Prediction of Oral Drug Absorption and Biopharmaceutic Risk Using a Dissolution-Hollow Fiber Membrane (D-HFM) System October 17, 2023

Webcast | Virtual

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• Date: October 17, 2023

University Of Maryland CERSI

Presented By

James E. Polli, Ph.D.
Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics
University of Maryland School of Pharmacy

About the Presentation

Two general aspects of drug tablet and capsule performance are (a) drug release/dissolution and (b) drug intestinal permeation. In this presentation, recent efforts to characterize a hollow fiber membrane module as part of a dissolution-permeation system was described, with an emphasis of biopharmaceutic risk assessment (1,2). The lecture also discussed potential utility of a dissolution-permeation system to better understand low solubility drugs and enabled formulations (e.g. amorphous solid dispersions), including where dissolution and permeation were dynamically linked in vivo, such that (b) drug intestinal permeation was required to allow for (a) additional drug dissolution.

About the Presenter

Dr. James Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption. His two main research interests are 1) maximizing oral bioavailability through formulation and chemical approaches and 2) developing public quality standards for oral dosage forms. He has served as the advisor to 24 PhD graduates. He is co-Director of the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI; www.cersi.umd.edu) and the Center for Research on Complex Generics (CRCG; www.complexgenerics.org). He is Director of the online M.S. in Regulatory Science program (www.pharmacy.umaryland.edu/regulatoryscience). He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of its flagship journal Pharmaceutical Research for 12 years. He was the recipient of the 2022 AAPS Global Leadership Award and 2021 TOPRA Education Award. He is a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB). He is a member of the Scientific Advisory Board of Simulations Plus.

Recording

Play recording (48 mins)

For Questions:

Please contact Ruize Li at Ruize.Li@fda.hhs.gov.