Abstract: The present study was aimed at the design, development, and in-vitro evaluation of Brivaracetam buccal films to improve drug bioavailability by bypassing hepatic first-pass metabolism and providing controlled drug release through the buccal mucosa. Buccal films were prepared by the solvent casting method using Hydroxypropyl Methylcellulose (HPMC) and Carbopol 934 as film-forming and mucoadhesive polymers, respectively. Eight formulations (F1–F8) were developed by varying the polymer concentration while maintaining a constant drug dose of 25 mg. The thickness of the films ranged from 0.71 to 0.89 mm, while drug content varied from 79.86% to 95.86%. Moisture studies and swelling behavior indicated acceptable stability and hydration characteristics suitable for buccal application. In-vitro drug release studies were carried out using phosphate buffer (pH 6.8), and all formulations demonstrated sustained drug release over 300 minutes. Among the formulations, F7 exhibited the highest cumulative drug release (98.88%) along with excellent folding endurance (195) and drug content (95.86%), indicating optimum formulation performance. Drug release kinetic analysis revealed that the optimized formulation best fitted the Korsmeyer–Peppas model (R² = 0.973), followed by the Higuchi model (R² = 0.965), suggesting diffusion-controlled drug release from the hydrated polymeric matrix. The optimized formulation was subjected to accelerated stability studies at 40 ± 2°C and 75 ± 5% RH for 90 days according to ICH guidelines.
B. VENKATA PHANI DEEPTHI, G. SRUJANA, A. SARITHA
Brivaracetam, Buccal film, Solvent casting, Mucoadhesion, HPMC, Carbopol 934, In-vitro drug release, Bioavailability, Epilepsy
