Fungal keratitis (FK) is a leading cause of corneal blindness worldwide. Although voriconazole (VOR) is effective, its poor corneal permeability limits its topical use, whereas intrastromal injections are invasive and risky. Over the past 9 years, dissolving microneedle array patches (dMAPs) has emerged as a promising approach for ocular drug delivery; however, these methods face challenges in delivering poorly soluble drugs that can form depots within the cornea, delay drug release into surrounding tissues, and require longer application times than conventional methods, such as intrastromal injections and eye drops. This study presents an ultrafast-dMAP incorporating a VOR/sulfobutylether-β-cyclodextrin (SBE-β-CD) inclusion complex as a novel ocular delivery system for localized FK treatment. The VOR/SBE-β-CD inclusion complex, prepared via freeze-drying, showed a marked increase in VOR solubility. Using an optimized concentration of inclusion complex, dMAPs were fabricated through a micromoulding technique, resulting in strong mechanical integrity and efficient insertion capability. Ex vivo studies on porcine eyes demonstrated complete dMAP tip dissolution within 15 s, which was significantly faster than that of conventional polymer-based dMAPs. Compared with the solution formulation, the dMAP resulted in a 3.06-fold increase in corneal drug permeation and a 2.2-fold increase in drug deposition. Additionally, these compounds displayed potent in vitro antifungal activity against Candida albicans and Aspergillus fumigatus, which was attributed to improved drug solubility. Cytocompatibility and HET-CAM assays confirmed the nonirritant and biocompatible nature of the formulation. Overall, the present study, for the first time, reports a VOR/SBE-β-CD-based ultrafast-dMAP for ocular drug delivery, providing a minimally invasive and highly efficient alternative to conventional topical and intrastromal antifungal therapies.
B.H.Jaswanth Gowda, Anjali K. Pandya, Shilpkala Gade, Ross M. Duncan, Mohammed Gulzar Ahmed, Yiwei Tian, Ryan F. Donnelly, Raghu Raj Singh Thakur, Lalitkumar K. Vora (2026) Ultrafast-dissolving voriconazole-cyclodextrin complex-based ocular microneedle patch: a novel approach for the treatment of fungal keratitis. International Journal of Pharmaceutics 127001. https://doi.org/10.1016/j.ijpharm.2026.127001.
