Development of a closed drug preparation method for oral anticancer drugs.

The objective of this article is to reduce the preparation time for oral anticancer drugs, reduce the exposure to drug preparations, and develop drug preparation equipment without external drug leaks in a closed state. In the newly developed closed oral drug preparation device, a 10 mL disposable syringe that was replaced with one projection for crushing tablets and a no-processing 30 mL disposable syringe were connected to a three-way stopcock. Using this instrument, Endoxan(®) tablets (principal components: cyclophosphamide) were crushed and suspended in water in a closed state. The drug was prepared to suspension and flowed out via a feeding tube by switching the handle of the three-way stopcock. To assess human exposure to cyclophosphamide, a high-performance volatile organic compound-solvent desorption passive sampler was attached to the preparer's mouth to collect air drifting in the vicinity, and cyclophosphamide levels were subsequently measured by liquid chromatography with tandem mass spectrometry. Using the developed drug preparation equipment, Endoxan(®) tablets were suspended in a closed state. According to liquid chromatography with tandem mass spectrometry analysis, the exposure of the preparer to cyclophosphamide was greatly reduced when using the developed device; cyclophosphamide was detected in only two of the five samples, though only at trace levels. The closed oral drug preparation device may permit the preparation and administration of toxic drugs to patients while greatly reducing the risk of occupational exposure among health-care workers and caregivers.