RESUMO
Objective To prepare the agomelatine orally disintegrating tablets (AGO-ODT) and evaluate their quality. Methods The AGO-hydroxypropyl-(β-cyclodextrin inclusion complex was prepared by saturated water solution method, and then mixed with auxiliary materials and compressed into ODT. The disintegration, dissolution and acceptability of the ODT were evaluated, and AGO content was measured by the HPLC method. Results The mean disintegration time of AGO-ODT was 13. 17 s and the cumulative dissolution was higher than 95% at 8 minutes. The taste, swallowing and feeling of AGO-ODT were desirable. In addition, good linearity was obtained between chromatographic peak area and AGO concentration in the range of 1.0-40.0 (μg/ml, and the recovery was between 98%-102% with the RSD less than 2%. Conclusion The disintegration and dissolution of prepared AGO-ODT work well. The test method is simple, exclusive and reproducible and it can be used as quality evaluation for AGO-ODT. © 2006 Editorial office of Foreign Medical Sciences.