Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance

Abstract

Intravenous (IV) administration of many sterile drug products requires admixture preparation using a diluent, brief storage in an IV container, and dosing through an infusion device. To ensure patient safety and drug effi cacy, regulatory agencies require that the sterile drug product is compatible with the diluents and the infusion devices. Therefore, admixture compatibility and stability studies are key components of the pharmaceutical development process. On the surface these studies may seem straightforward, but in practice they require detailed planning, meticulous execution, and appropriate data analysis. The purpose of this chapter is to discuss various requirements and challenges associated with conducting IV admixture studies and the related regulatory guidance.