Pharmacokinetics of Human Recombinant Interferon-γI after iv Infusion and im Injection in African Green Monkeys

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Abstract
The pharmacokinetics of recombinant human interferon-αI (rHuIFN-αI) were studied following a single 3 ×106 U/kg dose administered as a 30-min intravenous (iv) infusion and as an intramuscular (im) injection to four African green monkeys using a crossover design. Concentrations of rHuIFN-αI in serum were determined by bioassay. Serum rHuIFN-αI concentrations declined rapidly following an iv infusion. The elimination half-life ranged from 1.7 to 2.0 h. The volume of distribution at steady state and the total body clearance ranged from 0.42 to 2.4 L/kg and 28 to 233 ml/min, respectively. A protracted absorption profile was seen following im injection, with a highly variable bioavailability ranging from 16 to 680%, compared with the iv infusion. The overall disposition of rHuIFN-αI is comparable to that of rHuIFN-αA and other IFNs in monkeys.