Tarapon K. Development of the composition, technology and research of solid dosage forms with nimesulide

The dissertation work is dedicated to the theoretical and experimental substantiation of the composition, technology, and research of solid dosage forms (prolonged-release tablets and granules for oral suspension) with nimesulide. An algorithm for the pharmaceutical formulation of solid dosage forms containing nimesulide, specifically, prolonged-release tablets and a generic medicine in the dosage form of sachets – granules for oral suspension, has been suggested. Physico-chemical properties have been characterized and critical characteristics of drug substance nimesulide have been established. The technology of preparation of Nimesulide, 200 mg prolonged-release tablets by wet granulation technique has been proposed. The dependence of pharmaco-technological indicators on tablet compression parameters has been has been proven. A draft of quality control methods has been developed for Nimesulide, 200 mg prolonged-release tablets. The manufacturing process development of Nimesulide, granules for oral suspension 100 mg/2 g by the wet granulation technique has been described. The flow chart and a brief description of the stages of the technological process have been presented. The analytical methods “Related substances” by HPLC have been developed and validated.