Formulation and Evaluation of Mucoadhesive Bilayer Buccal Batches of Aceclofenac

Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) drug, exhibits poor aqueous solubility and low oral bioavailability due to extensive hepatic first-pass metabolism. Buccal delivery offers a potential alternative route to bypass first-pass metabolism and achieve sustained drug release for the clinical management of dental pain and arthritis. The aim of the work was to formulate and evaluate mucoadhesive bilayer buccal patch of Aceclofenac for sustained drug delivery and reducing dose frequency. Bilayer buccal patches were formulated by solvent casting method using an ethyl cellulose backing layer and mucoadhesive layers formulated with varying proportions of hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA) followed by evaluation of thickness, weight uniformity, folding endurance, surface pH, swelling index, drug content uniformity, in-vitro release and in-vitro release kinetics study. FTIR spectroscopy confirmed preformulation compatibility between the drug and excipients. Among six formulations (F1–F6) demonstrated that formulation F3 achieved optimal characteristics, exhibiting uniform thickness (0.41 ± 0.03 mm), weight uniformity (0.27 ± 0.03 g), folding endurance (>300), non-irritating surface pH (6.9 ± 0.10), high swelling index (61%), and uniform drug content (99.73 ± 0.06%). In-vitro dissolution testing showed sustained drug release from F3 over 8 hours (reaching 99.67%). Kinetic modeling fitted zero-order release (R² = 0.9983) governed by non-Fickian diffusion (Korsmeyer-Peppas n = 0.8851). The optimized F3 bilayer buccal patch represents a successful formulation for sustained buccal delivery to reduce dosing frequency suggesting its potential as an effective alternative clinical management of dental pain and arthritis.