title: Comparison of the Pharmacokinetics of Nicotine Following Single and Ad Libitum Use of a Tobacco Heating System or Combustible Cigarettes.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Department of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Picavet
authors.affiliation: Department of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
authors.forename: Christelle
authors.initials: C
authors.lastname: Haziza
authors.affiliation: Department of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
authors.forename: Nicola
authors.initials: N
authors.lastname: Lama
authors.affiliation: Department of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
authors.forename: Rolf
authors.initials: R
authors.lastname: Weitkunat
authors.affiliation: Department of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland frank.luedicke@pmi.com.
authors.forename: Frank
authors.initials: F
authors.lastname: Lüdicke
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000097:blood / Q000493:pharmacokinetics; D012907:Smoking / Q000097:blood / Q000503:physiopathology / Q000523:psychology; D062789:Tobacco Products; D055815:Young Adult
chemical_list: D009538:Nicotine