空隙形成指数 (VFI) 的应用：检测干粉吸入器制剂的物理特性对粉末内聚力的影响。,International Journal of Pharmaceutics

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空隙形成指数 (VFI) 的应用：检测干粉吸入器制剂的物理特性对粉末内聚力的影响。
International Journal of Pharmaceutics ( IF 5.3 ) Pub Date : 2020-08-13 , DOI: 10.1016/j.ijpharm.2020.119766
Sunao Maruyama ₁ , Shuichi Ando ₂ , Etsuo Yonemochi ₃

Affiliation

干粉吸入器 (DPI) 是非侵入性给药的一种有吸引力的替代方案，可以使患者更方便地使用关键的生物药物制剂。生物药物制剂的吸入可以提供对肺部的靶向递送以及全身递送。通常，生物制药 DPI 制剂由易于结块的高粘性粉末组成。为了成功输送到肺部，必须检测粉末内聚力及其对制剂性能的影响。在此，研究了甘露醇的物理性质对 DPI 制剂内聚力的影响。使用通过逆气相色谱 (iGC) 在 4 小时 (VFI4h) 测量的空隙形成指数 (VFI) 检测粉末内聚力，定义为 4 小时吹扫样品与初始样品的压降比。发现 VFI4h 与 DPI 制剂的内聚性密切相关。VFI 测量所需的研究样品量少于常规测量所需的样品量。VFI 显示 DPI 制剂的内聚力与甘露醇的物理性质之间存在良好关系。因此，VFI 可以成为评估 DPI 配方内聚力的可靠标准指标。

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Application of void forming index (VFI): Detection of the effect of physical properties of dry powder inhaler formulations on powder cohesion.

Dry powder inhaler (DPI) is an attractive alternative for non-invasive drug administration and can make the use of critical biopharmaceutical formulations more convenient for patients. Inhalation of biopharmaceutical formulations can provide targeted delivery to the lungs as well as systemic delivery. Generally, biopharmaceutical DPI formulations consist of highly cohesive powders that tend to agglomerate. For successful delivery to the lungs, the detection of powder cohesiveness and its effect on the performance of the formulations is mandatory. Herein, the effects of the physical properties of mannitol on the cohesiveness of DPI formulations were investigated. The powder cohesion was detected using the void forming index (VFI) measured by inverse gas chromatography (iGC) at 4 h (VFI4h), which was defined as the pressure drop ratio of 4 h purged sample to that of the initial sample. VFI4h was found to correlate well with the cohesiveness of DPI formulations. The amount of investigated samples required for VFI measurement was less than that required for conventional measurements. VFI showed a good relationship between the cohesiveness of DPI formulations and the physical properties of mannitol. Thus, VFI can be a reliable standard index to evaluate the cohesiveness of DPI formulations.

更新日期：2020-08-12

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