Formulation of fluocinolone Acetonide oral paste for Lichen Planus patients

Abstract

This study aimed to develop a stable and effective 0.1% fluocinolone acetonide oral paste for the treatment of oral lichen planus, based on the principle of mucoadhesive drug delivery systems. The study was conducted in two parts: (1) a preliminary evaluation of volunteer satisfaction with the formulation in 10 healthy individuals, and (2) an efficacy study involving 8 patients with oral lichen planus who received treatment at the Dental Department, Roi Et Hospital, between May 1 and May 31, 2025. The research instruments included: a physical and microbiological property assessment form for the formulation developed by the Pharmacy Department of Roi Et Hospital; a satisfaction questionnaire for healthy volunteers using the developed fluocinolone acetonide oral paste; and a patient data collection form for oral lichen planus cases. Data were analyzed using descriptive statistics (frequency, percentage, mean, standard deviation) and inferential statistics (Wilcoxon Signed Ranks Test). The results showed that Formulation 1, composed of 30% sodium carboxymethylcellulose, 3.3% pectin, 6.6% gelatin, and 60% of a 95:5 mixture of mineral oil and polyethylene glycol 400, demonstrated appropriate stability and high volunteer satisfaction. The developed fluocinolone acetonide oral paste significantly reduced the median severity score of oral lichen planus from 4.50 to 1.50, as well as the median pain score from 7.00 to 2.50 (p < 0.05). It is recommended that this formulation be produced for actual clinical use at Roi Et Hospital to accommodate the increasing number of patients. Continuous evaluation of patient satisfaction is also suggested to further optimize the formulation and better meet patient needs.