Effect of Extreme Temperature on Naloxone Nasal Spray Dispensing Device Performance.

INTRODUCTION: 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. STUDY OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Effect of Fluctuating Extreme Temperatures on Tranexamic Acid.

INTRODUCTION: Tranexamic acid (TXA) is an antifibrinolytic agent shown to reduce morbidity and mortality in hemorrhagic shock. It has potential use in prehospital and wilderness medicine; however, in these environments, TXA is likely to be exposed to fluctuating and extreme temperatures. If TXA degrades under these conditions, this may reduce antifibrinolytic effects. PROBLEM: This study sought to determine if repetitive temperature derangement causes degradation of TXA. METHODS: Experimental samples underwent either seven days of freeze/thaw or heating cycles and then were analyzed via mass spectrometry for degradation of TXA. An internal standard was used for comparison between experimental samples and controls. These samples were compared to room temperature controls to determine if fluctuating extreme temperatures cause degradation of TXA. RESULTS: The coefficient of variability of ratios of TXA to internal standard within each group (room temperature, freeze, and heated) was less than five percent. An independent t-test was performed on freeze/thaw versus control samples (t = 2.77; P = .17) and heated versus control samples (t = 2.77; P = .722) demonstrating no difference between the groups. CONCLUSION: These results suggest that TXA remains stable despite repeated exposure to extreme temperatures and does not significantly degrade. These findings support the stability of TXA and its use in extreme environments.