June 2026 marked the 25th anniversary of the shipment of the first Next Generation Impactor—the NGI™. In the late 1990s, the NGI Consortium of pharmaceutical companies defined the need for and the performance requirements for the NGI and awarded a contract to MSP Corporation to devise a suitable impactor. With substantial input from Consortium members, […]
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Successful preclinical studies depend on accurate and reproducible delivery of dry powder aerosol formulations to animal models. A variety of devices are available for this purpose, however, delivery to small animal models remains challenging. Although recent innovations have attempted to overcome technical issues, significant gaps still exist in standardization, scalability and regulatory harmonization. This article […]
When testing dry powder inhalers (DPIs) for the size of particles discharged during each dose, manufacturers largely choose a test protocol that is recognized by the regulatory community and that walks a narrow pathway among device design, typical patient breathing characteristics and design principles of the cascade impactor that size-fractionates the discharged particles. In this […]
Various microstructural characterization methods exist that can be used on pre-actuated formulations. Each is valuable and serves a slightly different purpose. Nevertheless, a complementary, orthogonal technique is needed, which can provide information in a non-destructive manner, especially deeper than the surface. A technique that has the potential to provide fully 3D, non-destructive details on pre-actuated […]
There are many disadvantages associated with in vivo animal models and excised nasal mucosa, including ethical considerations and interspecies variability. In vitro nasal anatomical models that are more physiologically representative of the nasal cavity can be of fundamental importance to study nasal drug deposition and predict in vitro–in vivo correlation (IVIVC), a regulatory requirement for […]
In this article we seek to define, as well as to elucidate the origin of, the terminology associated with understanding and reporting the data obtained when testing an orally inhaled product with a cascade impactor. In doing so, we aim to provide a clear and accessible resource both for seasoned participants and newcomers to the […]
The first Lung Modeling Congress was held in November 2023 to address the challenges related to lung modeling and creation of digital twins of the human respiratory system. This article, together with a previous article in Inhalation, presents a summary of the current state-of-the-art and future challenges in various research areas and was written by […]
To address the challenges related to lung modeling and creation of digital twins of the human respiratory system, the first Lung Modeling Congress was held in November 2023. This article, together with a second article in an upcoming issue of Inhalation, presents a summary of the current state-of-the-art and future challenges in various research areas […]
This article describes the development and validation of the Alberta Idealised Nasal Inlet (AINI), illustrating its use within existing test set-ups. It also discusses three experimental studies that demonstrate: 1) the ability of the AINI to capture in vivo deposition behavior for different nasal drug products, 2) use of the AINI to assess and optimize […]
Oddly missing from the pharmacopeial compendia and archival literature are flow resistance data for glass microfiber filters common to the delivered dose uniformity (DDU) testing protocols described in the USP and European Pharmacopeias. The authors undertook a laboratory investigation to provide insight into how filter flow resistance can vary across several similar products available commercially. […]