2018 RDD Conference: Analysis of a Dry Powder Inhaler Active Pharmaceutical Ingredient Using Scanning Electron Microscopy

Automated SEM-EDS has been evaluated as a potential tool for determining the API particle size distribution (PSD) and
morphological characteristics, such as aspect ratio and roundness of particles, of a DPI. The only requirement
for this technique is an elemental distinction, such as the presence of an inorganic element in the API, in comparison to the excipients. In this instance, the
automated SEM-EDS technology has been applied to characterize a bromine- containing API in comparison to the carbon-rich lactose excipient of a DPI product.