Formulation and Evaluation of Triamcinolone Acetonide Mucoadhesive Film as Treatment of Aphthous Stomatitis and Oral Inflammatory Diseases

Abstract

Background: Mucoadhesive drug delivery system can prevent first pass effect and produce high blood level. These films could adhere to oral mucosa and protect wound, reduce pain and also treat oral diseases more effectively. The aim of this study was to formulate bilayer buccal films of triamcinolone acetonide to be used for oral lesions such as recurrent aphthous stomatitis (RAS). Methods: Triamcinolone acetonide mucoadhesive film was prepared by solvent casting method. First layer formulated from different conventional bio-adhesive polymers such as chitosan, HPMC K4M, K15M, eudragit RL100 and glycerin and propylene glycol as the plasticizer. The second layer contained ethyl cellulose. Pharmaceutical properties of film and other parameters such as uniformity, thickness, swelling capacity, disintegration time, mucoadhesion and in vitro drug release were evaluated. Findings: Chitosan-contained formulations had high flexibility and maximum adhesion to the mucosa, but most of them were shrinking. HPMCK15M and eudragit had more amounts of formula-related mean dissolution time (MDT). The pattern of drug release from the HPMC-contained formulations was zero order (case II). Chitosan-contained formulations followed non-fickian zero order. The rate of drug release was same in formulations contained propylene glycol and glycerin. Eudragit adhesion to the mucosa was less than chitosan and HPMC. Drug release model of eudragit-contained formulations contain followed supper case II. Conclusion: The appropriate formulation was made from eudragit and ethyl cellulose (less than 200 mg). This formula has more amounts of MDT and good adhesion and suitable release. Keywords: Mucoadhesive, Film, Triamcinolone acetonide, Recurrent aphthous stomatitis, Eudragit