Abstract

This study aimed to simulate the in vivo behavior of indomethacin suppositories (reference and a generic formulation) using in vitro dissolution data and a numerical convolution method. The United States Pharmacopeia (USP) basket apparatus (USP apparatus I) at 100 rpm and the flow-through cell method (USP apparatus IV) with laminar flow at 16 ml/min were used. The dissolution medium phosphate buffer (0.1 M, pH 7.4) with or without 1% sodium dodecyl sulfate (SDS) was used. The dissolution profiles were compared with model-dependent and independent methods. For the reference drug product, tested with the USP apparatus IV and without 1% SDS, predicted Cmax and AUC0–inf were 2.39 and 8.46 μgh/ml, respectively; for the generic formulation, same medium but with the USP apparatus I, values of 0.73 and 3.11 μgh/ml were calculated. When comparing predicted pharmacokinetic parameters with in vivo data prediction errors

Key words: convolution, flow-through cell, indomethacin, suppositories