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Antifungal Combination Eye Drops for Fungal Keratitis Treatment
Victoria Díaz-Tomé1,2,3,4, Carlos Bendicho-Lavilla1,2,3, Xurxo García-Otero1,2,3,5
1Department of Pharmacology, Pharmacy and Pharmaceutical Technology, University of Santiago de Compostela (USC), 15705 Santiago de Compostela, Spain.
Abstract:
Fungal keratitis (FK) is a corneal mycotic infection that can lead to vision loss. Furthermore, the severity of FK is aggravated by the emergence of resistant fungal species. There is currently only one FDA-approved formulation for FK treatment forcing hospital pharmacy departments to reformulate intravenous drug preparations with unknown ocular bioavailability and toxicity. In the present study, natamycin/voriconazole formulations were developed and characterized to improve natamycin solubility, permanence, and safety. The solubility of natamycin was studied in the presence of two cyclodextrins: HPβCD and HPγCD. The HPβCD was chosen based on the solubility results. Natamycin/cyclodextrin (HPβCD) inclusion complexes characterization and a competition study between natamycin and voriconazole were conducted by NMR (Nuclear Magnetic Resonance). Based on these results, several eye drops with different polymer compositions were developed and subsequently characterized. Permeability studies suggested that the formulations improved the passage of natamycin through the cornea compared to the commercial formulation Natacyn®. The ocular safety of the formulations was determined by BCOP and HET-CAM. The antifungal activity assay demonstrated the ability of our formulations to inhibit the in vitro growth of different fungal species. All these results concluded that the formulations developed in the present study could significantly improve the treatment of FK.
Insights
New fungal keratitis (FK) eye drops improve drug delivery and safety. These novel formulations enhance natamycin solubility and corneal penetration, offering a better treatment for fungal eye infections.
Area of Science:
- Ophthalmology
- Mycology
- Pharmaceutics
Background:
- Fungal keratitis (FK) is a serious corneal infection leading to vision loss.
- Emerging resistant fungal strains and limited treatment options complicate FK management.
- Current treatments often involve off-label use of intravenous drugs with unknown ocular safety.
Purpose of the Study:
- To develop and characterize novel natamycin/voriconazole formulations for improved FK treatment.
- To enhance natamycin solubility, corneal permeability, and ocular safety.
- To evaluate the efficacy of new formulations against resistant fungal species.
Main Methods:
- Solubility studies of natamycin with cyclodextrins (HPβCD, HPγCD).
- Characterization of natamycin/HPβCD inclusion complexes using Nuclear Magnetic Resonance (NMR).
- Development and characterization of polymer-based eye drop formulations; permeability, ocular safety (BCOP, HET-CAM), and antifungal activity assays.
Main Results:
- HPβCD enhanced natamycin solubility.
- NMR confirmed natamycin/HPβCD complex formation and competition with voriconazole.
- Formulations demonstrated improved natamycin corneal permeability compared to Natacyn®.
- Ocular safety assessments (BCOP, HET-CAM) showed favorable results.
- Antifungal assays confirmed in vitro inhibition of fungal growth.
Conclusions:
- Developed natamycin/voriconazole formulations significantly improve solubility, permeability, and safety for FK treatment.
- These novel formulations offer a promising alternative to current therapeutic options for fungal keratitis.
- Further clinical evaluation is warranted to confirm the therapeutic benefits in patients with fungal keratitis.
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