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Sterility and Stability of Diluted Carprofen in a Multidose Vial in the Laboratory Animal Setting

Gregory D Simonek1, Gwendolyne G Alarcio2, Laurie L Brignolo3

  • 1School of Veterinary Medicine, University of California, Davis, California;,

Journal of the American Association for Laboratory Animal Science : JAALAS
|May 25, 2017
PubMed

Insights

Compounded multidose vials (cMDV) containing carprofen remained sterile and stable for 28 days at 5 and 24°C. Pragmatic techniques like using new needles can ensure the safety of cMDV in laboratory animal settings.

Area of Science:

  • Veterinary Medicine
  • Laboratory Animal Science
  • Pharmacology

Background:

  • Compounded multidose vials (cMDV) are frequently used in laboratory animal settings for medication dilution.
  • Bacterial contamination of multidose vials is a known issue in human and veterinary medicine.

Purpose of the Study:

  • To evaluate the sterility and stability of carprofen in cMDV stored at different temperatures.
  • To assess the risk of bacterial contamination and endotoxin presence in cMDV used for rodent dosing.

Main Methods:

  • 14 cMDV of carprofen (1:10 dilution in sterile water) were prepared and stored at 5°C and 24°C.
  • Vials were punctured twice daily for 28 days; sterility was assessed via bacterial growth and endotoxin testing.
  • Drug stability was analyzed using liquid chromatography-tandem mass spectrometry.

Main Results:

  • No bacterial contamination or endotoxin was detected in the cMDV throughout the 28-day study period.
  • Carprofen stability was maintained in both storage conditions over 28 days.
  • The study demonstrated that cMDV can remain sterile and stable under the tested conditions.

Conclusions:

  • Compounded multidose vials (cMDV) can be safely used for 28 days in laboratory animal settings.
  • Pragmatic techniques, including secondary containment and new needle use, are crucial for maintaining cMDV sterility.
  • This study supports the continued use of cMDV with appropriate handling procedures.

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