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干粉吸入制剂的分散行为不能在单一吸入流速下进行评估。

The dispersion behaviour of dry powder inhalation formulations cannot be assessed at a single inhalation flow rate.

机构信息

Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands.

出版信息

Int J Pharm. 2014 Apr 25;465(1-2):165-8. doi: 10.1016/j.ijpharm.2014.02.024. Epub 2014 Feb 15.

Abstract

The dispersion performances of inhalation powders are often tested at only one inhalation flow rate in mechanistic formulation studies. This limited approach is challenged by studies showing that interactions exist between inhalation flow rate and the effects on dispersion performance of several formulation variables. In this note we explain that such interactions with inhalation flow rate are, in fact, always to be expected. Because these interactions may greatly affect conclusions concerning the effects of formulation variables and their underlying mechanisms, the utility of future dry powder inhalation formulation studies may benefit from an approach in which dispersion performance is by default tested over a range of inhalation flow rates.

摘要

在机制配方研究中,吸入粉的分散性能通常仅在一个吸入流速下进行测试。这种有限的方法受到了挑战,因为研究表明,吸入流速与几个配方变量对分散性能的影响之间存在相互作用。在本说明中,我们解释说,与吸入流速的这种相互作用实际上是始终可以预期的。由于这些相互作用可能极大地影响有关配方变量及其潜在机制的影响的结论,因此默认情况下在一系列吸入流速下测试分散性能的方法可能会使未来的干粉吸入制剂研究受益。

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