Teva Branded Pharmaceutical Products R&D, Inc., Miami, Florida 33169, USA.
J Aerosol Med Pulm Drug Deliv. 2012 Apr;25(2):104-9. doi: 10.1089/jamp.2011.0891. Epub 2011 Dec 22.
Inhaler technique and spray characteristics are critical for adequate management of asthma symptoms with pressurized metered-dose inhalers (pMDIs). A lower spray force has been directly associated with a decrease in throat deposition of asthma medication, and a higher spray temperature may alleviate the "cold Freon effect" associated with pMDIs. The objective of the study was to characterize and compare the temperature, maximum spray force, and duration of the emitted plume from two pMDIs: ProAir(®) hydrofluoroalkane (HFA) and Ventolin(®) HFA.
A spray force tester model SFT1000 and thermocouple were used to test 10 units from three separate lots (total of 30 units) of each inhaler type. Three consecutive actuations were tested at a spray distance of 40 mm from the edge of the mouthpiece. Room temperature, humidity, and initial weight of the pMDI were recorded. Final weight of each pMDI was recorded to determine the spray weight of individual actuations. pMDIs were primed and operated according to instructions provided in the package insert. Aerodynamic particle size distribution (APSD) was also assessed using a next-generation impactor at a flow rate of 28.3 L/min.
Measurements were obtained from three consecutive actuations for each of 30 units of ProAir(®) HFA and Ventolin(®) HFA (10 units from three separate lots), resulting in a total of 90 actuations tested for each pMDI. Minimum plume temperatures recorded were 7.2 ± 0.7°C and -35.9 ± 12.7°C, respectively, for ProAir(®) HFA and Ventolin(®) HFA. ProAir(®) HFA produced more than a twofold greater plume duration (385 ± 46 ms vs. 156 ± 58 ms; p<0.001) and a significantly lower mean maximum spray force (33.6 ± 11.4 mN vs. 75.9 ± 12.0 mN; p<0.0001) compared with Ventolin(®) HFA. APSD analysis demonstrated that ProAir(®) HFA produced almost twice as much fine particle (<5 μm) dose with lower geometric standard deviation, compared with Ventolin(®) HFA. Two inhalers produced similar mass median aerodynamic diameters, ranging from 2.3 to 2.4 μm.
The ProAir(®) HFA delivers a warmer, lower-impact, and longer-lasting plume compared with Ventolin(®) HFA, which may provide a more consistent, comfortable experience for patients using a pMDI. ProAir(®) HFA produces higher fine particle dose than Ventolin(®) HFA.
在使用压力定量气雾剂（pMDI）治疗哮喘症状时，吸入器技术和喷雾特性对于充分控制症状非常重要。喷雾力较低与哮喘药物在喉咙沉积减少直接相关，而喷雾温度较高可能会减轻与 pMDI 相关的“冷氟利昂效应”。本研究的目的是描述和比较两种 pMDI（ProAir® 氢氟烷烃（HFA）和 Ventolin® HFA）的温度、最大喷雾力和喷出物羽流的持续时间。
使用喷雾力测试仪模型 SFT1000 和热电偶测试三种单独批次（每种吸入器类型各 3 个批次，共 30 个单位）的每个吸入器 10 个单位。在距吸嘴边缘 40mm 的喷雾距离处测试 3 次连续喷雾。记录室温、湿度和 pMDI 的初始重量。记录每个 pMDI 的最终重量，以确定每个单次喷雾的重量。按照包装插页中的说明对 pMDI 进行预喷雾和操作。还使用下一代撞击器在 28.3L/min 的流量下评估空气动力学粒径分布（APSD）。
对 ProAir® HFA 和 Ventolin® HFA 各 30 个单位的每个单位的三个连续喷雾进行了测量（每个 pMDI 共测试 90 个单位），每个 pMDI 的最小羽流温度分别记录为 ProAir® HFA 的 7.2±0.7°C 和 -35.9±12.7°C，Ventolin® HFA 的 7.2±0.7°C 和 -35.9±12.7°C。ProAir® HFA 的羽流持续时间比 Ventolin® HFA 长两倍以上（385±46ms 比 156±58ms；p<0.001），平均最大喷雾力低（33.6±11.4mN 比 75.9±12.0mN；p<0.0001）。APSD 分析表明，与 Ventolin® HFA 相比，ProAir® HFA 产生的几乎两倍多的细颗粒（<5μm）剂量，具有更低的几何标准偏差。两种吸入器产生的质量中值空气动力学直径相似，范围为 2.3 至 2.4μm。
与 Ventolin® HFA 相比，ProAir® HFA 产生的羽流温度更高、冲击力更小且持续时间更长，这可能为使用 pMDI 的患者提供更一致、更舒适的体验。ProAir® HFA 产生的细颗粒剂量高于 Ventolin® HFA。
