Unidirectional drug release from 3D printed personalized buccal patches using FDM technology

Oromucosal delivery of active ingredients of drugs provides a superior administration route for the treatment of oral diseases, due to avoidance of the first pass effect. In the present work, in view of the characteristics of large differences between oral ulcer symptoms and different lesion sizes, dexamethasone acetate unidirectional drug release buccal patches has been prepared based on Fused Deposition Modelling (FDM). Unidirectional drug release was achieved by covering the top and side with ethyl cellulose. Polyvinyl alcohol as a drug carrier, xylitol as a plasticizer. First, the protection effect of different thicknesses of the protective layer is investigated to determine the thickness of the protective layer. Co-extrusion printing method was adapted, utilizing blank filament to regulate preparations with different areas' drug loading. The results show that co-extrusion had no significant impact on the overall patches' drug release and adhesion properties. The physicochemical properties of the patches were also characterized. Evaluation of irritation is showed that these patches do not cause irritation to the oral mucosa of rats. Pharmacodynamic evaluation results showed that the preparation could promote the reduction of ulcer area. The results showed that FDM printing is a convenient and practical approach in manufacturing buccal patches.