Stability of Fentanyl Citrate, Hydromorphone Hydrochloride, Ketamine Hydrochloride, Midazolam, Morphine Sulfate, and Pentobarbital Sodium in Polypropylene Syringes.

Collin Anderson,Mark Mackay

doi:10.3390/pharmacy3040379

Abstract

Purpose: Determine the stability of fentanyl 10 mcg/mL in 0.9% sodium chloride, fentanyl 10 mcg/mL in 5% dextrose, fentanyl 50 mcg/mL, hydromorphone 100 mcg/mL in 0.9% sodium chloride, ketamine 10 mg/mL, midazolam 0.4 mg/mL in 5% dextrose, midazolam 5 mg/mL, morphine 1 mg/mL in 0.9% sodium chloride, morphine 1 mg/mL in 5% dextrose, and pentobarbital 50 mg/mL when stored as single drug entities at room temperature in polypropylene syringes. Methods: Four 5 mL samples of each drug and concentration were prepared in 10 mL polypropylene syringes. The samples were stored at ambient room temperature in a locked cabinet. Triplicate determinations of drug concentration for each sample were performed initially, on day 50 or 51, and on day 100 using high-performance liquid chromatography with diode-array detection. Results: With the exception of the hydromorphone 100 mcg/mL dilution, all compounds were found to contain greater than 95% of their initial concentration remaining at 100 days. Each sample remained clear and colorless when visually inspected.

Highlights

IntroductionControlled substances play an integral role in the pharmacological management of pain and sedation
Controlled substances play an integral role in the pharmacological management of pain and sedation.Frequent use of these agents as analgesics and sedatives make it desirable for them to be readily available in convenient dosage forms to those who will be administering the drug substances
The study results indicate that all analyzed compounds of fentanyl, ketamine, midazolam, morphine, and pentobarbital are stable for 100 days when stored at room temperature in polypropylene syringes

Summary

Introduction

Controlled substances play an integral role in the pharmacological management of pain and sedation Frequent use of these agents as analgesics and sedatives make it desirable for them to be readily available in convenient dosage forms to those who will be administering the drug substances. We currently compound five controlled substance drips at concentrations and in volumes suitable for a pediatric patient population (Table 1). Having controlled substance drips compounded and available from the central pharmacy narcotic station potentially reduces the risk of medication error which can occur at busy times during on demand compounding. The drips are loaded into the central narcotic station at the concentration and volume which they will be distributed to the patient, increasing efficiency of pharmacy operations. The drug compounds are tracked through our central narcotic station and automatic dispensing machines throughout the hospital. At the time of publication we are unaware of chemical stability studies for fentanyl 10 mcg/mL or midazolam 0.4 mg/mL compounds

Experimental Section

Results and Discussion

Conclusions