Carrier-based interactive powder mixtures are a cornerstone of drug delivery by inhalation, yet optimization is hampered by the complex interplay of various carrier particle properties including their geometry. Conventional approaches for carrier particle manufacture such as milling, sieving or spray drying can modify multiple attributes simultaneously, making it challenging to assess the effect of particle […]
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Biological therapeutics have reshaped modern medicine by offering high specificity, potency and durable efficacy across a broad spectrum of diseases, including cancer, inflammatory disorders and rare genetic conditions. Despite these transformative advances, inhaled biologics intended for local pulmonary action have experienced a notable and persistent quiescence in market introductions, particularly when contrasted with the rapid […]
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 […]
A significant challenge for pediatric asthma patients lies in generating the proper inspiratory flow required for effective drug delivery from dry powder inhalers. Furthermore, there are currently no devices available to assist these patients. In response, we propose a novel adaptor named the FlowMate®, which features a delay-and-release mechanism. It aims to ensure consistent and […]
In this opinion article, the authors discuss potential benefits of utilizing both empirical methods and in silico models for inhaled drug development. They also present two case studies, on modeling and the transition to low-GWP propellants, and modeling and predicting particle deposition. From fluid dynamics and propellant evaporation to PK and regional lung deposition simulations, […]
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 […]
Excipients (also called “inactive ingredients”) play a critical role in formulation performance. They are generally chosen based on their physico-chemical properties, functionality, compatibility with the formulation and device, dose, taste, fragrance (or lack thereof), color and/or ease of administration, as well as the availability of a “safety record.” This review provides a collation of the […]