When developing a dry powder inhaler formulation (DPI) for a biopharmaceutical two main aspects should be considered:

• Powder Aerodynamic Performance;
• Biopharmaceutical Integrity:

Thus...

Particle Engineering Technology plays a pivotal role - Spray Drying (SD) emerges as a viable candidate

• From an inhalation standpoint: Relative simplicity, cost effectiveness and scalability with increased control over key aerosol features;
• From a biopharmaceutical standpoint: Mild Temperature exposure, commercial availability of miniaturized SD set-ups;

However,

Spray Drying atomization step might constitute a stress source for the processed biopharmaceutical, ultimately causing its degradation:

• On conventional lab-scale spray dryers, this atomization step is performed using Two-Fluid (2F) Nozzle atomizers that produce a turbulent spray;
• Ultrasonic (US) Nozzle atomizers, on the other hand, produce a low velocity spray that could be envisaged as a possible alternative.