Evaluating Internal Microstructures of an
Extended Release Microsphere Depot
Characterizing polymeric drug delivery systems is a challenge due to the decreasing size of delivery vehicles and increasing microstructure complexity. A transport-controlling microporosity system often has pore throats as small as a few tens of nanometers—making it difficult to analyze. In this study conducted with OraPharma, a controlled release delivery system with monolithic poly(lactic-co-glycolic acid) PLGA microspheres, ranging from 30-80 micrometers, was investigated with FIB-SEM imaging and image-based analytics. The release profile of this controlled release delivery system was predicted through an image-based numerical simulation method.
This characterization approach provides a unique avenue to evaluate the microstructures and structural arrangement of controlled release microparticles and polymeric drug delivery systems. With image-based simulation, optimal formulations and release performance parameters can be fully evaluated.

FIB-SEM cross section images used to quantify the internal microstructures of PLGA microspheres. Microporosity and pore size distributions as well as the drug particle size and drug distribution were quantified in 3D using DigiM’s AI analytics.
Resources

Characterization of controlled release microspheres using FIB-SEM and image-based release prediction
AAPS PharmSci Tech Paper in collaboration with Bausch Health
DigiM Story: Micro-sphere Depot
DigiM Video introducing extended release of a monolithic microsphere depot
Micro-imaging characterization and release prediction of controlled release microspheres
2018 Controlled Release Society Poster