The SABINA study of SABA inhaler usage and risk of asthma exacerbations, funded by AstraZeneca, is the largest real-world observational data analysis of asthma inhaler therapy and has evaluated more than one million patients across 40 countries. In addition, at Queen Mary University of London, a study of more than 700,000 patient records evaluated SABA […]
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The earliest reference to therapeutic dry powder inhalation may also be the earliest reference to “engineered particles,” dating from 1849, in London. An initial article looks at the history of dry powder inhalers, including devices and formulations, and discusses considerations for future DPIs. Then an interview takes a new look at current challenges and opportunities […]
A large gap exists between the relatively straightforward robust methods in the pharmacopeias, developed primarily for product release, and the more elaborate approaches to assist in understanding how inhalers are likely to perform in the hands of the patient or caregiver. The authors propose that there is a middle way forward and believe it is […]
This article provides an overview of the considerations for the formulation development of inhaled biologics and the various excipients that are routinely investigated for use in dry powder formulations of biologics intended for oral inhalation, with particular emphasis on protein stabilization. Carbohydrates, including simple sugars, complex sugars and sugar alcohols; amino acids and surfactants are […]
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 […]
The UK National Health Service (NHS) has launched the PRECISION Asthma Mobile Clinic provided by AstraZeneca, which will partner with local NHS respiratory services to accelerate delivery of asthma care. More than one in 20 patients in the UK postponed emergency care due to the COVID-19 pandemic and more than a quarter of patients avoided […]
The Pulmonary Fibrosis Foundation maintains a database of molecules and clinical programs in development for IPF. As of June 2021, while it may not be comprehensive, it listed 33 programs, yet shows only five via the inhaled route. Why then, given the availability of the technology and manufacturing knowledge, and the inherent medical advantages of […]
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, […]
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 […]