Calcium/Phosphate Solubility Curves for Premasol and Trophamine Pediatric Parenteral Nutrition Formulations
Autor: | Thomas Gonyon, Steve T Wyrwa, Laura L Gripman, Dipa Patel, Jan Y Eilert, Heather Owen, John-Bruce D. Green |
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Rok vydání: | 2019 |
Předmět: |
0303 health sciences
030309 nutrition & dietetics business.industry Clinical Investigations chemistry.chemical_element Pharmacology Calcium Phosphate 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Parenteral nutrition chemistry Pediatrics Perinatology and Child Health Medicine 030211 gastroenterology & hepatology Pharmacology (medical) Solubility business Trophamine |
Zdroj: | The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG. 24(1) |
ISSN: | 1551-6776 |
Popis: | OBJECTIVES Calcium and phosphate incompatibility in parenteral nutrition formulations remains a critical concern for patient safety. This study examined calcium phosphate solubility for 2-in-1 admixtures prepared using 2 commercially available pediatric amino acid solutions (Premasol, Baxter Healthcare Corp; or Trophamine, B. Braun Medical Inc), applying identical test methods, storage conditions, and acceptance criteria. METHODS Parenteral 2-in-1 admixtures included amino acid; dextrose; static concentrations of sodium, potassium, and magnesium, and varying concentrations of calcium (0–60 mEq/L), phosphate (15–50 mmol/L), and cysteine. Three replicate samples were stored for 48 hours at 40°C ± 2°C and then visually inspected for particulate matter, evaluated for subvisible particulate matter, when particulate matter was noted, microscopic examination was performed to confirm the presence of calcium phosphate crystals. Pass criteria were: all replicates free of visible particulate matter related to calcium phosphate crystals and particle counts below US Pharmacopeia limits. RESULTS Premasol and Trophamine generated identical calcium phosphate curves for 2% amino acid formulations containing 20% dextrose with/without cysteine, and similar curves for the 1% or 3% amino acid formulations containing 10% or 20% dextrose with/without cysteine. Calcium phosphate particles were identified in failed samples by scanning electron microscopy/energy dispersive X-ray spectroscopy. Calcium phosphate solubility was higher in formulations containing cysteine 40 mg/g amino acid vs. cysteine 20 mg/g amino acid and in cysteine 20 mg/g amino acid vs. no cysteine. CONCLUSIONS Admixtures made with 1%, 2%, or 3% Premasol or Trophamine have essentially equivalent calcium phosphate solubility curves when tested with identical methods, storage conditions, and acceptance criteria. |
Databáze: | OpenAIRE |
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