Küllmar Hendrik, Schöler Martin, Leopold Claudia S
Division of Pharmaceutical Technology, University of Hamburg, Bundesstr. 45, 20146 Hamburg, Germany.
Fette Compacting GmbH, Grabauer Straße 24, 21493 Schwarzenbek, Germany.
Pharmaceutics. 2025 Apr 25;17(5):565. doi: 10.3390/pharmaceutics17050565.
A specially designed chamber setup for containment investigations of pharmaceutical dusts was recently developed. The aim of the present study was to optimize the measurement procedure with this chamber setup, focusing on the atomization parameters. The optimization was aimed at a maximization of the amount of detected dust and a minimization of the required sample mass. For this purpose, the safe surrogate substance acetaminophen was used for dust measurements. In addition to the atomization parameters investigated by a design of experiments, the cleaning of the chamber setup and the selection of two different types of acetaminophen with different physicochemical properties were examined. By altering the cleaning method of the chamber setup, more than a tenfold increase of detected acetaminophen was observed. In addition, by selecting the more appropriate acetaminophen type, the totally detected acetaminophen amount was further increased by more than 25%. By means of the design of experiments two models were developed, one dealing with the atomization parameters with regard to the atomization effectiveness and the other describing their influence on the spatial dust distribution of acetaminophen. Based on the model for atomization effectiveness, the totally detected acetaminophen amount may be increased by more than double at a constant sample mass. In summary, the measurement procedure of the chamber setup was optimized in terms of the cleaning method, surrogate choice, and the adjustment of the atomization parameters, giving valuable insights to deepen our understanding of dustiness and the spatial distribution of dust in the context of containment.
最近开发了一种专门设计的用于药物粉尘密闭性研究的试验箱装置。本研究的目的是利用该试验箱装置优化测量程序，重点关注雾化参数。优化旨在使检测到的粉尘量最大化，并使所需样品质量最小化。为此，使用安全替代物质对乙酰氨基酚进行粉尘测量。除了通过实验设计研究雾化参数外，还考察了试验箱装置的清洁以及两种具有不同物理化学性质的对乙酰氨基酚的选择。通过改变试验箱装置的清洁方法，观察到检测到的对乙酰氨基酚增加了十多倍。此外，通过选择更合适的对乙酰氨基酚类型，检测到的对乙酰氨基酚总量进一步增加了25%以上。通过实验设计开发了两个模型，一个处理关于雾化效果的雾化参数，另一个描述它们对乙酰氨基酚空间粉尘分布的影响。基于雾化效果模型，在样品质量恒定的情况下，检测到的对乙酰氨基酚总量可能会增加两倍以上。总之，试验箱装置的测量程序在清洁方法、替代物选择和雾化参数调整方面得到了优化，为加深我们对密闭环境中粉尘度和粉尘空间分布的理解提供了有价值的见解。
