Vitalea Science Completes Dermal Distribution Microdose Study
News Jun 11, 2007
Vitalea Science has announced the completion of a microdosing study assessing important ADME (Absorption, Distribution, Metabolism and Excretion) properties of a nutrient compound essential to prostate health and prevention of cellular oxidative damage.
The study was conducted at a global CRO's clinical research unit in Honolulu, HI. Vitalea advanced the boundaries of Accelerator Mass Spectrometry (AMS) applications by measuring the test compound in exhaled air taken from patients' breath and by determining distribution of the compound in skin. This study establishes improved capabilities to better determine ADME of new drugs, nutrients and chemical products.
The ability to assess distribution in target tissues and excretion of a test compound in exhaled air represents both the superb sensitivity of AMS analysis and its power to obtain key information for drug selection, formulation and dosing determinations.
AMS is a critical technology for microdosing studies, where extremely small-hence safe-doses of drugs, nutrients and other chemical compounds are administered to patients to evaluate pharmacokinetic parameters in humans.
The chemical microdoses are tagged with a carbon-14 label, which can be traced and quantitated by Accelerator Mass Spectrometry analysis. AMS is the most sensitive detection technology available, with attomolar sensitivity. This sensitivity enables testing of new drugs and other chemicals in humans at levels endorsed by the FDA as safe.
"Using only a microcurie dose of 14C-labeled test material, we are able to describe the pharmacokinetics of the nutrient in humans, particularly its distribution in target tissues. This study validates measurements of excreted compounds in breath and distribution in skin tissue as available and critical information to determine formulation and dosing," said Dr. Le Vuong, study principle investigator and Chief Operating Officer of Vitalea Science.
"We are particularly pleased with this joint project to demonstrate an exquisite application of particle physics for solving biological problems. We anticipate more and more studies such as this to be requested by our sponsors,” said Vuong.
The first 14C microdosing study based on AMS technology in the United States was completed by Radiant Research (now Covance) and Vitalea in 2005. This study evaluated the drug azidothymidine (AZT) at sub-therapeutic nanodose concentrations (520 nanograms).
This microdose was approximately one million-fold lower than the recommended daily dose in patients and was impossible to detect by traditional analytical methods. With AMS technology, Vitalea scientists quantified AZT concentrations in blood, urine, saliva, white blood cells more than 72 hours after administering the drug.