Tech Session V: Nanomedicine and Nanoscale Delivery (Focus: Oral)
Predicting Drug Delivery of Push Pull OROS: A Biorelevant Dissolution and PK Simulation Strategy
Thursday, July 17, 2025
11:16 AM - 11:27 AM EDT
Location: 121 B/C
Introduction: Osmotically-controlled systems are intended to deliver the drug with stable and reproducible release kinetics, unaffected by the gastro-intestinal conditions (1, 2). This study investigated the performance of glipizide push-pull osmotic pump (PPOP) tablets manufactured using different formulation strategies, focusing on their resistance to physiological forces under simulated conditions. Pharmacokinetic (PK) simulations were used to assess the impact of the manufacturing process on the predicted drug plasma profiles and estimated equivalence amongst formulations.
Learning Objectives:
At the completion of this activity, participants will know
Identify critical factors affecting the performance of oral dosage forms
Evaluate push-pull osmotic tablets using non-standard, biorelevant dissolution testing
Predict new formulations in-vivo performance based on in-vitro testing and PK simulations
Jadwiga Paszkowska – Group Leader, R&D Laboratory, Physiolution; Dorota Danielak – Group Leader, Pharmacokinetics, Physiolution; Justyna Dobosz – Senior Researcher, Physiolution; David Ferrizzi – Senior Product Development Scientist, Colorcon Ltd; Jeffrey Gimbell – Senior Product Development Scientist, Colorcon Ltd; Larry Martin – Senior Product Development Scientist, Colorcon Ltd; Daria Myslitska – Junior Researcher, Physiolution; Michał Romański – Assoc. Professor, Pharmacokinetics, Poznan University of Medical Sciences, Poland; Michał Smoleński – Senior Researcher, Physiolution; Marcela Staniszewska – Senior Researcher, Physiolution; Maciej Winiarski – Assoc. Professor, Institute of Low Temperature and Structure Research, Polish Academy of Sciences, Poland; Ali Rajabi-Siahboomi – Vice President and Chief Innovation Officer, Colorcon Ltd
