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首页> 外文期刊>Journal of aerosol medicine and pulmonary drug delivery >Spiromax, a New Dry Powder Inhaler: Dose Consistency under Simulated Real-World Conditions
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Spiromax, a New Dry Powder Inhaler: Dose Consistency under Simulated Real-World Conditions

机译：Spiromax，一种新型干粉吸入器：在模拟的实际条件下的剂量一致性

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Background: Spiromax((R)) is a novel dry powder inhaler for patients with asthma or chronic obstructive pulmonary disease (COPD). The studies presented here provide further data on attributes (in vitro dosing consistency with budesonide-formoterol (DuoResp) Spiromax; flow rates through empty versions of the Spiromax and Turbuhaler inhaler) of importance to patients with asthma or COPD. Methods: Dose-delivery studies were performed using low-, middle-, and high-strength DuoResp Spiromax. Dose consistency was assessed over inhaler life. Total emitted doses (TEDs) were measured at various flow rates, after exposure to high and low temperature or humidity, at different inhaler orientations, and after dropping the inhaler. The criterion for evaluating dose uniformity was whether mean TEDs were within the product specification limits. In separate studies, flow rates were measured after training, using the patient information leaflets, and again after enhanced training as part of a randomized, open-label, cross-over study. Results: Mean values for both budesonide and formoterol were within 85%-115% of the label claim for each strength of DuoResp Spiromax for initial dose uniformity and for the other investigated conditions (temperature, humidity, orientation, dropping, knocking), with the exception of approximately an 80% increase in first dose after dropping the inhaler (subsequent doses not affected). In the flow rate patient study, two patients' inhalations with Spiromax and six with Turbuhaler were <30L/min. The majority of asthma patients [91% (Spiromax) versus 82% (Turbuhaler)] achieved the preferred flow rate of >60L/min. Conclusions: DuoResp Spiromax consistently meets dose uniformity criteria, under controlled laboratory conditions and with variations intended to mimic real-world use. Following enhanced training, all patients in the flow study were able to achieve the minimal inspiratory flow rate of >30L/min, which is required for effective treatment.
机译：背景：Spiromax（R）是一种用于哮喘或慢性阻塞性肺疾病（COPD）患者的新型干粉吸入器。此处提供的研究提供了对哮喘或COPD患者重要的属性（与布地奈德-福莫特罗（DuoResp）Spiromax的体外剂量一致性;通过空版本的Spiromax和Turbuhaler吸入器的流速）的进一步数据。方法：使用低，中，高强度的DuoResp Spiromax进行剂量传递研究。在吸入器寿命期间评估剂量一致性。在暴露于高温和低温或湿气之后，在不同的吸入器方向上以及滴下吸入器后，以各种流速测量总发射剂量（TEDs）。评估剂量均匀性的标准是平均TEDs是否在产品规格范围内。在单独的研究中，在训练后，使用患者信息单页，以及在加强训练后，作为随机，开放标签，交叉研究的一部分，再次测量流速。结果：布地奈德和福莫特罗的均值在初始剂量均匀性和其他研究条件（温度，湿度，方向，滴落，爆震）下，对于DuoResp Spiromax的每种强度，均在标签要求的85％-115％之内。滴下吸入器后首次剂量增加约80％（后续剂量不受影响）的情况除外。在流量患者研究中，两名患者使用Spiromax吸入，六名使用Turbuhaler吸入<30L / min。大多数哮喘患者[91％（Spiromax）对82％（Turbuhaler）]的首选流速> 60L / min。结论：DuoResp Spiromax始终符合剂量均匀性标准，在受控实验室条件下进行变化，旨在模仿现实世界中的使用情况。经过加强培训后，血流研究中的所有患者均能够达到> 30 L / min的最小吸气流速，这是有效治疗所必需的。

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