The purpose of this study was to develop formulations and systematically evaluate in vitro performances of buccoadhesive bilayer patches of zolpidem tartrate. Backing layer was formulated using Ethylcellulose N10 as a hydrophobic polymer and 70% of triethylcitrate of dry polymer weight as a plasticizer for backing layer. The mucoadhesive polymer chitosan and hydrophilic polymer HPMC E15 were incorporated into the buccoadhesive patches, to provide bioadhesive properties to the patches and to modify the rate of drug release. The patches, which were prepared by the solvent casting method, were smooth and elegant in appearance; were uniform in thickness, weight, and drug content; showed no visible cracks; and showed good folding endurance. A 32 full factorial design was employed to study the effect of independent variables like mucoadhesive polymer chitosan and hydrophilic polymer HPMC E15, which significantly influenced characteristics like ex vivo mucoadhesive strength and in vitro drug release at different time points. A stability study of optimized buccoadhesive patches was done in natural human saliva; it was found that both drug and buccal patches were stable in human saliva. It can be concluded that the present buccal formulation can be an ideal system to improve the bioavailability of the drug by avoiding hepatic first-pass metabolism.
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