Dissolvable Microneedles assisted Minimally Invasive Transcleral Delivery of Conjugated Soluplus Nanomicelles targeting Retina in the management of Retinoblastoma.

Abstract

The present study focused on delivering sorafenib-loaded conjugated soluplus nanomicelles to the back of the eye targeting retina via dissolvable microneedle-mediated transcleral delivery. The research involved fabricating dissolvable microneedles by melt casting method using a blend of PVA and PVP 90F. Optical and scanning electron microscopy confirmed that the microneedles were sharp, smooth, non-sticky, and non-brittle, exhibiting no cracks. Mechanical testing revealed a hardness cycle of 71.63 g±5.12, with successful penetration into goat sclera, as indicated by blue dots from trypan blue staining. The drug content was consistent with the incorporation amount, measured at 10.04µg±0.67. Following rapid dissolution, the nanomicelles released the complete drug load within four hours. Drug permeation across the goat scleral membrane was estimated at 3.57±0.0.09 µg/cm², with scleral deposition of 4.99±0.13 µg, indicating effective penetration. Ocular tissue distribution analysis (LC-MS/MS) revealed sorafenib concentrations of 69.37±5.19 ng/g in the retina and 4.93±0.53 ng/g in the vitreous humor, confirming successful drug transport to the posterior eye segment. The final formulation remained stable for three months and was non-irritant, establishing a minimally invasive platform technology for the management of retinoblastoma relative to invasive eye injections.