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 […]
Excipients (also called “inactive ingredients”) play a critical role in formulation performance. They are generally chosen based on their physico-chemical properties, functionality, compatibility with the formulation and device, dose, taste, fragrance (or lack thereof), color and/or ease of administration, as well as the availability of a “safety record.” This review provides a collation of the […]
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, […]
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 […]
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 NEXThaler® DPI and Trelegy Ellipta® DPI were each tested using the Alberta Idealized […]
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 […]