At DigiM, we believe that microstructure science can change the world. We work with leading pharmaceutical innovators to enhance their development and process decisions through imaging characterization solutions.
At the Controlled Release Society 2021 Meeting, we were proud to present our work using high-resolution 3D imaging, AI analytics, and image-based simulations. In collaboration with our clients, we demonstrated how image analysis can assess the impact of microstructures on the performance of long-acting implants and injectables.
The DigiM team investigated Arestin PLGA microspheres to evaluate the effects of aging on microstructures and performance. Samples at two different time points after manufacturing were imaged to assess the changes that could occur during storage and market circulation. Applied AI-analysis to segment 3D FIB-SEM images revealed key performance attributes including API and porosity size distributions, spatial uniformity, and permeability. The DigiM I2S software calculated an image-based release prediction, demonstrating the correlation of increased porosity over time with faster release rate.
Left: FIB-SEM image from two-year aged sample, visualizing minocycline particles encapsulated in PLGA. Right: the AI-segmented image into three phases: Minocycline particles as green, porosity as red, and PLGA polymer as purple. The graph compares the particle and porosity size distributions of the two-year aged sample versus the one-year aged sample.
DigiM evaluated crystalline API dispersion in three polymer matrices using high-resolution imaging techniques, including X-ray Microscopy and FIB-SEM, then applied AI analyses to characterize the release mechanisms of each polymer family. The AI quantified matrix uniformity, size and spatial distributions, as well as physical transport properties to construct image-based release models. The predicted API release profiles correlated well with in vitro data, demonstrating how image-based characterization technology can serve as a powerful tool for controlled release modeling, formulation, and performance optimization decisions. Click here for our solutions in the long-acting polymer implant program.
With support from the Bill and Melinda Gates Foundation, the talk presents the characterization study of a next-generation bioresorbable implant for modern contraceptive technology. The new product will fulfill the need for contraceptives in developing countries who cannot easily remove biodurable implants through surgery. The sustained release drug delivery of API was examined with XRM imaging, allowing quantification of the implant degradation and providing novel insights into the drug release mechanism.