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首页> 外文期刊>Chronic respiratory disease. >Dose uniformity of budesonide Easyhaler? under simulated real-life conditions and with low inspiration flow rates
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Dose uniformity of budesonide Easyhaler? under simulated real-life conditions and with low inspiration flow rates

机译：布地奈德Easyhaler的剂量均匀性？在模拟现实条件下且吸气流速低

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Budesonide Easyhaler? multidose dry powder inhaler is approved for the treatment of asthma. Objectives were to determine the delivered dose (DD) uniformity of budesonide Easyhaler? in simulated real-world conditions and with different inspiration flow rates (IFRs). Three dose delivery studies were performed using 100, 200, and 400 μg/dose strengths of budesonide. Dose uniformity was assessed during in-use periods of 4–6 months after exposure to high temperature (30°C) and humidity (60% relative humidity) and after dropping and vibration testing. The influence of various IFRs (31, 43, and 54 L/min) on the DD was also investigated. Acceptable dose uniformity was declared when mean DD were within 80–120% of expected dose; all data reported descriptively. DD was constant (range: 93–109% of expected dose) at all in-use periods and after exposure to high temperature and humidity for a duration of up to 6 months. DD post-dropping and -vibration were unaffected (range 98–105% of expected dose). Similarly, DD was constant and within 10% of expected dose across all IFRs. Results indicate that budesonide Easyhaler? delivers consistently accurate doses in various real-life conditions. Budesonide Easyhaler? can be expected to consistently deliver a uniform dose and improve asthma control regardless of high temperature and humidity or varying IFR.
机译：布地奈德Easyhaler？多剂量干粉吸入器被批准用于治疗哮喘。目的是确定布地奈德Easyhaler的给药剂量（DD）均匀性？在模拟的现实条件下，并且具有不同的吸气流速（IFR）。使用布地奈德的100、200和400μg/剂量强度进行了三个剂量输送研究。在暴露于高温（30°C）和湿度（60％相对湿度）以及跌落和振动测试之后的4-6个月的使用期间，评估剂量的均匀性。还研究了各种IFR（31、43和54 L / min）对DD的影响。当平均DD在预期剂量的80-120％之内时，宣布剂量可接受。所有数据均以描述性方式报告。在所有使用期间以及暴露于高温高湿下长达6个月之后，DD均保持恒定（范围：预期剂量的93–109％）。滴下后DD和振动不受影响（预期剂量的98–105％）。同样，DD是恒定的，并且在所有IFR中均处于预期剂量的10％以内。结果表明布地奈德Easyhaler？在各种现实生活条件下都能提供始终如一的精确剂量。布地奈德Easyhaler？不论高温高湿或IFR变化如何，都有望持续提供均匀的剂量并改善哮喘控制。

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