PREVENTION OF THE CONVERSION OF PHARMACEUTICAL AGENTS INTO TOXIC N-NITROSAMINE COMPOUNDS
In the solid pharmaceutical compositions of the present invention, the formation of toxic N-nitroso-derivatives of the contained agents comprising a dialkylamino- or a trialkyl amino-group is prevented providing long-term storage stable formulations- of inherently problematic drugs, such as varenicl...
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Main Authors | , , , , , , , |
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Format | Patent |
Language | English French |
Published |
16.03.2023
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Subjects | |
Online Access | Get full text |
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Summary: | In the solid pharmaceutical compositions of the present invention, the formation of toxic N-nitroso-derivatives of the contained agents comprising a dialkylamino- or a trialkyl amino-group is prevented providing long-term storage stable formulations- of inherently problematic drugs, such as varenicline (e.g., in form of its tartrate or foe citrate). Means- for achieving the long-term storage stable formulations of the present invention are formulating the crucial active ingredients with antioxidants, using specific packaging materials for the pharmaceutical compositions- of the present invention, and/or employing specific manufacturing processes.
Dans les compositions pharmaceutiques solides de la présente invention, il est exclu que la formation de dérivés N-nitroso toxiques des agents contenus comprenant un groupe dialkylamino- ou trialkylamino donne des formulations stables au stockage à long terme de médicaments intrinsèquement problématiques, telle que la varénicline (par exemple, sous la forme de son tartrate ou citrate antagoniste). Des moyens pour obtenir les formulations stables au stockage à long terme de la présente invention sont la formulation des principes actifs cruciaux avec des antioxydants, en utilisant des matériaux d'emballage spécifiques pour les compositions pharmaceutiques de la présente invention, et/ou en employant des procédés de fabrication spécifiques. |
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Bibliography: | Application Number: WO2022EP77357 |