STABLE FORMULATION FOR PARENTERAL ADMINISTRATION OF TAPENTADOL

The invention relates to an aqueous pharmaceutical composition for parenteral administration comprising Tapentadol or a physiologically acceptable salt thereof; wherein the concentration of Tapentadolis greater than 8.00 mg/mL, based on the weight of Tapentadol free base and based on the total volume of the composition; wherein the composition comprises a buffer system; and wherein the pH value of the composition is within the range of from greater than 3.0 to less than 6.7.The invention also relates to a kit comprising the composition 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 adult patients. 本发明涉及一种用于肠胃外施用的水性药物组合物，其包含他喷他多或其生理学上可接受的盐；其中基于他喷他多游离碱的重量并基于所述组合物的总体积，他喷他多的浓度大于8.00mg/mL；其中所述组合物包含缓冲系统；并且其中所述组合物的pH值在大于3.0至小于6.7的范围内。本发明还涉及在包装中包含根据本发明的组合物的药盒。根据本发明的药物组合物特别适用于优选在成人患者中治疗疼痛，尤其是急性疼痛。