Formulation and Evaluation of Oral Trans-mucosal Delivery System of Eletriptan Hydrobromide

Background: To formulate, develop and evaluate sublingual tablet of anti-migraine agent (Eletriptan Hydrobromide). Materials and Methods: The sublingual tablet was prepared by direct compression method and the tablets were formulated using Kyron T-314, Sodium Bicarbonate, Mannitol, Neusilin US2, Stevia, PVP K-30, Magnesium Stearate and Talc as excipients. The prepared tablets were evaluated for various parameters like hardness, thickness, friability, weight variation, wetting time, in vitro disintegration time, in vitro dissolution and ex-vivo permeation study. A 32 full factorial design was applied to optimize the concentration of Kyron T-314(X1) and Sodium Bicarbonate (X2). Disintegration time (Y1) and % drug release at 15 min (Y2) were taken as dependent variables. Results: From the all batches, B9 was found to be the best batch with 3.5% of Kyron T-314 and 40% Sodium Bicarbonate. The optimized batch gave the best disintegration time of 9 sec and % drug release of 92.23% in 15 min. It showed maximum permeation of 93.17% in 30 min which is significant compared to the formulation without alkalizing agent. Conclusion: This indicates that the amount of the drug which remains unionised after the addition of the alkalizing agent lead to increase in permeability. Stability testing of the optimised batch was carried out and the results showed no significant change in the results of % drug release.