Optimization of chitosan-tapioca starch composite as polymer in the formulation of gingival mucoadhesive patch film for delivery of gambier (Uncaria gambir Roxb) leaf extract

The present study was intended to prepare and optimize the mucoadhesive buccal patch of gambier leaf extract using chitosan (CH) and tapioca starch (TS) composite as the polymer complexes. The patch formulation was designed based on 2² factorial design in order to optimize the composition of CH and TS. The physical and chemical characteristics of the prepared patches, including mass and thickness uniformity, folding endurance, surface pH, swelling index, percent of elongation, and mucoadhesive time were successfully evaluated. Based on statistical analysis, the optimum concentration of CH and TS was 900 mg and 300 mg, respectively, with desirability percent of 0.968. The characterization of the optimum patch showed that the variability coefficient of the mass and thickness uniformity was 0.4805 ± 0.1887% and 0.9716 ± 1.2026%, surface pH of the patch was 6, folding endurance >300 times, elongation percent was 53.333 ± 0.1082%, and mucoadhesive time was 320 ± 1.1547 min. The catechin content, as the active agent of the gambier leaf extract, was 92.1667 ± 0.3626%, and the FT-IR characterization indicated that there are no chemical interactions between each patch component.