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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 of a model poorly soluble drug for systemic delivery, while evaluating performance methodologies.
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 dispersible, shelf-stable powders in a scalable process.
Recognizing that “minoritized racial, ethnic, and low-income populations are consistently underrepresented in food allergy research and medical research in general,” Food Allergy Research & Education (FARE) conducted a study to “shed light on why this underrepresentation exists and how to address it.” This article also discusses FARE’s recommendations to increase diversity before, during and after a clinical trial, and FARE’s initiatives to encourage diversity.
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 formulations for intranasal vaccination, and 3) how the AINI enables more realistic assessment of the risk of pulmonary deposition.
Oddly missing from the pharmacopeial compendia and archival literature are flow resistance data for glass microfiber filters common to the delivered dose uniformity (DDU) testing protocols described in the USP and European Pharmacopeias. The authors undertook a laboratory investigation to provide insight into how filter flow resistance can vary across several similar products available commercially. They also discuss ways this variability can be handled in practice by users of inhaler testing methods.
The Association of Inhalation Toxicologists (AIT) presented a workshop at the 2023 Drug Delivery to the Lungs Conference. The focus was on methods used for in vitro toxicity screening, in vivo study designs, toxicological endpoints and regulatory toxicology. The workshop also covered technical aspects of the generation, characterization and dosimetry of aerosols in toxicology studies.
There has been a surge in interest surrounding the development of carrier-free dry powder formulations intended for pulmonary drug delivery. Spray drying is the preferred technique for the production of carrier-free dry powder formulations.
We investigated how the change from current generation to next-generation pMDI propellants might affect the technical performance of currently used pMDI hardware, with a focus on actuator designs that assist with achievement of in vitro equivalence. The key finding of the preliminary in vitro studies described is that the changes required to convert pMDI formulations from current HFAs to low-GWP alternatives require careful evaluation, but do not represent an insurmountable barrier.
The AAAAI is encouraging widespread and routine penicillin allergy evaluations for patients who have the allergy listed in their medical records but who are not truly allergic or have outgrown the allergy. Such evaluations demonstrate the overwhelming majority of patients tolerate penicillins so the allergy label can be removed and the patient can be delabeled. The article also provides examples of programs that are facilitating delabeling.
In the first article, we explored the robustness of the pharmacopeial methodology for the determination of delivered dose uniformity (DDU) for orally inhaled products to bias in volumetric flow rate setting from variations in ambient pressure. In this article, we extend the analysis to evaluate how the determination of the second performance-related critical quality attribute, aerodynamic particle size distribution (APSD) might be affected by similar ambient pressure changes, as well as other factors.
The relationship between RSV infection in infancy and development of childhood asthma has been unclear. Now a study has examined the effects of RSV infections of all different severities on childhood asthma risk at a population level.

Several major childhood allergies may share a common link to bacteria in the human infant gut, according to a study that identified gut microbiome features and early life influences associated with children developing allergies by age five.
This article discusses development of polymeric nanoparticles intended to obtain optimal features for loading therapeutic antibodies and be formulated into dry powders for inhalable lung cancer treatment. This may reduce serious side effects and toxicity and support therapeutic adherence, effectiveness and safety. The article also discusses dry powder formulation with respect to particle deposition profile and the spray-drying process.
In 2020 and 2021, Inhalation published three articles by the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium for Regulation and Science (IPAC-RS): (1) The liability of fine particle dose (FPD); (2) Cascade impactor stage groupings: Poor decisions from degraded data; and (3) Efficient data analysis (EDA): Size, mass and common sense. In this interview, one of the authors, Adrian Goodey, talks about reactions to the articles in the inhaler community since their publication.
The United States National Environmental Education Foundation (NEEF) and Hip Hop Public Health (HHPH) have collaborated to develop and launch a free multimedia collection called EMPOWER. Consisting of eight original songs, animated videos and printable educational materials, EMPOWER “aims to inspire young people with asthma to take charge of their health with evidence-based, self-management skills.”

