Container effects on the physicochemical properties of parenteral lipid emulsions.
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 degrees 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 degrees C plus 24 h at 25 degrees C (t = 7 + 1), and then after an additional 3 d at 25 degrees 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 >or=5 mum, pH, and zeta potential measurements. The percentages of oil droplets >or=5 mum 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.


CONCLUSIONS
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.
Gonyon
Thomas
T
Baxter International, Technology Resources, Round Lake, Illinois, USA.
Carter
Phillip W
PW
Dahlem
Olivier
O
Denet
Anne-Rose
AR
Owen
Heather
H
Trouilly
Jean-Luc
JL
D004349:Drug Packaging / Q000379:methods*; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D005217:Fat Emulsions, Intravenous / Q000737:chemistry*; D005898:Glass / Q000737:chemistry*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D010288:Parenteral Nutrition; D010316:Particle Size; D010969:Plastics / Q000737:chemistry*; D012449:Safety
D005217:Fat Emulsions, Intravenous; D010969:Plastics