Innovation in manufacturing as applied to dry powder inhaler formulation.
David A. Wyatt1,2, Jasdip S. Koner1, Eman Z. Dahmash1 & Afzal R. Mohammed1,2
1 Aston Particle Technologies Ltd., Aston University, Birmingham, B4 7ET, United Kingdom
2 Aston Pharmacy School, Aston University, Birmingham, B4 7ET, United Kingdom
Summary
An innovative process for development and manufacture of dry powder inhaler formulations is presented. The technology utilises a single stage, low mechanical-shear, ambient temperature, fluidisation process which conserves the physical and chemical integrity of all formulation components through control of well characterised process parameters. The technique’s utility is demonstrated with commercially sourced micronised fluticasone propionate and inhalation grade lactoses (IGLs). A bench-scale manufacturing process produces formulations with excellent content uniformity from which controllable respirable dose (RD) / fine particle fraction (FPF) is delivered when aerosolised. A designed experiment utilising the principles of Quality by Design (QbD) shows that broad design spaces can be found with two different IGLs. Most surprisingly, a single product formula manufactured by this process can be tuned for RD/FPF through controlled variations in the critical process parameters. This holds out the tantalising prospect of tuneable dry powder formulation performance (dial-a-dose).