American Clinical Solutions Releases a New Testing Service for BuTrans

Boca Raton, FL, June 30, 2013 --(PR.com)-- American Clinical Solutions is going to launch a new testing service for BuTrans (buprenorphine) in urine samples soon. Buprenorphine is a semi-synthetic opioid used for relieving moderate to severe pain. Buprenorphine exerts its analgesic effect as a partial agonist for opioid µ receptor and is about 30-60 times more potent than morphine. Several buprenorphine formulations are available for different clinical uses. Among them, the buprenorphine transdermal patch (BuTrans) has proven to be highly efficacious for relieving chronic pain. In a Butrans patch, buprenorphine is impregnated to a polymer matrix and released at a constant rate to achieve pain relief. Compared to other formulations, the BuTrans patch offers several distinct advantages. First, by delivering buprenorphine at a constant rate, the BuTrans patch is able to keep a fairly steady blood buprenorphine level and avoid spikes and troughs commonly experienced with other delivery routes. It usually takes up to 3 days for the patch to reach its targeted blood concentrations, although analgesic effects might already become evident at the first 24 hours. Likewise, when the patch is removed, it will take an equal amount of time for blood buprenorphine concentration to decline. Such pharmacokinetic properties are particularly suitable for treating chronic, around-the-clock pain. Second, one Butrans patch is designed to supply buprenorphine enough for a 7-day course of treatment, which reduces dosing frequency and promotes compliance among the users. Third, delivery of buprenorphine through the skin avoids first-pass metabolism which occurs with other routes of delivery, allowing for application of a lower dose of buprenorphine for pain relief and reduces chances for drug abuse and severe side effects.

While hailed as a great advance in pain management, the BuTrans patch has also proven to be a challenge for monitoring compliance. For one thing, extremely low concentrations of buprenorphine applied in a patch means that the overall amounts of buprenorphine excreted into urine would be much lower, not to mention only one third of the buprenorphine dose is eliminated through the urinary route and the other two thirds by feces. Because buprenorphine delivered by the skin patch bypasses first-pass metabolism, the formation of norbuprenorphine, the major breakdown metabolite of buprenorphine, is largely decreased. This is in marked contrast to what happens with other delivery routes, like sublingual delivery for example. Buprenorphine undergoes extensive metabolism when delivered sublingually, and norbuprenorphine in urine is generally at the level of several folds higher than buprenorphine. The BuTrans testing service is aimed specifically at detecting low levels of buprenorphine and norbuprenorphine in urinary samples. The cutoff values for buprenorphine and norbuprenorphine are lowered to 1 and 8 ng/ml, respectively, a measure to reflect the nature of the extremely low doses used in the BuTrans patch.

Cheng Fang, MD., PH D., DABT | cheng.fang@americanclinicalsolutions.com
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