Particle Interactions of Fluticasone Propionate and Salmeterol Xinafoate in Advair Diskus®
Martin Jetzer1,2, Bradley Morrical1, David Fergenson3 & Georgios Imanidis2
1Novartis Pharma AG, Global Development, Novartis Campus, Lichtstrasse 35, Basel, 4056, Switzerland
2University of Basel, Department of Pharmaceutical Sciences, Klingelbergstrasse 50, Basel, 4056, Switzerland
3Livermore Instruments Inc., 2038 Livingston Street, Oakland CA, 94606, USA
Particle co-associations between the active pharmaceutical ingredients (APIs) fluticasone propionate (FP) and salmeterol xinafoate (SX) were examined in a dry powder inhaled (DPI) combination product. Single Particle Aerosol Mass Spectrometry (SPAMS) was used to investigate the particle interactions in Advair Diskus® (500 mcg FP/50 mcg SX). A simple rules tree was used to identify each compound, either as a single API or co-associated at the level of the individual particle, using unique marker peaks in the mass spectra for the identification of each drug. High levels of API co-association were observed in the aerosols emitted from Advair Diskus®. The majority of the detected SX particles were found to be in co-association with FP in the tested device. Another significant finding was that rather coarse FP particles and fine SX particles were forming the particle co-associations in the DPI product.