STABLE FORMULATION FOR PARENTERAL ADMINISTRATION OF TAPENTADOL

• Main Authors: SCHILLER MARC, WULSTEN EVA CORNELIA, BERTRAM ULRIKE, STRAUB STEFANIE, VAN HEMELRIJCK CARLOS, REINHOLD ULRICH
• Format: Patent
• Language: Chinese; English
• Published: 27.03.2018
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The invention relates to an aqueous pharmaceutical composition for parenteral administration comprising Tapentadol or a physiologically acceptable salt thereof, wherein the concentration of Tapentadolis 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. 本发明涉及用于肠胃外给药的含水药物组合物，其包含他喷他多或其生理上可接受的盐，其中他喷他多的浓度为0.10至8.00mg/ml，基于他喷他多游离碱的重量并基于所述组合物的总体积；并且其中所述组合物的pH值被缓冲并为4.0至6.0。本发明还涉及包含所述药物组合物的容器和用于制备其的方法。本发明还涉及在包装中包含根据本发明的内容物的试剂盒。根据本发明的药物组合物特别用于治疗优选儿科患者中的疼痛，尤