Long-term stability of sodium folinate in dextrose 5% polyolefin bags at 4°C

Abstract

Preparation of intravenous solutions in advance could be an efficient approach to improve quality assurance, security, time management, and cost saving of drug provision. The purpose of this paper is to investigate the stability of sodium folinate solutions at 3.2 mg mL-1 in 5% dextrose polyolefin bags at 4degreesC. The stability of five polyolefin bags of solution containing approximately 3.2 mg mL-1 of sodium folinate in 5% dextrose prepared under aseptic conditions and stored at 48degreesC have been studied over 30 days. Sodium folinate concentrations have been measured by high performance liquid chromatography and the results have been analysed by regression analysis. Solutions have been visually inspected and pH measured. No colour change or precipitation occurred in the preparations. Based on a shelf-life of 90% residual potency, sodium folinate solutions have been observed to be stable for a period of at least 30 days at 4degreesC, where lower confidence limits of the results value remain above 90% of the initial concentration. During this stability period, the pH values of infusions have been observed to decrease slightly without affecting chromatographic parameters. Within these limits, sodium folinate in 5% dextrose infusion may be prepared and stored in advance by a centralized intravenous admixture service.