U. S. Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, Room 1002, St. Louis, Missouri 63101, USA.
AAPS PharmSciTech. 2011 Mar;12(1):337-43. doi: 10.1208/s12249-011-9594-1. Epub 2011 Feb 1.
Droplet velocity is an important parameter that can be used to characterize nasal spray products. In this study, a phase-Doppler anemometry (PDA) system was used to measure the droplet velocities of nasal sprays. A survey of seven commercial nasal spray products showed a range of droplet velocities from 6.7 to 19.2 m/s, all significantly different from each other. A three-level, four-factor Box-Behnken design of experiments (DOE) methodology were applied to investigate the influences of actuation parameters and formulation properties on nasal spray droplet velocity using a set of placebo formulations. The DOE study shows that all four input factors (stroke length, actuation velocity, concentration of the gelling agent, and concentration of the surfactant) have significant influence on droplet velocity. An optimized quadratic model generated from the DOE results describes the inherent relationships between the input factors and droplet velocity thus providing a better understanding of the input factor influences. Overall, PDA provides a new in vitro characterization method for the evaluation of inhalation drugs through assessment of spray velocity and may assist in product development to meet drug delivery equivalency requirements.
液滴速度是一个重要的参数，可以用来描述鼻喷雾剂产品。在本研究中，使用了相位多普勒粒子分析（PDA）系统来测量鼻喷雾剂的液滴速度。对七种商业鼻喷雾剂产品的调查显示，液滴速度范围为 6.7 至 19.2 m/s，彼此之间均有显著差异。采用三水平、四因素 Box-Behnken 实验设计（DOE）方法，使用一组安慰剂制剂，研究了致动参数和制剂特性对鼻喷雾剂液滴速度的影响。DOE 研究表明，所有四个输入因素（冲程长度、致动速度、凝胶剂浓度和表面活性剂浓度）对液滴速度都有显著影响。从 DOE 结果生成的优化二次模型描述了输入因素和液滴速度之间的内在关系，从而更好地理解了输入因素的影响。总的来说，PDA 通过评估喷雾速度为吸入药物的评估提供了一种新的体外表征方法，并且可能有助于产品开发以满足药物传递等效性要求。