A poster at the 2023 AAAAI Annual Meeting described results of a study about food allergy awareness on college campuses in the United States. “Previous research has shown that people with food allergies experience social events differently, causing exclusion, awkwardness and other feelings. As a result, food allergy education and knowledge are essential to improving food allergy management on college campuses,” said coauthor Kethan Bajaj.
In this opinion article, Inhalation talks with Alex Wilkinson and Gregor Anderson about aspects of a potential sustainability roadmap for inhalation platforms that could lead to reaching the UK’s National Health Service net zero goal. They believe that while new propellants are a major step forward, much more work must be done to meet this challenge.
The article describes a series of in vitro test methods that can be used to estimate the total and regional lung doses. The focus of the discussion is on research and development, with the view that the ability to estimate total and regional lung deposition is essential in the design of efficient orally inhaled products. In this context, a new filter-based apparatus that mimics both the aerodynamic particle size and flow rate dependencies of regional lung deposition will be described.
This article provides a brief history of the formation of The European Pharmaceutical Aerosol Group (EPAG), including its constitution, objectives, structure, influence, publications and input to regulatory guidance documents. A list of the organization’s publications and references since 2000 is also included.
An inflammatory molecule called LIGHT appears to be the cause of tissue remodeling and life-threatening airway damage in patients with severe asthma, according to scientists from the La Jolla Institute for Immunology (LJI).

It is not understood why some people who have allergies develop asthma while others do not. A new study from Massachusetts General Hospital has identified key differences in airway response to allergens between people who have allergic asthma and those who have allergies but do not have asthma.
A grant from the United States Environmental Protection Agency (EPA) is supporting Breath SMART (Safety Monitoring Air ‘Round Town). The program will create a community-based network of air quality monitors in Milwaukee, Wisconsin neighborhoods with the highest rates of hospitalizations and emergency room visits related to asthma.

The United States Environmental Protection Agency (EPA) and the Biden-Harris Presidential Administration have announced $53.4 million in funding for 132 air monitoring projects in 37 US states. The projects are focused on communities that are underserved, historically marginalized and overburdened by pollution.
A new United States law recognizing sesame as the ninth major food allergen is having unintended consequences. Some food manufacturers and commercial bakeries that support restaurants, stock grocery shelves and supply schools are intentionally adding sesame to various products that previously did not contain it. Consequently, this decreases the number of sesame-free products available for allergic consumers and creates the risk of accidental exposure through foods they previously considered safe.
An ex vivo study was designed to compare the dosing efficiency of different inhaler devices (soft mist inhaler [SMI], pressurized metered dose inhaler [pMDI] and dry powder inhaler [DPI]) and investigate their robustness to inhaler orientation. Stiolto® Respimat® SMI, Trimbow® pMDI, Fostair NEXTaler® DPI and Trelegy Ellipta® DPI were each tested using the Alberta Idealized Throat model, with realistic inhalation patterns for very severe COPD generated by a lung simulator.
Spray drying is used to produce engineered, inhalable dry powders and is a critical tool for new drug developers. It enables production of powders with a tightly controlled range of particle sizes and solid-state properties. Formulators have control over the crystalline and amorphous character and radial distribution of components and particle morphology. This comes from understanding the impact of each material’s physicochemical properties and the kinetics of droplet drying.
Much improvement has taken place in evaluating sources of variability in the measures of delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD). Methods described in the United States Pharmacopeia (USP) and European Pharmacopoeia (Pharm. Eur.) now include dimensions and diagrams for all components critical to their robustness. However, we show that there are sources of bias in the standard methods for DDU. A future article will address APSD.
The Biopharmaceutics Focus Group of the Academy of Pharmaceutical Sciences (APS) of Great Britain presented a workshop on nasal biopharmaceutics at the 2022 Drug Delivery to the Lungs Conference (DDL2022) in December 2022 in Edinburgh, UK. The aim was to bring together the scientific community to discuss challenges in the development of nasally administered therapies.