Stability of total nutrient admixtures in reference to ambient temperatures.
OBJECTIVE
To evaluate the stability of emulsions under different temperatures simulating clinical conditions of storage and exposure during infusion, five total nutrient admixture formulas in this institution were analyzed: adult, patients with hepatic failure, infants, stressed patients, and patients with renal failure.


METHODS
Each mixture was allocated in a sterile 100-mL glass bottle, which was prefilled and refilled with nitrogen gas. Bottles were stored at 4 degrees C for 0 d, 3 d, and 7 d and then exposed to three different temperatures: usual room temperature (18 degrees C to 25 degrees C), high (>28 degrees C) in a water bath, or storage (4 degrees C) for 24 and 48 h. The gross inspection of the emulsions and parallel measurements of pH, particle sizes, divalent ions, peroxide levels, and microbial cultures were performed.


RESULTS
Every lot was stable near 18 degrees C, but 8 of 10 lots stored for 7 d (25 degrees C and >28 degrees C) and 15 of 20 lots stored for 3 and 7 d (25 degrees C and >28 degrees C) showed coalescence. The overall coalescence incidences by storage, exposure, and heat were statistically significant (P < 0.005).


CONCLUSIONS
For the safety of total nutrient admixtures, special attention is required to keep the ambient temperature below 28 degrees C and completely exclude air from the container.
Lee
Myung Duk
MD
Nutritional Support Service, Department of Surgery, Kangnam St. Mary's Hospital, Seoul, South Korea. lmyungd@catholic.ac.kr
Yoon
Jeung-Ei
JE
Kim
Sang-In
SI
Kim
In-Chul
IC
D000328:Adult; D002413:Cations, Divalent / Q000032:analysis; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005217:Fat Emulsions, Intravenous / Q000032:analysis / Q000737:chemistry / Q000592:standards; D005526:Food, Formulated / Q000032:analysis / Q000592:standards*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007231:Infant, Newborn; D017093:Liver Failure / Q000628:therapy; D010289:Parenteral Nutrition, Total / Q000592:standards*; D010316:Particle Size; D010545:Peroxides / Q000032:analysis; D051437:Renal Insufficiency / Q000628:therapy; D013211:Staphylococcus aureus / Q000302:isolation & purification; D013696:Temperature; D013997:Time Factors
D002413:Cations, Divalent; D005217:Fat Emulsions, Intravenous; D010545:Peroxides