title: Evaluation of physical stability of all in one parenteral admixtures for pediatric home care with high electrolytes concentrations.
abstract: BACKGROUND
  The aim of the study was to evaluate stability of 48 total parenteral admixtures for pediatric patients who require home parenteral nutrition. Admixtures contain high amounts of electrolytes. In a clinical practice electrolytes-enrichment of the parenteral nutrition admixtures is a usual demand, especially on the neonatal/pediatric wards. The supplementation of parenteral nutrition with high concentration of electrolytes is a living problem due to decreased stability of lipid emulsions in nutrition admixtures caused by bivalent cations.
  
  
  METHODS
  Preliminary admixtures were prepared in two-chamber ethylene vinyl acetate bags: amino acids, glucose and electrolytes were combined in one chamber and 20% (w/w) lipid emulsions (SMOFlipid®, Intralipid ® or ClinOleic®) were placed separately in the second chamber. Organic salts of calcium and phosphates were used. Pre-admixtures were stored at +4ºC for up to 21 days after preparation. Each composition of admixtures was prepared twice, because contents of the two chambers were combined at t=0 or after 21 days of storage at +4ºC. Visual observations, globule size distribution (using optical microscopy, laser diffraction and photon correlation spectroscopy methods), pH analyses, zeta potential and surface tension were performed after combining all components together with vitamins.
  
  
  RESULTS
  Among 48 of investigated admixtures only two were problematic and other may be stored for at least 21 days at 4°C and completed admixtures demonstrated stability for at least 24 h at room temperature.
  
  
  CONCLUSIONS
  It was possible to obtain stable admixtures despite of the high concentration of electrolytes.
authors.affiliation: Department of Pharmaceutical Technology, Medical University of Gdansk, Gdansk.. dwatro@gumed.edu.pl.
authors.forename: Dorota
authors.initials: D
authors.lastname: Watrobska-Swietlikowska
authors.affiliation: Department of Pediatrics, Pediatric Gastroenterology, Hepatology and Nutrition, Medical University of Gdansk, Gdansk, Poland.. dwatro@gumed.edu.pl.
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Szlagatys-Sidorkiewicz
authors.affiliation: Department of Pharmaceutical Technology, Medical University of Gdansk, Gdansk.. dwatro@gumed.edu.pl.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Łuszkiewicz
mesh_terms: D002648:Child; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D004573:Electrolytes / Q000032:analysis*; D005217:Fat Emulsions, Intravenous / Q000032:analysis; D006801:Humans; D057947:Parenteral Nutrition Solutions / Q000032:analysis*; D016331:Parenteral Nutrition, Home / Q000592:standards*; D010372:Pediatrics / Q000592:standards*; D010938:Plant Oils; D013024:Soybean Oil
chemical_list: C568346:ClinOleic; D004573:Electrolytes; D005217:Fat Emulsions, Intravenous; D057947:Parenteral Nutrition Solutions; D010938:Plant Oils; D013024:Soybean Oil