Aerosolization Performance of Jet Nebulizers and Biopharmaceutical Aspects
Aerosolization Performance of Jet Nebulizers and Biopharmaceutical Aspects
复制标题
DOI：
10.3390/pharmaceutics11080406
复制
发表时间：
2019-08-01
期刊：
影响因子：
5.4
通讯作者：
Rossi, Alessandra
中科院分区：
文献类型：
--
作者：
Adorni, Greta;Seifert, Gerrit;Rossi, Alessandra
在这项工作中，对 13 种喷射雾化器（其中一些具有不同的配置）进行了研究，以确定与药品质量属性相关的生物制药限制，这些限制影响其安全性、效率、合规性和有效性。气溶胶参数，包括气溶胶输出、气溶胶输出速率、质量中值空气动力学直径和细颗粒分数，根据欧洲标准 EN 13544-1 确定，使用氟化钠作为参考配方。气溶胶输出雾化时间和细颗粒分数之间的比较显示了气溶胶质量和雾化率之间的相关性。事实上，当气溶胶排放率降低时，雾化质量显着提高。此外，还根据可呼吸输送剂量和可呼吸剂量输送速率对雾化器的性能进行了分析，这将雾化描述为可吸入肺部的产品的速率和数量。根据使用后两个参数中的哪一个，雾化器表现出不同的性能。气雾剂输送速率和量方面的差异可以为根据药品、治疗和患者特征适当选择雾化器提供相关信息。
In this work, 13 jet nebulizers, some of which in different configurations, were investigated in order to identify the biopharmaceutical constraints related to the quality attributes of the medicinal products, which affect their safety, efficiency, compliance, and effectiveness. The aerosolization parameters, including the aerosol output, aerosol output rate, mass median aerodynamic diameter, and fine particle fraction, were determined according to the European Standard EN 13544-1, using sodium fluoride as a reference formulation. A comparison between the aerosol output nebulization time and the fine particle fraction displayed a correlation between the aerosol quality and the nebulization rate. Indeed, the quality of the nebulization significantly increased when the rate of aerosol emission was reduced. Moreover, the performance of the nebulizers was analyzed in terms of respirable delivered dose and respirable dose delivery rate, which characterize nebulization as the rate and amount of respirable product that could be deposited into the lungs. Depending on which of these two latter parameters was used, the nebulizers showed different performances. The differences, in terms of the rate and amount of delivered aerosol, could provide relevant information for the appropriate choice of nebulizer as a function of drug product, therapy, and patient characteristics.