Formulación estable para la administración parenteral de tapentadol

• Main Authors: BERTRAM, Ulrike, WULSTEN, Eva Cornelia, SCHILLER, Marc, VAN HEMELRIJCK, Carlos, REINHOLD, Ulrich, STRAUB, Stefanie
• Format: Patent
• Language: Spanish
• Published: 24.04.2019
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

Una composición farmacéutica acuosa para administración parenteral que comprende tapentadol o una sal fisiológicamente aceptable del mismo, donde la concentración de tapentadol está dentro del intervalo de 0,10 a 8,00 mg/ml, basada en el peso de la base libre de tapentadol y basada en el volumen total de la composición; y donde el valor de pH de la composición está tamponado y dentro del intervalo de 4,0 a 6,0. 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 8.00 mg/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.