DDL 2012: Assessment of Drugs and Carrier PSD in a Commercial Combinational Dry Powder Inhaler Post Multistage Cascade Impaction Analysis by Raman Imaging

Authored by scientists at Gateway Analytical and University of Bath, this poster takes a look at how Raman Chemical Imaging (RCI) was used to investigate the active pharmaceutical ingredients (API), particle size distribution (PSD), carrier (Lactose) PSD and access qualitatively, a degree of API-carrier aggregation in a commercial DPI, ADVAIR DISCUS® 500/50 post multistage cascade impaction analysis.

Poster Summary

Multistage cascade impaction is the accepted analytical method for investigating the aerodynamic particle size of Dry Powder Inhalers (DPI). In addition to the cascade impaction, FDA recommends microscopic evaluation of the sample for “release and stability purposes” to check for the presence of large particles, aggregates and foreign contaminants, changes in morphology and crystal growth for both drug substance and carrier particles even though it is very subjective and not robust testing method.

In this study, RCI was used to investigate the active pharmaceutical ingredients (API) particle size distribution (PSD), carrier (Lactose) PSD and access qualitatively degree of API-carrier aggregation in a commercial DPI, ADVAIR DISCUS® 500/50 post multistage cascade impaction analysis.