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Published Online, 13 September 2005, www.theannals.com, DOI 10.1345/aph.1G194.
 The Annals of Pharmacotherapy: Vol. 39, No. 10, pp. 1654-1658. DOI 10.1345/aph.1G194
© 2005 Harvey Whitney Books Company.
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PAIN MANAGEMENT

Effect of Freezing, Long-Term Storage, and Microwave Thawing on the Stability of Ketorolac Tromethamine

Jean-Daniel Hecq, PharmD1, Laurence P Boitquin, PharmD2, Danielle F Vanbeckbergen3, Jacques Jamart, MD4, and Laurence M Galanti, MD PhD5

1 Pharmacist, Hospital Pharmacy, University Hospital of Mont-Godinne, Yvoir, Belgium
2 Pharmacist, Medical Laboratory, University Hospital of Mont-Godinne
3 Medical Laboratory, Hospital Pharmacy, University Hospital of Mont-Godinne
4 Center of Biostatistics and Medical Documentation, University Hospital of Mont-Godinne
5 Medical Laboratory, University Hospital of Mont-Godinne

Reprints: Dr. Galanti, Cliniques Universitaires UCL Mont-Godinne, Medical Laboratory, Avenue Therasse, 1, B-5530 Yvoir, Belgium, fax 32 81423204, galanti{at}mexp.ucl.ac.be

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 °C, thawed in a microwave oven with a validated cycle, and stored at 4 °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.

Key Words: drug stability, freezing, HPLC, infusion, ketorolac, microwave thawing

Published Online, September 13, 2005. www.theannals.com, DOI 10.1345/aph.1G194


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