Formulation, Optimization and In-Vivo Pharmacokinetic Evaluation of Carvedilol Mucoadhesive Buccal Films by Using Natural Polymers

Abstract

This study utilizes Quality by Design (QbD) principles to optimize carvedilol buccal film composition. The optimization  method used a factorial design, changing three important material attributes (CMAs): the concentration of lime basil  seed mucilage, the concentration of plasticizer (PG 10%), and the percentage of permeation enhancer at three different  levels (low, medium, and high). Critical quality attributes (CQAs) included drug content (%), drug release percentage,  and folding endurance. A 33 factorial experimental design created a first-order response surface model. The optimized  buccal formulation, R20, featured high polymer, plasticizer, and medium permeation enhancer concentrations. It yielded  favorable CQAs: 96.9 ± 2.4% drug content, 97.4 ± 2.4% drug release at 24 hours, and 422 ± 12 folding endurance.  The identified optimal concentrations, established through the solvent casting process, offer a promising buccal film  formulation for further research and potential in vivo studies.