Single-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 speed and extent of nicotine uptake from the 6 mg gum versus that from 2 mg and 4 mg Nicorette gum and 4 mg NiQuitin Mint lozenge, a randomized crossover study was conducted in 44 healthy adult smokers.
The amount of nicotine released from the 2, 4 and 6 mg gums increased with strength (1.44, 3.36 and 4.94 mg) upon 30 minutes of standardized chewing. The resulting Cmax and AUCinf increased almost proportionally with dose (5.9, 10.1 and 13.8 ng/mL, and 17.1, 30.7, 46.2 ng/mLxh, respectively). The Cmax and AUCinf of the 6 mg gum were 44% and 30% greater, respectively, than those for 4 mg lozenge. The AUC with 6 mg gum during the first 10 minutes was estimated to be 32%, 40% and 91% greater than those with 4 mg lozenge, 4 mg gum and 2 mg gum, respectively.
In summary, nicotine delivery via the 6 mg gum results in higher plasma nicotine concentrations at early as well as later time points after dose than with currently available oral NRT.
| 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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