Articles

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, the NGI was then designed, patented and manufactured by MSP Corporation. The NGI has since become the preferred multi-stage impactor across the inhalation community.

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 geometry. To address this, two innovative strategies were applied and are presented in this article: in-silico modeling and the use of 3D-printed carrier particles.

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.

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.

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 expansion and commercial success of systemically administered biologics.

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 California and 20 or more locations nationally.

Twenty-five to 50% of healthy infants born at term are infected with respiratory syncytial virus (RSV) in the first year of life. Now, analyzing data from more than 24,000 patients, scientists have discovered evidence that infection with RSV early in infancy may significantly increase the risk of developing childhood asthma, particularly for children with one or both parents who have asthma or allergy.

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.

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 formulations is X-ray computed tomography (XCT), also known as X-ray microscopy.

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 adequate drug delivery to the lungs for pediatric patients and those with limited inspiratory capacity.

Pathways linking the brain, immune system and lungs may drive stress-induced increases in disease severity and provide new targets to improve the management of asthma

Quickly differentiating between asthma and COPD based on symptoms alone can be clinically challenging, particularly in emergency or resource-limited settings when spirometry is impractical

Analysis of approximately one million patient records demonstrated that COVID-19 infection can increase the risk of respiratory type-2 inflammatory diseases including allergic asthma. However, vaccination provided protection.

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.

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.

Researchers from the Mayo Clinic have developed artificial intelligence (AI) tools that can help identify which children with asthma have the highest risk of serious asthma exacerbations and acute respiratory infections. The AI tools can detect those risks as early as age 3.

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 switch the propellant to a low global warming propellant (LGWP, 3GP) via the prior approval supplement (PAS) pathway.

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 reliever medications. This article reviews the last five years and projects how things might change in the future.

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 article was published.

In 2017, 3-year-old Elijah Silvera tragically died after having an anaphylactic reaction at his child care facility in New York state. Although the facility had documentation of his life-threatening dairy allergy and additional allergies, he was fed a grilled cheese sandwich. The facility then failed to follow emergency protocols to treat anaphylaxis. In response, his parents, Thomas Silvera and Dina Hawthorne-Silvera, co-founded the non-profit Elijah-Alavi Foundation.

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 publicly available information on excipients used in approved pediatric nasal products, compiled from multiple sources.

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 the development of inhalation products.

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 medical aerosol laboratory.

In asthma diagnosis, data from spirometry testing of patients is used in conjunction with reference equations to determine the degree and severity of a patient’s case. Those equations, adjust for parameters such as age, sex and height. Until recently, they have also—mistakenly—adjusted for race “based on the flawed premise that racial groups have innate differences in lung function.”

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, which has triggered efforts for a change to a new generation of low global warming potential (LGWP) propellants.

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 for nasal spray testing.

To address a lack of allergy data to guide decision-making in diagnosis and treatment for Asian Americans, researchers from Stanford University and Sutter Health conducted one of the first studies of subgroups of Asian American children under age 18. Using nearly 500,000 electronic health records, they determined rates, in aggregate and by subgroup, for four of the most common allergic conditions—eczema, food allergy, asthma and allergic rhinitis (hay fever).