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.
Highlights
Myopia is an ophthalmic condition that leads to blurred long-distance vision, generally characterized by a refractive error of −0.5 or −1 diopters
Because 0.1 mg/mL is the concentration with currently the most data concerning safety and efficacy, the aim of this study was to assess the physicochemical stability and to control the sterility of two 0.1 mg/mL atropine ophthalmic solutions in two different low-density polyethylene (LDPE) multidose eyedroppers at 25 ◦ C for six months in unopened eyedroppers
Our study presents new data on the physicochemical stability of 2 formulations of a 0.1 mg/mL atropine solution conditioned in two differently sterilized
Summary
Myopia (or short-sightedness) is an ophthalmic condition that leads to blurred long-distance vision, generally characterized by a refractive error of −0.5 or −1 diopters. The prevalence of myopia is variable between countries, affecting for example about 30% of young adults in Europe [2], 59% in North America [3], to more than 95% in some student populations of Asian countries [4,5], with onset of the disease occurring during childhood and adolescence. Many risk factors have been suggested or clearly identified, such as time spent performing close-vision activities, such as reading or looking at smart-device screens [6], lack of physical exercise, or exposure to sunlight [3,7], often all linked to higher education rates [8]. Several recommendations have been proposed to limit the onset of myopia, like encouraging children spending time outside, limiting close-vision activities, and adapting light conditions [11], but whilst fundamental, they might not be sufficient or implemented. Current therapeutic options all have limitations; for example, orthokeratology (reshaping of the cornea by a hard, hydrophilic, gas-permeable contact lens worn during sleep and removed during the day) does not stop disease progression to returning to its previous rate after treatment discontinuation and requires high levels of patient compliance [12]
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