About the API
Buprenorphine HCl is the hydrochloride salt form of buprenorphine, which belongs to the class of organic compounds known as morphinans. Buprenorphine is indicated for the treatment of opioid dependence, moderate to severe pain and peri-operative analgesia. It prevents symptoms of withdrawal from opiates such as heroin and is preferred for the induction phase of treatment (conducted under medical supervision). It is considered to be better tolerated without naloxone during the first days of treatment. Following induction, buprenorphine and naloxone are preferred due to the presence of naloxone which impedes intravenous abuse of the product. Buprenorphine HCl can be administered intravenously, as a sublingual tablet, sublingual film or subdermal implant.
Buprenorphine HCl was approved by the FDA in injectable form in 1981, under the trade name Buprenex. In 2002, it was approved in sublingual form under the trade name Subutex. Buprenorphine HCl is currently manufactured through large-scale semi-synthetic methods. Semisynthesis, or partial chemical synthesis, employs compounds isolated from natural sources as starting materials.