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Calcium and phosphate solubility in neonatal parenteral nutrient solutions containing Aminosyn-PF or TrophAmine
1Hospital Products Division (HPD), Medical Affairs, Abbott Laboratories, Abbott Park, IL 60064.
Insights
Calcium and phosphate solubility in neonatal parenteral nutrition was higher with increased amino acid and dextrose concentrations. No significant differences were found between Aminosyn-PF and TrophAmine amino acid solutions.
Area of Science:
- Parenteral Nutrition
- Clinical Pharmacy
- Biochemistry
Background:
- Neonatal total parenteral nutrition (TPN) requires careful formulation to ensure nutrient delivery and prevent precipitation.
- Calcium and phosphate are essential but prone to precipitation in TPN solutions, posing risks to neonates.
Purpose of the Study:
- To determine the maximum solubilities of calcium and phosphate in neonatal TPN solutions compounded with two different amino acid formulations.
- To evaluate the impact of amino acid and dextrose concentrations, and cysteine hydrochloride addition on calcium-phosphate solubility.
Main Methods:
- Eight TPN solutions were prepared using Aminosyn-PF or TrophAmine at varying amino acid and dextrose concentrations.
- Cysteine hydrochloride was added to half the solutions.
- Calcium and phosphate were added incrementally, and solutions were assessed for precipitation visually and microscopically after storage and heating.
- Solubility curves were generated.
Main Results:
- Calcium and phosphate solubility increased with higher concentrations of amino acids and dextrose.
- No significant differences in calcium and phosphate solubility were observed between Aminosyn-PF and TrophAmine at 2.5% amino acid concentration, with or without cysteine hydrochloride.
- Higher amino acid and dextrose concentrations improved calcium and phosphate solubility.
Conclusions:
- Higher concentrations of amino acids and dextrose enhance calcium and phosphate solubility in neonatal TPN solutions.
- Aminosyn-PF and TrophAmine demonstrated comparable calcium and phosphate solubility profiles at the tested 2.5% amino acid concentration.
- Formulation adjustments, including higher nutrient concentrations, can optimize TPN safety and efficacy.
Abstract:
The maximum solubilities of calcium and phosphate in neonatal total parenteral nutrient (TPN) solutions compounded using Aminosyn-PF or TrophAmine amino acid injection were determined. Eight solutions were compounded from Sterile Water for Injection, USP, 50% dextrose injection, usual electrolytes and trace metals, and Aminosyn-PF 7% or TrophAmine 6% to obtain concentrations of amino acids 2.5% and dextrose 25% and amino acids 1% and dextrose 10%. Cysteine hydrochloride was added to half of the solutions at a concentration of 40 mg/g of protein. The pH of each solution was determined at various times during admixture preparation. The solutions were divided into 20-mL aliquots, and phosphate and calcium were added to each aliquot at concentrations of 2.5 to 50 meq/L of calcium and 5 to 50 mmol/L of phosphate. All solutions were inspected visually for signs of precipitation or crystallization after 18 hours of storage at room temperature and again after 30 minutes in a 37 +/- 1 degrees C water bath. Samples with no visible signs of precipitation were filtered, and the filter membrane was inspected under a microscope. Solubility curves were prepared by plotting the concentrations of calcium and phosphate at which either visual or microscopic precipitation occurred. Calcium and phosphate solubility was greater in the solutions with higher concentrations of amino acids and dextrose. In contrast to the results of some previous studies, no important differences in calcium and phosphate solubility were observed between Aminosyn-PF and TrophAmine in solutions containing amino acid concentrations of 2.5%, with or without added cysteine hydrochloride.(ABSTRACT TRUNCATED AT 250 WORDS)