Comparison of caffeine disposition following administration by oral solution (energy drink) and inspired powder (AeroShot) in human subjects.
Comparison of caffeine disposition following administration by oral solution (energy drink) and inspired powder (AeroShot) in human subjects.
复制标题
人类受试者口服溶液（能量饮料）和激发粉末（AeroShot）后咖啡因处置的比较。
DOI：
10.1111/bcp.13389
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发表时间：
2017
影响因子：
3.4
通讯作者：
Parker,RobertB
中科院分区：
文献类型：
--
作者：
Laizure,SCasey;Meibohm,Bernd;Nelson,Kembral;Chen,Feng;Hu,Zhe-Yi;Parker,RobertB
目的：研究咖啡因新剂型给药后的分布和作用（AeroShot）通过吸入细粉将咖啡因吸入口腔，并将其与同等剂量的口服溶液进行比较（能量饮料）作为参考标准。在不同的研究日，使用AeroShot设备吸入100 mg咖啡因剂量或饮用能量饮料。在8小时内测量心率、血压和受试者效应评估。采用液相色谱-质谱联用法测定血浆中咖啡因及其主要代谢物的浓度。药代动力学，心血管和感知刺激的影响进行了比较AeroShot和能量饮料阶段使用pairedttest和标准bioequivalency analysis.ResultsCaffeine处置后，咖啡因管理的AeroShot设备和能量饮料：血浆峰浓度1790和1939 ng ml-1，浓度-时间曲线下面积（AUC）分别为15 579和17 569 ng ml-1× h，但它们不是生物等效的：与能量饮料相比，AeroShot AUC为80.3%（置信区间71.2-104.7%），血浆峰浓度为86.3%（置信区间62.8-102.8%）。女性受试者在饮用能量饮料后的AUC确实显著大于男性。心率和血压没有显着影响的100毫克咖啡因的剂量，并没有一贯认为刺激的影响，由受试者使用视觉模拟scales.ConclusionInspiration的咖啡因作为一种细粉使用的AeroShot设备产生类似的咖啡因的配置文件和效果相比，管理的口服溶液（能量饮料）。
AimsTo determine the disposition and effects of caffeine after administration using a new dosage form (AeroShot) that delivers caffeine by inspiration of a fine powder into the oral cavity and compare it to an equivalent dose of an oral solution (energy drink) as the reference standard.MethodsHealthy human subjects (n= 17) inspired a 100 mg caffeine dose using the AeroShot device or consumed an energy drink on separate study days. Heart rate, blood pressure and subject assessments of effects were measured over an 8‐h period. Plasma concentrations of caffeine and its major metabolites were determined by liquid chromatography–mass spectrometry. Pharmacokinetic, cardiovascular and perceived stimulant effects were compared between AeroShot and energy drink phases using a pairedttest and standard bioequivalency analysis.ResultsCaffeine disposition was similar after caffeine administration by the AeroShot device and energy drink: peak plasma concentration 1790 and 1939 ng ml–1, and area under the concentration–time curve (AUC) 15 579 and 17 569 ng ml–1× h, respectively, but they were not bioequivalent: AeroShot AUC of 80.3% (confidence interval 71.2–104.7%) and peak plasma concentration of 86.3% (confidence interval 62.8–102.8%) compared to the energy drink. Female subjects did have a significantly larger AUC compared to males after consumption of the energy drink. The heart rate and blood pressure were not significantly affected by the 100 mg caffeine dose, and there were no consistently perceived stimulant effects by the subjects using visual analogue scales.ConclusionInspiration of caffeine as a fine powder using the AeroShot device produces a similar caffeine profile and effects compared to administration of an oral solution (energy drink).