БАЕ Сунг Мин (KR),ИМ Дае Сеонг (KR),КИМ Мин Янг (KR),ЛИМ Чанг Ки (KR),ДЗУНГ Сунг Юб (KR),КВОН Се Чанг (KR)
申请号：
RU2015103071/15
公开号：
RU2015103071A
申请日:
2011.01.18
申请国别(地区):
RU
年份:
2015
代理人:
摘要：
1. A liquid pharmaceutical composition of a long acting erythropoietin conjugate (EPO) comprising a therapeutically effective amount of a long acting erythropoietin conjugate in which EPO is covalently linked to an immunoglobulin Fc fragment via a non-peptide polymer or peptide linker, and an albumin-free stabilizer comprising a buffer and mannitol, where the albumin-free stabilizer contains mannitol in an amount of 3 to 12% (w / v) and does not contain neutral amino acids, and where the buffer is a buffer on again sodium phosphate or sodium citrate buffer. 2. The liquid composition according to claim 1, where the concentration of the buffer lies in the range from 5 to 100 mm. The liquid composition according to claim 1, where the pH of the buffer lies in the range from 4 to 8.4. The liquid composition of claim 1, wherein the albumin-free stabilizer further comprises an ingredient selected from the group consisting of isotonic, polyhydroalcohol, sugar, non-ionic surfactant, and combinations thereof. The liquid composition according to claim 4, wherein the isotonic agent is a salt selected from the group consisting of sodium chloride, sodium sulfate, sodium citrate, and a combination thereof. The liquid composition according to claim 4, wherein the concentration of the isotonic agent is in the range of 5 to 200 mM. The liquid composition according to claim 4, wherein the nonionic surfactant is a polysorbate or poloxamer nonionic surfactant. The liquid composition of claim 7, wherein the polysorbate-based nonionic surfactant is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, and polysorbate 80.9. The liquid composition according to claim 4, where the concentration1. Жидкий фармацевтический состав конъюгата эритропоэтина (ЕРО) длительного действия, содержащий терапевтически эффективное количество конъюгата эритропоэтина длительного действия, в котором ЕРО ковалентно соединен с Fc-фрагментом иммуноглобулина посредством непептидного
