Formulation, Optimization and In-Vivo Pharmacokinetic Evaluation of Carvedilol Mucoadhesive Buccal Films by Using Natural Polymers
Keywords:Buccal film, critical material attributes, Critical quality attributes, Quality by design, Factorial design, Optimization
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.
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