Picavet Patrick, Haziza Christelle, Lama Nicola, Weitkunat Rolf, Lüdicke Frank
Department of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
Department of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland
Nicotine Tob Res. 2016 May;18(5):557-63. doi: 10.1093/ntr/ntv220. Epub 2015 Oct 5.
We aimed to compare the pharmacokinetics of nicotine between the heat-not-burn Tobacco Heating System 2.1 (THS 2.1) and combustible cigarettes (CCs). We also examined whether the subjective urge to smoke was associated with the pharmacokinetics of nicotine.
This open-label, randomized, two-period, two-sequence crossover study conducted in 28 healthy smokers assessed the pharmacokinetics of nicotine after single and ad libitum use of the THS 2.1 or CCs. During the 7-day confinement period, blood samples were drawn for pharmacokinetic analysis. Subjective effects related to THS 2.1 or CC use were assessed using the Questionnaire of Smoking Urges (QSU-Brief).
The nicotine delivery rate was similar with the THS 2.1 and CCs after single and ad libitum use. The time to the maximum nicotine concentration was 8 minutes after single use of the THS 2.1 and CCs. The time to the peak concentration following ad libitum use was similar between the THS 2.1 and CCs. The maximum plasma nicotine concentration after single use of the THS 2.1 was 8.4 ng/mL, 70.3% of that obtained with CCs. A transient reduction from baseline in the urge to smoke of 40% was observed 15 minutes after the single use of both the THS 2.1 and CCs. The mean QSU-Brief total scores following single and ad libitum use were similar for the THS 2.1 and CCs.
These results suggest that the THS 2.1 effectively delivers nicotine and achieves similar pharmacokinetic profiles to CCs. The THS 2.1 also reduced the urge to smoke similarly to CCs.
Reducing exposure to toxicants and safer delivery of nicotine are among the strategies that may reduce the harm of smoking-related diseases. In the present study, we investigated the pharmacokinetics of nicotine and their effects on the urge to smoke using the THS 2.1. It was developed to replicate the ritual of smoking as closely as possible by providing nicotine in a way that mimics CC smoking, but limits pyrolysis and combustion by heating tobacco at a much lower temperature than CCs (heat-not-burn).
我们旨在比较加热不燃烧烟草加热系统2.1（THS 2.1）和可燃香烟（CCs）中尼古丁的药代动力学。我们还研究了主观吸烟冲动是否与尼古丁的药代动力学有关。
这项开放标签、随机、两期、两序列交叉研究在28名健康吸烟者中进行，评估了单次和随意使用THS 2.1或CCs后尼古丁的药代动力学。在7天的限制期内，采集血样进行药代动力学分析。使用吸烟冲动问卷（QSU-简版）评估与使用THS 2.1或CCs相关的主观效应。
单次和随意使用后，THS 2.1和CCs的尼古丁递送率相似。单次使用THS 2.1和CCs后，达到最大尼古丁浓度的时间为8分钟。随意使用后达到峰值浓度的时间在THS 2.1和CCs之间相似。单次使用THS 2.1后，最大血浆尼古丁浓度为8.4 ng/mL，是使用CCs时的70.3%。单次使用THS 2.1和CCs后15分钟，观察到吸烟冲动较基线瞬时降低40%。THS 2.1和CCs单次和随意使用后的平均QSU-简版总分相似。
这些结果表明，THS 2.1能有效递送尼古丁，并实现与CCs相似的药代动力学特征。THS 2.1在减轻吸烟冲动方面也与CCs相似。
减少接触有毒物质和更安全地递送尼古丁是可能降低吸烟相关疾病危害的策略之一。在本研究中，我们使用THS 2.1研究了尼古丁的药代动力学及其对吸烟冲动的影响。它的开发目的是通过以模仿CC吸烟的方式提供尼古丁，尽可能紧密地复制吸烟仪式，但通过在比CCs低得多的温度下加热烟草来限制热解和燃烧（加热不燃烧）。
