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IMPROVED HIGH-CONCENTRATED LIQUID DRUGS ANTIBODIES AGAINST TNF
专利权人:
ЭББВИ БАЙОТЕКНОЛОДЖИ ЛТД. (BM)
发明人:
НОЙ Михаэль (DE),ЧЕПЕ Маркус (DE),ВЕБЕР Карстен (DE),РЕДДЕН Лаура (US),ФРАУНХОФЕР Вольфганг (US)
申请号:
RU2013126655/15
公开号:
RU2013126655A
申请日:
2011.11.11
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A liquid aqueous preparation comprising: (1) an isolated human anti-TNFα antibody or antigen binding portion thereof; (2) a surfactant; and (3) less than 50 mg / ml polyol; however, injection of the drug to a person results in pain with a visual analogue pain scale (VAS) rating of less than 1.0.2. A liquid aqueous preparation containing: (1) an isolated human anti-TNFα antibody or antigen binding portion thereof; (2) a surfactant; and (3) less than 50 mg / ml polyol; wherein the preparation does not contain buffer or salt, and the injection of the drug reduces the pain associated with the injection in humans by at least about 50% compared with the injection in the rest an identical formulation that contains salt and / or buffer. 3. A liquid aqueous preparation essentially consisting of: (1) more than 50 mg / ml of an isolated human anti-TNFα antibody or antigen binding portion thereof; (2) a surfactant; and (3) less than 50 mg / ml of the polyol, while injecting the drug into a person leads to pain with a visual analogue pain scale (VAS) rating of less than 1.0.4. The preparation according to claim 2, wherein the pain associated with the injection is evaluated using a visual analogue pain scale (VAS). The preparation according to claim 2, wherein the otherwise identical preparation contains citrate-phosphate buffer and sodium chloride. A liquid aqueous preparation containing: (1) an isolated human anti-TNFα antibody or antigen binding portion thereof; (2) a surfactant; and (3) less than 50 mg / ml of the polyol; wherein the preparation is stable up to about 30 ° C for at least 6 days. The drug according to claim 6, in which the drug is1. Жидкий водный препарат, содержащий:(1) выделенное человеческое антитело против TNFα или его антигенсвязывающую часть;(2) поверхностно-активное вещество; и(3) менее чем 50 мг/мл полиола;при этом инъекция препарата человеку приводит к боли с оценкой по визуальной аналоговой шкале боли (ВАШ) меньше 1,0.2. Жидкий водный препарат, сод
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