title: Interactions between Parenteral Lipid Emulsions and Container Surfaces.
abstract: OBJECTIVE
  To evaluate the relationship between changes in emulsion globule size distributions and container uptake of lipid emulsions in total nutrient admixtures.
  
  
  METHODS
  A total nutrient admixture was prepared from a commercial lipid emulsion, 20% ClinOleic®, separated into glass (borosilicate) and ethylene vinyl acetate (EVA) plastic containers, and then stored at ambient conditions for approximately 24 h. The large globule size distribution was monitored continuously for both containers, and the quantity of triglycerides associated with both containers was measured by liquid chromatography. The changes in mass of the EVA containers were also measured gravimetrically.
  
  
  RESULTS
  The volume percent of globules greater than 5 microns in diameter (PFAT5) levels for an emulsion admixture in EVA containers showed a 75% reduction compared to a marginal decrease of PFAT5 when in the glass container. Extraction of the containers showed that the quantity of triglycerides associated with the EVA surfaces steadily increased with emulsion exposure time, while the glass showed a significantly lower triglyceride content compared to the EVA. Gravimetric measurements confirmed that the EVA containers gained significant mass during exposure to the emulsion admixture.
  
  
  CONCLUSIONS
  A time-dependent decrease in PFAT5 values for an emulsion admixture was associated with container triglyceride absorption where EVA containers had a greater uptake than glass containers. The larger globules appear to absorb preferentially, and the admixture globule size distribution fraction represented by PFAT5 accounts for 15-20% of the total triglyceride adsorption to the container.
  The goal of this work is to evaluate how emulsions in total nutrition admixtures are affected by the containers within which they are stored. Specifically, the study examines how the emulsion globule size distribution in different containers is related to adsorption or absorption of the lipids onto or into the container. The admixtures were prepared from a commercial lipid emulsion, 20% ClinOleic®, and the containers were either glass (borosilicate) or plastic (ethylene vinyl acetate, EVA). The large globule size distribution was monitored continuously for both containers over the course of 24 h, and the quantity of triglycerides taken up by both containers was measured by liquid chromatography. The lipid uptake by the EVA containers was also monitored by gravimetric methods. Briefly, the percent of fat globules greater than 5 micrometers (PFAT5) in EVA containers showed a 75% reduction compared to a marginal decrease of PFAT5 when in the glass container. Extraction of the lipids from the containers showed that the quantity of triglycerides associated with the EVA surfaces steadily increased with admixture exposure time, while the glass showed a significantly lower triglyceride content. Gravimetric measurements confirmed that the EVA containers gained measurable mass during exposure to the emulsion admixture.
authors.affiliation: Baxter Healthcare, Round Lake, IL.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gonyon
authors.forename: Anthony E
authors.initials: AE
authors.lastname: Tomaso
authors.forename: Priyanka
authors.initials: P
authors.lastname: Kotha
authors.forename: Heather
authors.initials: H
authors.lastname: Owen
authors.forename: Dipa
authors.initials: D
authors.lastname: Patel
authors.forename: Phillip W
authors.initials: PW
authors.lastname: Carter
authors.forename: Jim
authors.initials: J
authors.lastname: Cronin
authors.forename: John-Bruce D
authors.initials: JB
authors.lastname: Green
mesh_terms: D004355:Drug Stability; D005217:Fat Emulsions, Intravenous / Q000737:chemistry; D010288:Parenteral Nutrition; D010289:Parenteral Nutrition, Total; D010316:Particle Size; D010969:Plastics / Q000737:chemistry
chemical_list: D005217:Fat Emulsions, Intravenous; D010969:Plastics
keywords: Container; Globule size distribution; Lipid emulsion; Liquid chromatography; Total nutrient admixture