4.7 Article

Aiming for a moving target: Challenges with impactor measurements of MDI aerosols

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INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 355, 期 1-2, 页码 53-61

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ELSEVIER
DOI: 10.1016/j.ijpharm.2007.11.047

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cascade impactor testing; aerodynamic particle size; variability; evaporation

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Experiments were conducted to illustrate some of the challenges associated with measuring dynamic MDI aerosols. Experimental HFA-134a solution MDIs containing 8 or 20% ethanol were measured using the Andersen cascade impactor using three different inlets. It was demonstrated that the size distribution of MDI aerosols changes substantially during the measurement process. The measured size distribution was shown to be dependent on the degree of evaporation that has occurred prior to size measurement. Additionally, the degree of evaporation prior to measurement also influences the number of modes present in the measured size distribution. While MDI aerosols appeared to have a separate large particle mode when measured using the U.S. Pharmacopeial induction port (USP inlet; [U.S. Pharmacopeia, 1996. Physical tests and determinations < 601 > aerosols, metered dose inhalers, and dry powders. Pharmacopeial Forum 22, pp. 3065-3095]), the aerosols were shown to be monomodal when measured using a large volume inlet. The apparent large particle mode observed with the USP inlet seem rather to be droplets from the same monomodal distribution that have not fully evaporated. The complex interaction of the MDI plume and inlet configuration was described. Inlet design was shown to influence inlet deposition, measured particle size, and even deposition in the actuator mouthpiece. Inlet deposition was shown to be highly size-dependent with large droplets being collected more efficiently than smaller droplets. (c) 2007 Elsevier B.V. All rights reserved.

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