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Combinaison des analyses thermodynamique, spectrale et chimique pour une approche intégrée de l'évaluation de la pureté et de la stabilité des substances actives pharmaceutiques Preview this item
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Combinaison des analyses thermodynamique, spectrale et chimique pour une approche intégrée de l'évaluation de la pureté et de la stabilité des substances actives pharmaceutiques

Author: Romain RotivalPhilippe EspeauMarek RogalskiCatherine PerrinFrançois GuyonAll authors
Publisher: 2012.
Dissertation: Thèse de doctorat : Chimie physique et analytique : Paris 5 : 2012.
Edition/Format:   Computer file : Document : Thesis/dissertation : French
Summary:
L'analyse et le contrôle de la qualité pharmaceutique suivent des recommandations internationales en évolution constante. Les exigences de pureté et de stabilité des substances actives sont fondamentales pour assurer l'efficacité et la sécurité des médicaments. A ce jour, les approches analytiques développées discriminent les niveaux de qualité physique et chimique des matériaux d'usage pharmaceutique.
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Genre/Form: Thèses et écrits académiques
Material Type: Document, Thesis/dissertation
Document Type: Computer File
All Authors / Contributors: Romain Rotival; Philippe Espeau; Marek Rogalski; Catherine Perrin; François Guyon; Yohann Cartigny; Université Paris Descartes (1970-2019).; École doctorale Médicament, toxicologie, chimie, environnement (2010-2013 / Paris).
OCLC Number: 867548694
Notes: Titre provenant de l'écran-titre.
Description: 1 online resource
Responsibility: Romain Rotival ; sous la direction de Philippe Espeau.

Abstract:

L'analyse et le contrôle de la qualité pharmaceutique suivent des recommandations internationales en évolution constante. Les exigences de pureté et de stabilité des substances actives sont fondamentales pour assurer l'efficacité et la sécurité des médicaments. A ce jour, les approches analytiques développées discriminent les niveaux de qualité physique et chimique des matériaux d'usage pharmaceutique. Une démarche analytique exhaustive permettant d'une part, l'évaluation de la pureté et de la stabilité physico-chimique des substances actives pharmaceutiques, et d'autre part, la corrélation entre les transformations physiques et chimiques, reste à établir. Ce travail est fondé sur l'exploitation des informations de type thermodynamique, cinétique et structural relatives aux transformations susceptibles d'affecter les substances à l'état solide et en solution. La stratégie développée comporte deux axes. Le premier est un axe exploratoire visant à caractériser la réactivité chimique et l'existence de phases solides alternatives constituées par les polymorphes et des hydrates. Le second axe consiste en la combinaison des méthodes d'analyse thermodynamique, spectrale et chimique, pour l'établissement du profil de stabilité de la substance active. Deux substances actives d'origine chimique entrant dans la composition de médicaments orphelins administrés à l'état solide permettent la mise en application de ce travail.

The international recommendations for the quality control of drugs are in continuous improvement. The purity and stability of drug substances is crucial to ensure the efficacy and safety of medicines. Traditional analytical approaches are either physical or chemical oriented. An integrated approach allowing (i) the assessment of purity and stability of drug substances and (ii) the correlation of physical and chemical phenomena are lacking. This work is based on the processing of thermodynamic, kinetic and structural information related to the transformations occurring in solution and in the solid state. The chosen strategy begins with the characterization of chemical reactivity of the drug substance, as well as the research of possible phase transitions to polymorphs and hydrates. A combination of thermodynamic, spectral and chemical analyses is then employed to establish an exhaustive stability profile. Two orphan drugs used in the solid state are examined as cases studies.

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