(625f) Linking Process & Performance of Drug Products with Micro-Image Analytics

Microstructures play an increasingly important role in drug formulation design and product development. The physical properties of API domains, excipients, and pores, dictate both manufacturability and performance of a final drug product. Furthermore, to achieve specific drug release patterns and rates, functional coatings and performance-enabling excipients have become increasingly common.

This poster will introduce a novel platform for evaluating the roles of microstructures from micro-images. The micro-scale nature of components and their interplay in a drug product demand a high-resolution technique to evaluate their role in performance. Three-dimensional micro-imaging, including X-Ray Microscopy (XRM) and Focused Ion Beam Scanning Electron Microscope (FIB-SEM), can be used separately and/or correlatively to qualitatively visualize these microstructures.

What’s more, the spatial and chemical distributions, as well as image-based modeling of release behaviors, can be assessed quantitatively and semi-quantitatively. The performance impact of microstructures on a PLGA long-acting formulation and spray-dried particles, including performance relation to process and manufacturing conditions, will be used to illustrate this micro-image based platform.

Image-based characterization can be utilized in drug product development for a fundamental understanding of the process-property-performance interplay, optimizing formulation process and design, and increasing manufacturability. The combination of micro-imaging, AI-based image analytics, and image-based modeling presents a new platform for advancing drug design and evaluation, with significantly reduced evaluation time, improved drug performance, and lowered costs of in vitro and in vivo experiments.