Evaluation of particle size distribution of albuterol sulfate hydrofluoroalkane administered via metered-dose inhaler with and without valved holding chambers
Evaluation of particle size distribution of albuterol sulfate hydrofluoroalkane administered via metered-dose inhaler with and without valved holding chambers
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DOI：
10.1016/s1081-1206(10)61290-2
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发表时间：
2005-01-01
影响因子：
5.9
通讯作者：
Lincourt, W
中科院分区：
文献类型：
--
作者：
Crim, C;Holmes, M;Lincourt, W
背景：通过计量吸入器 (MDI) 对 4 岁以下的儿科患者进行吸入药物治疗时，通常需要使用保存室或带有面罩的垫片。目的：确定与 2 个美国市场销售的带阀保存室 (VHC) 联合输送的硫酸沙丁胺醇氢氟烷烃中沙丁胺醇的粒径分布和总剂量，与通过不带 VHC 的 MDI 输送的剂量进行比较。方法：级联撞击方法使用高效液相色谱法评估在不使用和使用 2 种市售 VHC 的情况下施用的沙丁胺醇的细颗粒质量 (FPM)。结果：2 种 VHC 和对照的粒径分布相似。 2 个 VHC 和对照的平均 FPM 值分别为 32、28 和 30 杯。当评估与不带间隔基的沙丁胺醇氢氟烷烃的差异时，FPM 的统计比较显示出类似的情况。结论：在这些测试条件下获得的体外结果表明，测试的 VHC 的所有 FPM 值均在对照范围的 15% 之内，这一差异不太可能具有临床意义。这些结果并不保证在使用测试的 VHC 时改变沙丁胺醇氢氟烷的推荐剂量。 MDI 与 VHC 的结合使用为幼儿和其他难以单独施用 MDI 的患者提供了合理的治疗方法，用于施用沙丁胺醇氢氟烷。
Background: Administration of inhaled medications via metered-dose inhaler (MDI) to pediatric patients younger than 4 years usually requires use of a holding chamber or spacer with an attached face mask.Objective: To determine the particle size distribution and overall dose of albuterol from the albuterol sulfate hydrofluoroalkane delivered in conjunction with 2 US-marketed valved holding chambers (VHCs) compared with the dose delivered via MDIs without VHCs.Methods: Cascade impaction methods with high-performance liquid chromatography were used to evaluate the fine particle mass (FPM) of albuterol administered without and with the use of 2 commercially available VHCs. Results: Particle size distributions for the 2 VHCs and the control were similar. The mean FPM values for the 2 VHCs and the control were 32, 28, and 30 mug, respectively. Statistical comparison of the FPM shows a similar profile when differences from the albuterol hydrofluoroalkane without a spacer were evaluated.Conclusions: In vitro results obtained under these test conditions demonstrate that all the FPM values for the VHCs tested were within 15% of the control range, a difference that is unlikely to be clinically meaningful. These results do not warrant a change in the recommended dose of albuterol hydrofluoroalkane administered when using the VHCs tested. The use of an MDI in conjunction with a VHC provides a reasonable therapeutic approach for administration of albuterol hydrofluoroalkane to young children and other patients who have difficulty administering the MDI alone.