Workshop Report: USP Workshop on Exploring the Science of Drug Absorption

Abstract

In October 2018, the United States Pharmacopeia (USP) hosted a two-day workshop to explore the science of drug absorption. Experts from around the globe presented some of the challenges associated with drug product development from the perspective of the physiological attributes of the patient (human or canine) and the body site for drug activity. Included in the discussions were methods and approaches for answering complex questions, providing insights into the strengths and challenges of methods available in our biopharmaceutical tool chest. The following is a synopsis of the presentations and the highlights of the discussions that ensued. Disclaimer: This article reflects the views of the authors and should not be construed as representing the views or policies of the United States Food and Drug Administration.

In vitro models to evaluate ingestible devices: Present status and current trends

“…The evaluation of the biorelevance of the luminal media as based upon factors associated with the luminal composition used within the system. These were scored using the levels of simulation of luminal composition that have previously been reported [138,139]. These levels are: level 0 is pH only; level 1 is pH plus buffer capacity; level 2 includes bile components, dietary lipids, lipid digestion products and osmolality (this includes FaSSCoF and FeSSCoF) and level 3 also includes dietary proteins, enzymes (not digestion products) and viscosity effects.…”