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Ergotaminetartrate (ET), a serotonin 5-HT1 receptor agonist, is an anti-migraine drug. Due to high first-pass metabolism, ET shows a very lowbioavailability in oral administrations (<1%). Caffeine (CA)increases the rate and extent of water solubility of ET. The present studyintended to investigate the possibility of developing ET fast dissolving thinfilms for the fast drug dissolution in the oral cavity, and thus bypassingfirst pass metabolism for providing quick onset of action of the drug. Methods:The films (ET and CA) were prepared according to solvent casting method,separately. Low viscosity grade of hydroxylpropyl methylcellulose (HPMC E-15)was employed in preparation as a film forming polymer. Propylene glycol was theplasticizer used. All the films were evaluated for their thickness, weightvariations, folding endurance, surface pH, disintegration, drug content, DSC,in-vitro drug release, and ex-vivo permeation. Results: The bestpolymer drug ratio in ET/CA films was 1:20 (E2) and 1:4 (C2),respectively. The films E2 and C2 showed 9.9, 3.2 mgweight, 74, 45 µm thickness, 120.66, up to 300 folding endurance and 0.38, 0.52mg/cm2 drug content, respectively. The DSC showed nostable characteristic for ET and CA in the drug loaded films and revealed amorphous form. The results showed that ET filmsprepared had faster release and CA films had slower release (p<o.o5).Both films (ET and CA) exhibited good mucoadhesion properties and shorterretention time (36-150 s). Conclusion: The formulations werefound to be a suitable candidate for the development of oral thin films formigraine therapy.

Fast Dissolving Oral Thin Film Drug Delivery Systems Consist of Ergotamine Tartrate and Caffeine Anhydrous