RESUMEN
BACKGROUND: Parenteral nutrition(PN) solutions containing calcium gluconate and cysteine have elevated particle counts when analyzed using laser light obscuration (LO) as recommended by the United States Pharmacopeia. It is unclear whether increased particle formation in these solutions results in decreased availability of cysteine to neonatal patients due to filtration. OBJECTIVE: The purpose of this study was to measure cysteine concentrations in neonatal PN solutions before and after filtration as well as analyze precipitates on filters. METHODS: Solutions of PN containing amino acids with and without cysteine that were compounded with calcium chloride or calcium gluconate plus potassium phosphate were analyzed using LO. Concentrations of cysteine were measured before and after filtration. The effect on particle formation of magnesium sulfate (MgSO4 ) and D70 was also evaluated. RESULTS: Multiple additives including the specific calcium or D70 additive, cysteine, and MgSO4 influenced particle formation of particles detected using LO. There was no significant decrease in cysteine concentration because of filtering and there was no difference in the amount of calcium on filters of various solutions after filtration regardless of LO particle counts. Scanning electron micrographic (SEM) analysis found no significant differences in crystal composition. Light microscopic and SEM examination did not show evidence of high particle counts on filters. CONCLUSION: The increased particle counts detected in neonatal PN solutions containing cysteine added at the time of compounding does not appear to result in increased precipitate or crystal formation. It is not associated witha decrease in cysteine delivery to patients.
Asunto(s)
Cisteína , Soluciones para Nutrición Parenteral , Aminoácidos/química , Cloruro de Calcio/análisis , Gluconato de Calcio/química , Cisteína/química , Humanos , Recién Nacido , Soluciones para Nutrición Parenteral/químicaRESUMEN
BACKGROUND: Parenteral nutrition (PN) solutions containing calcium gluconate (CaGlu) and cysteine have elevated particle counts when analyzed using laser light obscuration (LO) as recommended by the United States Pharmacopeia (USP). There are no compatibility studies for solutions compounded with cysteine and containing calcium chloride (CaCl2 ) using LO. The purpose of this study was to conduct compatibility testing for neonatal PN solutions containing CaCl2 and CaGlu with cysteine. METHODS: Solutions of amino acids (2.5%), containing either CaCl2 or CaGlu plus potassium phosphate, were compounded with 50 and 100 mg/dL cysteine. Solutions were analyzed for particle counts using LO. Maximum concentrations tested were 20 mmol/L calcium and 15 mmol/L phosphate. Three solutions containing CaCl2 (144 total solutions) and 2 containing CaGlu (96 total solutions) and the same concentration of additives were compounded. If the average particle count of replicates exceeded USP guidelines, the solution was incompatible. RESULTS: All solutions containing CaGlu had particle counts that exceeded USP guidelines for particle counts ≥10 µm (range, 86-580 particles/mL). For CaCl2 , 90 of 144 solutions were compatible (range of particle counts for all solutions, 3-121 particles/mL). Maximum compatible concentrations of CaCl2 and potassium phosphate were 15 mmol/L and 12.5 mmol/L, respectively, for solutions containing both 50 and 100 mg/dL cysteine. CONCLUSION: This study found that neonatal PN solutions containing CaGlu with added cysteine have significantly higher particle counts, exceeding USP guidelines for compatibility, than those containing CaCl2 .
Asunto(s)
Cloruro de Calcio/química , Gluconato de Calcio/química , Cisteína/química , Dispersión Dinámica de Luz/métodos , Soluciones para Nutrición Parenteral/análisis , Soluciones para Nutrición Parenteral/química , Precipitación Química , Composición de Medicamentos/métodos , Humanos , Recién NacidoRESUMEN
There are no compatibility studies for neonatal parenteral nutrition solutions without cysteine containing calcium chloride or calcium gluconate using light obscuration as recommended by the United States Pharmacopeia (USP). The purpose of this study was to do compatibility testing for solutions containing calcium chloride and calcium gluconate without cysteine. Solutions of TrophAmine and Premasol (2.5% amino acids), containing calcium chloride or calcium gluconate were compounded without cysteine. Solutions were analyzed for particle counts using light obscuration. Maximum concentrations tested were 15 mmol/L of calcium and 12.5 mmol/L of phosphate. If the average particle count of three replicates exceeded USP guidelines, the solution was determined to be incompatible. This study found that 12.5 and 10 mmol/L of calcium and phosphate, respectively, are compatible in neonatal parenteral nutrition solutions compounded with 2.5% amino acids of either TrophAmine or Premasol. There did not appear to be significant differences in compatibility for solutions containing TrophAmine or Premasol when solutions were compounded with either CaCl2 or CaGlu-Pl. This study presents data in order to evaluate options for adding calcium and phosphate to neonatal parenteral nutrition solutions during shortages of calcium and cysteine.
Asunto(s)
Cloruro de Calcio/análisis , Gluconato de Calcio/análisis , Composición de Medicamentos , Incompatibilidad de Medicamentos , Fenómenos Fisiológicos Nutricionales del Lactante , Soluciones para Nutrición Parenteral/química , Aminoácidos/química , Aminoácidos/normas , Dispersión Dinámica de Luz , Electrólitos/química , Electrólitos/normas , Glucosa/química , Glucosa/normas , Humanos , Concentración de Iones de Hidrógeno , Recién Nacido , Rayos Láser , Concentración Osmolar , Soluciones para Nutrición Parenteral/normas , Farmacopeas como Asunto , Fosfatos/química , Compuestos de Potasio/química , Soluciones/química , Soluciones/normas , Estados UnidosRESUMEN
BACKGROUND: Previous studies of compatibility of calcium chloride (CaCl2) and phosphates have not included particle counts in the range specified by the United States Pharmacopeia. Micro-flow imaging techniques have been shown to be comparable to light obscuration when determining particle count and size in pharmaceutical solutions. OBJECTIVE: The purpose of this study was to do compatibility testing for parenteral nutrition (PN) solutions containing CaCl2 using dynamic light scattering and micro-flow imaging techniques. METHODS: Solutions containing TrophAmine (Braun Medical Inc, Irvine, CA), CaCl2, and sodium phosphate (NaPhos) were compounded with and without cysteine. All solutions contained standard additives to neonatal PN solutions including dextrose, trace metals, and electrolytes. Control solutions contained no calcium or phosphate. Solutions were analyzed for particle size and particle count. Means of Z-average particle size and particle counts of controls were determined. Study solutions were compared to controls and United States Pharmacopeia (USP) Chapter 788 guidelines. The maximum amount of Phos that was compatible in solutions that contained at least 10 mmol/L of Ca in 2.5% amino acids (AA) was determined. Compatibility of these solutions was verified by performing analyses of 5 repeats of these solutions. Microscopic analyses of the repeats were also performed. RESULTS: Amounts of CaCl2 and NaPhos that were compatible in solutions containing 1.5%, 2%, 2.5%, and 3% AA were determined. The maximum amount of NaPhos that could be added to TrophAmine solutions of > = 2.5% AA containing at least 10 mmol/L of CaCl2 was 7.5 mmol/L. Adding 50 mg/dL of cysteine increased the amount of NaPhos that could be added to solutions containing 10 mmol/L of CaCl2 to 10 mmol/L. CONCLUSION: Calcium chloride can be added to neonatal PN solutions containing NaPhos in concentrations that can potentially provide an intravenous intake of adequate amounts of calcium and phosphorus.