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STABLE ANTI-INFLAMMATORY INJECTION SOLUTIONS
专利权人:
ОМЕРОС КОРПОРЕЙШН (US)
发明人:
ДЕМОПУЛОС Грегори А. (US),ГОМБОТЦ Уэйн Р. (US),ШЭНЬ Хуэй-жун (US)
申请号:
RU2014108159/15
公开号:
RU2014108159A
申请日:
2012.08.03
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A liquid pharmaceutical composition containing from 550 μM to 1 M ketoprofen, from 55 μM to 1 M amitriptyline, from 350 μM to 1 M oxymetazoline, 1-100% (vol./about.) Polyol and 10-500 mm Na citrate pH 4.5-7.0, in which ketoprofen, amitriptyline and oxymetazoline are soluble and in which ketoprofen, amitriptyline and oxymetazoline are stable for at least six months when stored at a temperature between 2 ° C and 30 ° C. 2. The pharmaceutical composition according to claim 1, wherein the polyol concentration is 15-25% (v / v). The pharmaceutical composition according to claim 1, wherein the polyol is PEG 400.4. The pharmaceutical composition of claim 1, wherein the composition is an aqueous composition comprising 75-85% (v / v) water. The pharmaceutical composition according to claim 1, where the pH is between 5.2 and 5.8.6. The pharmaceutical composition according to claim 1, where the pH is between 5.4 and 5.6.7. The pharmaceutical composition according to claim 1, where ketoprofen, amitriptyline, oxymetazoline are stable for at least twelve months when stored at a temperature between 2 ° C and 30 ° C. The pharmaceutical composition according to claim 1, where ketoprofen, amitriptyline, oxymetazoline are stable for at least twenty-four months when stored at a temperature between 2 ° C and 30 ° C. The pharmaceutical composition according to claim 1, further comprising 0.01-0.05% (w / v) NaEDTA. The pharmaceutical composition according to claim 1, wherein the concentration of NaEDTA is 0.05% (w / v). The pharmaceutical composition of claim 1, wherein the concentration of Na citrate is about 50 mM. A liquid pharmaceutical composition containing 0.1-1.0 g / l of ketoprofen, 0.05-0.5 g / l of amitriptyline, 0.05-0.5 g / l of oxymetazoline, about 0.002-1.0% (wt. ./vol.) NaEDTA and 10-500 mM Na citrate in a medium containing 10-70% (vol./about.) PEG 400 and 30-90% (vol./about.) water, with a pH of 5.0- 6.2, �1. Жидкая фармацевтическая композиция, содержащая от 550 мкМ до
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