Formulation Development of Rizatriptan–cannabidiol-loaded Phospholipid Nanoemulsion for Migraine: Box–behnken Design-Based Optimization and In vitro Characterization
Abstract
Introduction: Migraine is a debilitating neurological disorder characterized by recurrent headaches and sensory disturbances. Current therapies are limited by poor bioavailability and adverse effects, necessitating novel delivery approaches. Nanoemulsions have emerged as promising carriers for lipophilic and hydrophilic drugs, offering improved solubility, stability, and targeted delivery. Methods: A phospholipid-based nanoemulsion was developed to co-deliver Rizatriptan and Cannabidiol for synergistic management of acute migraine. Box-Behnken design was employed to optimize critical formulation variables, including oil concentration, surfactant level, and sonication time. The optimized nanoemulsion was characterized for particle size, polydispersity index (PDI), zeta potential, entrapment efficiency, drug release profile, and stability. Ex-vivo permeation studies were also conducted using rat skin to evaluate transdermal delivery potential. Results: The optimized formulation exhibited a mean particle size of less than 200 nm with a narrow PDI, indicating uniform dispersion. Zeta potential values confirmed colloidal stability, while high entrapment efficiencies were achieved for both drugs. In-vitro release studies demonstrated sustained drug release over 24 hours, and ex-vivo permeation confirmed enhanced transdermal flux compared to conventional formulations. The nanoemulsion maintained stability under accelerated conditions, validating its robustness. Discussion: The…
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