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 […]
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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 […]
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. […]
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 […]
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 […]
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 […]
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. Currently, several cellular models […]
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 […]
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 […]
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 […]