Complex in vitro models of the upper gastrointestinal (GI) tract that mimic the dynamic GI environment can potentially accelerate preclinical formulation development, improve efficiency and shorten the time to market for (new) oral drug products as they may be capable of providing a better predictive ability than other preclinical models such as animal models. The dynamic gastrointestinal simulation technology (DyGIST) is a combination of the dynamic gastric model (DGM) with an automated gastrointestinal transfer model that simulate the hydrodynamics, transit and pH of the upper GI tract. The DyGIST is capable of accommodating a glass of water, as well as a full meal and thus, can be used to predict the in vivo PK behavior of oral dosage forms in both the fasted and fed state. In this presentation, the use of DyGIST to predict the PK performance (efficacy) of three immediate release products will be presented.
Learning Objectives:
Learn how biorelevant in vitro models may accelerate the drug development process
Understand why the stomach plays an important role for immediate release products
Discover that combining simple data convolution with complex in vitro models may prevent the need for advanced PBPK models