Applications of PBPK Modelling in Oral Peptide Delivery

Physiologically-based pharmacokinetic (PBPK) modelling and simulation (M&S) is a powerful component of the Model-Informed Drug Development (MIDD) strategy, applicable across a wide range of compound types.
Key advantages of PBPK modelling include its ability to provide mechanistic insights into processes, predict pharmacokinetic outcomes, and inform experimental design.
In this presentation, we highlight two case studies demonstrating the application of PBPK modelling in the development of oral peptide drugs:
1. A retrospective analysis of the impact of a permeation enhancer on the absorption of a highly soluble but poorly permeable peptide, administered as an enteric-coated formulation.
2. Evaluating drug-drug interactions using PBPK to assess how pretreatment and co-administration of Rybelsus® (semaglutide with a permeation enhancer) with metformin and furosemide influence their pharmacokinetics. These findings were extrapolated to other drugs to assess potential interactions and guide further experimental planning.