CFD Models to aid the development of generic inhalation products

The Food and Drug Administration (FDA) is seeking grant applications to use computational fluid dynamics (CFD) to produce verified and validated predictions of regional lung deposition for at least one currently marketed metered dose inhaler (MDI) or dry powder inhaler (DPI) in human upper and lower airways. The goal is to enhance the understanding of the relationships between in vitro study metrics and the rate and extent of drug delivery to the targeted lung tissue. The grant will support the development of CFD models to aid in the development of generic inhalation products. • The grant will focus on the use of CFD to predict regional lung deposition for MDIs and DPIs. • The grant will support the development of verified and validated predictions of regional lung deposition. • The grant will assess the biopredictive capabilities of relevant in vitro studies. • The grant will consider discrete element modeling (DEM) for predicting the effects of agglomeration and deagglomeration of carrier-active pharmaceutical ingredient combination particles on regional deposition.