Effect of freezing, long-term storage, and microwave thawing on the stability of ketorolac tromethamine.
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.
Hecq
Jean-Daniel
JD
Hospital Pharmacy, University Hospital of Mont-Godinne, Yvoir, Belgium.
Boitquin
Laurence P
LP
Vanbeckbergen
Danielle F
DF
Jamart
Jacques
J
Galanti
Laurence M
LM
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry* / Q000528:radiation effects / Q000592:standards; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D005615:Freezing; D020911:Ketorolac Tromethamine / Q000737:chemistry* / Q000528:radiation effects / Q000592:standards; D008872:Microwaves; D012996:Solutions; D013997:Time Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D012996:Solutions; D020911:Ketorolac Tromethamine