In vitro and in silico simulation of human GI behavior in pharmacokinetic studies

In this work a device which reproduces the mixing in the stomach due to the peristaltic waves has been realized and tested using a commercial diclofenac tablet. The tablet has been found to behave differently depending on the agitation conditions in comparison with the conventional method. Moreover, a conventional USP-approved dissolution apparatus 2 has been equipped with an hollow fibers filter, in order to allow the simulation of the absorption through the intestinal wall. The concentration of drug in the donor compartment has been found lower than that obtained in the conventional test. Finally, a PBPK in silico model has been tested and compared with the experimental data.