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. 2018 Jul;25(4):214-217.
doi: 10.1136/ejhpharm-2016-000965. Epub 2016 Oct 17.

Physicochemical stability of oxycodone-ketamine solutions in polypropylene syringe and polyvinyl chloride bag for patient-controlled analgesia use

Mikaël Daouphars  1 , Charles-Henri Hervouët  2 , Pierre Bohn  3 , Delphine Martin  4 , Jean Rouvet  1 , Florence Basuyau  1 , Rémi Varin  2
Affiliations

Physicochemical stability of oxycodone-ketamine solutions in polypropylene syringe and polyvinyl chloride bag for patient-controlled analgesia use

Mikaël Daouphars et al. Eur J Hosp Pharm. 2018 Jul.

Abstract

Objectives: The study evaluated the stability of three combinations of oxycodone and ketamine diluted in normal saline (NS) after storage for 7 days at 23°C and exposed to light.

Methods: The stability of three mixtures of oxycodone and ketamine (oxycodone 0.4 mg/mL+ketamine 40 mg/mL, oxycodone 10 mg/mL+ketamine 0.1 mg/mL and oxycodone 10 mg/mL+ketamine 40 mg/mL) in NS stored in a polypropylene syringe and a polyvinyl chloride (PVC) bag was studied. The physical characteristics, including pH, colour and precipitation, were evaluated. The samples were analysed in triplicate by a stability-indicating high-performance liquid chromatography method.

Results: There was no significant change in the pH values of any solution. No precipitation or change in colour was observed. All formulations maintained more than 95% of the initial concentration of each drug on day 7. No trace of degradation products was detected.

Conclusions: Ketamine (0.1-40 mg/mL) combined with oxycodone (0.4-10 mg/mL) is physically compatible and chemically stable for 7 days when diluted with NS, packaged in polypropylene syringe or PVC bag and stored at 23°C.

Keywords: HPLC; ONCOLOGY; PCA; ketamine; oxycodone.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Typical chromatogram for day 7. Oxycodone eluted at approximately 6.36 min, naloxone (internal standard) at approximately 7.94 min and ketamine at approximately 10.21 min. The degradation products seen in the accelerated degradation studies were not observed. The dotted line represents the percentage of phosphate buffer over time for the mobile phase concentration gradient phosphate buffer/acetonitrile.
Figure 2
Figure 2
Observed concentration of oxycodone (as mean percentage of initial concentration±SD) in mixtures with ketamine. Test solutions identified as ketamine (K) mixed with oxycodone (O) concentrations in mg/mL, with blue bars for polypropylene syringes and green bars for polyvinyl chloride bags.
Figure 3
Figure 3
Observed concentration of ketamine (as mean percentage of initial concentration±SD) in mixtures with oxycodone. Test solutions identified as ketamine (K) mixed with oxycodone (O) concentrations in mg/mL, with blue bars for polypropylene syringes and green bars for polyvinyl chloride bags.
See this image and copyright information in PMC

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