In Vitro and In Vivo Evaluation of Taste Masked Chlorhexidine-Releasing Oral Films

Abstract

The present investigation was undertaken with the objective of formulating chlorhexidine diacetate containing fast dissolving oral films to serve as superior alternative to mouthwash, aiming at consumer compliance. Various film forming agents, plasticizers and taste masking agents were evaluated for optimizing the composition of fast dissolving oral films. The potential of arginine hydrochloride as taste masking agent for fast dissolving oral films containing hydroxypropylmethylcellulose E5 (HPMC E5), propylene glycol and sucralose were formulated. Fast dissolving oral films of chlorhexidine diacetate were evaluated for the in vitro dissolution profile and in vitro microbiological assay. Oral films exhibited satisfactory in vitro dissolution profile and in vitro antimicrobial activity. Effect of incorporation of eugenol on the in vivo performance of oral films was evaluated in human volunteers. Arginine hydrochloride and eugenol containing oral films improved effectiveness and acceptability of films with respect to taste masking, mouth feel and mouth freshening without compromising the in vivo dissolution time.