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STABLE LIQUID ETHANERCEPT COMPOSITION
专利权人:
ЭлДжи Лайф Сайенсиз Лтд. (KR)
发明人:
ЧОЙ Сук Ян (KR),КО Янь Кьюн (KR),СО Джинь Еонь (KR)
申请号:
RU2013156112/10
公开号:
RU2013156112A
申请日:
2012.06.01
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A liquid etanercept composition comprising etanercept and one or more than one stabilizer selected from the group consisting of methionine, lysine, histidine and their pharmaceutically acceptable salts. The liquid composition according to claim 1, wherein the stabilizer is methionine and / or its pharmaceutically acceptable salts. The liquid composition according to claim 1, where the stabilizer is present in an amount of from 0.1 to 250 mm. The liquid composition according to claim 1, wherein etanercept is present in an amount of from 1 to 100 mg / ml. The liquid composition according to claim 1, having increased storage stability of etanercept compared to a composition without stabilizers, due to the reduction of by-products of etanercept that result from denaturation during storage. The liquid composition of claim 1, further comprising one or more than one substance selected from the group consisting of a buffer, an isotonic agent, an excipient, or a preservative. The liquid composition of claim 6, wherein the buffer is selected from the group consisting of citrate, phosphate, succinate, tartrate, fumarate, gluconate, oxalate, lactate, acetate, histidine, and Tris. The liquid composition of claim 6, wherein the buffer is present in an amount of from 0.1 to 100 mM. The liquid composition according to claim 6, wherein the isotonic agent is selected from the group consisting of sodium chloride, potassium chloride, boric acid, sodium borate, mannitol, glycerol, propylene glycol, polyethylene glycol, maltose, sucrose, erythritol, arabitol, xylitol, sorbitol and glucose. 10. The liquid composition according to claim 6, where the isotonic agent is present in an amount of from 1 to 1000 mm. The liquid composition according to claim 1, containing from 1 to 100 mg / ml etanercept, from 0.1 to 250 mm methionine or its pharmaceutically acceptable1. Жидкая композиция этанерцепта, содержащая этанерцепт и один или более чем один стабилизатор, выбранный из группы, состоящей и
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