Development and in vitro evaluation of tablets based on the antichagasic benznidazole

Abstract

This work aimed to verify the interferences caused by the use of excipients for immediate release tablets based on benznidazole obtained by direct compression and the accomplishment of a comparative study between the tablets developed and the reference medicine RochaganTM, obtained by wet granulation. Seven small-scale batches (SSB) were developed and aspects such as compressibility, powder flow, mean weight, friability, disintegration, hardness, assay, content uniformity, kinetic of release in vitro (dissolution) and drug/excipients physical-chemical compatibility were evaluated. Based on the obtained results it can be verified that the analyzed powders presented adequated characteristics for the direct compression process, beyond the inexistent evidence of a physical-chemical interaction between the drug and the tested excipients. The tablets obtained from SSB I and III were chosen for the comparative study with the reference medicine, demonstrating similarity with the statistically treated obtained results, becoming an alternative option of a medicine product for the treatment of Chagas' disease with reduced cost and satisfactory quality.