Lipodox® (generic doxorubicin hydrochloride liposome injection): in vivo efficacy and bioequivalence versus Caelyx® (doxorubicin hydrochloride liposome injection) in human mammary carcinoma (MX-1) xenograft and syngeneic fibrosarcoma (WEHI 164) mouse models

Table 4 Summary statistics based on pharmacokinetic data from DXR concentrations in plasma of fibrosarcoma-bearing mice^a

Parameter	Ln AUC_0-t (μg·hr./ml)^b	Ln AUC_0-∞ (μg·hr./ml)^b	Ln C_max (μg/mL)^b	T_max (hr)	T_1/2 (hr)	K_el (hr⁻¹)
SPIL DXR HCl liposome injection (batch no. LD-72)
Geometric mean	3002.27	3355.09	120.91	0.13	22.72	0.03
CV%	11.3	13.7	8.2	102.7	21.7	20.1
Reference DXR HCl liposome injection (lot no. 070382820)
Geometric mean	3166.07	3444.65	125.64	0.17	27.40	0.03
CV%	11.3	10.9	7.8	84.8	22.7	20.4
Least-squares means ratio (reference as B:SPIL as A)
A/B ratio	94.83	97.40	96.24
90% confidence interval	87.64–102.60	89.31–106.23	91.12–101.65
Analysis of variance
Form	0.2593	0.6071	0.2411
Power	0.9977	0.9935	1.0000
Interanimal CV%	11.27	12.42	7.81

Abbreviations: AUC area under the curve, C _max peak serum concentration, CV% coefficient of variation, DXR doxorubicin, HCl hydrochloride, K _el elimination rate constant, SPIL Sun Pharmaceutical Industries Ltd., T _1/2 elimination of half-life, T _max time taken to reach the maximum concentration
^aThe pharmacokinetic profiles of SPIL and reference DXR HCl liposome injections were evaluated following single intravenous injection in syngeneic fibrosarcoma (WEHI 164)-bearing BALB/c mice. Blood samples were collected at 0.08, 0.50, 3.00, 5.00, 8.00, 24.00, 48.00, 96.00, 168.00 and 240.00 h post injection. Twelve animals were used for a single time point per group. Plasma concentration data were used in the calculation of pharmacokinetic parameters by noncompartmental intravenous-bolus input model (WinNonlin 5.0).
^bGeometric least-squares mean values are represented.

ISSN: 1471-2407