Aluminum Content of Neonatal Parenteral Nutrition Solutions.
BACKGROUND
Calcium chloride (CaCl2) has been the only calcium additive available in the United States that has a low aluminum (Al) content. Calcium gluconate in glass vials (CaGluc-Gl) has a high Al content while calcium gluconate in plastic vials (CaGluc-Pl) has a low Al content. The purpose of this study was to measure Al concentrations in neonatal parenteral nutrition (PN) solutions prepared using various calcium additives.


METHODS
Samples of solutions compounded with CaCl2or CaGluc-Gl and sodium phosphate (NaPhos) as well as CaGluc-Pl and sodium glycerophosphate (NaGP) with and without cysteine were analyzed for Al content. Samples of the cysteine and calcium gluconate additives were also sent for analysis.


RESULTS
Solutions containing CaCl2and CaGlu-Pl had mean Al concentrations of 1.2-2.3 mcg/dL, while those with CaGlu-Gl had mean concentrations of 14.6-15.1 mcg/dL. Solutions made with NaGP were low in Al content. The measured Al content of 2 lots of the cysteine additive were 168 ± 23 mcg/L and 126 ± 5 mcg/L. The Al concentration equalled 2730 ± 20 mcg/L for the CaGlu-Gl additive and 310 ± 80 mcg/L for the CaGlu-Pl additive.


CONCLUSIONS
The study indicates that solutions containing CaCl2or CaGluc-Pl and NaPhos or NaGP are low in Al content. Using these options for calcium and phosphate additives can limit aluminum intake from neonatal PN to levels within the Food and Drug Administration guideline of ≤5 mcg/kg/d.
1 Northwest Newborn Specialists, PC, and Pediatrix Medical Group, Portland, Oregon, USA.
Robert K
RK
Huston
2 Neonatal Pharmacy, Randall Children's Hospital at Legacy Emanuel, Portland, Oregon, USA.
Carl F
CF
Heisel
2 Neonatal Pharmacy, Randall Children's Hospital at Legacy Emanuel, Portland, Oregon, USA.
Benjamin R
BR
Vermillion
3 Department of Pharmaceutical Sciences, Oregon State University, Corvallis, Oregon, USA.
J Mark
JM
Christensen
4 Radiation Center, Oregon State University, Corvallis, Oregon, USA.
Leah
L
Minc
D000535:Aluminum / Q000032:analysis*; D002122:Calcium Chloride / Q000737:chemistry; D002125:Calcium Gluconate / Q000737:chemistry; D003545:Cysteine / Q000737:chemistry; D005994:Glycerophosphates / Q000737:chemistry; D057947:Parenteral Nutrition Solutions / Q000008:administration & dosage / Q000737:chemistry* / Q000592:standards; D010710:Phosphates / Q000737:chemistry; D014481:United States; D014486:United States Food and Drug Administration
D005994:Glycerophosphates; D057947:Parenteral Nutrition Solutions; D010710:Phosphates; C029620:alpha-glycerophosphoric acid; D000535:Aluminum; D003545:Cysteine; D002122:Calcium Chloride; C018279:sodium phosphate; D002125:Calcium Gluconate
calcium chloride; calcium gluconate; cysteine; plastic vials; sodium glycerophosphate