SIMULATION OF BIOEQUIVALENCE STUDY ON THE BASE OF DISSOLUTION CURVES

Abstract

A computer method and software based on the in vitro dissolution ofdrug preparations has been elaborated for the estimation of bioequivalenceusing Microsoft Excel 2007, Visual Basic programming language. Themethod generates a „dissolution surface‖ from the parameters of time (Xaxis),from pH (Y-axis) and from the dissolved amount (A) in % of the drug.This dissolution surface allows the determination of the general dissolutioncurve of the test and reference preparations. By supposing that the absorptionrate constant is known from the literature, the change of the amount ofdissolved drug as the function of time can be determined. On the base of thisfunction the maximum amount of the dissolved drug in the gastrointestinaltract and the AUC can be calculated and the test/reference ratio can bedetermined. In the case of linear pharmacokinetics these ratios are identicalto the ratios of parameters that can be calculated in the circulation. Bygenerating parameters between the allowed biological limits the dissolveddrug – time curves of „volunteers‖ in the necessary number are created withthe randomly generated „residence times‖ and their confidence intervals canbe determined, i.e. on the base of dissolution curves bioequivalence can beestimated.