A multilayered nanofibrous mucoadhesive system for chamomile and Lidocaine controlled delivery in aphthous

Objective(s): The mucoadhesive systems are among the preferred dosage forms for oral disorders. They can be designed to concentrate the drug at the site of action, control the drug release, and reduce both the frequency of medication and the systemic side effects. This study aims to design and evaluate a multilayered oro-mucoadhesive film encompassing chamomile hydroalcoholic extract and Lidocaine to manage oral aphthous disorder. Materials and Methods: A three-layer film for controlled release of Lidocaine and chamomile extract was prepared stepwise. The solvent casting method was used to prepare the fast-dissolving layer containing Lidocaine and chitosan/eudragit® S100 mucoadhesive layers. The middle layer, i.e. polycaprolactone nanofiber loaded with chamomile hydroalcoholic extract, was prepared by electrospinning. Layers were evaluated for appearance, thickness, pH, mucoadhesion, folding endurance, swellability, film disintegration time, content uniformity, chemical structure, and drug release. By attaching layers, the final system was prepared while DDSolver software was used to assess the release mechanism of Lidocaine and chamomile extract.Results: The final dosage form had desirable physicochemical features, including mucoadhesive strength. The entire Lidocaine was released by diffusion over the first 4 hours, while the extract reached its maximum cumulative release (%) after about 24 hours under a combined release mechanism of diffusion and polymer relaxation. Conclusion: Due to having polymers with different properties in each layer, our multilayered system allowed the controlled release of Lidocaine and chamomile extract, enabling it effectively used in the treatment of oral disorders.