Abstract
To accommodate small fluid volumes, repackaging of intravenous lipid emulsions is frequently performed in hospitals providing parenteral nutrition to neonates and smaller pediatric patients. The physical stability of lipid commercial parenteral emulsions repacked and stored in polypropylene syringe up to 30 days at room temperature, refrigerator and 40°C was determined to establish options for extended storage. Lipid emulsions in the manufacturers’ original containers were used as references. Commercial lipid emulsions (20% of oil phase), ClinOleic, Intralipid, Smoflipid, Omegaven and Lipofindin LCT/MCT were repackaged under aseptic conditions in polypropylene syringes and stored at 4°C, 25°C and 40°C without light protection. Samples were assayed periodically over 30 days using validated, stability-indicating methods. Lipid emulsions in the manufacturers’ containers stored in the same conditions were as references. Analysis of variance showed differences in the physical parameters due to temperature (p<0.05) and study day (p<0.05) but not the type of the emulsion (p = 0.98). The parenteral lipid emulsions in polypropylene syringe exhibited identical (except Z-avarage at 40°C, t = 30 days) to original containers time-dependent behavior taking into account the mean globule size, pH, and zeta potential measurements. Size of oily droplets of all test conditions remained below the United States Pharmacopeia limits. The results allow safe repacking of commercial lipid emulsion in a syringe, which is a necessary condition for supplying parenteral nutrition using the two-in-one method for newborns. However, longer storage than 12 h of repacked emulsion needs microbiological studies.
Highlights
The beyond-use date for intravenous medications following reconstitution or repacking is often limited because of the potential for breaks in sterility and physicochemical stability in the new container
Regardless of the type, in each of the commercial lipid injectable emulsions tested in polypropylene syringes (ClinOleic, Intralipid, Lipofundin MCT/LCT, Omegaven and SMOFlipid) no visual changes were found
Lipid injectable emulsions in polypropylene syringes in the microscope image were characterized by drops of the oil phase with a size below 2 μm and the presence of 2–3 μm of oil droplets
Summary
The beyond-use date for intravenous medications following reconstitution or repacking is often limited because of the potential for breaks in sterility and physicochemical stability in the new container (interaction with the container’s surface). Extending the beyond-use date may reduce the physicochemical stability of parenteral emulsions and, results in the safe administration of such mixtures to patients. If a lipid emulsion is added to the parenteral nutrition solution, as is done in 3-in-1 (total nutrient admixture) solutions, the high amount of calcium and phosphorus needed by these infants may result in an unseen precipitate with serious consequences. Continuous fat infusion over 24 hours is the preferred method in neonates [3] For this reason, commercial lipid emulsions are repacked to a polypropylene syringe from original commercial bags and administered intravenously to neonates at neonates wards with a higher temperature [4]. There is very little information about the stability of lipid emulsion repacked to polypropylene syringe and stored at a higher temperature
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