Breakage and Elution of CSTD by Oil-based Solvents in Injection Drugs

Abstract

Busulfex ® is a non-aqueous injection of insoluble Busulfan dissolved in the oil-based solvents Polyethylene Glycol 400 (PEG400) and N,N -Dimethylacetamide (DMA). The use of a closed system transfer device (CSTD) is strongly recom-mended for the preparation of all hazardous drugs, and we use a CSTD for the preparation and administration of anticancer drugs at Nara Medical University Hospital. We experienced a case of frequent blockage of the intravenous route when Busulfex ® was administered. In the present study, when the test solution containing PEG400 and DMA mixed in the same ratio as Busulfex ® was syringe aspirated by CSTD, the CSTD was broken and foreign particles were generated within 3 minutes of aspiration. When DMA was syringe aspirated by CSTD, polycarbonate, the material of CSTD, was eluted, and functional abnormality of CSTD was observed 30 minutes after aspiration. Oil-based solvents are used as additives in many anticancer drugs. The suitability of a CSTD for the preparation of anticancer drugs should be deter-mined by considering not only the hazard classification of the anticancer drug, but also the type and ratio of the additives.