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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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 […]
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 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 […]
Pulmonary delivery of therapeutic proteins for the management of respiratory diseases has been receiving research attention, particularly after the COVID-19 pandemic. Yet its development barriers include the propensity of proteins to form aggregates, which poses a major challenge to protein stability. This article presents a summary on protein aggregation, illustrating its significance and the challenges […]
Employing in vitro dissolution studies of pressurized metered dose inhalers (pMDIs) is crucial for assessing release of drugs from pMDIs and their subsequent availability for systemic absorption. Utilization of in vitro dissolution systems yields valuable data for decision-making, enabling the prediction of drug pharmacokinetics during the initial phases of drug development and optimization. This data […]
Nasal powders have been recognized as an opportunity to improve stability and residence time on the nasal mucosa compared with liquids, where amorphous powders favor the formulation of poorly soluble drugs with improved biopharmaceutical profile, namely faster onset of action. This article presents two case studies focused on particle engineering strategies and nasal powder formulation […]
Nasal powder formulations represent a significant stride in drug delivery innovation, offering the potential for simplified, preservative-free compositions. Increased chemical stability and enhanced capacity for higher drug loads are additional benefits offered by formulating as a dry powder. Application of established production technologies, such as spray drying, allows for the design and manufacture of readily […]
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 […]