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The intent of this work was to study the effect of polymorphism on dissolution properties and to apply several methods to evaluate the dissolution profiles of immediate-release tablets containing alpha (α) and beta (β) forms of eletriptan hydrobromide (EH). The polymorphs were characterized by X-ray diffraction (XRD), differential scanning calorimetry (DSC), and diffuse reflectance infrared Fourier transform spectroscopy (DRIFTS). The dissolution conditions were USP Apparatus 2 (paddle) with 900 mL of 0.1 N HCl medium at a rotation speed of 100 rpm. The dissolution profiles were compared using model-independent, model-dependent, and statistical methods. In the model-independent approaches, dissolution efficiency (DE), mean dissolution time (MDT), difference factor (f1), and similarity factor (f2) were evaluated. A statistical assessment of DE data was performed using ANOVA and the t-test. Dissolution kinetics was determined using model-dependent approaches in which nine drug release mathematical models were evaluated. The dissolution profile of the α formulation was best represented by the Weibull model, and the β formulation by the Korsmeyer–Peppas model. The calculated fit factors infer that the two tablet formulations are similar with minor differences. Statistical and model-dependent approaches demonstrate that there may be a difference in the drug release mechanism.

Effect of Polymorphism and Application of Kinetic Models for the Evaluation of In Vitro Dissolution Profiles of an Eletriptan Hydrobromide Formulation