A randomised controlled single-centre open-label pharmacokinetic study to examine various approaches of nicotine delivery using electronic cigarettes

• Published in: Scientific reports 2020-11, Vol.10 (1), p.19980-10, Article 19980
• Main Authors: Ebajemito, James K., McEwan, Michael, Gale, Nathan, Camacho, Oscar M., Hardie, George, Proctor, Christopher J.
• Format: Article
• Language: English
• Subjects: 639/638/92/436; 639/638/92/436/1729; 639/638/92/436/2388; Adult; Aerosols; Benzoic acid; Bioavailability; Biological Availability; Cigarettes; Cross-Over Studies; Electronic cigarettes; Electronic Nicotine Delivery Systems - statistics & numerical data; Female; Healthy Volunteers; Humanities and Social Sciences; Humans; Male; Middle Aged; multidisciplinary; Nicotine; Nicotine - blood; Nicotine - pharmacokinetics; Pharmacokinetics; Science; Science (multidisciplinary); Smokers; Smoking - blood; Tobacco; Tobacco Products
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-020-76610-4

Smokers who switch completely to e-cigarettes may reduce their relative risk of tobacco-related disease. Effective nicotine delivery from e-cigarettes is important in consumer acceptance. We assessed whether protonated nicotine and e-cigarette devices delivering greater aerosol mass increase nicotine delivery and product liking. A randomised controlled non-blinded eight-arm crossover study was used to assess plasma nicotine pharmacokinetics and product liking for two e-cigarettes (Vype ePen3 and Vype ePen) with various nicotine e-liquid formulations and a conventional cigarette among 24 healthy dual-users of cigarettes and e-cigarettes. Product use and puff count were also assessed. Results show that nicotine bioavailability was greater for Vype ePen3 with greater aerosol mass delivery than for Vype ePen (C max , p  = 0.0073; AUC 0–120 min , p  = 0.0102). Protonated nicotine (18 mg/mL, medium protonation) e-liquid yielded higher nicotine bioavailability than unprotonated nicotine (18 mg/mL) e-liquid (C max , p  = 0.0001; AUC 0–120 min , p  = 0.0026). There was no significant difference in T max between e-liquids. Nicotine bioavailability did not differ between nicotine benzoate formulation (30 mg/mL nicotine, high protonation) and combustible cigarettes (C max , p  = 0.79; AUC 0–120 min , p  = 0.13). Vype ePen3 with protonated nicotine delivers nicotine more efficiently with the potential to increase product liking relative to earlier devices using unprotonated e-liquid.