No abstract

The dynamic in vitro method developed by the authors and other available in vitro methods were used to determine the degree of hemolysis induced by several cosolvent vehicles that have previously been evaluated in vivo. The in vitro data generated for each of these vehicles was compared with the in vivo hemolysis data to assess the ability of the method to estimate in vivo hemolysis. The results show that the in vitro data generated by the dynamic method are in agreement with the in vivo data for each vehicle. Therefore, the potential for formulations to induce intravascular hemolysis after injection can be determined by this dynamic in vitro method. With this information, hemolytically safe formulations can more easily be prepared.