Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell®)

Table 2 PK parameters of nicotine in plasma after intake of a single dose of lozenge or gum (mean ± SD; n = 9)

Formulation\PK parameter	Nicotinell^® lozenge		Nicorette^® gum
	1 mg	2 mg	2 mg
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 C _max (ng/ml) [adjusted]^†‡	2.3 ± 0.8 [3.5 ± 1.1]^†	4.8 ± 1.4 [7.0 ± 1.7]	2.9 ± 1.2
t _max (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)]
t _1/2 (h)	2.7 ± 0.7	2.8 ± 0.7	2.5 ± 1.0
AUC _0-t (h·ng/ml)	8.3 ± 2.5	15.8 ± 4.1	10.6 ± 4.4
observed AUC _0–∞ (h·ng/ml) [adjusted]^†‡	10.7 ± 3.1 [16.5 ± 4.6]	20.0 ± 5.9 [30.1 ± 9.7]	13.8 ± 5.6

†: 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.