Delivery of atropine complexed with hydroxypropyl beta-cyclodextrin via a contact lens.

Abstract

PURPOSE: Myopia is a global vision problem linked to a significant economic burden and potential blindness in severe cases. Current interventions-including atropine eye drops, contact lenses, spectacles, and lifestyle changes-are often combined due to limited individual effectiveness. This study aimed to develop and stabilize atropine formulations, load them into contact lenses, and evaluate atropine release profiles. METHODS: Atropine sulfate was converted to atropine base and complexed with 2-hydroxypropyl beta-cyclodextrin (HPBCD) in phosphate-buffered saline (PBS) at pH 6.5 or 7.4. Formulation stability was monitored over one year at room temperature (21°C) using high-performance liquid chromatography (HPLC). Etafilcon A and omafilcon A lenses were soaked in the formulations for 24 hours. The amount of atropine base loaded and released was quantified via HPLC, and toxicity was assessed according to ISO 10993-5. RESULTS: After 1 year, the formulations retained 97.3% (pH 6.5) and 80.3% (pH 7.4) of atropine base. At pH 6.5, etafilcon A and omafilcon A absorbed 3.2 ± 0.1 μg and 1.7 ± 0.6 μg of atropine base, respectively. Etafilcon A released 100% of the atropine base within 4 hours, and omafilcon A released 59% within 2 hours. Contact lens eluates showed no toxicity. CONCLUSIONS: These findings support the stability and safety of atropine base formulations for potential ocular drug delivery.

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