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Drug Dissolution in Oral Drug Absorption Workshop

The U.S. Food and Drug Administration (FDA)- in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)- will host a two-day in-person workshop entitled “Drug Dissolution in Oral Drug Absorption” on Tuesday, May 23 and Wednesday, May 24, 2023.

The aim of this two-day workshop is to facilitate dialogue between academic, industrial, and regulatory drug development scientists about current phenomena and methods in oral drug product dissolution. This workshop provides a forum for experts from regulatory agencies, innovator and generic drug industry, consultants, and academia, to focus on contemporary dissolution concepts, methods to anticipate oral drug product dissolution, and recent advancements in dissolution method development beyond compendial approaches. The workshop will include morning presentations on the advances of drug dissolution.

Afternoon breakout sessions will provide the opportunity to deep dive into current challenges/limitations and bring forth emerging approaches and techniques for complex formulations.

Topics:
A. In vivo dissolution and drug absorption
B. In vivo GIT imagining and dynamics
C. Regulatory considerations for Dissolution Method Development (focus on non-
compendial methods)
D. Critical amorphous solid dispersion (ASD) properties and dissolution method
development

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Tuesday May 23 
8:20 a.m. – 4:30 p.m.

 

Welcome & Introduction                                                                     

Welcome & Introductory Remarks

James Polli, PhD Professor and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics, Univ. of Maryland

Kimberly Raines, PhD Branch Chief, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA

 

Session Overview

Lynne S. Taylor, PhD Retter Distinguished Professor of Pharmacy, Department of Industrial and Physical Pharmacy, Purdue University
Supersaturation via Acid-Base Interactions Abu Serajuddin, PhD Professor of Industrial Pharmacy, St John’s University

 Presentation (PDF)
“Dissolved” Species: Biopharmaceutical Roles and Ways to Measure Martin Brandl, PhD, Dr. habil Full Professor, Department of Physics, Chemistry & Pharmacy, University of Southern Denmark

 Presentation (PDF)
Gastrointestinal Imaging with MRI: Providing Information about Conditions at the Site of Drug Delivery Werner Weitschies, PhD Professor of Biopharmaceutics, Center of Drug Absorption and Transport, University of Greifswald, Germany  Presentation (PDF)
In Vitro Evaluation of Drug Presence in the Micellar Phase of Contents of Upper Small Intestine: Rationale, Challenges, Opportunities

Christos Reppas, PharmD, PhD Professor of Pharmaceutics, Department of Pharmacy, National and Kapodistrian University of Athens, Greece

  Presentation (PDF)
Predicting Food Effects on Drug Absorption Anette Müllertz, PhD Professor in Oral Drug Delivery and Industrial Relations, University of Copenhagen, Denmark  Presentation (PDF)

Panel Discussion 

 

Abu Serajuddin, PhD Professor of Industrial Pharmacy, St John’s University

Martin Brandl, PhD, Dr. habil Full Professor, Department of Physics, Chemistry & Pharmacy, University of Southern Denmark

Werner Weitschies, PhD Professor of Biopharmaceutics, Center of Drug Absorption and Transport, University of Greifswald, Germany

Christos Reppas, PharmD, PhD Professor of Pharmaceutics, Department of Pharmacy, National and Kapodistrian University of Athens, Greece

Anette Müllertz, PhD Professor in Oral Drug Delivery and Industrial Relations, University of Copenhagen, Denmark

Bhagwant Rege, PhD Division Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA

  

Session Overview

Haritha Mandula, PhD Senior Pharmaceutical Quality Assessor, BB3, DB, ONDP, OPQ, CDER, FDA
Biorelevant In Vitro Testing-Dissolution Method Development Beyond Compendial Approach Zongming Gao, PhD Research Chemist, DCDA, OTR, OPQ, CDER, FDA

 Presentation (PDF)
In Vivo Formulation Behavior and Drug Absorption Patrick Augustijns, PhD Full Professor, University of Leuven

 Presentation (PDF)
Release Mechanisms of Amorphous Solid Dispersions Lynne S. Taylor, PhD Retter Distinguished Professor of Pharmacy, Department of Industrial and Physical Pharmacy, Purdue University

 Presentation (PDF)  

Panel Discussion 

Zongming Gao, PhD Research Chemist, DCDA, OTR, OPQ, CDER, FDA

Patrick Augustijns, PhD Full Professor, University of Leuven

Lynne S. Taylor, PhD Retter Distinguished Professor of Pharmacy, Department of Industrial and Physical Pharmacy, Purdue University

