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3PC-011 Study of the container−content interaction between Etopophos polyvinyl chloride (PVC) perfusion systems
  1. T Brégaint,
  2. V Archer,
  3. M Paul,
  4. L Tortolano
  1. Hôpitaux Universitaire Henri Mondor, Créteil, France


Background and importance Etopophos is an anticancer drug inhibiting type II topoisomerase, prodrug of etoposide. It is widely used in solid and haematological cancers in paediatric and adult populations. It is administered by the slow intravenous route, in 30−60-min injections, causing a risk of interaction with the polyvinylchloride (PVC) perfusion system.

Aim and objectives To study the interaction between Etopophos and the PVC perfusion system in real-life conditions at three concentrations corresponding at the extreme dosages (38 mg and 580 mg) and the mean one (150 mg).

Material and methods Bags of three concentrations of Etopophos were prepared in sterile conditions. In real-life conditions, Etopophos was injected into the perfusion system over 60 min. Etopophos was then analysed by UV Raman spectrometry via the Qcrx system, and compared to a standard to research plasticiser traces. The intact perfusion system was analysed by Fourier transform infrared spectrometry (FTIR), then dissolved into tetrahydrofuran (THF) at 35°C, precipitated by glacial methanol and analysed by high-performance liquid chromatography (HPLC) coupled to a UV spectrometry detector. Etoposide is known for its poor solubility, its short stability and its capacity to interact with plastic components, due to the presence of Polysorbate 80 as excipient into the formulation. The PVC perfusion system, intact of any chemotherapy administration, was analysed, as a blank sample, corresponding to a NaCl 0.9% bag.

Results HPLC analysis showed that the MS10 tubing (Fresenius Kabi) was plasticised by triethylhexyl trimellitate (TOTM), while the four route link (CAIR LGL) and the Connect-Z link (CAIR LGL) were plasticised by DINCH and TOTM. No trace of plasticiser was found after the 1-hour administration of chemotherapies. No trace of chemotherapy was found in the samples of the perfusion system used for the injection of either Etopophos or etoposide.

Conclusion and relevance No interaction between the PVC perfusion system and the chemotherapies Etopophos and etoposide was found in real-life conditions. However, further analysis, using a larger number of samples, other dosages of chemotherapies or in static conditions, to exacerbate the contact between the drug and the system may be necessary to confirm these results.

Conflict of interest No conflict of interest

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