Table 3.

Plasma pharmacokinetic parameters of paclitaxel after oral treatment of the SMEOF#3 formulation (with 1.5% w/w and 3.0% w/w paclitaxel) at different doses of 10, 30, or 60 mg/kg or after i.v. administration of paclitaxel in a Polysorbate80: ethanol solution in P-gp knockout and/or wild-type mice co-administered with or without Cyclosporin A (10 mg/kg). Data are mean ± Standard error (SE), oral and i.v. administration (n = 5)

Paclitaxel formulation	Paclitaxel	Cyclosporin A	AUC0-Tlast (ng/mL*h)	F (%)
P-gp knockout mice
SMEOF#3, (1.5%)	10 mg/kg, p.o.	–	1841 ± 166	29.9 ± 3.1
SMEOF#3, (1.5%)	30 mg/kg, p.o.	–	7110 ± 382	38.6 ± 2.8
SMEOF#3, (1.5%)	60 mg/kg, p.o.	–	11220 ± 1131	30.4 ± 3.4
Polysorbate 80:EtOH	10 mg/kg, i.v.	–	6147 ± 291	n/a
Wild-type mice
SMEOF#3, (1.5%)	10 mg/kg, p.o.	10 mg/kg, p.o.	2090 ± 174	15.2 ± 1.5
SMEOF#3, (1.5%)	30 mg/kg, p.o.	10 mg/kg, p.o.	3835 ± 430	9.3 ± 1.1
SMEOF#3, (1.5%)	60 mg/kg, p.o.	10 mg/kg, p.o.	5916 ± 765	7.2 ± 1.0
Polysorbate 80 EtOH	10 mg/kg, i.v.	10 mg/kg, p.o.	13754 ± 670	n/a
P-gp knockout mice
SMEOF#3, (3.0%)	10 mg/kg, p.o.		1710 ± 131	27.8 ± 2.5
SMEOF#3, (3.0%)	30 mg/kg, p.o.		3871 ± 621	21.0 ± 3.5
SMEOF#3, (3.0%)	60 mg/kg, p.o.		1764 ± 168	4.8 ± 0.5

AUC_0-Tlast Area under the concentration time curve from 0 to the last time point with a concentration above the LLQ (Tlast), F oral bioavailability, n/a not applicable