NDLI: Effect of freeze-thawing on the long-term stability of calcium levofolinate in 5% dextrose stored on polyolefin infusion bags.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Lebitasy, M. Hecq, J-D Athanassopoulos, A. Vanbeckbergen, D. Jamart, J. Galanti, L.
Description	Country affiliation: Belgium Author Affiliation: Lebitasy M ( Medical Laboratory, Cliniques UCL Mont-Godinne, Yvoir, Belgium.)
Abstract	BACKGROUND: Calcium levofolinate infusions could be prepared in advance by a centralized intravenous additive service (CIVAS) to improve safety and time management. OBJECTIVE: To investigate the effect of freezing, microwave thawing and long-term storage at 5 +/- 3 degrees C on the stability of calcium levofolinate in 5% dextrose solution. METHODS: Solutions of 250 mL of 5% dextrose in polyolefin bags (n = 5) containing approximately 400 mg of calcium levofolinate were prepared under aseptic conditions and frozen for 95 days at -20 degrees C. The solutions were then thawed using microwaves and stored at 5 +/- 3 degrees C for 1 month. The calcium levofolinate concentrations were measured by high performance liquid chromatography (HPLC). Visual inspection was performed and pH was measured periodically during the storage at 5 +/- 3 degrees C. Stability of the solution was defined as a concentration remaining superior to 90% of the initial concentration by regression analysis as recommended by the Food and Drug Administration (FDA). RESULTS: No colour change or precipitation in the solutions was observed. Calcium levofolinate infusions were stable when stored at 5 +/- 3 degrees C during 1 month after freeze-thaw treatment. Throughout this period, the lower confidence limit of the estimated regression line of concentration-time profile remained above 90% of the initial concentration. Slight change in pH values from 6.52 +/- 0.01 to 6.50 +/- 0.01 during storage time did not affect retention time on HPLC and has no clinical consequence, the solutions remaining in the acceptable range for perfusion (4
File Format	HTM / HTML
ISSN	02694727
Issue Number	4
Volume Number	34
e-ISSN	13652710
Journal	Journal of Clinical Pharmacy and Therapeutics
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2009-08-01
Publisher Place	Great Britain (UK)
Access Restriction	Subscribed
Subject Keyword	Discipline Therapeutics Discipline Pharmacology Glucose Chemistry Leucovorin Vitamin B Complex Chromatography, High Pressure Liquid Drug Packaging Drug Stability Drug Storage Freezing Hydrogen-ion Concentration Microwaves Pharmaceutical Vehicles Polyenes Regression Analysis Solutions Temperature Time Factors Journal Article
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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