Evaluation of mucoadhesive dexamethasone sodium phosphate gel in the treatment of arecoline-induced oral submucous fibrosis in wister albino rats: A cross-sectional study.

Abstract

The present work aimed to prepare an oral mucoadhesive gel of dexamethasone sodium phosphate to serve the purpose of treating oral submucous fibrosis by incorporating the drug in a polymeric matrix to facilitate the localisation of the drug at the absorption site, to prolong drug delivery and to provide patient convenience. The formulations F1, F2 and F3 were prepared using 2, 2.5 and 3% of carboxymethyl cellulose sodium, formulations F4, F5 and F6 were prepared using 2, 2.5 and 3% of hydroxypropyl methylcellulose, respectively, and formulations F7, F8 and F9 were prepared using equal mixtures of carboxymethyl cellulose sodium and hydroxypropyl methylcellulose in the concentrations of 1, 1.25 and 1.50%, respectively. The prepared formulations were subjected for screening of physicochemical parameters, viz, homogeneity, grittiness, viscosity studies, spreadability, extrudability, mucoadhesive strength, pH, drug content uniformity, in vitro drug diffusion, Fourier transform infrared spectroscopy spectral analysis and stability studies. Among the nine formulations prepared, the formulation F8 containing 1.25% carboxymethyl cellulose sodium, 1.25% hydroxypropyl methylcellulose having a mucoadhesive strength of 12.600 ± 0.01 g and drug release of 88.473 ± 0.457% was considered as the promising one and was further used for in vivo study. Oral application of the gel for 4 months in arecoline-induced oral submucous fibrosis rats showed more than 80% reduction in fibrosis. The histopathological results supported these findings.