Multiple-dose pharmacokinetics of nicotine with a novel 6 mg nicotine gum
| Author(s)
Anna Hansson and Thomas Rasmussen
| | Presenter(s) |
Anna Hansson Associate Director Pharmacokinetics, McNeil AB, Lund, Sweden | Abstract Under-dosing is a well-recognized problem with current NRT. Therefore, a new 6 mg nicotine gum has been developed. To compare the extent of nicotine uptake from the 6 mg gum versus that from 4 mg NiQuitin Mint lozenge and 4 mg Nicorette gum, a randomized, crossover, multiple-dose study over 11 hours was conducted in 45 healthy adult smokers. Treatments comprised: 6 mg gum given every hour and 90 minutes, respectively, 4 mg gum given every hour, and 4 mg lozenge given every hour.
Upon hourly administration, the maximum and average plasma nicotine concentrations at steady state (Cmax,ss and Cav,ss) with 6 mg gum were significantly higher (42.8 and 37.4 ng/mL, respectively) than those for 4 mg lozenge (31.0 and 28.3 ng/mL, respectively) and 4 mg gum (30.8 and 27.1 ng/mL, respectively). When given every 90 minutes the Cmax,ss and Cav,ss of 6 mg gum were similar (30.8 and 24.6 ng/mL, respectively) to those for 4 mg lozenge and gum given every hour.
In summary, nicotine delivered via 6 mg gum results in steady-state plasma levels higher than those for 4 mg gum or lozenge, when dosed at the same frequency.
| Presenter biography Anna Hansson
Current position: Associate Director Pharmacokinetics at Global Clinical Research, McNeil AB Lund/Helsingborg, Sweden.
Education: M.Sc. in Pharmacy from Uppsala University, Uppsala, Sweden.
Expertise: Pharmacokinetic and pharmacodynamics studies. Have published 6 papers within the smoking cessation area.
| Source of funding: This study was funded by McNeil AB, Sweden.
| Declaration of interest: Both authors are employees of McNeil AB, Sweden.
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