Optimizing the in vitro performance of Respimat
Optimizing the in vitro performance of Respimat
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DOI：
10.1089/jam.1999.12.suppl_1.s-19
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发表时间：
1999-01-01
期刊：
影响因子：
--
通讯作者：
Zierenberg, B
中科院分区：
文献类型：
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作者：
Zierenberg, B
用于吸入治疗的手持设备中的药物溶液的雾化可以通过振动或通过细喷嘴挤压来实现。后一种方法不需要使用电源，并且在Respimat公司得到了进一步的发展。该装置适用于批量生产，根据所需的尺寸和重量以及稳定性和技术性能选择适当的材料。在对喷嘴设计进行优化后，与氯氟烃驱动的计量吸入器（CFC-MDI）相比，Respimat在其首次志愿者肺沉积研究中取得了令人鼓舞的结果。呼吸器是一种可重复使用的装置，其作用方式与其他吸入器不同。来自螺旋弹簧的机械动力迫使一定体积的药物溶液通过一个独特组件（uniblock）的喷嘴。两股细射流的汇合产生了缓慢移动的软雾气溶胶。通过安德森级联冲击器（Anderson Instruments, Inc., Smyrna， GA）的实验确定，气溶胶中的细颗粒分数在水溶液中约为66%，在乙醇溶液中约为81%。该值比cfc - mdi测定的细颗粒组分高约2.5倍，流速低约5倍（例如，水溶液为10m /s），这两个因素都有助于改善肺沉积。此外，与CFC-MDIs相比，Respimat的剂量释放持续时间要长得多，约为1.2秒，这使得患者有更多的时间来协调驱动和吸气。Respimat给药的可靠性和一致性也已得到证实。
Aerosolization of a drug solution in a handheld device for inhalation therapy can be achieved either by vibration or extrusion through a fine nozzle. The latter method does not necessitate the use of an electrical power source and has been developed further in Respimat. The device was adapted for mass production, selecting appropriate materials for the desired size and weight as well as for stability and technical performance. After optimization of the nozzle design, Respimat produced encouraging results in its first lung deposition study in volunteers compared with a chlorofluorocarbon-driven metered dose inhaler (CFC-MDI). Respimat is a reusable device with a mode of action that differs from those of other inhalers. The mechanical power from a coiled spring forces a metered volume of drug solution through a nozzle in a unique component, the uniblock. The convergence of two fine jets of liquid generates a slow-moving aerosol of soft mist. The fine particle fraction in the aerosol, determined from experiments with the Anderson Cascade Impactor (Anderson Instruments, Inc., Smyrna, GA), is approximately 66% for an aqueous drug solution and 81% for an ethanolic solution. This value is about 2.5 times higher than the fine particle fractions determined for CFC-MDIs, and the velocity is about five times lower (e.g., 10 m/s for an aqueous solution), with both factors contributing to the improved lung deposition. In addition, the dose release duration from Respimat is considerably longer than that from CFC-MDIs at approximately 1.2 seconds, allowing more time for the patient to coordinate actuation and inspiration. The reliability and consistency of dose delivery from Respimat also have been confirmed.