Pharmacokinetics of tapentadol in laying hens and its residues in eggs after multiple oral dose administration

1. The aim of the study was to evaluate the pharmacokinetics (PKs) of tapentadol (TAP), a novel opioid analgesic, in laying hens after intravenous (IV) and oral (PO) administration and to quantify the concentrations of TAP residues in eggs.2. Twenty healthy laying hens were divided into three groups: A (n=6), B (n=6) and C (n=8). The study was conducted in two phases. Groups A and B received TAP by IV and PO routes at the dose of 1 and 5mg/kg, respectively.3. No visible adverse effects were observed after administration of the drug. TAP plasma concentrations were detectable up to 4h following administration. Following IV administration, TAP plasma concentrations were only higher than the minimal effective concentration (148ng/ml) reported for humans for 1h. After single PO administration, plasma concentrations of TAP would not conform to software algorithms and the PK parameters were not calculated. TAP concentration following multiple PO doses at 5mg/kg for 5 d was found to be higher and more persistent (12h vs. 7h) in yolk compared with albumen.4. This is the first PK study on the novel atypical opioid TAP in laying hens. Further studies are required to investigate the analgesic efficacy and actual effective plasma concentration of TAP in this species.