Articles

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.

Following “lower than expected demand,” Nestlé is exploring strategic options for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first and only drug approved by the US FDA for the treatment of peanut allergy in children.

The Food Allergy Bravery Clinic at Children’s Hospital of Philadelphia provides cognitive behavioral therapy to children who have severe food allergy-related anxiety, helping them reduce their fears and improve their quality of life.

When selecting biological models for testing inhalation products, careful consideration must be made regarding the area of the respiratory tract that is the target site for a product. Once the appropriate cellular models are selected, there are several cell culture techniques that can be utilized to mimic the physiologically relevant conditions.

Excipient enhanced growth (EEG) is progressing through toxicological studies and showing promise for treatment of asthma and lung cancer by delivering active molecules to target sites in the lungs. This article discusses development of two candidates, budesonide and gemcitabine, for local lung delivery using this formulation approach in combination with traditional spray drying for the generation of respirable engineered particles.

The United States Centers for Disease Control and Prevention (CDC) has published a report in the Annals of Allergy, Asthma and Immunology that offers recommendations and resources to assist allergists and immunologists in supporting patients as they become affected by climate change.

Climate change may have more severe effect on children’s health, according to a review published in the New England Journal of Medicine by researchers from Stanford University and Columbia University. In two interviews, one of the authors discussed the content of the review.

In spray-dried formulations, various excipients or carriers are incorporated to improve the aerosolization behavior, stability and mechanical properties of active pharmaceutical ingredients (APIs) as well as to modify the pharmacokinetics and pharmacodynamics of APIs. Sugars are the most common excipients used as diluents and flow enhancers. In addition, sugars can provide hydrogen bonding and act as product stabilizers when water is removed.

With the increasing prevalence and use of digital technologies applied to drug delivery devices and software solutions to support inhaled therapeutics, there are multiple considerations that patients, healthcare professionals, payors and pharmaceutical manufacturers can and should observe. Key considerations include identifying the stakeholders required, value to deliver to each stakeholder, system design and the laws and regulations with which the system must comply.

The SABINA study of SABA inhaler usage and risk of asthma exacerbations, funded by AstraZeneca, is the largest real-world observational data analysis of asthma inhaler therapy and has evaluated more than one million patients across 40 countries. In addition, at Queen Mary University of London, a study of more than 700,000 patient records evaluated SABA inhaler usage, patterns of prescribing and rates of asthma-related hospitalizations.

Local treatment of lung cancer by the inhalation route is an emerging therapeutic area, particularly for early stages of the disease when the cancer is localized in the lung tissue. This article outlines manufacturing and formulation considerations for local treatment of lung cancer by dry powder inhaler and highlights three recent case studies.

The earliest reference to therapeutic dry powder inhalation may also be the earliest reference to “engineered particles,” dating from 1849, in London. An initial article looks at the history of dry powder inhalers, including devices and formulations, and discusses considerations for future DPIs. Then an interview takes a new look at current challenges and opportunities for DPIs.

AAFA has launched the Health Equity Advancement and Leadership (HEAL) program to address findings from its 2020 report about asthma disparities in America. Each year, the HEAL Innovation program will award funding and resources to four local, pilot, community-based asthma programs tailored to at-risk populations most impacted by asthma and will focus on needs of adults and teens.

CFD modeling for product development requires knowledge of the capabilities of state-of-the-art software and the adoption of a well-controlled simulation workflow. This article will review previous work in this area, illuminating CFD capabilities and the processes and considerations required to create a trusted, useful, predictive simulation to support the product development process.

The four parts of a dry powder formulation (the formulation, excipient, composition and processing) must be thoroughly understood in order to develop and optimize adhesive mixtures for inhalation. In addition, their interactions can be highly complex. This article gives examples and discusses the complex interaction between the formulation and the device.