Formulation and efficacy of triamcinolone acetonide mouthwash for treating oral lichen planus.

PURPOSE: The stability of a triamcinolone acetonide mouthwash and its efficacy in treating oral lichen planus are described. METHODS: The solubility of triamcinolone acetonide in ethanol, propylene glycol, and glycerin was determined by shaking and equilibrating an excess of triamcinolone acetonide with the solvents for 72 hours. All three solvents were used in formulating a mouthwash. A stock solution of triamcinolone acetonide standard was prepared in ethanol and diluted to yield concentrations of 2, 4, 8, 12, and 16 microg/mL. Analytical sample solutions were prepared by pipetting 0.1 mL of triamcinolone acetonide mouthwash into 10-mL volumetric flasks and diluting to volume with the mobile phase. Accelerated stability studies were conducted by storing the samples in 60-mL amber glass bottles at 45, 60, 70, and 80 degrees C and 75% relative humidity until the triamcinolone concentration decreased markedly. Efficacy was tested by 20 subjects with a clinical diagnosis of and histologically confirmed symptomatic oral lichen planus who were randomized to use the mouthwash (n = 11) or the commercially available triamcinolone acetonide paste (n = 9). RESULTS: The mouthwash had a satisfactory shelf life and was well accepted by patients. Ten of 11 patients treated with the mouthwash for four weeks reported a positive response, and a complete response in signs and symptoms occurred in 4 and 5 of 11 patients, respectively. No significant difference in clinical improvement was observed between groups. CONCLUSION: A triamcinolone acetonide mouthwash had a satisfactory shelf life and was well accepted by patients. It did not have a significantly different therapeutic efficacy from the commercial paste dosage form in the treatment of oral lichen planus.