The long-term chemical stability of injectable drugs reconstituted in Hospital Pharmacy

Hecq, Jean-Daniel;Godet, Marie;Jamart, Jacques;Bihin, Benoît;Galanti, Laurence
(2015) Journal de Pharmacie de Belgique — Vol. 97, n° 3, p. 36-44 (2015)

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Authors
  • Hecq, Jean-DanielUCLouvain
    Author
  • Godet, MarieUCLouvain
    Author
  • Jamart, JacquesUCLouvain
    Author
  • Bihin, BenoîtUCLouvain
    Author
  • Galanti, LaurenceUCLouvain
    Author
Abstract
BACKGROUND: Other injectable preparations 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 program of chemical drug stability analysis in collaboration between Hospital Pharmacy, Medical Laboratory and Scientific Support Unit to determine the long-term stability of largely used injectable anti-infectious and non-anti-infectious drugs. MATERIAL AND METHODS: After a setup of the High Performance Liquid Chromatography (HPLCI method, 28 drugs were reconstituted in laminar air flow hood, 17 of them stored directly at 5 +/- 3 degrees C and 19 stored in the freezer at -20 degrees C, thawed by microwave following a standardised procedure and stored at 5 +/- 3 degrees C before use. Concentration stability was evaluated by regression analysis. RESULTS: For each drug, long-term stability has varied from 11 days to 180 days. The freeze-thaw treatment by microwave may enhance the stability (from 30 to 120 days) and allow batch-scale production of intravenous drugs, less expensive in term of manpower and sterile device than a drug reconstitution at the ward. The results were published by 55 posters in international congress and by 36 publications in national and international pharmaceutical journals. CONCLUSIONS: Our findings contribute to enhance the scale of drugs that may be take on by a CIVAS.
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Hecq, J.-D., Godet, M., Jamart, J., Bihin, B., & Galanti, L. (2015). The long-term chemical stability of injectable drugs reconstituted in Hospital Pharmacy. Journal de Pharmacie de Belgique, 97(3), 36-44. https://hdl.handle.net/2078.5/188350 (Original work published 2015)