Oral administration of an active pharmaceutical ingredient (API) is the most patient-preferred route of drug delivery. Important considerations of API oral formulation include its solubility in gastrointestinal (GI) fluids and permeability across the intestinal epithelium to elicit a pharmacological response. The prediction of the API bioavailability using in silico models is typically performed during drug product development. Traditionally, the key parameters to predict API bioavailability derive from static Transwell in vitro studies and preclinical animal models. However, the oversimplified static Transwell model along with differences in digestive system in animal models often result in poor translation of bioavailability in humans. To help overcome this challenge, microfluidic models have been developed to recapitulate the complexities of the intestinal tract to predict oral bioavailability more accurately. In this study, we focused on method development to establish and validate the intestinal chip model as a potential additional parameter to predict oral bioavailability.
Learning Objectives:
Upon completion, participants will be able to visualize the different drug permeability between the static Transwell and dynamic chip systems.
Upon completion, participants will be able to understand how a new modality is validated to test permeability of orally delivered drugs