Evaluation of the nimesulide content in splitting tablets

Abstract

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that inhibits the action of the enzyme cyclooxygenase-2 and is widely used in many countries for the treatment of pain and inflammation. It is often given on a dosage adjustment basis mainly in the elderly and children. In the present work the nimesulide tablet splitting process from three different suppliers was studied using a tablet cutter in order to verify the influence of the breakdown of the same on the content of each obtained fragment. The tests of average weight, hardness, friability, disintegration, dosage and uniformity of unit doses were performed following the official methodology established by the Brazilian Pharmacopoeia. The samples studied met the official specifications before being submitted to the partition procedure; however, after dividing the tablets, the drug content in the halves presented excessive variation, showing that this procedure should not be performed for the drug Nimesulide. In cases of need for varying administration doses of Nimesulide, it is recommended that the drug be manipulated or that another pharmaceutical form is used in order to ensure dosage in each unit of the dosage form.

Keywords

• nimesulide, splitting tablets, quality control.