Container effects on the physicochemical properties of parenteral lipid emulsions
2008
Gonyon, Thomas | Carter, Phillip W. | Dahlem, Olivier | Denet, Anne-Rose | Owen, Heather | Trouilly, Jean-Luc
Objective: We evaluated the effects of glass and plastic containers on the physicochemical properties of parenteral nutrition lipid emulsions and total nutrient admixtures with an emphasis on globule size distribution and colloidal stability. Methods: A commercial lipid emulsion, 20% ClinOleic, was separated into glass (type II soda-lime-silica) and plastic (polypropylene multilayer) containers, sterilized, and then stored for 16 wk at 40°C. Globule size distribution, pH, and zeta potential measurements were made every 4 wk. Admixtures derived from parent lipid emulsions were tested after admixing (t = 0), storage for 7 d at 5°C plus 24 h at 25°C (t = 7 + 1), and then after an additional 3 d at 25°C (t = 7 + 4). Results: The parent lipid emulsions in glass and plastic containers exhibited identical time-dependent behavior with respect to mean globule size, percentage of oil droplets >=5 μm, pH, and zeta potential measurements. The percentages of oil droplets >=5 μm of all test conditions remained well below the United States Pharmacopeia <729> limits of 0.05%. The total nutrient admixture time-dependent physicochemical characteristics were also found to be independent of the parent lipid emulsion container type. Conclusion: Plastic and glass containers were found to be suitable, safe, and indistinguishable with respect to physicochemical stability of a representative parenteral nutrition lipid emulsion and total nutrient admixtures derived from the parent lipid emulsion.
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