Abstract

RODRIGUEZ CHANFRAU, Jorge Enrique  and  GIL APAN, Jose Manuel. Dissolution Assay for Tilo ^® tablets prepared with dry extract of Justicia pectoralis Jacq. Rev Cubana Farm [online]. 2013, vol.47, n.1, pp. 117-128. ISSN 0034-7515.

Introduction: dissolution testing is one of the most common analytical techniques performed in a pharmaceutical analytical laboratory. A technological process for the production of tablets was developed. The active pharmaceutical ingredient used was Tilo ® dry extract. Objective: to develop and to validate the dissolution assay aimed at evaluating the stability study and the quality of this product. Methods: some samples from the experimental batch, the placebo batch and the pilot batches were used in this study. Distilled water and 0,1 mol/L chlorhidric acid were evaluated as dissolution media. The dissolution profiles at 50, 75 and 100 rpm and two types of dissolution devices (basket and paddle) recommended for the USP were evaluated. Coumarin content was analyzed by HPLC method. The dissolution assay was validated according to the United States Pharmacopeia. Results: the results showed that the distilled water was an appropriate dissolution medium, where percentages of released drug higher to 85 % in 30 minutes were obtained; there were no significant differences among the types of dissolution devices recommended by the USP. The dissolution profiles at different shaking times and speeds showed gradual release of the active principle. As the shaking speed increases, the percentage of the drug dissolution increases in the medium. The assay was considered specific and precise. Conclusions: a type II (paddle) dissolution device, 500 ml of distilled water at 37 ± 0,5 ºC and 100 rpm, were established as parameters of the dissolution assay.

Keywords : Dissolution test; Dissolution profiles; Justicia pectoralis; Tablets; Validation. Coumarin.

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