Parameters to consider in software for respiratory drug and device testing

Ensuring that an inhaled drug reaches the required parts of the lung is essential for achieving a good clinical response. Characterization of the aerodynamic particle size distribution of such an inhalable drug substance is therefore important during product formulation, inhaler device design and thereafter during stability trials. Aerodynamic particle size distribution testing requires complex and lengthy initial device/sampling plan setup procedures. Such testing generates large numbers of samples for liquid chromatographic (LC) analysis. These analyses, in turn, generate even larger results data sets that require transcription, collation, calculation and reporting in accordance with USP Chapter 601 or Ph.Eur. Chapter 2.9.18 guidelines.