Linda (Lingzhi) Liao, Karina Ramos, and Dino Farina. Poster presented at Drug Delivery to the Lungs 2019; 2019 Dec 11 – 13; Edinburgh, Scotland

BACKGROUND: The May 2019 FDA guidance document for beclomethasone dipropionate mentions, for the first time, an alternative approach to comparative clinical endpoint bioequivalence (BE) studies that includes characterization of the emitted aerosol spray velocity profiles (spray velocity). However, no description or details for how to perform such characterization studies were given. This paper describes a clear methodology for measuring the spray velocity and presents results from four (4) US approved inhalation products. The spray velocity has been reported as being closely related to effective pulmonary delivery, and hence would be an important parameter for drug-device combination products such as pMDIs and SMIs. In this study, we extended the well-established SprayVIEW® technique for providing time- synchronized plume characterization in a novel way to determine the spray velocity from pMDI and SMI test samples available in the USA.