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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To provide better protection for consumers who have food allergies, the United States Food and Drug Administration (FDA) is considering a major change in the way nutrition labels on packaged foods communicate about potential food allergy risks due to cross-contact. In place of current allergen advisory statements, the FDA is considering use of a standardized […]
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 […]
California has become the first state in the US to require written notification of the nine major food allergens in restaurant menu ingredient descriptions. The Allergen Disclosure for Dining Experiences (ADDE) Act (Senate Bill SB 68), which will go into effect on July 1, 2026, applies to restaurants that have at least one location in […]
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, […]
Researchers at the Indiana University (IU) School of Medicine and the Regenstrief Institute have developed a passive digital marker to more accurately predict which children would later be diagnosed with asthma between 4 and 11 years of age. The Indiana researchers hope to improve the early detection of asthma risk in high-risk children, allowing for […]
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 […]
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 […]