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PK parameters of nicotine in plasma after intake of a single dose of lozenge or gum (mean ± SD; n = 9) |
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| Formulation\PK parameter |
Nicotinell® lozenge |
Nicorette® gum |
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| 1 mg |
2 mg |
2 mg |
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| Amount of nicotine released after 30 min (mg) [% of minimal content] |
0.67 ± 0.14 [67%] |
1.39 ± 0.28 [67%] |
0.81 ± 0.25 [42%] |
| observed Cmax (ng/ml) [adjusted]†‡ |
2.3 ± 0.8 [3.5 ± 1.1]† |
4.8 ± 1.4 [7.0 ± 1.7] |
2.9 ± 1.2 |
| tmax (h) [median (range)] |
1.1 ± 0.7 [0.8 (0.8–3.0)] |
0.8 ± 0.2 [0.8 (0.6–1.1)] |
0.8 ± 0.1 [0.8 (0.5–1.0)] |
| t1/2 (h) |
2.7 ± 0.7 |
2.8 ± 0.7 |
2.5 ± 1.0 |
| AUC0-t (h·ng/ml) |
8.3 ± 2.5 |
15.8 ± 4.1 |
10.6 ± 4.4 |
| observed AUC0–∞(h·ng/ml) [adjusted]†‡ |
10.7 ± 3.1 [16.5 ± 4.6] |
20.0 ± 5.9 [30.1 ± 9.7] |
13.8 ± 5.6 |
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†: Since in this trial nicotine lozenges were not completely dissolved after 30 min of sucking, an adjustment was made for nicotine delivery by a full 1 mg dose. ‡: Adjustment for nicotine delivery by a full 2 mg dose. | |||
Dautzenberg et al. BMC Clinical Pharmacology 2007 7:11 doi:10.1186/1472-6904-7-11 |
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