Eric Peterson, Rodrigo Amorim, Jason Allenby, Amy Hansen, Alex Williams
Lonza – Bend, 63045 Corporate Place, Bend, Oregon 97701, United States of America
Summary
The particle engineering toolbox for dry powder inhalers (DPIs) continues to grow, with an ever-increasing number of manufacturing and formulation strategies available. To better enable the rapid choice of an appropriate drug development strategy, this study directly compares spray-dried powders formulated with an l-leucine or DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine) shell former. The design goal was a high-dose drug product, targeting stabilization of an amorphous model compound with a moderate glass transition temperature (Tg) and relatively low aqueous solubility, thereby requiring organic solvent during manufacture. The amino acid and phospholipid platforms possess distinct powder properties and aerosol performance. These differences in turn have implications for manufacturability and the general development strategy for creating a drug product. While both platforms tested were able to deliver a high fine particle dose (FPD), the aerosolization of l-leucine powders was significantly more efficient for this model system.