Testing the In Vitro Product Performance of Inhalation and Nasal Drug Products: Views of the USP Expert Panel

While inhalation and nasal drug products are available as various different drug-device combination products for the treatments of local and systemic diseases, their compendial performance testing has concerned with only delivered dose uniformity (DDU) and aerodynamic particle/droplet size distribution (APSD). This Stimuli article presents the views of the USP Expert Panel on New Advancements in Product Performance Testing (EP-NAPPT), providing the gap analysis and the recommendations for in vitro product performance testing for these local and systemic drug-device combination products. The gap analysis identified the following performance testing areas to be improved: 1) in vivo-predictive lung and nose delivery testing; 2) fast particle/droplet size testing; 3) spray pattern and plume geometry testing; 4) drug release/dissolution testing; and 5) in vitro product performance and physiologically based pharmacokinetic (PBPK) modeling. Recommendations were then made to each area for identification of testing needs and improved in vivo prediction.