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Master Thesis

Développement et étude de stabilité de solutions ophtalmiques d’atropine à 100 μg/mL (0.01%) pour la prévention de l’évolution de la myopie en pédiatrie

Abstract : Myopia is an ophthalmic condition affecting more than 1/5th of the world population, especially children. Low-dose atropine eyedrops have been shown to limit myopia evolution during treatment. However, there are currently no commercial industrial forms available and there is little data published concerning the stability of medications prepared by compounding pharmacies. The objective of this thesis was to present the scientific and regulatory approach to obtain atropine eyedrops formulation and the stability study realized on this formulation. The study was to evaluate the stability of two 0.1 mg/mL atropine formulations (with and without antimicrobial preservatives) for 6 then 9 months in two different low-density polyethylene (LDPE) multidose eyedroppers. Analyses used were the following: visual inspection, turbidity, chromaticity measurements, osmolality and pH measurements, atropine quantification by a stability-indicating liquid chromatography method, breakdown product research, and sterility assay. In an in-use study, atropine quantification was also performed on the drops emitted from the multidose eyedroppers. All tested parameters remained stable during the 6 then 9 months period, with atropine concentrations above 94.7% (6 month) and 93.4% (9 months) of initial concentration. A breakdown product (tropic acid) did increase slowly over time but remained well below usually admitted concentrations. Atropine concentrations remained stable during the in-use study. Both formulations of 0.1 mg/mL of atropine (with and without antimicrobial preservative) were initially proved to be physicochemically stable for 6 months and then for 9 months at 25°C when stored in LDPE bottles, with an identical microbial shelf-life.
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Master Thesis
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Submitted on : Wednesday, March 23, 2022 - 9:42:13 AM
Last modification on : Thursday, March 24, 2022 - 3:41:06 AM


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  • HAL Id : dumas-03616940, version 1


Baptiste Berton. Développement et étude de stabilité de solutions ophtalmiques d’atropine à 100 μg/mL (0.01%) pour la prévention de l’évolution de la myopie en pédiatrie. Sciences pharmaceutiques. 2022. ⟨dumas-03616940⟩



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