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

Table 5 PK parameters of nicotine in plasma at steady state after 12 hourly doses^† of 2 mg lozenge or 4 mg gum (mean ± SD; n = 31)

Formulation\PK parameter	Nicotinell^® lozenge	Nicorette^® gum	90% CI (lozenge/gum)^‡
	2 mg	4 mg
C _max (ng/ml)	22.5 ± 7.0	30.5 ± 12.8	0.69–0.89 (F = 0.78)
t _max (h) Median [range]	0.5 [0.25–1.02]	0.5 [0.25–1.00]	NS (Friedman ANOVA)
AUC _11–12 (h·ng/ml)	20.2 ± 6.8	27.5 ± 11.4	0.68–0.88 (F = 0.77)

NS: not significant.
†: PK parameters were determined from blood samples drawn after dose 12 (t = 11 h) until t = 23 h.
‡: Standard 90% CI for the expected mean ratio (test/reference = lozenge/gum) was derived from ANOVA for continuous parameters and compared to standard BAR [0.80–1.25] and enlarged BAR [0.7–1.43]. F: relative bioavailability ratio.