Mucosal delivery of anti-inflammatory IL-1Ra by sporulating recombinant bacteria

BMC Biotechnology

Table 2 Pharmacokinetic analysis of IL-1Ra in rabbit serum after administration of IL-1Ra-producing B. subtilis

Intra-colon instillation	IL-1Ra (mg/kg)	C_max (μg/ml)	T_max (min)	AUC (0–6 h)/dose (g × h)/ml
IL-1Ra	1.00	0.482	60	1.34
IL-1Ra + pSM241	1.00	0.372	60	1.05
pSM539	0.44	0.136	200	1.10

Groups of four rabbits received an intra-colonic instillation of highly purified human recombinant IL-1Ra (1.0 mg/kg) alone or admixed with control pSM214 bacteria (4 × 10⁸ cells/kg), or of IL-1Ra-producing pSM539 bacteria (4 × 10⁸ cells/kg). Serum samples were taken just before treatment (time zero) and after 1, 2, 4, and 6 h from intra-colonic instillation. The presence of human IL-1Ra in serum samples was determined by ELISA.

ISSN: 1472-6750