Optimization and evaluation of chitosan buccal films containing tenoxicam for treating chronic periodontitis: In vitro and in vivo studies

The objective of the present study was to optimize and evaluate a buccal mucoadhesive tenoxicam (TNX) local delivery system for the treatment of chronic periodontitis. Full 32 factorial design was adopted to evaluate the effect of the concentration of chitosan and polyvinyl pyrrolidone (PVP) on buccal film characteristics. The results showed that PVP concentration exerted a significant synergistic effect on film swelling, while chitosan slightly, but insignificantly, retarded film swelling. In addition, chitosan exhibited the only significant agonistic effect on mechanical film properties. Furthermore, PVP significantly enhanced the Higuchi diffusion slope of the drug release from buccal films, while it was antagonized by chitosan. The optimized formula showed adequate mechanical properties for buccal films. The in vivo salivary pharmacokinetic study of the optimized film revealed rapid and sustained salivary TNX delivery in the buccal cavity. This study indicated that the optimized TNX mucoadhesive buccal film is an optimal alternative dosage form to oral therapy for the treatment of chronic periodontitis and can provide a means to overcome the off-targeted side effects of orally delivered drug.