Enterion is a proprietary electromechanical device used by Pharmaceutical Profiles to deliver a drug under test to specific regions of the GI tract.
By loading a formulation in an Enterion capsule, which incorporates a radiotracer port, progress through the GI tract can be tracked in real time using images taken with a gamma camera. The capsule is triggered when it reaches its target, releasing the dose form. Blood and urine samples taken at regular intervals provide pharmacokinetic data, with results providing absorption profiles for each region of the GI tract.
Studies with ivMicrotracer typically involve both oral and intravenous administration of the test drug at 1/100th of the pharmacological dose, or up to 100micrograms, to 8-10 healthy volunteers.
These microdoses contain trace amounts of 14C-radiolabelled drug, usually <100nanoCi. Serial blood samples are taken at regular intervals over 1-2days and accelerator mass spectrometry (AMS) utilised to accurately measure the 14C-drug levels in these blood samples.
Pharmaceutical Profiles provides additional time savings as a result of its ability to rapidly manufacture and evaluate new intravenous and oral formulations through onsite GMP facilities which are situated alongside the company's GCP clinical unit
