Microstructures play critical roles in the key quality attributes of extended-release (ER) drug formulations. This talk will detail a correlative imaging and artificial intelligence (AI)-based microstructure investigation of an ER drug formulation. Specifically, how this characterization approach can be utilized in visualizing and quantifying key performance attributes will be presented via live “Google Earth'' style demos. Basic principles and advantages of x-ray microscopy and mosaic field of view SEM will be introduced as a means of probing these microstructures. The process of AI-based phase segmentation will be discussed. How image-based microstructure characterization can complement traditional physical characterization of extended-release drug formulations and help to demystify the interrelationship of microstructure, physical properties, and performance will be presented.
Learning Objectives:
Describe the essential role microstructures play in determining the key quality attributes of extended-release formulations.
List and describe hallmark imaging modalities that can be implemented to probe drug product microstructures with the aid of AI phase segmentation and analytics.
Describe how image-based characterization of extended-release drug products can immensely compliment traditional physical characterization and play an invaluable role in accelerating drug development.
