Pharmacokinetic Comparison of a Novel Non-tobacco-Based Nicotine Pouch (ZYN) With Conventional,Tobacco-Based Swedish Snus and American Moist Snuff
Pharmacokinetic Comparison of a Novel Non-tobacco-Based Nicotine Pouch (ZYN) With Conventional,Tobacco-Based Swedish Snus and American Moist Snuff
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DOI：
10.1093/ntr/ntaa068
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发表时间：
2020-10-01
影响因子：
4.7
通讯作者：
Pendrill, Robert
中科院分区：
文献类型：
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作者：
Lunell, Erik;Fagerstrom, Karl;Pendrill, Robert
介绍：将一种新型非烟草尼古丁袋ZYN， 3和6 mg与8 mg普通鼻烟（第1部分）和18 mg长角湿润鼻烟（第2部分）的单剂量药代动力学（PK）进行比较。本研究展示了一种新型无烟草口服鼻烟ZYN的三个优点，即从口腔中提取尼古丁并将其吸收到全身血液循环中。与瑞典通用鼻烟和美国长角湿润鼻烟进行比较，并从文献中得出4毫克尼古丁口香糖和13个品牌电子烟的平均值。目的与方法：采用单剂量随机交叉设计。测定体内提取和PK参数。结果：第一部分。zyn3mg的AUC（inf）比8mg的AUC（inf）小27%，zyn6mg的AUC（inf）比8mg的AUC（inf）大34%。从zyn3mg （1.5 mg）中提取的尼古丁较少，而从zyn6mg （3.5 mg）中提取的尼古丁多于从8mg General （2.4 mg）中提取的尼古丁。两种ZYN产品的尼古丁提取率（56%和59%）均显著高于8 mg General产品的尼古丁提取率（32%）。结果：第二部分。ZYN 8 mg和Longhorn Natural 18 mg湿鼻烟的AUC（inf）和C-max曲线基本一致。ZYN 8 mg烟碱的提取量（3.8 mg）大于Longhorn Natural 18 mg烟碱的提取量（3.0 mg），但小于General 2 × 8 mg烟碱的提取量（5.0 mg）。ZYN 8 mg鼻烟的尼古丁提取率（50%）高于Longhorn Natural（19%）和General 2 × 8 mg鼻烟（33%）。结论：两种较高剂量的ZYN （6 mg和8 mg）与现有无烟产品释放尼古丁的速度和程度相似，没有明显的不良反应。
Introduction: The single-dose pharmacokinetics (PK) of a novel, non-tobacco-based nicotine pouch, ZYN, 3 and 6 mg, were compared with 8 mg General snus (part 1) and ZYN 8 mg was compared with 18 mg Longhorn moist snuff (part 2). The present study demonstrates the characteristics of three strengths of a novel tobacco-free oral snus, ZYN, viz. the extraction of nicotine from the oral cavity and its uptake into the systemic blood circulation. Comparison is made to Swedish General snus and American Longhorn moist snuff and from literature 4 mg Nicorette gum and mean of 13 brands of e-cigarettes.Aims and Methods: A single-dose randomized crossover design was used. In vivo extraction and PK parameters were determined.Results: Part 1. The AUC(inf) of ZYN 3 mg was 27% smaller than that of 8 mg General and the AUC(inf) of ZYN 6 mg was 34% larger than that of 8 mg General. Less nicotine was extracted from ZYN 3 mg (1.5 mg) and more from ZYN 6 mg (3.5 mg) than from 8 mg General (2.4 mg).The extracted fractions of nicotine for both ZYN products (56% and 59%) were significantly larger than for 8 mg General (32%).Results: Part 2. Close to identical plasma nicotine curves, AUC(inf) and C-max were found for ZYN 8 mg and Longhorn Natural 18 mg moist snuff. The extracted amount of nicotine from ZYN 8 mg (3.8 mg) was larger than the amount extracted from Longhorn Natural 18 mg (3.0 mg), but smaller than the extracted amount of nicotine from General 2 x 8 mg snus pouches (5.0 mg).The extracted fraction of nicotine for ZYN 8 mg (50%) was larger than for Longhorn Natural (19%) and General 2 x 8 mg snus pouches (33%).Conclusions: The two higher doses of ZYN (6 and 8 mg) deliver nicotine as quickly and to a similar extent as existing smokeless products, with no significant adverse effects.