Han Yahui – Vice President, Scrianen
Han Yahui from Chinese folic acid specialist Scrianen outlines her company’s role in keeping mothers and newborns healthy in China, Scrianen’s approach to international partnerships, and the next horizons in…
Address: Av. San Juan 2266 (C1232AAR),Argentina
Tel: +54 11 5921 6388
Web: http://www.amarintech.com/
Amarin technology is all about innovation. Formed in 1986, this Argentine research team is now a duly organised company present within the research and development sector as well as in pharmaceuticals. Its main objective is to be a reliable partner for foreign companies in the transdermal development and licensing fields. With projects as diverse as testosterone replacement therapy to transdermal fentanyl it is a truly diverse company controlling each step from R&D, registration to commercialization activities.
AMARIN has developed a Transdermal Delivery System (TDS) for Fentanyl, a narcotic analgesic agent, formulated as a drug-in-adhesive monolithic-type device.
AMARIN´s Fentanyl TDS is a transparent thin device designed to release fentanyl continuously upon application to skin. This device has demonstrated an excellent chemical and physical stability and comprises three structures:
A transparent and flexible film (backing).
A two-layer adhesive formulation containing fentanyl and excipients (including permeation enhancer).
A polyester release liner that is attached to the adhesive surface and must be removed before its application.
AMARIN´s Fentanyl TDS is indicated for the management of chronic and severe pain in patients who require continuous opioid analgesia.
Eight preclinical studies and two pharmacokinetic pilot studies in humans have been carried out during the formula optimization of Amarin’s Fentanyl TDS. Finally, two regulatory bioequivalence studies (n=34-35) were conducted in Germany with the final formulation. Amarin’s Fentanyl TDS proved to be bioequivalent to Durogesic® SMAT both under single-dose and multiple-dose regimens.
Dose linearity has also been demonstrated for Amarin’s Fentanyl TDS.
A patent application has been filed at the Argentinean and UK Patent Offices in 2002, and an International Patent Application was filed in 2003. The European Patent was granted in 2007 and was also applied in USA, Mexico and India.
The product is being commercialized by Sandoz in Argentina (Talnur®) since 2006. Four strengths of Amarin’s Fentanyl TDS are currently being sold by different companies in Europe and Asia. Amarin’s Fentanyl TDS is under registration in other countries of South America, Europe, Asia and South Africa.
Han Yahui from Chinese folic acid specialist Scrianen outlines her company’s role in keeping mothers and newborns healthy in China, Scrianen’s approach to international partnerships, and the next horizons in…
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