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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 […]

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 […]

This paper focuses on the regulatory aspects of propellant switch programs for pressurized metered dose inhalers (MDIs) where products currently regulated by the United States Food and Drug Administration (FDA) are involved. Currently, several critical regulatory parameters and questions are yet to be decided upon by the FDA. There is much to be learned from […]

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 […]

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 […]

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. There is a clear need for alternatives […]

There is a need to adopt more environmentally friendly pMDI propellants, not only to reduce carbon footprint, but also to mitigate supply issues that may result from the decline in the use of existing propellants. HFA-152a and HFO-1234ze(E) are two potential candidates. It is critical that drug developers and manufacturers prepare their facilities for the […]

As the inhalation community explores propellants with lower global warming potential that could be used in pressurized metered dose inhalers (pMDIs), we hear the term “Kigali Amendment to the Montreal Protocol.” But how does that differ from the Paris Agreement? A useful explanation is shown in this table, reprinted with kind permission of the Montreal […]

In the case of formulations under development for indications such as pain management, migraine, seizure and biologics such as vaccines, which require a delivery system with precision control over spray plume geometry and deposition to the nasal mucosa for systemic uptake, pharmaceutical manufacturers have turned their attention to unit-dose, aseptic intranasal drug products. This type […]