Evaluation of a controlled-released membrane infusion device for delivery of gentamicin.

A new controlled-release membrane infusion device has been developed which consists of a drug and a fluid chamber separated by a 0.2-microns proprietary membrane. Drug transfer is based on electrodiffusion across the membrane. The objective of this study was to determine the feasibility of using this device to achieve adequate serum concentrations of gentamicin in adult healthy volunteers. Ten subjects (age 20-40 years) received a single dose of gentamicin, 1.7 mg/kg through the device. Multiple blood samples were collected and gentamicin was measured by EMIT. Peak serum concentrations of gentamicin ranged from 4.8 to 10.5 micrograms/ml. The mean total clearance, apparent distribution volume and elimination half-life were 0.96 ml/min/kg, 0.16 l/kg and 1.9 h, respectively. No adverse events occurred. These data suggest that a simple membrane device can be used for gentamicin delivery using gravity flow. The device should be evaluated in patients to define its role in therapy.