Compatibility of Maximum Inorganic and Organic Calcium and Phosphate Content in Neonatal Parenteral Solutions

Abstract

The purpose of the study was to determine the maximum safe concentration of calcium and phosphate in neonatal parenteral nutrition (PN) solutions when various combinations of inorganic and organic salts are applied. Twelve PN solutions for neonatal use were aseptically prepared. Increasing concentrations of inorganic and organic calcium and phosphate were added to the standard formulas. Each admixture was separately tested according to the following conditions; after mixing, at 37 °C for 24 hr, and the maximum safe combination of calcium and phosphate were stored at 4 °C for 30 days and followed by 24 hr at 37 °C. Visual inspections and microscopic observation of undiluted PN solutions as well as the membrane filter after filtration of the PN solution, pH evaluation, and absorbance were examined. The safe maximum concentration of organic and inorganic calcium and phosphate were proposed individually for each composition of parenteral nutrition solutions. Surprisingly, organic calcium with organic phosphate showed precipitation but over the therapeutic range. The protective effect of amino acid was observed and higher concentrations of calcium and phosphate were free of precipitation. This work is valuable in daily practice as it allows an increase in the limits of calcium and phosphate in PN solutions for infants.

S3-Leitlinie Heimenterale und heimparenterale Ernährung der Deutschen Gesellschaft für Ernährungsmedizin (DGEM)

“…Die Stabilität und Kompatibilität von auf individuellen Rezepturen basierenden AiO-Nährlösungen müssen durch geeignete Labormethoden geprüft und dokumentiert werden. Hierbei sollten verschiedene validierte Methoden kombiniert werden, um die Stabilität zu überprüfen, wie beispielsweise die Öl-/Wasser-Stabilität von Nährlösungen, Lichtmikroskopie oder pH-Messung [172,217,442,443], siehe hierzu auch Empfehlung 120.…”

“…Die Literaturextrapolation für die Stabilität ist aufgrund der Komplexität der Beimischungen nicht ausreichend [3,217,[443][444][445].…”

Parenteral nutrition compatibility and stability: A comprehensive review

“…Lysine has been identified as the amino acid most likely to complex with calcium, and the degree of that complexation is also pH dependent. Better determination of safe PN admixtures, especially for neonates, will require additional study using different amino acids products, as well as varying the salt form and concentrations of calcium and phosphate 116 …”

“…Better determination of safe PN admixtures, especially for neonates, will require additional study using different amino acids products, as well as varying the salt form and concentrations of calcium and phosphate. 116…”

The Role of Nutrition in the Prevention and Management of Bronchopulmonary Dysplasia: A Literature Review and Clinical Approach

“…Recently, doses of calcium and phosphate provided through PN were reviewed and much higher doses were recommended than previously: in the first postnatal week Ca 32-80 mg/kg/day and P 31-62 mg/kg/day; subsequently, Ca 100-140 mg/kg/day and P 77-108 mg/kg/day, with a Ca/P ratio of 1.3 (mass) or 1 (molar) [76,86]. These very high doses are difficult to achieve in infants with BPD due to fluid restriction and the inherent risk of calcium phosphate precipitation in parenteral nutrition solutions [87,88]. During the first postnatal days, it seems prudent not to exceed concentrations of Ca and P of 68 mg/dL and 52.7 mg/dL, respectively [89].…”