Stability of all-in-one standard formulae for paediatric parenteral nutrition.
The Robert Debré Hospital pharmacy unit ensures an annual manufacturing rate of 20,000 parenteral nutrition bags. Until 1999, these bags consisted in binary admixtures, fat emulsions being administered to the patient via a "Y" connexion on the catheter. Since then, all-in-one standard formulae have been established and are manufactured using a Baxa MM23 automated compounder. The aim of this study was to assess the physico-chemical stability of all-in-one admixtures, in order to ensure patient administration safety (mainly avoiding precipitation risks between the nutrients). Three bags of each standard formula were manufactured in monocompartmental bags. Stability assays consisted in the assessment of the admixture's (1) macroscopic aspect, (2) drop size measurement, (3) zeta potential measurement, (4) pH measurement, and (5) osmolality measurement. Tests were conducted between D0 (manufacturing day) and D10 (10 days after manufacture). All-in-one admixtures manufactured according to the established standard formulae were found to be stable for at least 10 days, provided they are kept away from light and at a temperature of +4 degrees C.
Rey
J B
JB
Service Pharmacie et Laboratoire de Toxico-pharmacologie, Hôpital Robert Debré, 48, boulevard Sérurier-75019 Paris, France. jbrey@chu-reims.fr
Faure
C
C
Brion
F
F
D000596:Amino Acids / Q000032:analysis; D011232:Chemical Precipitation; D002648:Child; D004355:Drug Stability; D004573:Electrolytes / Q000032:analysis; D005217:Fat Emulsions, Intravenous / Q000032:analysis; D006801:Humans; D006863:Hydrogen-Ion Concentration; D009994:Osmolar Concentration; D010288:Parenteral Nutrition / Q000592:standards*; D014131:Trace Elements / Q000032:analysis; D014815:Vitamins / Q000032:analysis
D000596:Amino Acids; D004573:Electrolytes; D005217:Fat Emulsions, Intravenous; D014131:Trace Elements; D014815:Vitamins