CORESTA Congress, Berlin, 2016, Smoke Science/Product Technology Groups, ST 23

Pharmacokinetics of nicotine following single controlled use of a new type of tobacco: heated tobacco product

(1) JT International SA, Ballymena, Co. Antrim, U.K.; (2) Japan Tobacco Inc., Yokohama, Kanagawa, Japan; (3) Neil Sherwood Consulting, Commugny, Switzerland; (4) Celerion, Lincoln, NE, U.S.A.

Nicotine is one of the most characteristic compounds contained in any type of tobacco product including cigarettes. Previous studies have reported that different types of tobacco products display differences in nicotine pharmacokinetics. NHTP is a new type of heated tobacco product and there are currently no published studies examining the nicotine pharmacokinetics of this product. The objective of this clinical study was to investigate the pharmacokinetics of nicotine following use of NHTP as compared to a combustible cigarette (CC1, 1 mg tar). This open-label, randomised, two-period, two-sequence crossover study was conducted in healthy adult smokers in the U.K., and assessed the pharmacokinetics of nicotine after a single controlled use of NHTP or a CC1. During the 4-day study confinement period, blood samples were drawn from subjects for measurement of plasma nicotine concentrations and nicotine intake was estimated from mouth level exposure (MLE). The resulting Cmax and AUClast values showed 5 to 7 times lower nicotine uptake with NHTP use as compared to CC1 use. Estimated MLE following use of NHTP was half that obtained following the use of CC1 and the tmax value was longer for NHTP as compared to CC1. The results from this study showed differences in the nicotine pharmacokinetic profiles between NHTP and CC1. Such differences might be explained by differences in product use behaviour, as demonstrated by the differences observed in MLE between NHTP and CC1. Furthermore, it may be postulated that the differences in nicotine pharmacokinetic profiles observed in the present study may be due to differences in the nicotine absorption site and/or the rate of nicotine absorption from NHTP or CC1.