QbD-Guided Formulation and Evaluation of Clove Oil-Based Glibenclamide Microemulsion for Mucoadhesive Buccal Patch Delivery
Abstract
Type II diabetes requires long-term drug therapy; however, oral glibenclamide is limited by poor solubility, erratic absorption, and high first-pass metabolism, affecting bioavailability and adherence. This study developed a QbDguided clove oil-based glibenclamide microemulsion incorporated into a mucoadhesive buccal patch for sustained delivery and better compliance. Glibenclamide was quantified using a validated UV–visible method (R²=0.9989/0.9993, accuracy 98–100%, precision %RSD<2, LOD 6.40 µg/mL, LOQ 19.17 µg/mL). FT-IR confirmed drug–excipient compatibility. Solubility screening identified 50 mg/mL clove oil as optimal. Pseudoternary phase diagrams showed the largest microemulsion region at a S_mix of 2:1. A factorial design evaluated oil and surfactant concentrations against particle size, drug load, and transmittance; analysis revealed a quadratic design space (oil 5–7%, Smix 60–70%). The optimized microemulsion was clear, stable, highly transmittant (~98.45%), with nanometric droplets (78–96 nm; PDI ~0.03), zeta potential −1.23 mV, high drug loading (~95%) and entrapment (91.35%), pH ~6.4, and low viscosity (~25 cP). The patch (Polyvinyl Alcohol and Polyvinylpyrrolidone (PVA:PVP 1:1 with Carbopol); solvent casting) was uniform (88.25–88.33 mg; 0.162–0.214 mm), flexible (250-fold endurance), buccal-compatible (pH ~6.7), and drug-uniform (~95%). It released the drug over 8 h (~74% in-vitro vs. ~88% marketed tablet), followed Korsmeyer–Peppas kinetics, had good ex vivo…
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