AAPS PharmSci 360: Microstructure Intelligence in Predictive Drug Development, Part 1

In part 1 of this 2-part preview of AAPS PharmSci 360’s keynote on predictive drug development, Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, explains microstructure intelligence and how it can enhance how drug developers understand dosage forms.

According to Holt, “microstructure intelligence” is the science of understanding exactly where drug particles sit inside a dosage form, down to the microscopic level. Holt argues this spatial information is something traditional dissolution and content-uniformity testing simply can't capture. Two tablets can show identical drug content when tested, but if one has API concentrated at the surface and the other has it buried in the core, they will perform very differently. Conventional testing methods may miss this distinction, especially for extended-release products where uniformity matters most.

digiM employs multiple imaging modalities to understand the hidden architecture of a drug using an approach the company calls "correlative imaging." Based on the length scale specific to the given product and question, the approach will use electron microscopy, X-ray microscopy, polarized light microscopy and synchrotron CT. Its dissoLab and ivisLab tools then convert these real images into in silico microstructure models, applying physics-informed simulation kernels to predict dissolution and release behavior directly from the imaged sample. The company’s I2S tools use artificial intelligence (AI) for image segmentation, while a newer generative AI capability called sGAN lets scientists digitally alter traits like drug loading, particle size, porosity, and wall thickness to model how reformulated products would perform without manufacturing and testing new physical samples.

For manufacturers, microstructure intelligence may provide root-cause clarity: instead of just flagging that a batch dissolved faster or slower than expected, it can explain why. Holt notes the tools are browser-based and designed to be accessible regardless of company size, positioning this as a scalable diagnostic and formulation-optimization capability rather than a large-biopharma-only resource.

AAPS PharmSci 360 is happening in New Orleans from October 25-28, 2026.

Click the video above to watch part 1 of the interview.