Abstract

Four ibuprofen products in two or three concentrations of active pharmaceutical ingredient were evaluated in vitro, using the conditions recommended for the upper pH- value of the three stage dissolution testing. The experimental data were included in the in silico prediction of the plasma concentration profiles, with consecutive analysis of the main pharmacokinetic parameters and assessment of the bioequivalence with the official reference drug product for the intermediate, 400 mg concentration. The results indicated an apparent feasibility of the biowaiver procedures, based on the dissolution similarity. Even when significantly different release profiles were obtained in vitro, the in vivo bioequivalence was concluded. The high permeability characteristic seems to be the key factor controlling the absorption profile of ibuprofen.