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

Abstract

BackgroundRegular human insulin 100 units added to a sufficient quantity of 0.9% sodium chloride, to yield a total volume of 100 mL within a polyvinylchloride bag, is accepted to be stable for 24 hours due to physical denaturation and chemical modification. The objective of this study was to evaluate the extended stability of such extemporaneously prepared regular human insulin, stored under refrigeration, to the maximum beyond-use-date allowed by United States Pharmacopeia chapter 797.MethodsAt time “0” three admixtures of regular human insulin 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 bag to yield a total volume of 100 mL. The three admixtures were stored under refrigeration (2°C–8°C [36°F–46°F]), and one sample of each admixture was withdrawn and tested in duplicate at 0, 6, 24, 48, 72, 144, 168, 192, 216, 240, 312, and 336 hours. Utilizing high performance liquid chromatography, each sample underwent immediate testing. The time points were stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at 6 hours.ResultsThe equilibrium concentration was 0.89 units/mL. Time points were stable if the mean concentration was at least 0.80 units/mL. All time points retained at least 90% of the equilibrium concentration, with the exception of hour 168 (0.79 ± 0.03 units/mL). At 192 hours the mean concentration was 0.88 ± 0.03 units/mL. At 336 hours the mean concentration was 0.91 ± 0.02 units/mL.ConclusionBased on these results, regular human insulin 100 units added to 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL is stable for up to 336 hours when stored at 2°C–8°C (36°F–46°F).

Expert consensus on the glycemic management of critically ill patients

“…Insulin dissolved in 0.9% sodium chloride solution in a PVC container keeps stable for 168 h at 2–8°C. [126] Insulin can be adsorbed onto the tubing used for intravenous infusion, and the degree of adsorption is influenced by temperature, insulin concentration, and the injection rate. The use of a 20 mL insulin solution to prime the tubing reduces the loss of insulin resulting from adsorption.…”

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.…”

Implications of Storage Conditions on the Characteristics of Alginate Dialdehyde and Its Hydrogels

“…To use the stored solution for clinical applications, knowledge of storage stability and shelf life is important. [25] Literature documented stability studies of numerous compounds and drugs, including but not limited to human insulin, [26] Nacetylcysteine, [27,28] linezolid, [29] voriconazole, [30] dexmedetomidine, [31] and penicillin G. [32] To date, there are no reports investigating the storage stability of polysaccharide solutions designed for medical applications.…”