抄録
Recomodulin® Inj. 12800 is an injectable form of thrombomodulin alfa, the extracellular domain of human thrombomodulin that includes the active site. It is produced as a soluble molecule in CHO cells by recombinant techniques. Thrombomodulin alfa is a novel therapeutic for disseminated intravascular coagulation (DIC) with a mechanism of action completely unlike those of existing drugs. It is conveniently administered by intravenous infusion for 30 min once daily via a peripheral vein.
However, since adsorption on to lines and filters of infusion sets and other medical equipment is a problem with protein formulations such as insulin and G-CSF, we performed adsorption testing on 12 commonly used commercial infusion sets with the aim of assessing the adsorption of thrombomodulin alfa in such sets. The lines of the infusion sets were made of 2 different materials, polyvinyl chloride and polybutadiene, and filters of 3 different materials, polyethersulfone, polysulfone and nylon 66.
The recovery rates of thrombomodulin alfa from the infusion sets were 92-107%. Such very low levels of adsorption indicate that thrombomodulin alfa can be administered without concern over adsorption-related decreases in the amount of drug delivered.
