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 4degreesC for 0 d, 3 d, and 7 d and then exposed to three different temperatures: usual room temperature (18degreesC to 25degreesC), high (>28degreesC) in a water bath, or storage (4degreesC) for 24 and 48 It. 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 18degreesC, but 8 of 10 lots stored for 7 d (25degreesC and >28degreesC) and 15 of 20 lots stored for 3 and 7 d (25degreesC and >28degreesC) showed coalescence. The overall coalescence incidences by storage, exposure, and heat were statistically significant (P < 0.005). CONCLUSION: For the safety of total nutrient admixtures, special attention is required to keep the ambient temperature below 28degreesC and completely exclude air from the container. (C)Elsevier Inc. 2003.