Prediction of Oral Drug Absorption & Biopharmaceutic Risk Using a Dissolution-Hollow Fiber Membrane

Tuesday, October 17, 2023
3:00 p.m.-4:00 p.m.

Prediction of Oral Drug Absorption and Biopharmaceutic Risk Using a Dissolution-Hollow Fiber Membrane (D-HFM) System: An overview of an example project with M-CERSI and FDA

Tuesday, October 17, 2023 

3:00-4:00 PM ET

Remote Access Information Link: Zoom 

Please join us as Dr. James Polli presents his recent work on a dissolution-hollow fiber membrane (D-HFM) system.

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) and the Center for Research on Complex Generics (CRCG). He is Director of the online M.S. in Regulatory Science program. 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.

Presentation abstract

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 will be described, with an emphasis of biopharmaceutic risk assessment (1,2). The lecture will also discuss 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 are dynamically linked in vivo, such that (b) drug intestinal permeation is required to allow for (a) additional drug dissolution.

Please view the presentation slides here 

Please view the recording here 

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