Safety Evaluation of EXPAREL (DepoFoam Bupivacaine) Administered by Repeated Subcutaneous Injection in Rabbits and Dogs: Species Comparison

Table 2

Accumulation ratios for EXPAREL and bupivacaine HCl solution (Day 25 versus Day 1) (mean ± SD; N = 3/sex/group).

(a) Rabbit

Treatment	Bupivacaine (mg/kg/dose)	Accumulation ratio (Day 25 versus Day 1)
		𝐴𝑈𝐶0-72hr(ng⋅hr/mL)	C max(ng/mL)	t 1/2(hr)	t max(hr)
Bupivacaine HCl	9	0.88	1.02	1.17	1.07
EXPAREL	9	0.94	2.30	0.35	0.41
	18	1.55	2.36	0.36	1.40
	30	2.14	3.09	1.42	0.29

(b) Dog

Treatment	Bupivacaine (mg/kg/dose)	Accumulation ratio (Day 25 versus Day 1)
		𝐴𝑈𝐶0-72hr(ng⋅hr/mL)	C max(ng/mL)	t 1/2(hr)	t max(hr)
Bupivacaine HCl	9	0.94	1.40	0.60	1.0
EXPAREL	9	1.90	2.46	0.61	1.0
	18	1.90	2.34	0.25	1.5
	30	1.71	1.44	1.38	0.26