Development of orodispersible films for buccal antiseptic delivery of chlorhexidine: preparation, evaluation, and in vitro antimicrobial activity

Abstract

This study focuses on formulating and evaluating orodispersible films (ODFs) for targeted chlorhexidine delivery as a buccal antiseptic. ODFs were prepared using blends of natural polymers, either alone or in combination with polyvinylpyrrolidone (PVP), employing the solvent-casting method. The ODFs were loaded with a chlorhexidine digluconate solution at concentrations of 0.625, 1.25, and 2.5% w/w, and subjected to characterization, encompassing parameters such as appearance, thickness, average weight, folding endurance, disintegration time, pH, and residual water content. These analyses revealed favorable attributes for buccal administration. In vitro dissolution studies revealed rapid disintegration and release, facilitating the achievement of therapeutic levels of chlorhexidine within a short timeframe. The antimicrobial activity of the released chlorhexidine against Gram-positive and Gram-negative bacterial strains, as well as a fungus, was evaluated via agar diffusion assays. The ODF containing 1.25% w/w chlorhexidine exhibited the highest antimicrobial activity, with chlorhexidine content of 3.76 mg, meeting content uniformity standards. The compounding process proved to be simple, fast, reproducible, and robust, using low-cost excipients and a film applicator device. These findings hold significant implications for improving oral hygiene practices and addressing oral infections. In conclusion, this personalized formulation shows promise for magistral pharmacies in the compounding of buccal antiseptics as ODFs.