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.
FDA’s Evolving Stance on In-Silico Studies in Bioequivalence Testing
The paper titled “Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques” explores the use of advanced analytical methods to improve our understanding of the performance of dry powder inhalers (DPIs).