Formulation, Technology, and Biopharmaceutical Evaluation of Triamcinolone Oral Mucoadhesive Films

Abstract

Background: Rational pharmacotherapy of oral diseases (lichen planus, pemphigus, pemphigoid) is one of the complex challenges of the modern era. The existing drug forms (gels, tablets, lozenges), despite their mucoadhesiveness, are not characterized by high pharmacological effectiveness. Mucoadhesive films made by nanotechnology provide a new method of treating lichen planus. Objectives: The research aimed to determine the formulation of triamcinolone oral mucoadhesive, two-layered films based on biopharmaceutical studies and technology development. Methods: Modern pharmaco-technological, biopharmaceutical, and physicochemical methods were used for the research. The appearance and organoleptic properties of the drug form were controlled (color, smell, consistency). Homogeneity, pH, flexibility, thumb test, and moisture absorption were determined during the research process. The active substance release dynamics were studied under in vitro tests by applying Franz diffusion cells with subsequent spectrophotometry. Results: Based on biopharmaceutical studies, triamcinolone mucoadhesive, two-layered films are formulated %: (Triamcinolone acetonide-0,20. Lidocaine hydrochloride -2,0. Ethylcellulose-2,4. METHOCEL K100 -2,4. Sorbitol 70% solution -4,0. Polyethylene glycol 400 -4,0. Glycerin-4,0. Polysorbate 60 -2,4. Sorbic acid-0,2. Eucalyptus essential oil-0,4. Peppermint essential oil-0,2. 96% ethyl alcohol-up to 100. Conclusions: Quality indicators of mucoadhesive films are determined. The quality and consumer properties of the provided films are within optimal limits. The dynamics of triamcinolone release are studied. The release of API from the films reaches 70% within 180 minutes. Triamcinolone films maintain stability throughout the study period-3 months when stored under different conditions.