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WATER PHARMACEUTICAL COMPOSITION CONTAINING A THERAPEUTIC AGENT AND GUANIDINE, GUANIDINE DERIVATIVE AND INJECTION INCLUDING THIS COMPOSITION
专利权人:
НОВАРТИС АГ (CH)
发明人:
ШМИТТ Дэвид (FR),ВАЛЛЬНИ Ханс-Йоахим (DE)
申请号:
RU2014152803
公开号:
RU2014152803A
申请日:
2013.05.23
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. An aqueous composition suitable for injection, comprising: a biological therapeutic agent which, when used to create a solution with a concentration of 100 mM of a biological therapeutic agent in water, results in a solution with a viscosity of at least 10 cP; guanidine and / or a guanidine derivative, moreover, the guanidine derivative has the following formula: where R1 is absent, or represents CH, CH, CH, or CH (n = 1-10); and / or R2 is absent, or is any chemical functional group that slightly reduces the ability of the guanidine group to lower the viscosity of the composition; and R1 and R2 are never absent simultaneously; where guanidine and / or a guanidine derivative are present in the composition at a concentration of at least 25 mM, but not more than 100 mM; iodine; in this case, the composition has a viscosity of not more than 10 cP.2. A composition according to claim 1, characterized in that it is an aqueous ophthalmic composition suitable for intravitreal injection. The composition of claim 1, further comprising a stabilizer. 4. A composition according to claim 3, characterized in that the stabilizer is trehalose. The composition of claim 1, further comprising a surfactant. The composition according to claim 1, characterized in that the viscosity of the composition does not exceed 7 cP. 7. The composition of claim 1, wherein the biological therapeutic agent is an antibody. A composition according to claim 1, wherein the biological therapeutic agent is an IgG1 / lambda isotype antibody. The composition of claim 1, wherein the biological therapeutic agent is an isolated monoclonal antibody that specifically binds to a C5 protein. The composition according to p. 1, characterized1. Водная композиция, пригодная для инъекции, содержащая:биологический терапевтический агент, который при использовании для создания раствора с концентрацией от 100 мМ биологического терапевтического агента в воде приводит к образованию раствора с вязкостью по меньшей мере 10 сП;
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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