DTF-Aerodrug, Faculté de Médecine, Bâtiment M, 10 ter bd Tonnellé, F-37032, Tours, France.
Pharm Res. 2014 Jan;31(1):228-37. doi: 10.1007/s11095-013-1157-6. Epub 2013 Sep 25.
Intranasal deposition of aerosols is often studied using in vitro nasal cavity models. However, the relevance of these models to predict in vivo human deposition has not been validated. This study compared in vivo nasal aerosol deposition and in vitro deposition in a human plastinated head model (NC1) and its replica constructed from CT-scan (NC2).
Two nebulizers (Atomisor Sonique® and Easynose®) were used to administer a 5.6 μm aerosol of (99m)Tc-DTPA to seven healthy volunteers and to the nasal models. Aerosol deposition was quantified by γ-scintigraphy in the nasal, upper nasal cavity and maxillary sinus (MS) regions. The distribution of aerosol deposition was determined along three nasal cavity axes (x, y and z).
There was no significant difference regarding aerosol deposition between the volunteers and NC1. Aerosol deposition was significantly lower in NC2 than in volunteers regarding nasal region (p < 0.05) but was similar for the upper nasal cavity and MS regions. Mean aerosol distribution for NC1 came within the standard deviation (SD) of in vivo distribution, whereas that of NC2 was outside the in vivo SD for x and y axes.
In conclusion, nasal models can be used to predict aerosol deposition produced by nebulizers, but their performance depends on their design.
气溶胶的鼻腔沉积通常使用体外鼻腔模型进行研究。然而,这些模型对预测体内人类沉积的相关性尚未得到验证。本研究比较了人鼻塑化模型(NC1)及其 CT 扫描重建模型(NC2)中体内鼻内气溶胶沉积和体外沉积。
使用两种雾化器(Atomisor Sonique®和 Easynose®)向 7 名健康志愿者和鼻模型施用(99m)Tc-DTPA 的 5.6μm 气溶胶。通过γ闪烁扫描术在鼻腔、上鼻腔和上颌窦(MS)区域定量气溶胶沉积。沿着三个鼻腔轴(x、y 和 z)确定气溶胶沉积的分布。
志愿者和 NC1 之间的气溶胶沉积没有显著差异。NC2 与志愿者相比,鼻腔区域的气溶胶沉积明显降低(p<0.05),但上鼻腔和 MS 区域的沉积相似。NC1 的平均气溶胶分布在体内分布的标准偏差(SD)范围内,而 NC2 的 x 和 y 轴的分布则超出了体内 SD。
总之,鼻模型可用于预测雾化器产生的气溶胶沉积,但它们的性能取决于其设计。