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      Stability of Ophthalmic Atropine Solutions for Child Myopia Control

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          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 study was to evaluate the stability of two 0.1 mg/mL atropine formulations (with and without antimicrobiobial preservatives) for 6 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 months period, with atropine concentrations above 94.7% 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 proved to be physicochemically stable for 6 months at 25 °C when stored in LDPE bottles, with an identical microbial shelf-life.

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          Most cited references47

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          Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops.

          To compare the safety and efficacy of different concentrations of atropine eyedrops in controlling myopia progression over 5 years.
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            Low-Concentration Atropine for Myopia Progression (LAMP) Study

            Low-concentration atropine is an emerging therapy for myopia progression, but its efficacy and optimal concentration remain uncertain. Our study aimed to evaluate the efficacy and safety of low-concentration atropine eye drops at 0.05%, 0.025%, and 0.01% compared with placebo over a 1-year period.
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              Atropine for the treatment of childhood myopia.

              To evaluate the efficacy and safety of topical atropine, a nonselective muscarinic antagonist, in slowing the progression of myopia and ocular axial elongation in Asian children. Parallel-group, placebo-controlled, randomized, double-masked study. Four hundred children aged 6 to 12 years with refractive error of spherical equivalent -1.00 to -6.00 diopters (D) and astigmatism of -1.50 D or less. Participants were assigned with equal probability to receive either 1% atropine or vehicle eye drops once nightly for 2 years. Only 1 eye of each subject was chosen through randomization for treatment. The main efficacy outcome measures were change in spherical equivalent refraction as measured by cycloplegic autorefraction and change in ocular axial length as measured by ultrasonography. The primary safety outcome measure was the occurrence of adverse events. Three hundred forty-six (86.5%) children completed the 2-year study. After 2 years, the mean progression of myopia and of axial elongation in the placebo-treated control eyes was -1.20+/-0.69 D and 0.38+/-0.38 mm, respectively. In the atropine-treated eyes, myopia progression was only -0.28+/-0.92 D, whereas the axial length remained essentially unchanged compared with baseline (-0.02+/-0.35 mm). The differences in myopia progression and axial elongation between the 2 groups were -0.92 D (95% confidence interval, -1.10 to -0.77 D; P<0.001) and 0.40 mm (95% confidence interval, 0.35-0.45 mm; P<0.001), respectively. No serious adverse events related to atropine were reported. Topical atropine was well tolerated and effective in slowing the progression of low and moderate myopia and ocular axial elongation in Asian children.
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                Author and article information

                Journal
                Pharmaceutics
                Pharmaceutics
                pharmaceutics
                Pharmaceutics
                MDPI
                1999-4923
                17 August 2020
                August 2020
                : 12
                : 8
                : 781
                Affiliations
                [1 ]CHU Clermont-Ferrand, Pôle Pharmacie, F-63003 Clermont-Ferrand, France; baptiste-berton@ 123456hotmail.fr (B.B.); myessaad@ 123456chu-clermontferrand.fr (M.Y.); mjouannet@ 123456chu-clermontferrand.fr (M.J.); mwasiak@ 123456chu-clermontferrand.fr (M.W.)
                [2 ]Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA, ICCF, 63000 Clermont-Ferrand, France; ybouattour@ 123456chu-clermontferrand.fr (Y.B.); vsautou@ 123456chu-clermontferrand.fr (V.S.)
                Author notes
                Author information
                https://orcid.org/0000-0001-8086-7517
                https://orcid.org/0000-0002-6937-1796
                https://orcid.org/0000-0002-3944-3752
                Article
                pharmaceutics-12-00781
                10.3390/pharmaceutics12080781
                7465901
                32824572
                27c139a2-0410-4ebb-9aed-464ca628a4a2
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 25 June 2020
                : 07 August 2020
                Categories
                Article

                atropine,ophthalmic solution,stability,myopia
                atropine, ophthalmic solution, stability, myopia

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