• November 16, 2017

Understanding the mechanisms by which changes to particle size occur and monitoring such changes through ongoing stability testing may be vital to the commercial success of a product. Failure to consider particle size stability in the early stages of drug development can lead to costly setbacks, batch rejection and delays in clinical trials. It is […]

It is now widely recognized that coating of particle collection surfaces prior to impactor measurements is often necessary to avoid bias caused by particle re-entrainment of solid particles. The amount of re-entrainment is dependent on the particle and collection surface characteristics, but in most cases can be reduced or eliminated by applying a sticky material […]

The results bear directly on the question of accuracy of the nozzle diameter data gathered with an optical system. The repeatability of optical system measurements is a separate question that is also addressed briefly in the context of the accuracy determination.

A simple, optical method provides accurate and fast measurements (approximately 1 minute) with few sources of bias due to specific device design choices or operating conditions. A proof-of-concept for the method is demonstrated by measuring APSDs for widely available commercial dry powder inhalers, then comparing the results with previously published data from cascade impactors and […]

Utilizing a forensic approach to foreign particulates in drug products can play a unique and important role in quality control. In order to source contamination and thereby design a controlled environment to avoid contamination in the future, one must begin with an identification of the material, not just the detection of it.

  • November 15, 2017

This article fosters understanding about the proposed stepwise cascade impactor equivalence test, including the PBE test and the mCSRS. The PBE test is compared with the ABE test and the outcome of the stepwise cascade impactor equivalence test is compared with performing statistical tests on individual stages.

  • November 1, 2017

This article focuses on APSD determinations with the purpose of identifying potential pitfalls in set-up, execution and analysis that could obscure the findings, and therefore the interpretation of data, that are derived from such measurements.

An ideal instrument for characterizing the charges on aerosol particles would provide data showing the distribution of charge across the particle size distribution at patient relevant flow rates. To meet this need, the University of Sydney has developed a system using a modified Next Generation Pharmaceutical Impactor (NGI). The electrostatic NGI (eNGI) represents a major […]