改善IVIVC - Copley Scientific

改善IVIVC

Making a relatively small investment in systems that enhance the clinical realism of standard pharmacopoeial in-vitro test set-ups for the delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement may help bridge the gap between data collected during QC testing and in vivo performance helping to accelerate and improve R&D.

吸入药物溶出度

对于经口吸入和鼻腔给药的制剂，一旦药物沉积到目标部位，药物吸收或肺部吸收以及药物治疗效果就取决于溶解于少量水性液体的活性物质以及可用的肺部表面活性剂。

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面罩测试

许多储雾罐/单向阀储雾罐VHC和雾化器配合面罩来吸入气雾剂，而不再使用吸入咬嘴。对于婴儿和幼儿以及无法使用咬嘴的使用者，使用面罩是常见做法。

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形态学

Whilst cascade impaction provides a useful indication of where inhaled drug particles are likely to deposit within the respiratory tract, it does not profile the morphological properties of these particles.

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冷媒效应

冷媒效应意指通常在启动MDI或经鼻送药装置后，抛射剂冷气对咽喉刺激后的无意反应。

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用于DDU和APSD的IVIVC测试系统

Two factors have been identified as being critical to improving the clinical relevance of DDU testing and APSD measurement: realistic breathing profiles and realistic throat and nasal models.

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