Stability of total nutrient admixtures using various intravenous fat emulsions

Abstract

The stability of four lipid emulsions with amino acids and dextrose in total nutrient admixtures (TNAs) was studied. The admixtures were divided into three groups. In group 1, 24 admixtures representing 20 different combinations of Liposyn II (safflower oil-soybean oil fat emulsion) with various manufacturers' amino acids (FreAmine III, Travasol, Novamine, Nephramine, and RenAmin) were tested. In group 2, 19 TNAs representing 14 combinations containing soybean-oil emulsions (Intralipid, Travamulsion, and Soyacal) and Aminosyn II amino acids were studied. In group 3, 14 TNAs representing 9 combinations containing the above soybean oil emulsions and Aminosyn II with Electrolytes were tested. Both 10% and 20% concentrations of fat emulsion, various amino acid concentrations ranging from 5.4% to 11.4%, and dextrose injections of 10, 20, 40, 50, and 70% were used. The admixtures were compounded in an ethylene vinyl acetate container. The mixing sequence involved transfer of fat emulsion to the empty container, followed by amino acids and dextrose. One of two electrolyte and trace metal profiles was added to each core admixture after compounding. Multivitamins were added just before the 24-hour room-temperature (25 +/- 4 degrees C) storage. Admixtures were tested initially and after one day at room temperature or nine days at 5 degrees C plus one day at room-temperature storage. Measurements of pH, emulsion particle size, osmolality, and zeta potential (electrostatic surface charge of lipid particles) were made after visual inspection of each admixture. In general, the TNAs retained a uniform, milk-like appearance under both storage conditions. The values of pH, zeta potential, particle size, and osmolality remained essentially unchanged throughout the study. Under the conditions of this study, the TNA formulations tested are stable for up to 10 days.