Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride

Abstract

Aim: Mucoadhesive buccal films provide drug delivery for both local and systemic circulation with increased patient compliance. The objective of this study was to develop a buccal film containing benzydamine hydrochloride (BNZ) by using hyaluronic acid (HA) as a film-forming agent and glycerin (Gly) as a plasticizer for the anti-inflammatory effect on the mucosal ulcer. Material and Methods: The effects of different concentrations of HA and Gly on responses were analyzed using 23 factorial design. The HA and Gly ratio were selected as independent factors, and work of mucoadhesion, tensile strength, elongation at break, and contact angle values were chosen as dependent factors. Nine different film formulations were prepared at constant BNZ concentration (0.15%) by solvent casting method. Mechanical and mucoadhesion properties of film formulations were evaluated, and also contact angles were calculated. The BNZ release profiles were evaluated in simulated saliva solution (pH 6.8). Results: All film formulations were successfully prepared by solvent casting method. Increasing HA concentration from 0.5 to 2 % raised the mechanical and mucoadhesion properties of film formulations. Although the addition of Gly decreased the tensile strength values, it increased the elongation at break values about ten times. All formulations released more than 60 % BNZ in 60 mins. Conclusion: It is concluded that HA oral mucoadhesive film formulations containing BNZ are promising for treating oral ulcers.