In-Vitro Characterization and In-Vivo Pharmacokinetic Study of Zolmitriptan Mucoadhesive Buccal Film for Expedited Migraine Relief

Significance: The study aims to address the need for an efficient and patient-friendly alternative for migraine relief. Utilizing Zolmitriptan (ZMT) -loaded buccal films offers a promising avenue for rapid onset of action and enhanced efficacy compared to traditional tablets.Methods: Film formulations were prepared and analyzed for ZMT content, mechanical properties, pH values, thickness, amorphization through Differential Scanning Calorimetry, and moisture uptake at varying drug loading. The swelling index and adhesion properties were also investigated. In vitro dissolution profiles were determined. In vivo studies assessed Tmax enhancement compared to traditional tablets.Results: ZMT buccal films demonstrated ZMT content between 2.38±0.19 and 2.46±0.16 mg/film, with optimal mechanical properties and pH values suitable for oral cavity application. DSC analysis highlighted ZMT amorphization during preparation, and moisture uptake decreased with higher drug loading. Concentration-dependent effects were observed in the swelling index and adhesion properties. In vitro studies revealed rapid erosion and quicker drug release. In vivo studies demonstrated a significant shortening in Tmax (from 1.33 ± 0.61 to 0.63 ± 0.26 hr) compared to traditional tablets.Conclusions: The prepared ZMT-loaded mucoadhesive buccal film showcases immense potential as a patient-friendly alternative for swift alleviation from migraine episodes. The findings underscore the formulation's robustness, demonstrating enhanced drug release and significant clinical advantages over conventional treatments.