LYSIS OF HUMAN RED-BLOOD-CELLS .4. COMPARISON OF IN-VITRO AND IN-VIVOHEMOLYSIS DATA

The dynamic in vitro method developed by the authors and other availab le in vitro methods were used to determine the degree of hemolysis ind uced by several cosolvent vehicles that have previously been evaluated in vivo. The in vitro data generated for each of these vehicles was c ompared with the in vivo hemolysis data to assess the ability of the m ethod to estimate in vivo hemolysis. The results show that the in vitr o data generated by the dynamic method are in agreement with the in vi vo data for each vehicle. Therefore, the potential for formulations to induce intravascular hemolysis after injection can be determined by t his dynamic in vitro method. With this information, hemolytically safe formulations can more easily be prepared.