Complex in vitro models of the upper gastro-intestinal (GI) tract that mimic the dynamic GI environment (in terms of hydrodynamics and fluid composition/characteristics) are potentially of high value for the preclinical development and understanding of new oral pharmaceutical products as they may be capable of providing a similar or better predictive ability than animal models. The dynamic gastric model (DGM) is one such model that simulate the hydrodynamics, emptying and pH profile of the fed or fasted stomach. The DGM is capable of accommodating a glass of water, as well as a full meal and thus, can be used to evaluate the in vivo behavior of a dosage form in both the fasted and fed state. In the presentation, examples of positive and negative food effects predicted using the DGM are presented.
Learning Objectives:
Understand the complexity of fed state conditions, and food effect mechanisms
List the physiological differences (biochemistry and hydrodynamics) between the fasted and fed state conditions
Learn that combining simple data convolution with complex in vitro gastro-intestinal models may prevent the need for advanced PBPK modelling
