The need for accurate thermophysical property prediction for diverse formulation mixtures is expected to grow, as next-generation formulations with low global warming potential (GWP) are introduced and as usage of predictive simulation increases during pMDI development. This need can be supported by appropriate experimental measurement campaigns for formulation mixtures, spanning the full range of temperature, […]
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For many years, the nasal route of administration has been used very successfully for the non-invasive delivery of small molecule drugs. The anatomy and physiology of the nasal cavity have been exploited to deliver 1) locally acting medications, to combat ailments such as seasonal and year-round allergies, 2) systemically delivered drugs, via the highly vascularized […]
Production of inhalable drug particles traditionally involves milling, spray drying, spray freeze drying and supercritical fluid processes. Many of these processes expose the formulation to thermal or mechanical stresses, leading to changes in the particles’ surface and physicochemical properties. Among various particle properties (particle size and size distribution, surface properties, hygroscopicity, electrostatic charge and relative […]
The authors believe that the decision-making framework used to demonstrate product quality consists of both the metrics themselves and the way they are used to make the decision. In the context of inhaler APSD, they contend that good decision-making requires independent assessments of each dimension of the APSD, namely size and mass, which they propose […]
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 […]
The FDA’s Draft Guidance for Industry, “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations” released in April 2018, discusses quality attributes for metered dose inhalers (MDIs) and dry powder inhalers (DPIs). Regardless whether pursuing innovator or generic product development, the importance of establishing a desired quality target product profile (QTPP) […]
A key objective of this article is to guide the newcomer to the field, as well as those with familiarity of the topic. Four misconceptions are discussed: Misconception 1: Impactor-sized mass (ISM) always includes data from all impactor stages; Misconception 2: Geometric standard deviation (GSD) is always suitable as the measure of spread of a […]
INFORM2020 is a five-year collaboration of academia and industry to investigate critical parameters that influence the performance of dry powder inhaled (DPI) formulations. In part, the collaboration has been attempting to shed light on key questions through X-ray microscopy, which can offer new insights into the microstructure of inhalable formulations for DPIs. The article also […]
When repurposing oral or parenteral therapies for inhaled administration, there are a number of important factors to evaluate early in the drug development process. Considering these factors may increase chances that a repurposed product could be positioned for successful clinical studies and commercial adoption by patients. A key question is, “Why are we repurposing the […]