Pharmaceutical researchers, regulatory and drug discovery scientists, and biopharmaceutics colleagues from industry, academia, and regulatory agencies are invited to attend an in-person workshop on drug dissolution in oral drug absorption on May 23-24, 2023, from 8:20 a.m. to 4:30 p.m. (ET). The event will be held in-person at the University of Maryland School of Pharmacy.
Oral bioavailability of a drug is dependent on many factors including drug dissolution rate, solubility, and intestinal permeability. Often, the rate-limiting step in drug absorption from the gastrointestinal tract is drug release and drug dissolution from the dosage form. Physicochemical, formulation-related, and physiological factors can all influence drug dissolution.
In vitro dissolution testing is used throughout the development life-cycle, from product release throughout its shelf-life stability. It is a pivotal analytical test used for detecting physical changes in an active pharmaceutical ingredient and formulated drug product. At the early stages of the drug development process, in-vitro dissolution testing underpins the optimization of drug release from a given formulation.
Despite being a commonly employed test in the pharmaceutical and biopharmaceutical industry, advances and scientific developments of drug dissolution are evolving and impacting dissolution test conditions as the most clinically relevant. It is imperative that the dissolution test is both robust and reproducible, with the ability to detect any key changes in product performance (i.e., discriminate between different formulations and non-bioequivalent batches).
The purpose of this workshop is to facilitate dialogue between academic, industrial, and regulatory drug development scientists about current phenomena and methods in oral drug product dissolution method development and application.
This workshop provides a forum for experts from regulatory agencies, the 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
- In vivo dissolution and drug absorption
- In vivo GIT imagining and dynamics
- Regulatory considerations for Dissolution Method Development (focus on non-compendial methods)
- Critical amorphous solid dispersion (ASD) properties and dissolution method development
Who Should Attend
Regulatory agencies, regulatory professionals, members of innovator and generic drug industry, consultants, academia and commercial software providers and others in the field of modeling and simulation.
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.
