Preparation and evaluation of buccal mucoadhesive patch of betamethasone sodium phosphate for the treatment of Oral submucous fibrosis

The aim of the present study was to develop the mucoadhesive buccal film of Betamethasone sodium phosphate (BSP) by solvent casting method using Hydroxy propyl methyl cellulose (HPMC) E5 LV and carbopol (CP) 940P as polymer, Polyethylene glycol (PEG) 1000 as plasticizer. All the formulations were examined for film thickness, weight variation, drug content, percentage moisture loss, percentage moisture absorption, surface pH, folding endurance, tensile strength, in vitro and in vivo residence time and in vitro release. The all prepared buccal patches were transparent, smooth, consistent and flexible. The percentage moisture loss and percentage moisture absorption of optimised formulation (F3) were found to be 6.59 ± 0.54 and 5.74 ± 0.21 respectively. The surface pH of all formulation showed to be neutral. In vitro and in vivo residence time of all patches showed above 30 minutes. The formulation F3 showed optimum tensile strength (7.72 ± 0.41 kg/mm²) which indicates less probability of rupture. In vitro drug release of optimised formulation (F3) was found to be 88.59 ± 2.74 at the end of 30 min. Stability studies were performed for optimised formulation (F3) and showed no appreciable change in physical structure and in drug content. The optimized formulation was given for Clinical study at Manipal College of Dental Sciences, Mangalore.