Table II.

TDS Dimensions and Nicotine Transport and Partition Parameters (ANOVA Least Squares Mean ± SE, n = 4 Skin Donors, 3–4 Replicates Per Donor) Calculated from the Optimization Analyses of 0–24-h 32°C and 42°C In Vitro Permeation Data in Franz Diffusion Cells (Protocols 1 and 2)

Product	Nicotine content mg/cm2	Thickness (cm)			C0 (mg/mL)			KSCpb	Dscc × 1010 (cm2/s)		EAd (kJ/mol)
		Total	Backing	Reservoira	Modelb	Expe	Sigma minusb		32°C	42°C
TDS-N1 (two-layer TDS)	5.86	0.027	0.006	0.015	384 ± 7	391 ± 7	381 ± 10	3.73 ± 0.17	20f	44g	65 ± 6
TDS-N2 (homogeneous TDS)	1.72	0.030	0.006	0.021	108 ± 7	83 ± 2	115 ± 10	1.14 ± 0.04	8.1 ± 0.5	16.0 ± 0.6	58 ± 5

^aDrug reservoir thickness (h_res) calculated from: total thickness – thickness of backing membrane – thickness of membrane inside TDS

^bProducts significantly different, p < 0.001

^cProducts significantly different, p < 0.05

^dExperimentally determined activation energy value for aqueous nicotine: 65.9 kJ/mol

^eExperimentally determined nicotine concentration in TDS (mean ± SEM), calculated as: (Nicotine content) / h_res

^fValue is the modified optimization value, and thus, SEM is not applicable; other values used in this model were: D_adh = 4 × 10⁻⁸ cm² /s; D_p (32°C) = 2.27 × 10⁻¹⁰ cm² /s; D_p (42°C) = 6.1 × 10⁻¹⁰ cm² /s; c_adh = 10 mol/m³

^gValue calculated from the modified optimization value at 32°C using E_A; SEM is not applicable