In our activity of DPI process and product design we daily deal with complex, non-linear, multi-phase flows involving powders and gasses, e.g. the dose entrainment in the swirling air flow inside inhalers, the fine API particles deposition in the deep airways, the air/nitrogen borne particles colliding during API or excipient micronization in jet mills. Standard techniques of computational engineering, such as computational fluid dynamics (CFD), discrete element modeling (DEM) and their coupling, proved to be ideal tools to tackle the above-mentioned phenomena. Applications of the coupled CFD-DEM approach to both process and product design will be shown highlighting their potential and describing their current limitations.