University of Rochester School of Medicine and Dentistry, Rochester, New YorkUSA.
Department of Emergency Medicine, University of Rochester, Rochester, New YorkUSA.
Prehosp Disaster Med. 2020 Jun;35(3):272-275. doi: 10.1017/S1049023X20000400. Epub 2020 Apr 13.
The opioid epidemic has led to the wide-spread distribution of naloxone to emergency personnel and to the general public. Recommended storage conditions based on prescribing information are between 15°C and 25°C (59°F and 77°F), with excursions permitted between 4°C and 40°C (39°F and 104°F). Actual storage likely varies widely with potential exposures to extreme temperatures outside of these ranges. These potentially prolonged extreme temperatures may alter the volume of naloxone dispensed from the nasal spray device, which could result in suboptimal efficacy.
The aim of this study was to assess the naloxone volume deployed following nasal spray device storage at extreme temperatures over an extended period of time.
Naloxone nasal spray devices were exposed to storage temperatures of -29°C (-20°F), 20°C (68°F), and 71°C (160°F) to simulate extreme temperatures and a control for 10 hours. First, the density was measured under each temperature condition. Following the density calculation part of the experiment, the mass of naloxone dispensed from each nasal spray device at each temperature was captured and used to calculate volume: calculated volume (microliter, µl) = spray mass (mg converted to g)/mean density (g/mL). Measurements and calculations are reported as means with standard deviation and standard error, and a one-way ANOVA was used to evaluate mean dispensed volume differences at different temperatures.
There was no difference in the mean volume deployed at -29°C (-20°F), 20°C (68°F), and 71°C (160°F), and measurements were 101.44µl (SD = 9.56; SE = 5.52), 99.01µl (SD = 6.31; SE = 3.64), and 108.28µl (SD = 2.04; SE = 1.18), respectively; P value = .289, F-statistic value = 1.535.
The results of this study suggest that naloxone nasal spray devices will dispense the appropriate volume, even when stored at extreme temperatures outside of the manufacturer's recommended range.
阿片类药物泛滥导致纳洛酮广泛分发给急救人员和公众。根据处方信息，推荐的储存条件在 15°C 到 25°C（59°F 到 77°F）之间，允许在 4°C 到 40°C（39°F 到 104°F）之间波动。实际储存情况可能因超出这些范围的极端温度暴露而有很大差异。这些潜在的长时间极端温度可能会改变纳洛酮从鼻喷雾剂装置中分配的体积，从而导致疗效不理想。
本研究旨在评估纳洛酮鼻喷雾剂装置在长时间暴露于极端温度下的储存后，从鼻喷雾剂装置中分配的纳洛酮体积。
将纳洛酮鼻喷雾剂装置暴露于-29°C（-20°F）、20°C（68°F）和 71°C（160°F）的储存温度下 10 小时，以模拟极端温度和对照条件。首先，在每个温度条件下测量密度。在实验的密度计算部分之后，从每个鼻喷雾剂装置在每个温度下分配的纳洛酮质量被捕获，并用于计算体积：计算体积（微升，µl）=喷雾质量（mg 转换为 g）/平均密度（g/mL）。测量值和计算值以平均值加标准差和标准误差表示，采用单因素方差分析评估不同温度下平均分配体积的差异。
在-29°C（-20°F）、20°C（68°F）和 71°C（160°F）下，分配的平均体积没有差异，测量值分别为 101.44µl（SD = 9.56；SE = 5.52）、99.01µl（SD = 6.31；SE = 3.64）和 108.28µl（SD = 2.04；SE = 1.18）；P 值=.289，F 统计值= 1.535。
这项研究的结果表明，即使在制造商推荐范围之外的极端温度下储存，纳洛酮鼻喷雾剂装置也会分配适当的体积。
