Physicochemical stability of ternary admixtures of butorphanol, ketamine, and droperidol in polyolefin bags for patient-controlled analgesia use

Drug Des Devel Ther. 2016 Nov 24:10:3873-3878. doi: 10.2147/DDDT.S123411. eCollection 2016.

Abstract

Background: Delivery of drug admixtures by intravenous patient-controlled analgesia is a common practice for the management of postoperative pain; however, analytical confirmation of the compatibility and stability of butorphanol tartrate, ketamine hydrochloride, and droperidol combined in ternary admixtures is not available.

Methods: Butorphanol tartrate, ketamine hydrochloride, and droperidol have been examined for compatibility and stability when combined with 0.9% sodium chloride injection stored at 4°C and 25°C with light protection for a total of 14 days. Concentrations were 0.067 mg/mL, 1.33 mg/mL, and 0.033 mg/mL for butorphanol tartrate, ketamine hydrochloride, and droperidol, respectively. Drug concentrations were determined using high-performance liquid chromatographic analysis.

Results: All three drugs were very stable (>97%) at 4°C and 25°C for 14 days. The ternary admixtures were initially clear and colorless throughout the observation period, and the pH value did not change significantly.

Conclusion: The results confirm that the ternary admixture of butorphanol tartrate 0.067 mg/mL, ketamine hydrochloride 1.33 mg/mL, and droperidol 0.033 mg/mL in 0.9% sodium chloride injection were stable for 14 days when stored in polyolefin bags at 4°C and 25°C and protected from light.

Keywords: HPLC; analgesia; butorphanol; droperidol; drug stability; ketamine; patient-controlled analgesia.

MeSH terms

  • Analgesia, Patient-Controlled
  • Analgesics / administration & dosage
  • Analgesics / chemistry*
  • Analgesics / isolation & purification
  • Butorphanol / administration & dosage
  • Butorphanol / chemistry*
  • Butorphanol / isolation & purification
  • Calibration
  • Chromatography, High Pressure Liquid
  • Droperidol / administration & dosage
  • Droperidol / chemistry*
  • Droperidol / isolation & purification
  • Drug Combinations
  • Drug Packaging
  • Drug Stability
  • Ketamine / administration & dosage
  • Ketamine / chemistry*
  • Ketamine / isolation & purification
  • Polyenes / chemistry

Substances

  • Analgesics
  • Drug Combinations
  • Polyenes
  • Ketamine
  • PL 732
  • Droperidol
  • Butorphanol