Physicochemical stability of highly concentrated total nutrient admixtures for fluid-restricted patients.
OBJECTIVE
The physicochemical stability of highly concentrated total nutrient admixtures (TNAs) for fluid-restricted patients was studied.


METHODS
Five TNAs made from lipid injectable emulsions (50:50 mixture of medium-chain and long-chain triglycerides) designed to meet the full nutritional needs of adults with body weights of 40-80 kg were chosen. Protein was included in the TNAs at 1.5 g/kg for each body weight and was supplied from a concentrated 16% mixture containing the essential and non-essential amino acids. All admixtures were contained in ethylene vinyl acetate bags and were aseptically prepared. Triplicate preparations of each TNA were investigated over 30 hours at room temperature by dynamic light scattering (DLS) and light extinction with single-particle optical sensing (LE-SPOS).


RESULTS
No significant changes in the physicochemical stability of the TNAs were observed by DLS (mean droplet size) or LE-SPOS (large-diameter tail) from time 0 (immediately after compounding) to 30 hours. All TNAs met the mean-droplet-size criteria outlined by USP for 20% lipid injectable emulsions.


CONCLUSIONS
Concentrated TNA formulations made from lipid injectable emulsions were stable for 30 hours at room temperature.
Driscoll
David F
DF
Department of Medicine, Nutrition/Infection Laboratory, Beth Israel Deaconess Medical Center (BIDMC), Boston, MA 02215, USA.
Silvestri
Anthony P
AP
Nehne
Jörg
J
Klütsch
Karsten
K
Bistrian
Bruce R
BR
Niemann
Wilhelm
W
D006801:Humans; D007267:Injections; D018977:Micronutrients / Q000008:administration & dosage; D010289:Parenteral Nutrition, Total; D012996:Solutions / Q000737:chemistry*
D018977:Micronutrients; D012996:Solutions