Design and development of surface modified epigallocatechin 3-gallate NanoCubogel for localized delivery to oral submucous fibrosis therapy

The present study is aimed at the development of stearylamine (SA) modified epigallocatechin 3-gallate (EGCG) loaded NanoCubes incorporated in mucoadhesive hydrogel (NanoCubogel), for the local treatment of oral submucous fibrosis (OSF) owing to its anti-fibrotic, anti-inflammatory, and oxygen radical scavenging properties with a better safety profile. The prepared NanoCubes and mucoadhesive NanoCubogel were evaluated and characterized for various parameters including in-vitro release and ex-vivo permeation studies. The optimized NanoCubes had a particle size, polydispersity index, zeta potential, and entrapment efficiency of 140.3 ± 1.12 nm, 0.173 ± 0.08, 46.9 ± 1.69 mV, and 59.0 ± 1.73%, respectively with cube-shaped morphology. The viscosity of the NanoCubogel was found to be 9253 ± 112 cps. The SA modified NanoCubogel showed slower and sustained release of EGCG with higher permeation across buccal mucosa when compared to that of unmodified and pure EGCG. The formulation was found to be stable during the storage period. The developed NanoCubogel was capable of getting retained at the diseased site for a longer duration and releasing the EGCG locally for the desired time. Thus, the developed formulation may be used as an alternative treatment for OSF. • Epigallocatechin 3-gallate (EGCG) NanoCubes were loaded in mucoadhesive hydrogel (NanoCubogel) for oral submucous fibrosis. • Stearylamine modified NanoCubogel showed faster permeation of EGCG to buccal mucosa than unmodified. • EGCG NanoCubogel was found to be mucoadhesive and released the drug locally over a prolonged period of time.