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Worapot Srimanan


PURPOSE: When commercial atropine eye drops are not available, diluted atropine eye drops are used for myopia control. However, long-term stability and sterility of self-prepared 0.01% atropine, even using aseptic techniques, are a concern. The purpose of this study was to investigate the sterility and stability of extemporaneously prepared 0.01% atropine sulfate (atropine) eye drops over a 90-day period.

METHODS: A 0.01% atropine solution was extemporaneously prepared by diluting commercially available 1% atropine eye drops with two artificial tear solutions, namely hydroxypropyl methylcellulose and polyethylene glycol. The preparations were stored at 4 °C and 25 °C. Sterility and stability were determined every month on days 0, 30, 60, and 90 after the solutions were prepared. For stability analysis, the amount of atropine was quantified using high performance liquid chromatography and comparing to that at day 0 (percentage of initial content). Bacterial and fungal cultures were performed to evaluate sterility.

RESULTS: No bacterial or fungal growth was observed during the study period. The 0.01% content of atropine prepared from hydroxypropyl methylcellulose at both 4 °C and 25 °C and polyethylene glycol kept at 4 °C remained constant, while that of atropine prepared in polyethylene glycol stored at 25 °C declined over time to approximately 20% of the initial amount.

CONCLUSIONS: The extemporaneous preparations of 0.01% atropine eye drops diluted from the concentrated commercial pharmaceutical product showed no microorganism growth after the 90-day storage period. However, preparations in different types of artificial tear solutions and storage temperatures can affect their stability.

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นิพนธ์ต้นฉบับ (Original Article)


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