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Evaluation of a device modification and hand-related variability on the performance of nasal sprays and metered dose inhalers.

机译：对鼻喷雾剂和定量吸入器的性能进行设备修改和手相关变化的评估。

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摘要

Drug delivery to the nose and lungs using nasal sprays and metered dose inhalers (MDIs) is complicated by a reliance on the formulation, device, and patient to generate droplets or particles within a suitable particle size range so that drug deposits at an appropriate location. Many properties of the formulation, device, and patient have been investigated for their role in nasal spray and MDI performance. However, no published works have studied the influence of the dip tube during emptying of the nasal spray, or how patient-relevant hand technique affects nasal sprays or MDIs. Therefore, the purpose of this work is to investigate the effects of a flexible dip tube modification on emptying characteristics of nasal sprays, and to evaluate the influence of hand technique on nasal sprays and MDIs.;The number of full sprays and the number of sprays in the tail-off period generated at thirty degrees to the vertical by flexible and rigid dip tubes were determined in five over-the-counter nasal sprays. Results showed that flexible dip tubes were able to generate significantly more sprays before the tail-off period in four of the five nasal sprays tested. Three of the five nasal sprays showed significantly fewer sprays in the tail-off period when flexible dip tubes were used in place of their rigid counterparts.;Hand data recorded from adults and children were used to conduct in vitro tests on nasal sprays using force-controlled and velocity-controlled actuators. Variability in hand spraying led to significant differences in patient-relevant actuator settings between the adult and pediatric groups. Also, a significantly decreased spray weight was recorded in children compared to adults. While variability among participants was high, only actuation force, force rise time, and compression velocity resulted in significantly different in vitro test results.;Although hand variability was high when adults sprayed two MDIs, the variability in the recorded spray weight was low. This suggests that hand technique does not play a dominant role in the resultant dose and/or spray characteristics, as long as the participant is able to apply enough force to the MDI to compress the valve spring and release the product.
机译：使用鼻喷雾剂和计量吸入器（MDI）将药物输送到鼻子和肺部的过程非常复杂，这取决于对制剂，设备和患者的依赖，以在合适的粒径范围内产生液滴或颗粒，从而使药物沉积在合适的位置。已经研究了制剂，装置和患者的许多特性，它们在鼻喷雾剂和MDI性能中的作用。但是，尚未有研究工作研究过鼻腔排空期间汲取管的影响，或与患者相关的手部技术如何影响鼻腔喷雾剂或MDI。因此，这项工作的目的是研究柔性浸入管的改进对鼻喷雾剂排空特性的影响，并评估手工技术对鼻喷雾剂和MDI的影响。;全喷雾剂的数量和喷雾剂的数量在五个非处方鼻喷雾剂中，确定了由挠性和刚性浸入管在与垂直线成30度产生的尾巴排出时间中的浓度。结果表明，在所测试的五种鼻喷雾剂中的四种中，挠性浸入管能够在尾喷期之前产生更多的喷雾。在使用柔性浸入管代替刚性浸入管的情况下，五次鼻喷剂中的三项在尾巴喷出期间显示出明显减少。;使用成人和儿童记录的手数据，使用力进行鼻喷剂的体外测试，控制和速度控制的执行器。手动喷涂的可变性导致成人和小儿组之间患者相关致动器设置的显着差异。此外，与成人相比，儿童的喷雾重量明显降低。尽管参与者之间的变异性很高，但只有促动力，力上升时间和压缩速度才导致体外测试结果显着不同。;尽管成年人喷涂两个MDI时手的变异性很高，但记录的喷雾重量的变异性却很低。这表明，只要参与者能够对MDI施加足够的力以压缩气门弹簧并释放产品，手动技术就不会在最终的剂量和/或喷雾特性中起主导作用。

著录项

  • 作者

    Doughty, Diane Veronica.;

  • 作者单位

    University of Maryland, Baltimore.;

  • 授予单位 University of Maryland, Baltimore.;
  • 学科 Health Sciences Pharmacy.
  • 学位 Ph.D.
  • 年度 2010
  • 页码 220 p.
  • 总页数 220
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 地球物理学;
  • 关键词

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