Development and Optimization of Eletriptan Hydrobromide Sublingual Tablet Using Central Composite Design and in vitro Characterization

Abstract

Background: In the current research, the sublingual tablets were formulated by utilizing a solid dispersion by physical mixture technique using sodium starch glycolate works as a super disintegrant and cyclodextrin works as a solubility enhancer, which can provide a rapid onset of action. Objectives: To prevent first-pass metabolism sublingual drug delivery of an Eletriptan hydrobromide which is considered to be one of the finest surrogate routes of administration. Additionally, it will lead to patient adherence as well as increased therapeutic efficacy. Materials and Methods: The undeviating (direct) compression technique was used to develop the tablet formulation. The amount of sodium starch glycolate (X1) as well as PVP K-30 (X2) was chosen as the unconventional (independent) variable, while the dependent variables were the disintegration time (Y1) in seconds and the fraction of medication released in vitro (Y2). This was accomplished using a central composite design. The prepared tablets were assessed for a number of parameters, comprising hardness testing, friability testing, thickness, weight variation method, wetting time analysis and water absorption ratio. Results: The solid core dispersion of eletriptan hydrobromide escorted by β-cyclodextrin ratio 1:2 in distilled water and phosphate buffer pH 6.8 showed improved solubility (3.632±0.006, 11.327±0.003) than that of corresponding pure eletriptan (1.936±0.004, 8.471±0.007). Conclusion: The SLT4 formulation showed the best results in terms of disintegration time of 01 min and in vitro drug release of 96.36% in 15 min implying that the sublingual route of eletriptan hydrobromide direction can be a better alternative for migraine disease.