Estudo comparativo do controle de qualidade de comprimidos de nimesulida complexada e não complexada com β - ciclodextrina

Abstract

The quality control of medicines through chemical product tests is of great importance in ensuring the quality of medicines. Therefore, this study aimed to compare the quality of nimesulide tablets with β-cyclodextrin (Maxsulid®) and without β-cyclodextrin (Nisulid®) as a way to investigate the current tests that are tested during the duration of clinical tests that are used in pharmaceutical conditions that include cyclodextrins in their composition, using methods described in the Brazilian Pharmacopoeia 6th edition. Given the exposure, both drugs obtain good results in most tests of physical-chemical characterization. Only Nisulid® failed due to a tablet break in the reliability test. The dosage and dissolution tests were performed through quantitative determinations using High Performance Liquid Chromatography. As expected, the results of the dosing showed that the applied methodology was inefficient for the drug with inclusion complex (Maxsulid®). On dissolution, both drugs were approved according to the criteria used in the Brazilian Pharmacopoeia, however Maxsulid® was the only one to have its recovery dissolved in 120 minutes. Thus, it is clear the importance of implementing analytical protocols applicable to new technologies applied in the production of medicines.