BackgroundUnintended exposure to antitumor agents from an oral medicine may place healthcare workers and patients taking medicine at risk. In this study, the exposure to blister pack by CP (cyclophosphamide) and appropriate preventive procedures were examined.FindingsCP detected inside the blister pack of the tested seven lots by LC-MS/MS ranged from 8.2 to 199.6 ng. Raman imaging clearly showed that CP ingredient was completely covered by the tablet coating layer and had not leached out of the tablet. In addition, the amount of CP detected inside the vials was suppressed under the lower detection limit until day 28, and only 6.0 ng was detected only at day 56.ConclusionsVarious amounts of CP were contaminated to not only the inside of the blister pack but also the outside. This contamination may be caused not only by the manufacturing environment but also by the CP oral tablets themselves through volatilization of CP. Refrigerated storage of CP oral tablets may protect healthcare workers and patients from contact with CP.Electronic supplementary materialThe online version of this article (doi:10.1186/s40780-015-0020-9) contains supplementary material, which is available to authorized users.
We recently reported that various amounts of cyclophosphamide (CP) had contaminated both the inside and outside of the blister pack, and refrigerated storage of CP oral tablets can protect healthcare workers and patients from contact CP exposure. However, the contamination from a non-volatile agent, fluorouracil (FU), and its preventive procedures are not elucidated. Here we showed high levels of FU were detected from inside the blister pack. Raman imaging showed that the FU ingredient was not attached to the surface of the tablet coating layer and had not leached out of the tablet. In addition, the amount of FU detected inside the blister pack had no significant change by physical loading including shaking and heating. Thus, the FU contamination could be because of the manufacturing environment rather than the FU oral tablets themselves. We suggest that the pharmacists should instruct the patients to administer or handle tablets and capsules containing antitumor agents without direct hand contact. In addition, pharmacists should provide information about the contamination state and effective decontamination procedures for antitumor agents.
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