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简化撞击器测量(AIM)概念:第1部分——颗粒反弹和再夹带的影响——基于“干式”压力定量吸入器(pMDI)制剂的评估

The abbreviated impactor measurement (AIM) concept: part 1--Influence of particle bounce and re-entrainment-evaluation with a "dry" pressurized metered dose inhaler (pMDI)-based formulation.

作者信息

Mitchell J P, Nagel M W, Avvakoumova V, MacKay H, Ali R

机构信息

Trudell Medical International, 725 Third Street, London, Ontario, Canada.

出版信息

AAPS PharmSciTech. 2009;10(1):243-51. doi: 10.1208/s12249-009-9202-9. Epub 2009 Mar 12.

Abstract

The abbreviated impactor measurement concept is a potential improvement to the labor-intensive full-resolution cascade impactor methodology for inhaler aerosol aerodynamic particle size distribution (APSD) measurement by virtue of being simpler and therefore quicker to execute. At the same time, improved measurement precision should be possible by eliminating stages upon which little or no drug mass is collected. Although several designs of abbreviated impactor systems have been developed in recent years, experimental work is lacking to validate the technique with aerosols produced by currently available inhalers. In part 1 of this two-part article that focuses on aerosols produced by pressurized metered dose inhalers (pMDIs), the evaluation of two abbreviated impactor systems (Copley fast screening Andersen impactor and Trudell fast screening Andersen impactor), based on the full-resolution eight-stage Andersen nonviable cascade impactor (ACI) operating principle, is reported with a formulation producing dry particles. The purpose was to investigate the potential for non-ideal collection behavior associated with particle bounce in relation to internal losses to surfaces from which particles containing active pharmaceutical ingredient are not normally recovered. Both abbreviated impactors were found to be substantially equivalent to the full-resolution ACI in terms of extra-fine and fine particle and coarse mass fractions used as metrics to characterize the APSD of these pMDI-produced aerosols when sampled at 28.3 L/min, provided that precautions are taken to coat collection plates to minimize bounce and entrainment.

摘要

简化撞击器测量概念有可能改进用于吸入器气溶胶空气动力学粒径分布(APSD)测量的、劳动强度大的全分辨率级联撞击器方法,因为它更简单,因此执行起来更快。同时,通过去除收集到很少或没有药物质量的阶段,应该可以提高测量精度。尽管近年来已经开发了几种简化撞击器系统的设计,但缺乏实验工作来用现有吸入器产生的气溶胶验证该技术。在这篇分为两部分的文章的第1部分中,重点关注加压定量吸入器(pMDI)产生的气溶胶,报告了基于全分辨率八级安德森无活力级联撞击器(ACI)工作原理的两种简化撞击器系统(科普利快速筛选安德森撞击器和特鲁德尔快速筛选安德森撞击器)对一种产生干燥颗粒的制剂的评估。目的是研究与颗粒反弹相关的非理想收集行为的可能性,以及与通常无法回收含有活性药物成分颗粒的表面的内部损失有关的情况。结果发现,当以28.3 L/min进行采样时,只要采取措施对收集板进行涂层以尽量减少反弹和夹带,这两种简化撞击器在用作表征这些pMDI产生的气溶胶的APSD的超细、细颗粒和粗质量分数方面,与全分辨率ACI基本相当。

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