Date Range



Article Type


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.
This article discusses CFD simulations of nasal spray transport and use of CFD modeling to design nasal spray devices and analyze spray delivery performance. In silico testing using CFD, guided with in vitro measurements, is a potentially valuable approach that can reduce time and costs of evaluating nasal spray delivery performance under variable usage conditions in realistic nasal airway models.
HEI undertook the Global Burden of Disease from Major Air Pollution Sources (GBD-MAPS) project to determine which air pollution sources or fuels contribute most to outdoor PM2.5 concentrations and their associated health burden. The study provides the first comprehensive estimates at global, regional and national levels, which can help inform policy.
Dry powder inhalation (DPI) products basically consist of a powder formulation and a device. The formulation, which contains active pharmaceutical ingredient(s) (APIs) micronized to inhalable particle size and a few excipients may, at first glance, appear simple. However, a large number of factors are critical to the performance of dry powder formulations for inhalation. Furthermore, many of these interact in complex ways.
Greater associations between risk of mortality and long-term exposures to relatively low concentrations of fine particulate matter (PM2.5) have been reported. Recognizing “more stringent air quality standards and guidelines will likely be considered,” The Health Effects Institute has funded three studies—in the United States, Europe and Canada—“to explore health effects from air pollution exposure at levels below government recommended standards."
Considering flow conditions in the DPI test system has led to understanding more about why experts have improved the pharmacopeial protocol over time. Still, there are aspects of the fundamentals that are not yet clarified but worth understanding and accommodating in the protocols. The authors believe these include specifications for the solenoid valve, the effect of the pre-separator, control of the flow rate and measurement of the flow rate.
A large gap exists between the relatively straightforward robust methods in the pharmacopeias, developed primarily for product release, and the more elaborate approaches to assist in understanding how inhalers are likely to perform in the hands of the patient or caregiver. The authors propose that there is a middle way forward and believe it is possible to retain robustness in methodologies, while achieving significant gains in clinical realism.
Researchers from Tulane University School of Medicine analyzed operating costs of a partnership between school-based health centers (SBHCs) and a local allergist providing asthma care for students. Results showed the program was sustainable and cost-neutral and did not rely on grant funding.

A community-based program to help manage children’s asthma, developed with and successfully piloted in four Bronx schools, is expanding in up to 40 schools across the Bronx. The five-year “Asthma-PASS” study is supported by a $4.2 million grant from the United States National Institutes of Health (NIH).
This article provides an overview of the considerations for the formulation development of inhaled biologics and the various excipients that are routinely investigated for use in dry powder formulations of biologics intended for oral inhalation, with particular emphasis on protein stabilization. Carbohydrates, including simple sugars, complex sugars and sugar alcohols; amino acids and surfactants are discussed.
This article describes legislative and commercial drivers for propellant change and potential propellants, as well as the Respitab® technology platform, which provides a novel approach to formulation and manufacturing of lower global warning potential (GWP) pMDIs. Studies are presented and manufacturing and considerations for its use are discussed.
The UK National Health Service (NHS) has launched the PRECISION Asthma Mobile Clinic provided by AstraZeneca, which will partner with local NHS respiratory services to accelerate delivery of asthma care.

A respiratory nurse realized that understanding asthma could help children gain better disease control, and reduce emergency department attendance and length of hospital admissions. She wanted to reach children quickly and cover a geographical area efficiently. So she asked, “Could we have an asthma bus?”
The Pulmonary Fibrosis Foundation maintains a database of molecules and clinical programs in development for IPF. As of June 2021, while it may not be comprehensive, it listed 33 programs, yet shows only five via the inhaled route. Why then, given the availability of the technology and manufacturing knowledge, and the inherent medical advantages of inhaled drugs, are manufacturers pursuing conventional oral and IV formulations?
The article provides a rationale for and examples demonstrating the applicability of NGI gravimetric insert cups for measurement of APSDs of homogeneous liquid suspension and dry particle aerosols. This method can be an alternative or complement to drug-specific NGI or non impaction-based methods to avoid drug-specific assay variability or satisfy regulatory expectations for impaction-based APSD approaches. It may also help address aerosol characterization needs in phase-appropriate product development strategies.
For millions in the US newly experiencing food insecurity due to the COVID-19 pandemic, those with food allergies are facing “a particular crisis” in that most charitable and government food programs offer limited options that are safely edible. The Food Equality Initiative and Porchlight Community Services are two organizations that support clients with food allergies.

Multiple studies have been conducted to determine whether food insecurity is associated with asthma and, if so, to evaluate the extent of such a relationship. However, results are conflicting.
In this article, the fundamental thermophysical properties that control the complex internal flow and aerosol formation process in a pMDI will be examined, from the perspective of their measurement, representation and prediction. Activity coefficient models that enable simultaneous description and prediction of important formulation thermophysical properties will also be presented. The performance of these models is demonstrated using existing data for HFA134a/ethanol mixtures, to show their potential application alongside experimental property data collection involving future propellants.
Some commercially available liquid nasal spray formulations include excipients that can act as penetration enhancers or mucoadhesives. They may thereby provide the benefit of increasing contact/residence time in the nasal cavity or increasing absorption of drug molecules by enhancing permeability through nasal mucosal membranes. This review may assist readers in considering the utility of various penetration enhancers and mucoadhesives for use in research and development.
Surface composition and interfacial properties of dry powder particles play a significant role in the processing, structure and functionality of orally inhaled dry powders. Therefore, advanced surface characterization techniques, such as AFM, XPS and ToF-SIMS, are critical to better understanding powder behavior in the early stages of DPI formulation, which may help avoid stability issues later in development.
The third in a series of articles from the IPAC-RS Cascade Impaction Working Group concerning the limitations of metrics commonly used in the assessment of aerodynamic particle size distributions (APSDs) of orally inhaled products (OIPs). The current article takes a broader view to discuss why we make quality control measurements such as inhaler APSD.
The most severe thunderstorm asthma (TA) event reported caused approximately 14,000 people in Melbourne, Australia to seek emergency care for respiratory symptoms and contributed to 10 deaths. The Victorian Grass Pollen Emission Module is being used to study mechanisms for these rare events. Surprisingly, high humidity was not a factor but strong winds, lightning strikes and static electricity due to low humidity may be causes.
The Kigali Amendment to the Montreal Protocol aims to phase-down global HFA consumption. While volumes of hydrofluoroalkane (HFA) gases used by the inhalation and respiratory healthcare industry are relatively small, it is likely we will see supply shortages in the future as other industries completely phase out their use. This article discusses ways the inhalation industry can prepare for and be ready to adopt new propellants to guarantee continued, reliable manufacture and supply of vital medicines for patients.
A useful explanation is provided in a table that compares the Kigali Amendment to the Montreal Protocol and the Paris Agreement, with respect to substances, goals, criteria for entering into force, differences between developing/developed countries, approach and compliance. Reprinted with kind permission of the Montreal Protocol Division at the United Nations Industrial Development Organization (UNIDO).
This article presents case studies and highlights ways key physical properties of drug substance particles might be adjusted and measured to meet a quality target product profile (QTPP). Morphic form, particle shape and surface characterization were studied and a variety of analytical techniques were used. Characterization results for fluticasone propionate, fluticasone furoate, vilanterol trifenatate and/or salmeterol xinafoate powders, micronized by jet milling and/or wet polishing, and various process parameters for the techniques, are discussed.