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DEVELOPMENT OF BIGEL SYSTEMS FOR BUCCAL ADMINISTRATION OF ELETRIPTAN HYDROBROMİDE: A COMPARATIVE FORMULATION STUDY

MELİHA GÜNEŞ ¹, KEISI NAKU ², BEGÜM DEMİR ², SİNEM YAPRAK KARAVANA ¹*

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The present study focused on the development and characterization of hydrogel, oleogel and bigel systems for the buccal delivery of eletriptan hydrobromide (EHBr) as an alternative to oral therapy for acute migraine management. Hydrogel and oleogel formulations were optimised for composition, homogeneity and stability, and then combined in ratios of 30:70 and 40:60 to form bigels. The formulations were evaluated through rheological analyses, including viscosity profiling, linear viscoelastic region (LVR) determination and oscillatory frequency sweeps, which confirmed pseudoplastic and weak gel-like behaviour for all systems. Texture profile analysis assessed mechanical attributes such as hardness, compressibility, adhesiveness, cohesiveness and elasticity, with bigel (40:60) exhibiting superior mechanical strength and mucoadhesive potential. Mucin interaction tests confirmed the enhanced buccal retention of bigel systems compared to single-phase gels. In vitro release studies revealed a biphasic profile, where bigel (30:70) showed faster drug release (~70% in 24 h), whereas bigel (40:60) achieved more sustained release (~60% in 24 h) due to its denser oleogel network. By combining the hydrophilic nature of hydrogels with the lipophilic phase of oleogels, bigel formulations demonstrated tuneable mechanical and drug-release properties. Among these, the 40:60 bigel was identified as the most promising candidate for buccal EHBr delivery, offering a patient-friendly, non-oral platform for effective migraine therapy.