AUTHOR=Tarara Thomas E. , Miller Danforth P. , Weers Audrey E. , Muliadi Ariel , Tso Jerry , Eliahu Avi , Weers Jeffry G. TITLE=Formulation of Dry Powders for Inhalation Comprising High Doses of a Poorly Soluble Hydrophobic Drug JOURNAL=Frontiers in Drug Delivery VOLUME=2 YEAR=2022 URL=https://www.frontiersin.org/journals/drug-delivery/articles/10.3389/fddev.2022.862336 DOI=10.3389/fddev.2022.862336 ISSN=2674-0850 ABSTRACT=

Spray-dried formulations of a hydrophobic, crystalline drug, GDC-A, were prepared using the suspension-PulmoSphere™ technology. Increases in drug loading resulted in decreases in the primary particle size distribution and increases in tapped density. This enabled fine particle doses of up to 25 mg to be achieved with a portable dry powder inhaler from a size three capsule. The powders were physically and chemically stable, with no changes in physical form or degradants observed during processing or on storage in an open configuration at 40°C for 1 month. The potential benefits of the suspension-based spray drying process relative to solution-based spray drying in terms of stability, lung targeting, and safety/tolerability are discussed.