Formulation, Optimization and In-Vivo Pharmacokinetic Evaluation of Carvedilol Mucoadhesive Buccal Films by Using Natural Polymers http://www.doi.org/10.26538/tjnpr/v7i10.32
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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.
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