Lorena Gasparini1, Laura Campochiaro1, Diego Copelli1 & Snezana Radivojev1
1 Chiesi Farmaceutici SpA, Via Palermo 26/A, Parma, Italy
Summary
The complexity of drug product development, from the early development to commercialization requires profound understanding of international requirements. This paper highlights the key differences between United States (US) and European Union (EU) requirements, focusing on the analytical aspects of Aerodynamic Particle Size Distribution (APSD) and Delivered Dose (DD) characterization for device-metered inhalers with a powder reservoir. The main distinctions encompass varying methodologies for dose collection in DUSA and NGI analyses, different evaluations of Uniformity of Delivered Dose (UDD), and variations in the air volume passing through the inhaler during DUSA analysis. This study employed experimental designs and multivariate analysis studies to optimize and harmonize the EU and US analytical regimen for APSD and DD. Our results show that harmonization between requirements can be achieved, both in terms of collected doses and air volume. This outcome, in turn, results in significant cost and resource savings in the perspective of a worldwide product development and commercialization.