Calcium Chloride and Calcium Gluconate in Neonatal Parenteral Nutrition Solutions without Cysteine: Compatibility Studies Using Laser Light Obscuration Methodology

Nutrients. 2018 Feb 14;10(2):208. doi: 10.3390/nu10020208.

Abstract

There are no compatibility studies for neonatal parenteral nutrition solutions without cysteine containing calcium chloride or calcium gluconate using light obscuration as recommended by the United States Pharmacopeia (USP). The purpose of this study was to do compatibility testing for solutions containing calcium chloride and calcium gluconate without cysteine. Solutions of TrophAmine and Premasol (2.5% amino acids), containing calcium chloride or calcium gluconate were compounded without cysteine. Solutions were analyzed for particle counts using light obscuration. Maximum concentrations tested were 15 mmol/L of calcium and 12.5 mmol/L of phosphate. If the average particle count of three replicates exceeded USP guidelines, the solution was determined to be incompatible. This study found that 12.5 and 10 mmol/L of calcium and phosphate, respectively, are compatible in neonatal parenteral nutrition solutions compounded with 2.5% amino acids of either TrophAmine or Premasol. There did not appear to be significant differences in compatibility for solutions containing TrophAmine or Premasol when solutions were compounded with either CaCl₂ or CaGlu-Pl. This study presents data in order to evaluate options for adding calcium and phosphate to neonatal parenteral nutrition solutions during shortages of calcium and cysteine.

Keywords: calcium chloride; calcium gluconate; compatibility; neonates; parenteral nutrition.

Publication types

  • Comparative Study

MeSH terms

  • Amino Acids / chemistry
  • Amino Acids / standards
  • Calcium Chloride / analysis*
  • Calcium Gluconate / analysis*
  • Drug Compounding*
  • Drug Incompatibility*
  • Dynamic Light Scattering
  • Electrolytes / chemistry
  • Electrolytes / standards
  • Glucose / chemistry
  • Glucose / standards
  • Humans
  • Hydrogen-Ion Concentration
  • Infant Nutritional Physiological Phenomena*
  • Infant, Newborn
  • Lasers
  • Osmolar Concentration
  • Parenteral Nutrition Solutions / chemistry*
  • Parenteral Nutrition Solutions / standards
  • Pharmacopoeias as Topic
  • Phosphates / chemistry
  • Potassium Compounds / chemistry
  • Solutions / chemistry
  • Solutions / standards
  • United States

Substances

  • Amino Acids
  • Electrolytes
  • Parenteral Nutrition Solutions
  • Phosphates
  • Potassium Compounds
  • Solutions
  • amino-acid, glucose, and electrolyte solution
  • potassium phosphate
  • Glucose
  • Calcium Chloride
  • sodium phosphate
  • Calcium Gluconate