This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Bouma, M. Articles by Beijnen, J. H Search for Related Content PubMed Articles by Bouma, M. Articles by Beijnen, J. H Social Bookmarking                   What's this?

Stability and compatibility of the investigational antimetastatic ruthenium complex NAMI-A in infusion systems and its hemolytic potential

Slotervaart Hospital/The Netherlands Cancer Institute, Department of Pharmacy and Pharmacology, 1066 EC Amsterdam, The Netherlands

Bastiaan Nuijen, PhD

Slotervaart Hospital/The Netherlands Cancer Institute, Department of Pharmacy and Pharmacology, 1066 EC Amsterdam, The Netherlands

Eric E Challa, PhD

Slotervaart Hospital/The Netherlands Cancer Institute, Department of Pharmacy and Pharmacology, 1066 EC Amsterdam, The Netherlands

Gianni Sava, PhD

Fondazione Callerio, 34127 Trieste, Italy

Antonella Flaibani, PhD

SIGEA Srl, 34012 Trieste, Italy

Auke Bult, Prof

Faculty of Pharmaceutical Sciences, Utrecht University, 3584 CA Utrecht, The Netherlands

Jos H Beijnen, Prof

Slotervaart Hospital/The Netherlands Cancer Institute, Department of Pharmacy and Pharmacology, 1066 EC Amsterdam, The Netherlands, Faculty of Pharmaceutical Sciences, Utrecht University, 3584 CA Utrecht, The Netherlands

NAMI-A (imidazolium trans-imidazole dimethylsulfoxide tetrachlororuthenate (III)) is a novel antimetastatic ruthenium complex currently undergoing Phase I clinical trials. It is pharmaceutically formulated as a lyophilized product to be reconstituted and diluted before infusion. The aim of this study was to determine the reconstitution and dilution fluid of choice, and to investigate the stability and compatibility of NAMI-A in solution under different storage conditions and with several container materials. Furthermore, the hemolytic potential and buffer capacity of NAMI-A infusion solution were investigated in vitro. Normal saline or Water for Injections (WfI) can be used for reconstitution of NAMI-A, and the reconstituted solution should be diluted with normal saline to infusion concentration immediately after dissolution if stored at room temperature (1 20 - 258C), but can be stored for up to 48 hours at refrigerated conditions (1 2 - 88C). Infusion solutions can be stored for a maximum of four hours at room temperature or 24 hours at refrigerated conditions before administration to the patient. The infusion solutions can be prepared in either glass or PVC containers, although for practical reasons PVC containers are recommended. The infusion solutions are compatible with a PVC infusion system consisting of a PVC container, PVC infusion line, and needle. Furthermore, NAMI-A infusion solutions have a low buffer capacity and do not cause hemolysis in vitro. Therefore, no pain or hemolysis upon infusion of NAMI-A in the clinical setting is expected.

Key Words: compatibility • hemolysis • infusion devices • NAMI-A • stability

Journal of Oncology Pharmacy Practice, Vol. 10, No. 1, 7-15 (2004)
DOI: 10.1191/1078155204jp118oa


CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?