- Enabling Drug Delivery Technologies (ER and ASD systems)
- Commonly used functional polymers
- Impact of polymer properties on formulation/process design
- Impact of polymer variability on drug release, stability & processing
Polymers are integral and essential components of extended-release (ER) and amorphous solid dispersion (ASD) formulations. Hence, understanding polymer functionality, properties and variations is not only a core part of rational product and process design, but also crucial for ensuring consistent product quality and building robustness into manufacturing process. In this presentation, an overview of the basic principles and functional polymers commonly used in ER and ASD product/process design will be provided. Case studies will be used to discuss
(1) key considerations of polymer characteristics in product/process development; (2) importance of polymer evaluation based on an integrated knowledge of API, formulation and process, and (3) impact of critical properties and “natural” variations of polymers on product quality and performance, such as dissolution, stability and in vivo absorption.
Yihong Qiu, Ph.D., Senior Research Fellow Formulation Sciences, AbbVie