title: Droplet-size distribution and stability of commercial injectable lipid emulsions containing fish oil.
abstract: OBJECTIVE
  The droplet size of commercial fish oil-containing injectable lipid emulsions, including conformance to United States Pharmacopeia (USP) standards on fat-globule size, was investigated.
  
  
  METHODS
  A total of 18 batches of three multichamber parenteral products containing the emulsion SMOFlipid as a component were analyzed. Samples from multiple lots of the products were evaluated to determine compliance with standards on the volume-weighted percentage of fat exceeding 0.05% (PFAT(5)) specified in USP chapter 729 to ensure the physical stability of i.v. lipid emulsions. The products were also analyzed to determine the effects of various storage times (3, 6, 9, and 12 months) and storage temperatures (25, 30, and 40 °C) on product stability. Larger-size lipid particles were quantified via single-particle optical sensing (SPOS). The emulsion's droplet-size distribution was determined via laser light scattering.
  
  
  RESULTS
  SPOS and light-scattering analysis demonstrated mean PFAT(5) values well below USP-specified globule-size limits for all the tested products under all study conditions. In addition, emulsion aging at any storage temperature in the range studied did not result in a significant increase of PFAT(5) values, and mean droplet-size values did not change significantly during storage of up to 12 months at temperatures of 25-40 °C.
  
  
  CONCLUSIONS
  PFAT(5) values were below the USP upper limits in SMOFlipid samples from multiple lots of three multichamber products after up to 12 months of storage at 25 or 30 °C or 6 months of storage at 40 °C.
authors: University of Huelva, Huelva, Spain. cgallego@uhu.es
authors: Críspulo
authors: C
authors: Gallegos
authors: Concepción
authors: C
authors: Valencia
authors: Pedro
authors: P
authors: Partal
authors: José M
authors: JM
authors: Franco
authors: Omay
authors: O
authors: Maglio
authors: Malin
authors: M
authors: Abrahamsson
authors: Edmundo
authors: E
authors: Brito-de la Fuente
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000592:standards*; D004349:Drug Packaging / Q000592:standards; D004355:Drug Stability; D005217:Fat Emulsions, Intravenous / Q000737:chemistry / Q000592:standards*; D005395:Fish Oils / Q000737:chemistry / Q000592:standards*; D010316:Particle Size
chemical_list: D005217:Fat Emulsions, Intravenous; D005395:Fish Oils