Category: Automation and High-Throughput Technologies
Formulating low solubility compounds as nanocrystal suspensions can improve in vivo dissolution and bioavailability. This enabling formulation technology has been used in several commercial drug products for different routes of administration including oral, IV, and inhalation. A highly-automated nanocrystal suspension formulation screening workflow utilizing an in-situ milling technique has been designed to decrease the resources, time, and effort typically invested in developing and selecting a suitable nano formulation. The resulting formulations are characterized by milling efficiency at multiple milling time points, particle size distribution, and physicochemical stability. This workflow not only allows for evaluating numerous formulation compositions in 96-well plate format using minimal API material, but is also well-suited to formulation scale-up in for in vivo dose administration.
Stephanie Azali– Senior Associate, Amgen, Newbury Park, California