Stability of Regular Human Insulin Extemporaneously Prepared in 0.9% Sodium Chloride in a Polyvinyl Chloride Bag

Abstract

Purpose The purpose of this study was to evaluate the extended stability of extemporaneously prepared regular human insulin 100 units in 0.9% sodium chloride at a total volume of 100 mL under refrigeration. Methods Three admixtures of regular human insulin were prepared aseptically under a laminar flow hood at time zero. They were prepared by withdrawing 1 mL of regular human insulin with a concentration of 100 units/mL and adding it to a sufficient quantity of 0.9% sodium chloride for injection in a Polyvinylchloride (PVC) bag to yield a total volume of 100 mL. The 3 admixtures were stored refrigerated(2°C to 8°C [36°F to 46°F]) and three 1 mL samples of each admixture were withdrawn, transferred to a test tube, and frozen(–30°C to −15°C [–22°F to 5°F]) at hours 0, 6, 12, 36, 48, 72, 96, 120, 144, and 168. Insulin concentrations were measured by chemiluminescent immunoassay. The time points were considered stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at hour 6. Results The equilibrium concentration was 0.57 units/mL. Time points were considered stable if the mean concentration was at least 0.52 units/mL. All time points retained at least 90% of the equilibrium concentration with the exception of hour 120(0.46 ± 0.05 units/mL). At hour 168, the mean concentration was 0.63 ± 0.07 units/mL. Conclusion Regular human insulin 100 units added to 0.9% sodium chloride for injection in a PVC bag to yield a total volume of 100 mL is stable for 168 hours when stored at 2°C to 8°C(36°F to 46°F).

Guidelines for the use of an insulin infusion for the management of hyperglycemia in critically ill patients

“…Insulin may be prepared in glass or plastic containers (polyvinyl chloride [PVC], ethylene vinyl acetate, polyethylene, and other polyolefin plastics), although loss will occur through adsorption to containers and to IV tubing and filters. Adsorption is immediate upon contact, producing a bioavailability of approximately 50-60% in PVC with sustained stability for 168 hrs (146). Factors such as storage temperature, concentration, and infusion rate influence the extent of adsorption.…”

Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag

“…Previously, all IV insulin admixtures at our institution had a 7-day expiration date 4. Based on these results, we have extended the expiration date of all extemporaneously prepared bags of regular human insulin to 14 days under refrigeration.…”

“…In our recent pilot analysis, we showed stability for up to 168 hours 4. In response to the critique of that pilot analysis, the current analysis had three modifications: (1) high performance liquid chromatography was utilized for stability testing, (2) the samples were never frozen, and (3) each sample was tested in duplicate 4.…”

Advances in safe insulin infusions

“…The use of published studies limits the beyond-use dates (BUDs) of insulin products and should be validated at each site. 20 , 21 The quality and safety of on-demand compounding may be reduced by interruptions and distractions. Medication error prevention during pharmacy compounding is critical, especially for insulin as it is a high-risk medication and has significant potential for patient harm.…”