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. This article […]
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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 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. From fluid dynamics and propellant evaporation to PK and regional lung deposition simulations, […]
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 […]
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 […]
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, […]
Delivering biologics to the lungs presents challenges related to maintaining stability and potency during nebulization. The choice of nebulization device—whether air jet, ultrasonic, vibrating mesh or soft mist—greatly influences the preservation of biologic integrity, with each technology offering distinct benefits and limitations. Formulation strategies, including the use of surfactants, stabilizers and optimized nebulizers, are crucial […]
This article provides an overview of parameters that should be investigated during early development and routine testing of a soft mist inhaler (SMI). For reliable results, the methods should be validated for the unique properties of the aerosol generated by the SMI. Moreover, a thorough understanding of the device as well as the formulation characteristics […]
This in vitro study evaluated how rational selection of device resistance can be used to minimize flow rate dependence in dose delivery in vivo. Aerosol performance of amphotericin B inhalation powder was assessed using a Next Generation Impactor (NGI) at a range of pressure drops (1, 2, 4 and 6 kPa) with low, medium, high, […]