Background and Importance Elastomeric pumps (EP) are self-sufficient delivery systems for the continuous intravenous administration of drugs and are mainly used in outpatient settings (e.g. oncology, infectiology).

The product-contacting materials of EP consist of various polymers and additives. In contrast to sterile plastic syringes, data on leachables for EP are only available in individual cases.¹

Aim and Objectives In order to assess the suitability of the EP for the storage of drug solutions, a transfer of substances from the pump material into the drug solution was investigated.

Furthermore, the weight loss of the pump contents due to the water vapour permeability of the plastic layers was determined, which can lead to an increased concentration of active substances.

Material and Methods Seven different EP devices were examined: 5 to 10 pumps of each device were filled with isotonic sodium chloride solution. At day 1, 7, 28, 90 and 180 the pump contents were quantified to determine the water vapour permeability as well as according to Ph. Eur. 3.3.8 in terms of absorption, acidic or alkaline reacting and reducing substances.

By means of HPLC-MS leachables were identified from a database of 200 substances and recorded semi-quantitatively.²

Results Six of seven EP showed weight loss <8% after 180 days (upper limit: 9.0%). One device showed weight loss ≤7.0% at 90 days and ≥11.4% at 180 days.

All seven EP devices met the requirements according to the monograph Ph. Eur. 3.3.8 regarding absorption, acidic or alkaline reacting and reducing substances.

The transfer of up to five antioxidants and plasticisers into the contained isotonic sodium chloride solutions was detected by HPLC-MS for all seven EP devices from day 1.

Conclusion and Relevance Regarding water vapour permeability and the adapted requirements from Ph. Eur. 3.3.8 six EP devices are suitable for 180 days and one for 90 days for the storage of drug solutions.

The effects of the identified leachables on the human organism are the subject of current investigations and cannot be assessed conclusively at present.³

References and/or Acknowledgements 1. Trittler R, Hauk A, Hug MJ. Krankenhauspharmazie. 2016;37:479–84.

2. Bello W, Pezzatti J, Berger-Gryllakia M, Rudaz S, Sadeghipour S. J. Pharm. Biomed. Anal. 236(2023):115640.

3. https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table/[cited: 04.09.2023].

Conflict of Interest No conflict of interest.