Formulation, Optimization and <i>In-Vivo</i> 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.