Poster Title: Assessment of Drugs and Carrier PSD in a Commercial Combinational Dry Powder Inhaler Post Multistage Cascade Impaction Analysis by Raman Imaging
Date: Wed., December 5, 2012
Time: 3:30 pm - 5:00 pm
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.
If you are attending DDL23 and interested in the poster session, please stop by at the designated presentation time and speak with Dr. Oksana Olkhovyk, Senior Scientist, at Gateway Analytical who will be presenting. You can also stop by booth #37 to speak with any Gateway Analytical representative.
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.
As data suggest, there is a good correlation of both drug and carrier PSD as it related to the cut-off diameter of stage 3 and 4 of the cascade impactor from where DPI was sampled for ingredient-specific particle sizing (ISPS) analysis by RCI.
Assessment of free-standing API particles and bound to Lactose API particles was done on the fusion brightfield and RCI images by visual inspection of all detected API particles as it relates to the spatial location of all detected Lactose particles on a fusion image. 30% increase in the percentage of agglomerated with lactose API particles was detected on Stage 4 as compared to Stage 3.