ГОЛЬДБАХ Пьер (FR),МАЛЕР Ханс-Кристиан (CH),МЮЛЛЕР Роберт (CH)
申请号：
RU2014140137
公开号：
RU2014140137A
申请日:
2013.03.05
申请国别(地区):
RU
年份:
2016
代理人:
摘要：
1. A stable liquid pharmaceutical preparation of an antibody, comprising: from about 50 mg / ml to 200 mg / ml of an anti-Abeta antibody, from about 0.01% to 0.1% poloxamer, preferably poloxamer 188, from about 5 mM to 50 mM buffer, from about 100 mM to 300 mM stabilizer, at a pH of about 4.5-7.0.2. The pharmaceutical preparation of claim 1, wherein the concentration of anti-Abeta antibody is from about 100 mg / ml to about 200 mg / ml, preferably about 150 mg / ml. A pharmaceutical preparation according to claim 1 or 2, wherein the poloxamer is present in a concentration of from about 0.02% to 0.06%, preferably about 0.04%. The pharmaceutical preparation of claim 1, wherein the buffer is a sodium acetate buffer or histidine buffer, preferably histidine / histidine-HCl buffer. The pharmaceutical preparation of claim 1, wherein the buffer has a concentration of about 10 to 30 mM, preferably about 20 mM. The pharmaceutical preparation of claim 1, wherein the pH of the preparation is about 5-6, preferably about 5.5.7. The pharmaceutical preparation of claim 1, wherein the stabilizer is selected from sugars and amino acids. The pharmaceutical preparation of claim 7, wherein the stabilizer is selected from trehalose and arginine. A pharmaceutical preparation according to claim 7 or 8, wherein the stabilizer has a concentration of from about 100 mM to 300 mM. The pharmaceutical preparation of claim 9, wherein the stabilizer is trehalose and has a concentration of about 150 mM to 250 mM, preferably about 200 mM. The pharmaceutical preparation of claim 9, wherein the stabilizer is arginine and has a concentration of from about 100 mM to 150 mM, preferably about 135 mM. The pharmaceutical preparation of claim 1, wherein the anti-Abeta antibody is a monoclonal antibody comprising a heavy chain and a light chain. The pharmaceutical preparation of claim 12, wherein the heavy chain of the anti-Abeta antibody contains a VH domain that1. Стабильный жидкий фармацевтический препарат
