发明名称 |
STABLE FORMULATION FOR PARENTERAL ADMINISTRATION OF TAPENTADOL |
摘要 |
The invention relates to an aqueous pharmaceutical composition for parenteral administration comprising Tapentadol or a physiologically acceptable salt thereof, wherein the concentration of Tapentadol is within the range of from 0.10 to 8.00mg/mL, based on the weight of Tapentadol free base and based on the total volume of the composition; and wherein the pH value of the composition is buffered and within the range of from 4.0 to 6.0. The invention also relates to a container comprising the pharmaceutical composition and a process for the preparation thereof. The invention also relates to a kit comprising the contained according to the invention in a packaging. The pharmaceutical composition according to the invention is particularly useful for treating pain, especially acute pain, preferably in pediatric patients. |
申请公布号 |
WO2016156147(A1) |
申请公布日期 |
2016.10.06 |
申请号 |
WO2016EP56376 |
申请日期 |
2016.03.23 |
申请人 |
GRÜNENTHAL GMBH |
发明人 |
SCHILLER, Marc;VAN HEMELRIJCK, Carlos;STRAUB, Stefanie;WULSTEN, Eva Cornelia;BERTRAM, Ulrike;REINHOLD, Ulrich |
分类号 |
A61K31/137;A61K9/00 |
主分类号 |
A61K31/137 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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