Grunenthal Gmbh

Gruenenthal Gmbh

Ulrike Bertram

Johannes Bartholomäus

Johannes Heinrich Bartholomaeus

Sebastian Schwier

Lutz Barnscheid

Ulrich Reinhold

Eric Galia

Anja Geissler

Kornelia Griessmann

Marc Schiller

Klaus Wening

Fatima Bicane

Eva Wulsten

Udo Rüttgers

Wolfgang Prange

Angelika Ellermann

Stefanie Straub

Carlos Van Hemelrijck

Gerd Bartz

Annette Grave

Anika-Anina Philipp

Norbert Poellinger

Christian Grosse

Carmen Hartmann

Eva Cornelia Wulsten

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.

Stable formulation for parenteral administration of tapentadol

The invention relates to an an aqueous pharmaceutical composition for parenteral administration comprising Tapentadol or a physiologically acceptable salt thereof; wherein the concentration of Tapentadol is 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.

Stable formulation for parenteral administration of Tapentadol

The invention relates to a pharmaceutical dosage form which is particularly useful for the prevention of an overdose of the pharmacologically active ingredient contained therein after accidental or intentional simultaneous administration of a plurality of the dosage forms containing an overall supratherapeutic dose of the pharmacologically active ingredient.

Protecting oral overdose with abuse deterrent immediate release formulations

A thermoformed pharmaceutical dosage form having a breaking strength of at least 300 N, said dosage form comprising

Oxidation-stabilized tamper-resistant dosage form

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Aachen, Germany

Ulrike Bertram