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 […]
In this opinion article, the author suggests that, supported by multiple precedents, a propellant for a pressurized metered dose inhaler (pMDI) may be feasibly regulated as a device component in these drug-device combination products. Furthermore, this new paradigm may apply particularly well when an applicant for an approved pMDI combination product provides a submission to […]
In 2020, this author published a paper that described a clear need for alternatives to the current pMDIs that remained both affordable and had a lower global warming potential propellant. He also suggested that 2025 could be a tipping point, due to a significant increase in the cost of existing propellants, which might particularly impact […]
In 2024, Inhalation published the article “Point of View: A better way to set specifications and control quality—General concepts and examples” from the Product Quality Demonstration Strategy (PQDS) Working Group of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). This article presents an interview with the authors, approximately one year after the initial […]
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 […]
In the mid-1990’s, substitution of chlorofluorocarbon (CFC) propellants with hydroflouroalkane (HFA) propellants in metered dose inhalers was made to address the ozone depleting potential of CFCs. The transition was supported by full clinical development programs that were extensive, expensive and extremely time-consuming. HFAs were considered acceptable until their identification and classification as global warming gases, […]
In 2022, an update to the United States Pharmacopeia (USP) General Chapter <601> Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests introduced changes to the sampling procedures for Delivered Dose Uniformity (DDU) testing of nasal spray and nasal aerosol products. These revisions recommend the use of Dosage Unit Sampling Apparatus (DUSA) tubes […]
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 […]