NOVEL STABLE HIGH-CONCENTRATION FORMULATION FOR ANTI-FXIA ANTIBODIES

The present invention refers to novel liquid pharmaceutical high-concentration formulations particularly suitable for subcutaneous administration comprising human antibodies against coagulation factor FXIa as active ingredient, especially those described in WO2013167669, which are stable as liquid f...

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Hauptverfasser: HEKE, STEFAN, VEURINK, MARIEKE, PLITZKO, MATTHIAS, GOMBERT, NIKLAS, KLAK, ALEXANDER, SCHNEID, STEFAN CHRISTIAN
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creator HEKE, STEFAN
VEURINK, MARIEKE
PLITZKO, MATTHIAS
GOMBERT, NIKLAS
KLAK, ALEXANDER
SCHNEID, STEFAN CHRISTIAN
description The present invention refers to novel liquid pharmaceutical high-concentration formulations particularly suitable for subcutaneous administration comprising human antibodies against coagulation factor FXIa as active ingredient, especially those described in WO2013167669, which are stable as liquid formulations over a long period. The invention also refers to lyophilizates of the specified liquid formulation with reduced reconstitution time and also to the use of these formulations in the therapy and prophylaxis of thrombotic or thromboembolic disorde. La présente invention concerne de nouvelles formulations pharmaceutiques liquides à haute concentration particulièrement appropriées pour une administration sous-cutanée comprenant des anticorps humains contre le facteur de coagulation FXIa en tant que principe actif, en particulier ceux décrits dans la demande de brevet WO2013167669, qui sont stables en tant que formulations liquides sur une longue période. L'invention concerne également des lyophilisats de la formulation liquide spécifiée avec un temps de reconstitution réduit ainsi que l'utilisation de ces formulations dans la thérapie et la prophylaxie de troubles thrombotique ou thromboembolique.
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subjects BLASTING
DRYING
DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
HEATING
HUMAN NECESSITIES
HYGIENE
LIGHTING
MECHANICAL ENGINEERING
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
WEAPONS
title NOVEL STABLE HIGH-CONCENTRATION FORMULATION FOR ANTI-FXIA ANTIBODIES
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