• November 29, 2017

If graphene proves to be toxic upon inhalation, it may be due to a complex interaction of several mechanisms. Short term toxicity studies and other evaluations are needed to characterize and understand the aerodynamic behavior and deposition mechanisms of graphene derivatives in human respiratory pathways, as well as biological responses following inhalation.

This review relates the anatomy and pathology of the small airways to their physiological and radiological assessment, and finally highlights the technological advances in inhaled drug delivery that have allowed us to deliver aerosolized medicines that can target and treat the small airway region of the lungs.

This article will describe some established and emerging imaging systems that can be utilized to picture two-piece capsules and will highlight potential benefits and limitations of each.

The Human Factors Engineering (HFE) process is based on user studies to identify risks and improve the device design accordingly. HFE also considers competence and user satisfaction to be equally important in ensuring patients’ adherence to their treatment. Verifying both a safe and user-friendly device eventually relies on a combination of very different factors, ranging […]

This article summarizes the historic and current US and European regulations driving human factors. The authors also explore some of the more common cognitive, physical, social and environmental use challenges seen with pMDIs and DPIs and discuss how these devices can challenge patients, the types of research that can be employed to better understand these […]

This article provides a summary of the current best practices for AIM testing of orally inhaled products, with a focus on dry powder inhalers (DPIs). In addition, this article builds on these best practices with the intention of providing counsel to those considering the implementation of an AIM-based measurement program for DPIs.

With so much recent interest in the use of computational fluid dynamics (CFD) for developing inhalation and nasal products – an entire afternoon at RDD 2008 was devoted to papers on the topic – you may be wondering how to get started using CFD yourself. The benefits are pretty obvious; why spend months tweaking device […]

In genetic association studies of asthma, relevant environmental exposures need to be taken into account, and when assessing the effect of environment, we need to factor in genetic predisposition. If we extrapolate this to identification of the new therapeutic targets for asthma, the data suggest only a proportion of the population will benefit from a […]

A lasting solution would be the adoption of sample-independent quality standards and statistical process controls, for example, by incorporating in the pharmaceutical industry some of the statistical methods standardized by ASTM, ISO and other standard-setting organizations, appropriately adjusted throughout a product’s lifecycle (from early to late development to commercial production).

Fluidda’s “functional respiratory imaging” combines high-resolution, low-dose computerized tomography (CT) scans and computational fluid dynamics (CFD) to yield regional information related to lung structure and function.