Compatibility and Stability of Dexamethasone Sodium Phosphate and Ketamine Hydrochloride Subcutaneous Infusions in Polypropylene Syringes

Abstract

The stability of ketamine hydrochloride injection and dexamethasone sodium phosphate injection, when mixed and stored in polypropylene syringes, was studied. Formulations containing ketamine hydrochloride (50 mg or 600 mg) and dexamethasone sodium phosphate (1 mg) in 0.9% sodium chloride injection (to 14 ml) were prepared and stored at 4 degrees C, 23 degrees C, and 37 degrees C, under normal fluorescent light conditions, for 192 hours. The concentrations of the drugs were determined at 0, 2, 4, 8, 24, 48, 96, and 192 hours using a validated high-pressure liquid chromatography method. The pH, color, and visible particles of each solution were also assessed at each time point. All formulations tested maintained more than 98% of the initial concentrations of both drugs, and no degradation products were detected. The solutions remained clear and colorless and the pH varied within 0.05 units throughout 192 hours. The results indicate that, at the concentrations studied, combinations of ketamine hydrochloride and dexamethasone sodium phosphate in 0.9% sodium chloride injection were physically and chemically stable for at least 192 hours (8 days) when stored in polypropylene syringes.

Compatibility and stability of tramadol and dexamethasone in solution and its use in terminally ill patients

“…It is stable for 8 days when combined with ketamine hydrochloride, hydromorphone, metoclopramide and ranitidine http://www.palliative.org. (13) but precipitates, at certain concentrations, with midazolam hydrochloride (5), morphine hydrochloride (14) and haloperidol lactate (15) due to pH modifications. In our study pH modification did not affect drug stability.…”

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

“…As for ketamine hydrochloride, the stability and compatibility test of ketamine hydrochloride combined with other drugs in infusion solutions has been widely demonstrated that ketamine hydrochloride is a highly stable drug. It has been reported to be stable with tramadol hydrochloride,25 morphine hydrochloride,26–29 hydromorphone,30,31 fentanyl citrate,32 dexamethasone sodium phosphate,33 clonidine hydrochloride,34 midazolam hydrochloride,34 lormetazepam,34 and propofol35 in binary admixtures. Regarding droperidol, the solubility showed strong pH dependence (pKa was 7.64), which is stable in acid solution and may cause drug precipitation or crystallization in alkaline solution.…”

Butorphanol and Ketamine Combined in Infusion Solutions for Patient-Controlled Analgesia Administration: A Long-Term Stability Study

“…Ketamine hydrochloride was found to be compatible when diluted with water or 0.9% sodium chloride injection, packaging in glass vials, or polypropylene syringes at room temperature [ 34 – 36 ]. The compatibility and stability studies also reported that most of the tested drugs, such as morphine [ 37 – 40 ], hydromorphone [ 41 , 42 ], fentanyl citrate [ 43 ], and dexamethasone sodium phosphate [ 44 ], were stable and compatible in the presence of ketamine hydrochloride. Unfortunately, no published information is available on the compatibility and stability of butorphanol in combination with ketamine in PCA solution.…”