Smutney Chad C, Friedman Emil M, Polidoro John M, Amin Nikhil
MannKind Corporation, Danbury, Connecticut 06810, USA.
J Diabetes Sci Technol. 2009 Sep 1;3(5):1175-82. doi: 10.1177/193229680900300524.
The Technosphere Insulin (TI) inhalation system comprises TI powder premetered into unit dose cartridges and the patient-friendly, reusable, breath-powered MedTone inhaler. This high-resistance system uses a patient's inspiratory effort to effect TI powder de-agglomeration and promote subsequent deep-lung delivery. This study reports on flow and pressure data achieved by patients with diabetes using the MedTone system.
MedTone inhalers containing empty cartridges were adapted with pneumotach measuring devices to capture inhalation profiles. The measuring apparatuses had negligible impact on the nominal MedTone system resistance level of 0.117 kPa(0.5)/liters/min. Each of 56 subjects inhaled twice to mimic TI clinical study dosing instructions. Achieved inhalation profiles were characterized by peak inspiratory flow (PIF), peak inspiratory pressure (PIP), and average pressure drop from the time of PIP to 4 s (P(avg)).
The achieved mean PIF (+/- standard deviation [SD]) in all subjects was 26.74 (+/-6.06) liters/min after the first inhalation and was similar to the mean PIF of 26.25 (+/-6.23) liters/min achieved after the second inhalation. Mean PIP (+/-SD) achieved by subjects was 8.49 (+/-2.86) and 8.1 (+/-2.99) kPa, and mean P(avg) drop (+/-SD) in all subjects was 6.53 (+/-2.24) and 6.09 (+/-2.08) kPa after the respective inhalations.
Patients with diabetes demonstrated consistent inhalation efforts over two inhalations using the MedTone system. The achieved PIFs and PIPs demonstrate the capacity of this population to obtain sufficient inspiratory effort necessary for delivery of TI using the MedTone inhaler. Adequate postpeak pressures were also revealed, further supporting reliable and sustained inhalation efforts.
技术型胰岛素（TI）吸入系统由预先定量装入单位剂量药筒的TI粉末和患者友好型、可重复使用的、依靠呼吸驱动的MedTone吸入器组成。这种高阻力系统利用患者的吸气力量实现TI粉末的解聚，并促进随后的肺部深部给药。本研究报告了糖尿病患者使用MedTone系统获得的流量和压力数据。
将装有空药筒的MedTone吸入器与气动测量装置适配，以获取吸入曲线。测量设备对MedTone系统标称阻力水平0.117 kPa(0.5)/升/分钟的影响可忽略不计。56名受试者每人吸入两次，以模拟TI临床研究的给药说明。获得的吸入曲线以吸气峰流速（PIF）、吸气峰压（PIP）以及从PIP时刻到4秒的平均压力降（P(avg)）为特征。
所有受试者第一次吸入后获得的平均PIF（±标准差[SD]）为26.74（±6.06）升/分钟，与第二次吸入后获得的平均PIF 26.25（±6.23）升/分钟相似。受试者获得的平均PIP（±SD）分别为8.49（±2.86）和8.1（±2.99）kPa，所有受试者在相应吸入后获得的平均P(avg)降（±SD）分别为6.53（±2.24）和6.09（±2.08）kPa。
糖尿病患者使用MedTone系统进行两次吸入时表现出一致的吸气努力。获得的PIF和PIP表明该人群有能力产生足够的吸气力量，以使用MedTone吸入器递送TI。还显示出足够的峰后压力，进一步支持了可靠且持续的吸气努力。
