Nanocubospray of Epigallocatechin Gallate for Prevention of Oral Submucous Fibrosis.

Abstract

NanoCubes loaded film-forming spray (NanoCuboSpray) is a new formulation that can be explored for nanoscale drug delivery. In the present work, epigallocatechin 3-gallate (EGCG) was encapsulated into NanoCuboSpray (NCS) for oral submucous fibrosis (OSF) treatment. The newly formulated EGCG NCS is then evaluated for ex vivo permeation, drug retention, in vivo efficacy, and safety. The developed formulation was homogeneous, viscous, spreadable and mucoadhesive on the buccal mucosa. EGCG NCS had good permeation and buccal mucosal retention in the ex vivo studies. The NCS with 81.81 mg/kg EGCG dose significantly enhanced mouth opening and effectively upregulated collagen and downregulated TGF-β1 in rats with areca nut extract-induced OSF. EGCG NCS demonstrated better improvements in histopathological and antioxidant parameters compared to EGCG hydrogel and betamethasone injection (BTM Inj.). In the safety evaluation, NCS treatment had negligible changes in histopathological features and serum biochemical markers, maintaining results comparable to the normal control group. Therefore, the optimized NCS presents a safer alternative strategy for treating OSF and holds the potential for further evaluation of its clinical efficacy.