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Am J Health-Syst Pharm
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American Journal of Health-System Pharmacy, Vol. 63, Issue 1, 79-85
Copyright © 2006 by American Society of Health-System Pharmacists
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Reports

Physicochemical stability of highly concentrated total nutrient admixtures for fluid-restricted patients

David F. Driscoll, Anthony P. Silvestri, Jörg Nehne, Karsten Klütsch, Bruce R. Bistrian and Wilhelm Niemann

DAVID F. DRISCOLL, PH.D., is Senior Researcher, Nutrition/Infection Laboratory, Beth Israel Deaconess Medical Center (BIDMC), and Assistant Professor of Medicine, Harvard Medical School (HMS), Boston. ANTHONY P. SILVESTRI, B.S., is Clinical Pharmacist, Sterile Compounding Unit, BIDMC. JORG NEHNE, PH.D., is Director, Hospital Care, Pilot Plant Pharma, and KARSTEN KLUTSCH, PH.D., is Manager, Hospital Care, Strategic Marketing for IV Therapeutics, B. Braun, Melsungen, Germany. BRUCE R. BISTRIAN, M.D., PH.D., is Chief, Nutrition/Infection Laboratory, BIDMC, and Professor of Medicine, HMS. WILHELM NIEMANN, PH.D., is Director, Hospital Care, Pharmaceutical Development, B. Braun.

Address correspondence to Dr. Driscoll at the Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, 185 Pilgrim Road, Suite 605, Boston, MA 02215.


Purpose. 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.

Conclusion. Concentrated TNA formulations made from lipid injectable emulsions were stable for 30 hours at room temperature.

Index terms: Additives; Amino acids; Compounding; Containers; Copolymers; Drops; Ethylene-vinyl acetate copolymer; Fat emulsions; Formulations; Nutrition; Size; Stability; Storage; Triglycerides

 



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