Recent reports on mesh nebulizers suggest the possibility of stable nebulization of various therapeutic protein drugs. In this study, the in vitro performance and drug stability of jet and mesh nebulizers were examined for dornase alfa and compared with respect to their lung delivery efficiency in BALB/c mice. We compared four nebulizers: two jet nebulizers (PARI BOY SX with red and blue nozzles), a static mesh nebulizer (NE-U150), and a vibrating mesh nebulizer (NE-SM1). The enzymatic activity of dornase alfa was assessed using a kinetic fluorometric DNase activity assay. Both jet nebulizers had large residual volumes between 24% and 27%, while the volume of the NE-SM1 nebulizer was less than 2%. Evaluation of dornase alfa aerosols produced by the four nebulizers showed no overall loss of enzymatic activity or protein content and no increase in aggregation or degradation. The amount of dornase alfa delivered to the lungs was highest for the PARI BOY SX-red jet nebulizer. This result confirmed that aerosol droplet size is an important factor in determining the efficiency of dornase alfa delivery to the lungs. Further clinical studies and analysis are required before any conclusions can be drawn regarding the clinical safety and efficacy of these nebulizers.

中文翻译：

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由喷射和网状雾化器产生的Dornase Alfa气雾剂输送。

关于网状喷雾器的最新报道表明，稳定地雾化各种治疗性蛋白质药物的可能性。在这项研究中，检查了喷射式喷雾器和网状喷雾器的体外性能和药物稳定性，以确定其是否在酶中被氧化，并就其在BALB / c小鼠中的肺部递送效率进行了比较。我们比较了四种雾化器：两个喷射雾化器（带有红色和蓝色喷嘴的PARI BOY SX），静态网状雾化器（NE-U150）和振动网状雾化器（NE-SM1）。使用动力学荧光DNase活性测定法评估dornase alfa的酶促活性。两种喷射雾化器的残留量在24％至27％之间，而NE-SM1雾化器的体积小于2％。对由四个雾化器产生的氧化酶Alfa气雾剂的评估表明，酶活性或蛋白质含量没有整体损失，聚集或降解没有增加。对于PARI BOY SX-red喷射雾化器，输送到肺部的氧化酶α量最高。该结果证实，气溶胶液滴大小是确定氧化酶α向肺的递送效率的重要因素。在得出关于这些雾化器的临床安全性和有效性的任何结论之前，需要进行进一步的临床研究和分析。