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Physical stability of an all-in-one parenteral nutrition admixture for preterm infants upon mixing with micronutrients and drugs
  1. Vigdis Staven1,2,3,
  2. Siri Wang4,
  3. Ingrid Grønlie5,6,7,
  4. Ingunn Tho2,3
  1. 1Hospital Pharmacy of North Norway Trust, Tromsø, Norway
  2. 2Department of Pharmacy, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway
  3. 3School of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway
  4. 4Norwegian Medicines Agency, Oslo, Norway
  5. 5Norwegian Medicines for Children Network, Bergen, Norway
  6. 6Hospital Pharmacy at Haukeland University Hospital, Bergen, Norway
  7. 7Department of Pediatrics, Haukeland University Hospital, Bergen, Norway
  1. Correspondence to Professor Ingunn Tho, School of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo 0315, Norway; ingunn.tho{at}farmasi.uio.no

Abstract

Objectives The main objective was to investigate Y-site compatibility of intravenous drugs with one standard total parenteral nutrition (TPN) admixture for preterm infants. Since micro-precipitation was observed in the water phase after addition of trace elements, the concentration effect on micro-precipitation formation developed as a sub-goal.

Methods Seven drugs (ampicillin, ceftazidime, fluconazole, fosphenytoin, furosemide, metronidazole and paracetamol) were mixed in three mixing ratios with one preterm TPN admixture. Samples were investigated within 1 hour and again after 4 hours. Precipitation was studied in a lipid-free version called TPNaq by light obscuration, turbidimetry and visual examination. Emulsion stability data were assessed by light obscuration and laser diffraction. pH was measured to assess the theoretical risk of precipitation and emulsion destabilisation. The influence of different concentrations of trace elements on precipitation was investigated by visual examination, turbidimetry and light obscuration.

Results Ampicillin, ceftazidime, fosphenytoin and furosemide led to precipitation after mixing with TPNaq. In some samples of TPN and fluconazole, metronidazole and paracetamol, the emulsion droplet size was above the acceptance limit, although this might also be inherent to the TPN admixture. An unexpected formation of micro-precipitate correlating with increasing amounts of added trace elements might be caused by an interaction of cysteine and copper, and complicated the compatibility assessment with drugs.

Conclusions The micro-precipitate resulting from the addition of trace elements should be investigated further. This study did not provide sufficient evidence to recommend Y-site infusion of the tested drugs and the preterm admixture; however, it might offer some additional support to other compatibility data.

  • Y-site compatibility
  • copper
  • cysteine
  • emulsion stability
  • precipitation
  • trace elements
  • TPN
  • total nutrition admixture

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