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Effect of freezing, long-term storage, and microwave thawing on the stability of ketorolac tromethamine.

Onglets principaux

Hecq, Jean-Daniel Boitquin, Laurence P Vanbeckbergen, Danielle F Jamart, Jacques [UCL] Galanti, Laurence [UCL]

BACKGROUND: Ketorolac tromethamine is a nonsteroidal agent with potent analgesic and moderate antiinflammatory activity. Advance preparation of intravenous solution could be useful to improve quality assurance, time management, and cost-savings of drug delivery. OBJECTIVE: To investigate the effect of freezing, long-term storage, and microwave thawing on the stability of ketorolac tromethamine in dextrose 5% infusion. METHODS: Five polyolefin bags of solution containing ketorolac tromethamine 20 mg per 100 mL of dextrose 5% were frozen for 3 months at -20 degrees C, thawed in a microwave oven with a validated cycle, and stored at 4 degrees C. The concentration of ketorolac was measured by HPLC. Visual inspection and pH measurement were also carried out. RESULTS: No color change or precipitation was observed. Ketorolac was stable for at least 60 days under refrigeration after freeze-thaw. Throughout this period, the lower confidence limit of the estimated regression line of the concentration-time profile remained >90% of the initial concentration, and the pH value decreased slightly without affecting chromatographic parameters. CONCLUSIONS: Within these limits, ketorolac tromethamine in dextrose 5% infusion may be prepared and frozen in advance by a centralized intravenous admixture service, then thawed before use in clinical units.

Type de document Article de périodique (Journal article) – Journal Article
Année de publication 2005
Information sur le périodique "The Annals of pharmacotherapy" - Vol. 39, no. 10, p. 1654-8 (2005)
Peer reviewed oui
issn 1060-0280
Statut de la publication Publié
Affiliations UCL - MD/MIGE - Département de microbiologie, d'immunologie et de génétique
MESH Subject Anti-Inflammatory Agents, Non-Steroidal - chemistry - radiation effects - standards ; Chromatography, High Pressure Liquid ; Drug Stability ; Drug Storage ; Freezing ; Ketorolac Tromethamine - chemistry - radiation effects - standards ; Microwaves ; Solutions ; Time Factors
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Référence bibliographique Hecq, Jean-Daniel ; Boitquin, Laurence P ; Vanbeckbergen, Danielle F ; Jamart, Jacques ; Galanti, Laurence. Effect of freezing, long-term storage, and microwave thawing on the stability of ketorolac tromethamine.. In: The Annals of pharmacotherapy, Vol. 39, no. 10, p. 1654-8 (2005)
Permalien http://hdl.handle.net/2078.1/26887