DigiM Virtual Exhibition

Advancing Controlled Release Development with Microstructure Characterization

Drug Release Modeling

Published in AAPS PharmSciTech
In collaboration with Bausch Health

For polymer-based controlled release drug products, active pharmaceutical ingredient distribution and microporosity inside the polymer matrix are critical for product performance. In this study, controlled release poly(lactic-co-glycolic acid) microspheres are investigated with focused ion beam scanning electron microscope imaging at high resolution. Image data is quantified with artificial intelligence-based image analytics to provide size distributions of drug particles and pores within the microsphere sample. With an innovative image-based numerical simulation method, release profiles are predicted in a matter of days.

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Characterization & Release Prediction
for Long Acting Implants

In collaboration with Genentech

Long-acting drug delivery systems require lengthy in vitro testing to evaluate drug formulations and performance. Using DigiM I2S software, we demonstrate how A.I. can accurately characterize microstructures and quality attributes for a PLGA rod implant. The application of image-based release modeling, which can predict month-long release profiles in a matter of days, is also presented.

DigiM Featured in FDA Workshops

Workshop on Generic Drug
Bioequivalence

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Workshop on Modeling Strategies
for Long-acting Drugs

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