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TCH-036 Results of a Systematic Long-Term Stability Study For Ready-To-Use Injectable Drugs Produced by a Centralized Intravenous Admixture Service
  1. JD Hecq1,
  2. M Godet2,
  3. J Jamart3,
  4. L Galanti2
  1. 1CHU UCL de Mont-Godinne, Pharmacy, Yvoir, Belgium
  2. 2CHU UCL de Mont-Godinne, Medical laboratory, Yvoir, Belgium
  3. 3CHU UCL de Mont-Godinne, Scientific suppor unit, Yvoir, Belgium

Abstract

Background Injectable preparations other than parenteral nutrition admixture and injectable cytotoxic drugs could be prepared by Centralised IntraVenous Admixture Service (CIVAS) if the long-term stability of the drugs is known. However, this information is not always available.

Purpose To develop a programme of chemical drug stability analysis in collaboration between the hospital pharmacy, the medical laboratory and a Biostatistics Centre to determine the long-term stability of widely-used injectable anti-infectious and non-anti-infectious drugs.

Materials and Methods After setting up the High Performance Liquid Chromatography (HPLC) method, 25 drugs (10 anti-infectives, 4 anaesthetics, 2 propulsives, 2 detoxifying agents for antineoplastic treatment and 7 drugs with other properties) were reconstituted in a laminar air flow hood. 15 of them were stored directly at 5 ± 3°C and 16 stored in the freezer at –20°C, thawed by microwave following a standardised procedure and stored at 5 ± 3°C before use. The stability of the product was evaluated by regression analysis.

Results For each drug, long-term stability varied from 11 days to 70 days. The freeze-thaw treatment by microwave may extend the stability (from 30 to 120 days) and allow batch-scale production of intravenous drugs, less expensive in term of manpower and sterile devices than drug reconstitution on the ward. The results were published by 47 posters in international congresses and by 34 publications in national and international pharmaceutical journals.

Conclusions Our findings contribute to improving the number and variety of drugs that may be take on by a CIVAS. This collaboration led to the foundation in 2009 of a drug stability research group at the University Hospital of Mont-Godinne that has already been awarded 4 prizes and nominations.

No conflict of interest.

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