This case study reviews the development of a novel aerosol collection apparatus, UniDose, for dissolution testing of orally inhaled drug products (OIDPs). The study highlights the limitations of current aerosol collection systems and presents UniDose as a robust method for collection and discriminating the dissolution properties of the aerosolized dose of inhalable formulations. The case study also discusses the potential applications of UniDose, including its use in quality control for evaluating material properties, processing effects on the active ingredient dissolution, and its potential to provide an in vitro-in vivo correlation (IVIVC) based technique for OIDPs. This case study is a valuable resource for anyone interested in the development of OIDPs and the future of inhaler technology.

Analytical Services
GDUFA: FDA adds further weight to modelling and simulation’s role in bioequivalence
GDUFA 2026: FDA strengthens role of modeling & simulation for inhaled generic drug bioequivalence. Learn how this shift enhances efficiency for OINDP development.
