Formulation and Characterization of Bilayered Mucoadhesive Buccal Patch
Drug delivery through buccal mucosa offers a novel route of controlled drug delivery by mucoadhesivity using mucoadhesive polymer specially natural polymers. Mucoadhesive patch allows maximum drug to reach systemic circulation without first pass effect. In this study, buccal patch comprises of bi-layers i.e., fast releasing layer made of pectin and sustained releasing layer made in combination with pectin & guar gum. The layers were made by solvent casting method. Different concentrations of pectin in fast as well as sustained release layer, and guar gum in sustained release layer, and drug with different excipients were tried in formulations and evaluated. Incorporation of β-cyclodextrin enhanced the drug permeation through buccal mucosa. FT-IR and DSC methods revealed that there is no interaction between Ondansetron Hcl and polymers. The patches were evaluated for weight variation, thickness, drug content uniformity, folding endurance, surface pH, mucoadhesivity, residence time, and in vitro drug release study. Optimized patch (F6) showed satisfactory results in all evaluation parameters as compared to rest of the batches. Data of in-vitro release from patches were fit in to different equations and kinetic models to explain release kinetics. The models used were zero and first-order, Hixon-Crowell, Higuchi and Korsemeyer-Peppas models equation. The optimized patch demonstrated well in-vitro results with matrix release in immediate as well as sustained release layer. Thus no mucosal irritation is expected.