Problématiques de formulations de protéines thérapeutiques destinées à la voie injectable

Abstract : The therapeutic peptides and proteins restore, correct or modify the physiological functions when they are lacking in the diseased individual. However, producing and formulating a protein for the injectable route is a real challenge as it can be particularly unstable. Moreover, its half-life in vivo is limited. A bibliographic review was first carried out in order to understand these problems of stability. Among the solutions envisaged, the choice has been made on microparticulate suspensions based on biocompatible and biodegradable polymers such as copolymers derived from lactic and glycolic acids called PLGA, administered IM or SC, making it possible to deliver the API in the organism during more or less long periods. In this context, an experimental work has been initiated within the company Bertin Pharma to develop suspensions of white microparticles (without active ingredient) whose characteristics would be compatible with IM administration. The technique of solvent evaporation based on the formation of a double emulsion has been adopted as a manufacture method. The study was carried out through a design of experiment. This allowed to select several excipients favoring the creation of microspheres of sizes smaller than 100 μm, monodisperse, smooth and non-porous. This experimental work will serve as the basis for a future development of suspensions of biodegradable microspheres whose operating conditions will have to be adjusted and optimized in the presence of the active molecule of interest to be encapsulated.
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Master Thesis
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Virginie Fayolle. Problématiques de formulations de protéines thérapeutiques destinées à la voie injectable. Sciences pharmaceutiques. 2017. ⟨dumas-01610200⟩



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