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Thursday May 8, 2025 9:00am - 9:30am EDT
Modified release (MR) drug delivery systems play a critical role in optimizing therapeutic outcomes, improving patient compliance, and extending product lifecycles. This presentation explores a comprehensive, science-driven approach to MR formulation development, integrating modern modeling tools, robust technology platforms, and strategic development methodologies.
The session will highlight the role of physiologically based pharmacokinetic (PBPK) modeling in assisting formulation design, enabling prediction of in vivo performance and supporting accelerated development with minimal pharmacokinetic study iterations. The use of biorelevant and predictive dissolution methods to establish in vitro-in vivo correlations (IVIVC) that reduce development time and risk will also be discussed.
A broad spectrum of modified release technologies will be discussed, including matrix-based systems (erodible and diffusion-controlled), multiparticulates, bilayer tablets, osmotic tablets, and controlled-release of amorphous solid dispersions.
Each technology will be evaluated in terms of its ability to meet specific pharmacokinetic profiles, align with the Quality Target Product Profile (QTPP), and fulfill therapeutic goals. The presentation will explore how to select the most cost-effective technology without compromising performance, guided by a Quality by Design (QbD) framework that ensures a scientifically sound and risk-managed development strategy.
Attendees will gain insight into rational technology selection, efficient formulation pathways, and how MR systems can be leveraged not only to improve patient outcomes but also to strategically position products throughout their lifecycle.



Speakers
avatar for Stephen Csernica, PhD

Stephen Csernica, PhD

Manager, Product Development, Ardena
Steve has 11 years of industrial solid oral formulation development experience,including complex controlled release formulations and solubility enhancementtechniques. He joined Ardena (formerly Catalent Somerset) in 2021 as Manager ofProduct Development and works to provide clients... Read More →
Thursday May 8, 2025 9:00am - 9:30am EDT
Brunswick Ballroom

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