Studies on the stability and compatibility of cytotoxic drug Infusions with the Tevadaptor device

Abstract

Introduction: The role of closed-system drug transfer devices (CSDTD) in the preparation of cytotoxic infusions has attracted considerable interest in recent years. The use of such devices can subject drug infusions to contact with the materials used to construct the CSDTD, with potential implications for compatibility and stability of the drug. This study investigated the stability and compatibility of 11 frequently used cytotoxic drug infusions with the Tevadaptor device. Methods: Test infusions of 11 cytotoxic drugs at clinically-relevant concentrations were prepared in either prefilled syringes (5) or infusion bags (6) and were stored under controlled conditions. The syringes and bags were divided into two groups; one group fitted with the Tevadaptor device (test), and a second group with no device fitted (controls). At predetermined times each infusion was sampled and subjected to testing for chemical and physical stability against defined acceptance criteria. Results: In each case there was no difference between test and control groups in chemical or physical test data. The addition of the CSDTD did not influence the infusion stability. Conclusion: The 11 cytotoxic drug infusions tested were compatible with the Tevadaptor device and infusion stability was not affected.