This article discusses CFD simulations of nasal spray transport and use of CFD modeling to design nasal spray devices and analyze spray delivery performance. In silico testing using CFD, guided with in vitro measurements, is a potentially valuable approach that can reduce time and costs of evaluating nasal spray delivery performance under variable usage conditions […]
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Dry powder inhalation (DPI) products basically consist of a powder formulation and a device. The formulation, which contains active pharmaceutical ingredient(s) (APIs) micronized to inhalable particle size and a few excipients may, at first glance, appear simple. However, a large number of factors are critical to the performance of dry powder formulations for inhalation. Furthermore, […]
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 […]
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, […]
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 author provides a brief history of nasal delivery devices and their applications then look to potential uses in the future. Article topics include: device platforms, locally acting products, vaccines, systemic nasal drug delivery, patient considerations, regulatory considerations and future opportunities. In addition, the article includes a table listing samples of US FDA-approved nasal products […]
It is in the best interest of all key stakeholders to have inhaled medications accessible and affordable to all who need them. At the same time, it is necessary to continue to reward companies and individuals who work with innovator products for their efforts and investments that bring better inhaled medications to patients. Both innovator […]
Synchrotron X-rays can provide valuable quantitative information on drug distribution, spray density, droplet and particle properties; metrics that are difficult or virtually impossible to obtain by other means. Unlike many traditional measurement techniques, synchrotron measurements can provide direct evidence of the effects of changes to actuator design and formulation composition on the behavior of a […]
The authors provide a brief history of dry powder inhalers then discuss considerations for future development such as formulation, dose storage, moisture protection and metering, de-aggregative processes, counters, the environment, patient considerations and non-respiratory indications.