DigiM works with clients to characterize, predict and optimize pharmacokinetics (PK) of active pharmaceutical ingredient (API) using 3D imaging, image-based Quality by Design (QbD) and microstructure physical simulation.
Based on Focused Ion Beam Scanning Electron Microscopy (FIB-SEM) and micro-computed x-ray tomography (MicroCT), DigiM provides a unique 3D high resolution imaging solution for effective microstructure evaluation of drug release profiles. Our superior technique visualizes microstructures of drug products, and quantifies a suite of microstructure parameters. The case study below shows that the microstructure difference between a generic drug and a brand-name drug has a robust correlation with different drug release profiles. Enabled by DigiM’s technologies, bioequivalence studies are completed, which helped clients to achieve well-informed market strategy in a cost-effective manner. Potentials exist on broad applications in controlled PK, Chemistry, Manufacturing and Control (CMC) manipulation, and manufacturing quality assurance.