An agenda for "Drug Dissolution in Oral Drug Absorption" is provided below for the convenience of conference attendees.
Scheduled for May 23-24, 2023, "Drug Dissolution in Oral Drug Absorption" is a two-day workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and Food and Drug Administration (FDA).
Tuesday, May 23, 2023
| Time | Activity |
|---|---|
| 8:20 – 8:25 a.m. | Welcome James Polli, PhD, University of Maryland, and Kimberly Raines, PhD, FDA |
| 8:25 – 8:30 a.m. | Session Overview Lynne S. Taylor, PhD, Purdue University |
| 8:30 – 9:00 a.m. | Supersaturation via Acid-Base Interactions Abu Serajuddin, PhD, St John’s University |
| 9:00 – 9:30 a.m. | “Dissolved” Species: Biopharmaceutical Roles and Ways to Measure Martin Brandl, PhD, Dr. habil, University of Southern Denmark |
| 9:30 – 10:00 a.m. | Gastrointestinal Imaging with MRI: Providing Information about Conditions at the Site of Drug Delivery Werner Weitschies, PhD, University of Greifswald |
| 10:00 – 10:30 a.m. | Break |
| 10:30 – 11:00 a.m. | In Vitro Evaluation of Drug Presence in the Micellar Phase of Contents of Upper Small Intestine: Rationale, Challenges, Opportunities Christos Reppas, PhD, National and Kapodistrian University of Athens |
| 11:00 – 11:30 a.m. | Predicting Food Effects on Drug Absorption Anette Müllertz, PhD, University of Copenhagen |
| 11:30 a.m. – Noon |
Panel Moderator:
Panelists:
|
| Noon – 12:55 p.m. | Lunch |
| 12:55 – 1:00 p.m. | Session Overview Haritha Mandula, PhD, FDA |
| 1:00 – 1:30 p.m. | Biorelevant In Vitro Testing-Dissolution Method Development Beyond Compendial Approaches Zongming Gao, PhD, FDA |
| 1:30 – 2:00 p.m. | In Vivo Formulation Behavior and Drug Absorption Patrick Augustijns, PhD, University of Leuven |
| 2:00 – 2:30 p.m. | Release Mechanisms of Amorphous Solid Dispersions Lynne S. Taylor, PhD, Purdue University |
| 2:30 – 2:45 p.m. |
Panel Moderator:
Panelists:
|
| 2:45 – 3:00 p.m. | Break |
| 3:00 – 4:00 p.m. |
Breakout Sessions A
|
| 4:00 – 4:30 p.m. | Breakout Session Read-Outs |
Wednesday, May 24, 2023
| Time | Activity |
|---|---|
| 8:20 – 8:25 a.m. | Welcome James Polli, PhD, University of Maryland, and Kimberly Raines, PhD, FDA |
| 8:25 – 8:30 a.m. | Session Overview Leah W. Falade, PhD, FDA |
| 8:30 – 9:00 a.m. | An FDA Perspective on QC Dissolution Test for Oral Drug Products Containing ASDs Kevin Wei, PhD, FDA |
| 9:00 – 9:30 a.m. | Non-compendial Tools in Early Drug Product Development Kerstin Schaefer, PhD, Boehringer-Ingelheim Pharmaceuticals Inc. Corrine Jankovsky, PhD, Boehringer-Ingelheim Pharmaceuticals Inc. |
| 9:30 – 10:00 a.m. | Setting Up Dissolution Studies to Reflect Product Performance in the GI Tract Jennifer Dressman, PhD, Fraunhofer Institute of Translational Pharmacology and Medicine |
| 10:00 – 10:30 a.m. | Break |
| 10:30 – 11:00 a.m. | Considering Free-Drug Concentrations in the GI Tract: Impact of Cyclodextrin and Food Shinji Yamashita, PhD, Ritsumeikan University |
| 11:00 – 11:30 a.m. | Combined Dissolution/Permeation: Input for Rationalized Drug Formulation Development Annette Bauer-Brandl, PhD, University of Southern Denmark |
| 11:30 a.m. – Noon |
Panel Moderator:
Panelists:
|
| Noon – 12:55 p.m. | Lunch |
| 1:00 – 2:00 p.m. |
Breakout Sessions B
|
| 2:00 – 2:15 p.m. | Break |
| 2:15 – 3:15 p.m. |
Breakout Sessions C
|
| 3:15 – 4:00 p.m. | Breakout Session Read-Outs |
| 4:00 – 4:30 p.m. | Summary |
| End of Workshop | |
Breakout Session Topics
Session #1: Drug dissolution from amorphous solid dispersions
Topic Question: What basic and applied laboratory methods provide the best insight into drug dissolution from amorphous solid dispersions?
Lead – Dana Moseson (Pfizer) / Debasis Ghosh (FDA)
Session #2: Drug dissolution from nano-formulations
Topic Question: What in vitro dissolution and dissolution/permeation methods have been most useful for nano-formulations?
Lead – David Curran (GSK) / Anitha Govada (FDA)
Session #3: Drug dissolution from co-crystals
Topic Question: What in vitro dissolution and dissolution/permeation methods have been most useful for co-crystals?
Lead – Abu Serajuddin (St. John's) / Alaadin Alayoubi (FDA)
Session #4: Drug dissolution from lipid-based formulations
Topic Question: What in vitro dissolution methods have been most useful for lipid-based formulations?
Lead – Anette Mullertz (University of Copenhagen) / Leah Falade (FDA)
Session #5: Non-USP methods versus regulatory methods: biopharmaceutic risk assessment
Topic Question: For various types of products, what non-USP methods have provided enhanced assessment of biopharmaceutic risk compared to regulatory dissolution methods?
Lead – Yi Gao (AbbVie) / Tapash Ghosh (FDA)
Session #6: Non-compendial testing for ASDs from industry and regulatory perspective
Topic Question: For ASDs, what non-USP methods are most useful compared to regulatory dissolution methods?
Lead – Lynne Taylor (Purdue) / Andre Hermans (Merck) / Rajesh Savkur (FDA)
Session #7: Non-compendial methods
Topic Question: Under what conditions has any particular non-compendial method been helpful, and why? Are such non-compendial methods complementary or potential replacements for compendial methods?
Lead – Kerstin Schaefer (Boehringer-Ingelheim) / Hansong Chen (FDA)
Session #8: Ionizable drugs or excipients: buffer capacity considerations
Topic Question: When and how should in vitro dissolution buffer capacity be modified due to ionizable drugs and excipients?
Lead – Rohit Jaini (Pfizer) / Parnali Chatterjee (FDA)
Session #9: RTRT to replace in vitro dissolution
Topic Question: What are the best real-time release testing (RTRT) practices to replace in vitro dissolution testing?
Lead – Hanlin Li (Vertex) / Haritha Mandula (FDA)
Session #10: In vitro approaches to interpret/predict food effects
Topic Question: What in vitro dissolution or dissolution/permeation methods have been shown to anticipate positive, negative, or no food effect?
Lead – Martin Brandl (U of Southern Denmark) / Annette Bauer-Brandl (U of Southern Denmark) / Kimberly Raines (FDA)