title: Assessment of the physicochemical stability of all-in-one parenteral emulsions for neonates according to USP specifications.
abstract: BACKGROUND
  The purpose of this study was to describe the methodology to assess the stability of all-in-one (AIO) parenteral nutrition admixtures, containing glucose, proteins, and lipids, to the standards of U.S. Pharmacopoeia (USP <729>). The influence of calcium and commercially available lipid emulsions and amino acid solutions were also examined.
  
  
  METHODS
  Four batches of 5 AIO admixtures containing calcium were compounded with commercially available lipid emulsions and amino acid solutions. Two of them contained calcium. Their stability was tested under conditions simulating clinical use. All the admixtures were assessed for criteria set by the USP <729>: (1) mean droplet diameter (MDD) and (2) percentage of volume weighted particles with diameter > 5 μm (PFAT5).
  
  
  RESULTS
  All admixtures were within the specifications set by the USP with respect to the MDD at 0, 24, and 48 hours, but only those batches lacking calcium met the benchmarks set by the pharmacopoeia, with respect to PFAT5, on the day of preparation.
  
  
  CONCLUSIONS
  The presence of calcium destabilized the admixtures, while the use of different commercial ingredients altered the admixtures' characteristics. Only 1 batch of the AIO admixtures studied was found to be compliant with USP <729> standards.
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Athens, Athens, Greece.
authors: Christos
authors: C
authors: Athanasiou
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Athens, Athens, Greece shatzi@pharm.uoa.gr.
authors: Sophia
authors: S
authors: Hatziantoniou
authors: Department of Diabetics and Nutritional Science, Harokopio University, Athens, Greece.
authors: Maria
authors: M
authors: Skouroliakou
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Athens, Athens, Greece.
authors: Sophia
authors: S
authors: Markantonis-Kyroudis
mesh_terms: D000596:Amino Acids / Q000008:administration & dosage; D002136:Calcium, Dietary / Q000008:administration & dosage; D004355:Drug Stability; D005217:Fat Emulsions, Intravenous / Q000592:standards; D005947:Glucose / Q000008:administration & dosage; D019983:Guideline Adherence; D006801:Humans; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D008055:Lipids / Q000008:administration & dosage; D010288:Parenteral Nutrition / Q000592:standards*; D057947:Parenteral Nutrition Solutions / Q000592:standards*; D010316:Particle Size; D011506:Proteins / Q000008:administration & dosage
chemical_list: D000596:Amino Acids; D002136:Calcium, Dietary; D005217:Fat Emulsions, Intravenous; D008055:Lipids; D057947:Parenteral Nutrition Solutions; D011506:Proteins; D005947:Glucose
keywords: all-in-one parenteral emulsion; emulsions; neonates; physicochemical stability