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Copyright © 2006 by American Society of Health-System Pharmacists
Practice Reports |
Establishing a stability window for medium- and long-chain-triglyceride lipid-based total nutrient admixtures using USP standards
DAVID F. DRISCOLL, PH.D., is Senior Researcher, Nutrition/Infection Laboratory, Beth Israel Deaconess Medical Center (BIDMC), Boston, MA, and Assistant Professor of Medicine, Harvard Medical School (HMS), Boston. MANSI PARIKH, M.S., is Associate Research Scientist, Pharmaceutical Research and Development, Johnson and Johnson, Spring House, PA. ANTHONY P. SILVESTRI, B.S., is Clinical Pharmacist, Sterile Compounding Unit, BIDMC. 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. JORG NEHNE, PH.D., is Director, Hospital Care, Pilot Plant Pharma, B. Braun.
Address correspondence to Dr. Driscoll at the Department of Medicine, Beth Israel Deaconess Medical Center, Baker 605, 185 Pilgrim Road, Boston, MA 02215 (ddriscol{at}bidmc.harvard.edu).
Methods. Sixteen different admixtures were selected for study. Of these, eight base macronutrient concentrations representing low and high concentrations were selected, along with low and high concentrations of electrolytes. All TNAs studied contained 2 mg of elemental iron as part of the trace-element formulation, an amount previously shown to produce unstable TNAs with pure LCT-based lipid injectable emulsions. All admixtures were prepared in triplicate and analyzed over five time intervals: time 1 (immediately after preparation), time 2 (after four days of storage at 6 ± 2 °C), and times 3, 4, and 5, corresponding to 6, 24, and 30 hours of storage at 25 ± 2 °C, respectively, after time 2. Stability was measured by comparing results with USP standards for fat globule size in lipid injectable emulsions.
Results. A total of 48 admixtures were studied. Samples at each time interval showed an inconsistent but general increase in the number of globules with a diameter of >1.8 µ m over time. All admixtures met both the proposed pharmacopeial criteria for stability with respect to mean droplet size and volume-weighted proportion of fat globules with a diameter of >5 µ m.
Conclusion. A wide range of macronutrients and micronutrients were tested in a series of MCT–LCT-based TNAs and found to be stable. The use of MCTs and LCTs in lipid injectable emulsions confers greater stability to TNAs than has been achieved with pure LCT-based formulations.
Index terms: Additives; Concentration; Drops; Electrolytes; Fat emulsions; Formulations; Iron; Minerals; Nutrition; Size; Stability; Standards; Storage; Temperature; Triglycerides; United States Pharmacopeia
Purpose. The stability window of medium-chain triglyceride (MCT) and long-chain-triglyceride (LCT) lipid-based total nutrient admixtures (TNAs) was studied.
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