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°C for 0 d, 3 d, and 7 d and then exposed to three different temperatures: usual room temperature (18°C to 25°C), high (>28°C) in a water bath, or storage (4°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°C, but 8 of 10 lots stored for 7 d (25°C and >28°C) and 15 of 20 lots stored for 3 and 7 d (25°C and >28°C) 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 28°C and completely exclude air from the container.