Stability of Ophthalmic Atropine Solutions for Child Myopia Control
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 co...
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| Format: | Article |
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MDPI AG
2020-08-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/12/8/781 |
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| author | Baptiste Berton Philip Chennell Mouloud Yessaad Yassine Bouattour Mireille Jouannet Mathieu Wasiak Valérie Sautou |
| author_facet | Baptiste Berton Philip Chennell Mouloud Yessaad Yassine Bouattour Mireille Jouannet Mathieu Wasiak Valérie Sautou |
| author_sort | Baptiste Berton |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T17:17:52Z |
| format | Article |
| id | doaj.art-113ae9bed3b243c4b0d29377177eb450 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T17:17:52Z |
| publishDate | 2020-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-113ae9bed3b243c4b0d29377177eb4502023-11-20T10:25:40ZengMDPI AGPharmaceutics1999-49232020-08-0112878110.3390/pharmaceutics12080781Stability of Ophthalmic Atropine Solutions for Child Myopia ControlBaptiste Berton0Philip Chennell1Mouloud Yessaad2Yassine Bouattour3Mireille Jouannet4Mathieu Wasiak5Valérie Sautou6CHU Clermont-Ferrand, Pôle Pharmacie, F-63003 Clermont-Ferrand, FranceUniversité Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA, ICCF, 63000 Clermont-Ferrand, FranceCHU Clermont-Ferrand, Pôle Pharmacie, F-63003 Clermont-Ferrand, FranceUniversité Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA, ICCF, 63000 Clermont-Ferrand, FranceCHU Clermont-Ferrand, Pôle Pharmacie, F-63003 Clermont-Ferrand, FranceCHU Clermont-Ferrand, Pôle Pharmacie, F-63003 Clermont-Ferrand, FranceUniversité Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA, ICCF, 63000 Clermont-Ferrand, FranceMyopia 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.https://www.mdpi.com/1999-4923/12/8/781atropineophthalmic solutionstabilitymyopia |
| spellingShingle | Baptiste Berton Philip Chennell Mouloud Yessaad Yassine Bouattour Mireille Jouannet Mathieu Wasiak Valérie Sautou Stability of Ophthalmic Atropine Solutions for Child Myopia Control Pharmaceutics atropine ophthalmic solution stability myopia |
| title | Stability of Ophthalmic Atropine Solutions for Child Myopia Control |
| title_full | Stability of Ophthalmic Atropine Solutions for Child Myopia Control |
| title_fullStr | Stability of Ophthalmic Atropine Solutions for Child Myopia Control |
| title_full_unstemmed | Stability of Ophthalmic Atropine Solutions for Child Myopia Control |
| title_short | Stability of Ophthalmic Atropine Solutions for Child Myopia Control |
| title_sort | stability of ophthalmic atropine solutions for child myopia control |
| topic | atropine ophthalmic solution stability myopia |
| url | https://www.mdpi.com/1999-4923/12/8/781 |
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