COMPARATIVE STUDY OF QUALITY CONTROL OF COMPLEXED AND NON-COMPLEXED NIMESULIDE TABLETS WITH Β-CYCLODEXTRIN

Abstract

The quality control of medicines through physicochemical analysis is of great importance in ensuring the quality of drugs. Therefore, this study compared the quality of nimesulide tablets with β-cyclodextrin (Maxsulid®) and without β-cyclodextrin (Nisulid®) as a way to investigate if the current tests are suitable to dosage forms that have included complexes with β-cyclodextrin on their composition. Physicochemical assays were carried out following the Brazilian Pharmacopeia 6th edition for nimesulide tablets. Both drugs showed good results in most tests of physicochemical characterization. The drug content and dissolution tests were performed with quantitative determinations by High Performance Liquid Chromatography. The results of drug content showed that the standard methodology is inadequate to extract the drug from inclusion complex and to quantify it efficiently. On dissolution, both drugs were approved according to the requirements established in the Brazilian Pharmacopeia. However, Maxsulid® was the only one to obtain its minimum dissolution in 120 min. It is clear the importance of implementing analytical protocols appropriated to new technologies applied in the production of new medicines commercially available.