMACEUTICAL COMPOSITIONS CONTAINING IGF-I PROTEINS, BUFFER SUBSTANCE AND SUBSTANCE REGULATING TONICITY
专利权人:
Ф. ХОФФМАНН-ЛЯ РОШ АГ (CH)
发明人:
МАЛЕР Ханс-Кристиан (CH),ПАППЕНБЕРГЕР Астрид (CH)
申请号:
RU2012130606/15
公开号:
RU2012130606A
申请日:
2010.12.20
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A pharmaceutical composition comprising an IGF-I protein, a tonicity regulating agent, and a buffer. The pharmaceutical composition according to claim 1, where the buffer is a histidine, citrate, acetate or succinate buffer, and where the pH is from 4.5 to 6.5.3. The pharmaceutical composition according to claim 1, where the pH is from 5.0 to 6.0.4. The pharmaceutical composition of claim 1, wherein the buffer is a citrate buffer of 5 to 100 mM. The pharmaceutical composition according to claim 1, wherein the buffer is a histidine buffer of 5 to 100 mM. The pharmaceutical composition according to claim 1, wherein the tonicity regulating agent is an amino acid, sugar, or combinations thereof. The pharmaceutical composition according to claim 1, wherein the tonicity regulating agent is trehalose, sucrose or arginine, or a combination thereof in a concentration of from 10 to 1000 mM. The pharmaceutical composition according to claim 1, wherein the tonicity regulating agent is arginine in a concentration of from 50 to 300 mM. The pharmaceutical composition according to claim 1, which further comprises a surfactant. The pharmaceutical composition of claim 9, wherein the surfactant is polysorbate or poloxamer, or a combination thereof. The pharmaceutical composition according to claim 9, wherein the surfactant is Polysorbate 20, Polysorbate 80 or Poloxamer 188 in a concentration of from 0.001 to 1% (w / w). The pharmaceutical composition of claim 1, further comprising an antioxidant. The pharmaceutical composition of claim 11, wherein the antioxidant is methionine in a concentration of 1 to 50 mM. The pharmaceutical composition according to claim 1, where the IGF-I protein is an IGF-I variant, characterized in that it is derived from amine�1. Фармацевтическая композиция, содержащая белок IGF-I, вещество, регулирующее тоничность, и буфер.2. Фармацевтическая композиция по п.1, где буфер представляет собой гистидиновый, цитратный, ацетатный или сукцинатный буфер, и где рН
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