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Updated: Jun 23, 2026
Experimental Protocol to Investigate Particle Aerosolization of a Product Under Abrasion and Under Environmental Weathering
Published on: September 16, 2016
A methodology to study impactor particle reentrainment and a proposed stage coating for the NGI
Jenny Rissler1, Lars Asking, Jakob Kisbye Dreyer
1Ergonomics and Aerosol Technology, Lund University, Lund, Sweden. jenny.rissler@design.lth.se
Background:
Mass-weighted aerodynamic particle-size distribution (APSD) is a key attribute for pharmaceutical products developed to deliver drugs to or through the lungs. In development and quality control, APSD is primarily determined using multistage cascade impactors. For impactor techniques, particle reentrainment is critical because it may lead to an overestimation of the respirable fraction. To avoid reentrainment, the collection surfaces need to be coated with a suitable material.
Methods:
In this study a method was developed to test flow dependence of particle reentrainment in the Next Generation Pharmaceutical Impactor (NGI) at flow rates ranging from 20 to 80 L/min, and was used to test three coating materials: glycerol coating, aqueous coating with, and without soaked filter paper. Uncoated cups were also tested. In the experimental setup a Vilnius Aerosol Generator generated a flow-independent dry powder aerosol, consisting of micronized insulin.
Results:
The glycerol coating was not well suited to reduce particle reentrainment at flows >or=40 L/min. The soaked filter paper coating was found to give nearly the same particle size distributions regardless of flow and was therefore judged to be the best of those tested. Using liquid only, without the filter paper, gave the same particle size distributions as soaked filter paper for flows
Conclusions:
This study shows the advantage of using a stable and flow-independent aerosol generation method to examine particle reentrainment at various flows through the NGI. For insulin dry powder, the use of an aqueous solution as cup coating, preferably with a filter, reduced particle reentrainment to a minimum. The results were confirmed in a study with a DPI.
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