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 […]
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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 […]
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 […]
FARE believes that “consistent innovation and advancements have provided hope that researchers can finally find a new solution for diagnosing food allergies.” They have launched a global research competition “to motivate innovative researchers to develop a novel, safe and compassionate method to accurately diagnose food allergies in children and adults. The new solution will replace […]