Design, Formulation, and Evaluation of Opthalmic Multilayer Nanofiber Insert for Management of Dry Eye Disease

Due to changing lifestyles, millions of people worldwide experience dry eye disease (DED). The treatment for DED primarily involves the topical use of artificial tears and anti-inflammatory eye drops. Frequent administration of conventional eye drops leads to reduced patient adherence. This study aims to improve the convenience and reduce the dosing frequency, by designing dexamethasone sodium phosphate (DSP)-loaded multilayer nanofiber inserts (MLNI) for managing DED. The drug-loaded electrospun nanofibers were sandwiched between two blank nanofiber scaffolds. The outer nanofiber scaffolds will aid mucoadhesion and lubricate the cornea to reduce the dryness. The middle layer of the insert was fabricated using chitosan(1%w/v), polyvinyl alcohol (10%w/v), and DSP (0.1%w/w), while the outer layer consisted of hyaluronic acid (0.8%w/v) and polyvinyl alcohol (10%w/v). The developed nanofibers exhibited a diameter of 125 ± 30 nm and entrapment efficiency of 95.6 ± 0.52%. The optimized nanofiber insert had a thickness of 0.48 ± 0.03 mm, porosity of 55 ± 5%, swelling index of 94.8 ± 10%, surface pH of about 6.5 ± 0.2, and folding endurance of about 245 ± 3. Ex vivo permeation studies using goat eye cornea demonstrated a sustained drug release of 85.90 ± 1.243% up to 32 h, following the Hixson–Crowell model ( R 2 of 0.931). A hemocompatibility study showed compatibility of developed scaffold with blood cells. Results of HET-CAM, cell culture studies on SIRC cells, and sterility studies indicate that the developed sterile multilayered sandwich type nanofiber ocular insert is safe and effective in the delivery of DSP for management of DED. Graphical Abstract