Investigating the Dispersion Capability of High Dose DPI Formulations Manufactured Through Isothermal Dry Particle Coating (iDPC™)
Rhys Jones1, Amandip Gill1, David Wyatt1,2, Afzal Mohammed1,2 & Jasdip S Koner1
1Aston Particle Technologies, Aston Triangle, Birmingham, B4 7ET, United Kingdom
2Aston University, School of Life & Health Sciences, Birmingham, B4 7ET, United Kingdom
Summary
Isothermal Dry Particle Coating (iDPC) technology is a proprietary powder blending/coating technology highly suitable for the development and manufacture of DPI formulations The object of this study was to investigate the delivery performance of concentrated dispersions (containing 75%w/w active material) in a range of in different size Monodose RS01™ devices and at different capsule fill volumes. The active materials investigated were micronised fluticasone propionate (FP) and micronised salmeterol xinafoate (SX) which were dispersed by iDPC separately in alpha-lactose monohydrate (Lactohale® 100 (LH100)) and in spray-dried mannitol (Pearlitol® 200 SD (P200SD) model carriers. Aerodynamic particle size distribution data for all formulations demonstrated the iDPC uniformly dispersed FP and SX across both carriers, with highly efficient delivery observed. Fine particle doses demonstrated linear increases when FP and SX was formulated with lactose for all delivery systems. A similar pattern was observed with mannitol based formulations for both FP and SX with size 2 and 3 capsules, with relative doses being higher than lactose. However at size 0 a large reduction in emitted dose was observed at 60% fill volume, FPF performance was high across the board, highlighting the capability of iDPC to develop highly efficient high dose DPI formulation. Lactose based formulations highlighted a negative correlation to fill volume, with higher volumes lowering FPF. Mannitol based formulations displayed no particular pattern, with FPF remaining high even at 60% fill volume where FPD performance was disrupted. This work demonstrates that when concentrated iDPC formulations are coupled to the appropriate carrier and Monodose RS01 architecture excellent DPI performance can be achieved.