Medical devices, stents, implants
Drug-eluting stents (DES) in current clinical use were approved by the FDA after clinical trials showed they were statistically superior to bare-metal stents. To test the drug release characteristics, flow-through cell dissolution tests as described in United States Pharmacopeia USP <711>, Apparatus 4 and European Pharmacopoeia 2.9.3 have proven to be a robust method for the determination of elution of the active drug substance. A profile over 24 hours can mirror the 30 day in vivo porcine profile, providing a in vitro release method that captures the entire release profile of the stent. Flow-through dissolution using special cell designs is also suitable for other medical devices such as drug-eluting beads, implants, and coated ocular lenses.
Quality control tests
SOTAX flow-through dissolution systems are routinely used to test the drug release of medical devices.