Preparation and In vitro, Ex vivo Evaluation of Benzidamine Hydrochloride Loaded Fast Dissolving Oral Strip Formulations: Treatment of Oral Mucositis Due to Side Effects of Chemotherapy and Radiotherapy

Abstract

Background: Rapidly dissolving oral strips have many advantages, especially in pediatric and geriatric use. Benzydamine hydrochloride is an active substance with local analgesic, anesthetic, antimicrobial and non-steroidal anti-inflammatory properties. Objective: The aim of the study was to formulate and characterize orally dispersible benzydamine hydrochloride-loaded fast dissolving oral strips for the sufficient treatment of oral mucositis with high loading capacity as well as high patient compliance considering ease of use. Methods: Oral strips were prepared by solvent casting method with many different polymer combinations and evaluated for different characteristics. In vitro and ex vivo characterizations were performed. Results: In appearance oral strips were smooth and they were also uniform in thickness and weight. The release rates of the active agent from oral strips reached 100 % within 25 minutes. The disintegration time was within the range of 15.5 ± 1.2 seconds. Due to ex-vivo permeation studies steady-state flux of benzydamine hydrochloride in simulated saliva and pH 6.8 were found to be 27.1 μg cm−2 h−1 ± 1.4 and 26.2 μg cm−2 h−1 ± 1.7, respectively. No significant difference (p˃0.05) in permeability studies was observed using pH 6.8 phosphate buffer compared to simulated saliva. Conclusion: Active agent was successfully loaded into the strips and the targeted system was successfully performed. Benzydamine hydrochloride as oral strips can be a better solution for the efficient treatment of oral mucositis for cancer patients during chemotherapy and radiotherapy stages.