Formulation of Propolis-Based Recurrent Aphthous Stomatitis (Ras) Protective Patch With Combination of PVP and Cellulose Materials

Abstract

Objective: The objective of this study was to obtain a mucoadhesive patch for recurrent aphthous stomatitis (RAS) with propolis, proven propolis’ antibacterial ability against bacteria in the oral cavity, and to obtain the physical characteristics of the produced patch. Methods: The patch was produced using a solvent-casting method. The antibacterial properties were determined by the disc diffusion method against S. mutans, S. oralis, S. sanguinis, and S. gingivalis. The physical characteristics of the patch was determined by examining weight and thickness dimension, swelling, surface pH, and structure observation. Results: The patch was made from 8 formulations with different propolis concentrations, Polyvinylpyrrolidone (PVP), and the use of cellulose materials (Hydroxypropyl methylcellulose and Carboxymethylcellulose). The concentrations of propolis used were 3%, 5%, 7%, and 10%. While the ratio of PVP and cellulose material in the formulation is 2:1. Results showed that propolis had a zone of inhibition greater than 2 mm against S. oralis, S. sanguinis, S. mutans, and P. gingivalis bacteria. Patches produced were clear to brown-colored films with high swelling percentage due to hydrophilic polymers used. The patch thickness that is closest to the requirements of the buccal patch was F8 with 0.36+0.04 mm. The mean values of the patches have matched normal salivary pH of 5.5–7. Physically, PVP/CMC formulations were more sticky, and the PVP/HPMC patches were more solid and stronger. Conclusion: A mucoadhesive patch was obtained with a combination of PVP/CMC and PVP/HPMC, tween 80 as a surfactant, glycerin as a plasticizer, peppermint oil as a flavor enhancer and preservative, with the active ingredient propolis.