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 Tapentadol is within the range of from 0.10 to 8.00 mg/mL, based on the weight of Tapentadol free base and bas...

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Main Authors BERTRAM, Ulrike, WULSTEN, Eva Cornelia, SCHILLER, Marc, VAN HEMELRIJCK, Carlos, REINHOLD, Ulrich, STRAUB, Stefanie
Format Patent
LanguageEnglish
French
German
Published 31.01.2018
Subjects
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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Abstract 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.
AbstractList 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.
Author BERTRAM, Ulrike
REINHOLD, Ulrich
WULSTEN, Eva Cornelia
VAN HEMELRIJCK, Carlos
SCHILLER, Marc
STRAUB, Stefanie
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– fullname: STRAUB, Stefanie
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DocumentTitleAlternate STABILE FORMULIERUNG ZUR PARENTERALEN VERABREICHUNG VON TAPENTADOL
FORMULATION STABLE POUR L'ADMINISTRATION PARENTERALE DE TAPENTADOL
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Snippet The invention relates to an aqueous pharmaceutical composition for parenteral administration comprising Tapentadol or a physiologically acceptable salt...
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SubjectTerms HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
Title STABLE FORMULATION FOR PARENTERAL ADMINISTRATION OF TAPENTADOL
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