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.
Benznidazole; Excipients; Direct compression; Tablet; Chagas' Disease
