In vitro hemolysis: guidance for the pharmaceutical scientist

Abstract

Pharmaceutical excipients are commonly incorporated into parenteral formulations to increase solubility and stability of active pharmaceutical ingredients. The biocompatibility of these excipients is an important consideration during formulation development. Despite the importance of hemolytic potential of parenteral formulations, there is considerable contradictory information in the literature related to the hemolytic potential of various excipients. The hemolytic potential of various formulation vehicles in dog, rabbit, and human blood by means of an in vitro hemolysis assay is compared. The selected formulation vehicles are found in currently marketed drug products. The guidance presented here considers formulations with a hemolysis value of <10% to be nonhemolytic while values > 25% to be at risk for hemolysis.