  
Breakout Session A 

Breakout Session A1 [Session Leads: Hanlin Li, Vertex and Haritha Mandula, FDA] RTRT to replace in vitro dissolution: best practices to incorporate in vitro dissolution data into modeling

Breakout Session A2 [Session Leads: David Curran, GSK and Anitha Govada, FDA] Drug dissolution from nano-formulations

Breakout Session A3 [Session Leads: Kerstin Schaefer, Boehringer-Ingelheim and Hansong Chen, FDA] Non-compendial methods

Breakout Session A4 [Session Leads: Anette Mullertz, Uof Copenhagen and Leah Falade, FDA] Drug dissolution from lipid-based formulations

  

Wednesday May 24
8:20 a.m. – 4:30 p.m.

 

Welcome & Introduction                                                                     

Welcome & Introductory Remarks

James Polli, PhD Professor and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics, Univ. of Maryland

Kimberly Raines, PhD Branch Chief, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA

 

Session Overview

Leah W. Falade, PhD Pharmacologist, Division of Biopharmaceutics, ONDP, OPQ,CDER, FDA
An FDA Perspective on QC Dissolution Test for Oral Drug Products Containing ASDs Kevin Wei, PhD Pharmacologist, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA

 Presentation (PDF)
Non-compendial Tools in Early Drug Product Development

Kerstin Julia Schaefer, PhD Senior Associate Director, Material and Analytical Sciences
Department, Boehringer-Ingelheim Pharmaceuticals Inc

Corrine Jankovsky, PhD Senior Scientist, Material and Analytical Sciences Department, Boehringer-Ingelheim Pharmaceuticals Inc.

 Presentation Not Available 
Setting Up Dissolution Studies to Reflect Product Performance in the GI Tract Jennifer Dressman, PhD Group Leader, Pharmaceutical Technology, Fraunhofer Institute of Translational Pharmacology and Medicine  Presentation (PDF)
Considering Free-Drug Concentrations in the GI Tract: Impact of Cyclodextrin and Food

Shinji Yamashita, PhD Visiting Professor of College of Pharmaceutical Sciences, Ritsumeikan University

  Presentation (PDF)
Combined Dissolution/Permeation: Input for Rationalized Drug Formulation Development Annette Bauer-Brandl, PhD Full Professor, Department of Physics, Chemistry & Pharmacy, University of Southern Denmark Presentation (PDF)

Panel Discussion 

 

Kevin Wei, PhD Pharmacologist, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA

Kerstin Julia Schaefer, PhD Senior Associate Director, Material and Analytical Sciences Department, Boehringer-Ingelheim Pharmaceuticals Inc.

Corrine Jankovsky, PhD Senior Scientist, Material and Analytical Sciences Department, Boehringer-Ingelheim Pharmaceuticals Inc.

Jennifer Dressman, PhD Group Leader, Pharmaceutical Technology, Fraunhofer Institute of Translational Pharmacology and Medicine

Shinji Yamashita, PhD Visiting Professor of College of Pharmaceutcial Sciences, Ritsumeikan University

Annette Bauer-Brandl, PhD Full Professor, Department of Physics, Chemistry & Pharmacy, University of Southern Denmark

  
Breakout Sessions B

Breakout Session B1 [Session Leads: Abu Serajuddin, St Johns U and Alaadin Alayoubi, FDA] Drug dissolution from co-crystals

Breakout Session B2 [Session Leads: Rohit Jaini, Pfizer and Parnali Chatterjee, FDA] Ionizable drugs or excipients: buffer capacity considerations

Breakout Session B3 [Session Leads: Lynne Taylor, Purdue; Andre Hermans, Merck; and Rajesh Savkur, FDA) Non-compendial testing for ASDs from industry and regulatory perspective

  
Breakout Session C 

Breakout Session C1 (Session Leads: Martin Brandl, U of Southern Denmark; Annette Bauer-Brandl, U of Southern Denmark; and Kimberly Raines, FDA) In vitro approaches to interpret/predict food effects

Breakout Session C2 (Session Leads: Dana Moseson, Pfizer and Debasis Ghosh, FDA) Drug dissolution from amorphous solid dispersions

Breakout Session C3 (Session Leads: Yi Gao, AbbVie and Tapash Ghosh, FDA) Non-USP methods versus regulatory methods: biopharmaceutic risk assessment

  

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