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LIQUID COMPOSITIONS FOR LONG-TERM ETHYTROPOETIN CONJUGATE
专利权人:
ХАНМИ САЙЕНС КО.; ЛТД. (KR)
发明人:
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:
RU2012135505/15
公开号:
RU2012135505A
申请日:
2011.01.18
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A long-acting erythropoietin conjugate liquid composition containing a therapeutically effective amount of a long-acting erythropoietin conjugate in which the EPO is covalently linked to an immunoglobulin Fc moiety through a non-peptide polymer or peptide linker, and an albumin-free stabilizer comprising a buffer and mannitol. . The liquid composition according to claim 1, where the concentration of mannitol is in the range from 1 to 20% (w / v), based on the total volume of the liquid composition. The liquid composition according to claim 1, wherein the buffer is selected from the group consisting of citrate, phosphate, tartrate, carbonate, succinate, lactate and acetate buffers. 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 8.6. The liquid composition of claim 1, wherein the albumin-free stabilizer further comprises an ingredient selected from the group consisting of an isotonic agent, polyhydroalcohol, sugar, a nonionic surfactant, a neutral amino acid, and a combination thereof. The liquid composition according to claim 6, 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 6, where the concentration of the isotonic agent is in the range from 5 to 200 mm. The liquid composition according to claim 6, where the non-ionic surfactant is a non-ionic surfactant based on polysorbate or poloxamer. The liquid composition according to claim 9, where the non-ionic polysorbate-based surfactant is selected from the group consisting of polysorbate 20, polysorbate 40, polysorb1. Жидкий состав конъюгата эритропоэтина (EPO) длительного действия, содержащий терапевтически эффективное количество конъюгата эритропоэтина длительного действия, в котором EPO ковалентно соед
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