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PK parameters of nicotine in plasma at steady state after 12 hourly doses† of 1 mg lozenge or 2 mg gum (mean ± SD; n = 24) |
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| Formulation\PK parameter |
Nicotinell® lozenge |
Nicorette® gum |
90% CI (lozenge/gum)# |
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| 1 mg |
2 mg‡ |
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| Cmax (ng/ml) |
10.6 ± 2.9 |
11.4 ± 3.8 |
0.86–1.04 |
| Cmin (ng/ml) |
8.1 ± 2.4 |
9.3 ± 3.4 |
ND |
| tmax (h) [range] |
0.54 ± 0.21 [0.00–0.77] |
0.47 ± 0.19 [0.20–0.95] |
ND |
| t1/2 (h) |
3.6 ± 1.2 |
3.2 ± 0.9 |
ND |
| AUC11–12 (h·ng/ml) |
9.2 ± 2.6 |
10.2 ± 3.4 |
0.84–1.01 |
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Initial nicotine concentrations in plasma were 1.1 ng/ml (range: 0.0–6.5) with lozenge and 0.9 ng/ml (0.0–5.1) with gum, reflecting volunteers' heavy smoking habits (≥ 20 cigarettes per day). Correction for initial nicotine concentrations did not modify the results and thus was not retained. ND: not determined. †: PK parameters were determined from blood samples drawn after dose 12 (t = 11 h) until t = 23 h. ‡: a dose adjustment of the raw data was done for a last standard dose of 1 mg nicotine delivery from the gum. #: Standard 90% CI for the expected mean ratio was derived from ANOVA for continuous parameters and compared to standard BAR [0.80–1.25]. | |||
Dautzenberg et al. BMC Clinical Pharmacology 2007 7:11 doi:10.1186/1472-6904-7-11 |
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