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Stability of sufentanil citrate with levobupivacaine HCl in NaCl 0.9% infusion after microwave freeze-thaw treatment.

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

BACKGROUND: Sufentanil is a powerful central anesthetic and analgesic of the opiate family that can be used with levobupivacaine for epidural administration. Advance preparation of intravenous solution could be useful to improve quality, time management, and cost-savings of drug delivery. OBJECTIVE: To investigate how freezing, long-term storage, and microwave thawing can affect the stability of sufentanil citrate and levobupivacaine HCl in NaCl 0.9% (saline) (w/v) polyvinyl chloride (PVC) bags. METHODS: The stability of 5 bags of solution containing sufentanil 500 microg and levobupivacaine 625 mg per 500 mL of saline solution in PVC bags was studied after freezing for 4 months at -30 degrees C, thawing in a microwave oven with a validated cycle, and storage at 4 degrees C. The concentrations of the drugs were measured by HPLC using a reversed-phase column, a mobile phase consisting of 18% acetonitrile (v/v) in tertabutyl ammonium hydrogen sulfate buffer 0.03 M pH 3.00 +/- 0.05, and UV detection at 235 nm for sufentanil and 260 nm for levobupivacaine. Visual inspection and pH measurement were also performed. RESULTS: No color change or precipitation was observed. Sufentanil and levobupivacaine were stable for at least 70 days at 4 degrees C after freezing and thawing. Throughout this period, the 95% lower confidence limit of the concentration-time profile remained >90% of the initial concentration. During this period, the pH value remained stable. CONCLUSIONS: Within the limits defined here, a mixture of sufentanil citrate and levobupivacaine HCl may be prepared in advance and kept frozen.

Document type Article de périodique (Journal article) – Journal Article
Publication date 2004
Journal information "The Annals of pharmacotherapy" - Vol. 38, no. 11, p. 1836-9 (2004)
Peer reviewed yes
issn 1060-0280
Publication status Publié
Affiliation UCL - MD/MIGE - Département de microbiologie, d'immunologie et de génétique
MESH Subject Analgesics, Opioid ; Bupivacaine - analogs & derivatives ; Chromatography, High Pressure Liquid ; Drug Combinations ; Drug Stability ; Drug Storage ; Freezing ; Injections, Epidural ; Microwaves ; Sodium Chloride ; Sufentanil ; Technology, Pharmaceutical
Links
  1. Monk Jon P., Beresford Rosemary, Ward Alan, Sufentanil : A Review of its Pharmacological Properties and Therapeutic Use, 10.2165/00003495-198836030-00003
  2. McClellan Karen J., Spencer Caroline M., Levobupivacaine : , 10.2165/00003495-199856030-00005
  3. Galanti L. M., Hecq J.-D., Vanbeckbergen D., Jamart J., Long-term stability of cefuroxime and cefazolin sodium in intravenous infusions, 10.1111/j.1365-2710.1996.tb00020.x
  4. Galanti L. M., Hecq J.-D., Vanbeckbergen D., Jamart J., Long-term stability of vancomycin hydrochloride in intravenous infusions, 10.1111/j.1365-2710.1997.tb00018.x
  5. Galanti LM, Int J Pharmaceut Compound, 5, 397 (2001)
  6. Vigneron J, J Pharm Belg, 47, 504 (1992)
  7. Holmes CJ, Am J Hosp Pharm, 39, 104 (1982)
  8. Holmes C. J., Ausman R. K., Walter C. W., Kundsin R. B., Activity of Antibiotic Admixtures Subjected to Different Freeze-Thaw Treatments, 10.1177/106002808001400505
  9. Schlesser V, Int J Pharmaceut Compound, 6, 391 (2002)
  10. Brouwers JRBJ, Eur Hosp Pharm, 1, 12 (1995)
  11. Farhang-Asnefi S, J Pharm Clin, 19, 248 (2000)
  12. Roos P. J., Glerum J. H., Meilink J. W., Zwang L., Effect of pH on absorption of sufentanil citrate in a portable pump reservoir during storage and administration under simulated epidural conditions, 10.1007/bf02113943
  13. Roos P. J., Glerum J. H., Schroeders M. J. H., Effect of glucose 5% solution and bupivacaine hydrochloride on absorption of sufentanil citrate in a portable pump reservoir during storage and simulated infusion by an epidural catheter, 10.1007/bf01871129
  14. Guideline for submitting documentation for the stability of human drugs and biologics (1987)
  15. Ruberg Stephen J., Stegeman James W., Pooling Data for Stability Studies: Testing the Equality of Batch Degradation Slopes, 10.2307/2532658
Bibliographic reference Boitquin, Laurence P ; Hecq, Jean-Daniel ; Vanbeckbergen, Danielle F ; Jamart, Jacques ; Galanti, Laurence. Stability of sufentanil citrate with levobupivacaine HCl in NaCl 0.9% infusion after microwave freeze-thaw treatment.. In: The Annals of pharmacotherapy, Vol. 38, no. 11, p. 1836-9 (2004)
Permanent URL http://hdl.handle.net/2078.1/26890