Physicochemical and microbiological evaluation of dexamethasone-based mouthwash formulations

Abstract

IntroductionOral mucositis is a common and painful side effect of chemotherapy and radiotherapy in cancer patients, significantly impairing their quality of life and adherence to treatment. Although dexamethasone is recognized for its anti-inflammatory properties, no commercial mouthwash formulation exists at a concentration of 0.1 mg/mL. This study aimed to formulate and evaluate the physicochemical and microbiological stability of hospital-prepared dexamethasone-based mouthwashes.MethodsNine different formulations were developed by varying the humectants, cosolvents and surfactants. Stability was assessed over 28 days by monitoring pH, viscosity, density, zeta potential and dexamethasone concentration using HPLC. Microbiological quality was also evaluated. Statistical analyses were conducted using Student's t-test and ANOVA.ResultsFormula F9, composed of sorbitol as humectant and propylene glycol as cosolvent, demonstrated optimal physicochemical stability, with non-significant variation in viscosity and acceptable pH levels. The dexamethasone content remained within 98.48% after 52 days. Microbiological analyses showed no contamination at Day 28.ConclusionThe F9 formulation appears to be a stable and safe candidate for clinical use as a dexamethasone-based mouthwash. The recommended dosage for adults and children over five years of age is 10 mL (swish and spit) four times daily, while for children under five years, the recommended dosage is 5 mL (swish and spit) twice daily. Further clinical studies are warranted to confirm its therapeutic benefits in the management of oral mucositis.