DESIGN, DEVELOPMENT AND EVALUATION OF BUCCAL MUCOADHESIVE PATCH OF DEXAMETHASONE SODIUM PHOSPHATE FOR THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS, ULCERATION AND LICHEN PLANUS

The objective of the present study was to develop mucoadhesive buccal patch of Dexamethasone for the treatment of oral submucous fibrosis. In formulation, chitosan is used as a polymer and PEG 400 as a plasticizer. Backing membrane was prepared by using ethyl cellulose and isopropyl alcohol. The solvent casting method was used for the preparation of mucoadhesive buccal patch as it is cost effective and efficient method. Preformulation studies of Dexamethasone were carried out. FTIR studies implied that there were no interactions between drug and polymers. The prepared batches were evaluated for visual appearance, thickness, folding endurance, weight variation, swelling index, surface pH, mucoadhesive time, % drug content, in-vitro diffusion and ex-vivo permeation study. Total nine batches of Dexamethasone mucoadhesive buccal patch were prepared successfully using chitosan as a polymer and PEG 400 as a plasticizer by solvent casting method. Based on results batch F2 was selected as optimized formulation. From invitro release of batches, F2 was found best, showing release of drug 64.53% in 4 hours. A clinical examination of the oral cavity was carried out under artificial light which includes extra oral examination and intra oral examination. The results of the present study of mucoadhesive semi-solid drug design for the treatment of OSMF will be useful for drug industry for the benefit of patients suffering from OSMF. The most important advantage of the Mucoadhesive buccal films is that it contains a lower drug dose, adequate for therapeutic effect as it is placed directly on the site of the inflammation, when compared to conventional administration. Moreover, this Mucoadhesive buccal patch is very convenient because it is non-irritant and self-administration is possible. Given promising therapeutic effects, the buccal film developed here could become a local drug delivery device for management of oral submucous fibrosis, ulceration and lichen planus.