One of the industrial approaches for manufacturing long acting injectable (LAI) suspensions is to employ wet bead milling process, which reduces the particle size of API crystals in a liquid vehicle via grinding using ceramic/polymeric beads. This “top-down” high energy process needs the desired mechanical and physicochemical properties of APIs, which should not undergo amorphization upon milling and render the final suspension product in a feasible milling time. In this study, crystal modeling, nanoindentation, compaction-based techniques and solid-state characterization were used to calculate/measure these properties of APIs for LAI suspensions at crystal and bulk level. The potential link between crystal properties and LAI manufacturing were explored. As a part of this rapid fire, we are providing the early view of these material sparing approaches that will underpin the acceleration of LAI product design and development in compressed timelines with “right first” particle and process selection.
Learning Objectives:
grasp the complex understanding of challenges involved in selecting the suitable suspension manufacturing process (for example, wet bead milling process) with limited API availability
evaluate the potential of crystal modeling, nanoindentation and compaction-based material characterization techniques in suspension product development
understand the importance and applicability of material-sparing approaches in selecting “right first time” particle and process for product manufacturing
