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INTRODUCTION: Aluminum (Al) is a toxic element which may contaminate pharmaceutical products used as individual components to prepare total parenteral nutrition mixtures (TPN). OBJECTIVES: 1) to determine Al levels in the individual components used to prepare TPN mixtures; 2) to compare detected Al levels with those imposed by international regulations (FDA); 3) to calculate the total amount of Al administered to adult and children receiving those typical TPN mixtures. METHODS: Al was determined by Inductively Coupled Plasma- Atomic Emission Spectrometry (ICP-OES) (Perkin Elmer OPTIMA 5100 DV) in 44 individual products, from different labs and lots, belonging to 16 components available in Argentina: dextrose and amino acids for adult formulas and for pediatric formulas: lípids; potassium chloride; sodium chloride, magnesium sulfate; sodium phosphate; calcium gluconate; sodium glycerophosphate, zinc sulfate; multitrace elements; steril water (ampoules and great volume presentations). RESULTS: Al levels were detected in 43 of the 44 the studied components, except sterile water. The components of large volume presented between 249 y 1,580 µg Al/ L, between 4 and 180 times FDA established levels (25 µg Al/ L). Small volume components presented Al levels between 85 y 4,909 g/ L, not declared in labels. CONCLUSIONS: The highest amounts of Al were detected in calcium gluconate, sodium phosphate and multitrace elements. 2) Usually prescribed TPN mixtures would have higher Al levels than those accepted by FDA regulation; 3) The highest aluminum concentration was provided by dextrose, amino acids and lipids in adult TPN mixtures. In neonate TPN mixtures, Al highest amounts were provided by dextrose and calcium gluconate. The calculated concentration of Al in TPN mixtures was higher than those stipulated by international regulation (5 µg Al/kg (body weight)/ d). It would be advisable for manufacturers to declare the content of aluminum in the label, with the aim of avoiding toxicities which would compromise the critical patients' evolution.

Introducción: aluminio (Al) es un elemento tóxico que puede ser contaminante de productos farmacéuticos utilizados para preparar mezclas de nutrición parenteral (NP). Objetivos: 1) determinar la concentración de Al en componentes individuales utilizados para preparar mezclas de NP; 2) comparar las cantidades detectadas con los límites de la regulación internacional (FDA); 3) calcular la cantidad de Al administrada en fórmulas habituales de NP para neonatos, niños y adultos. Materiales y métodos: El Aluminio fue determinado por Espectroscopía de Emisión Atómica-Plasma-Inductivo de Argón (Perkin Elmer 5100 DV) en 44 productos comerciales, de diferentes laboratorios y lotes, correspondientes a 16 componentes individuales: dextrosa; aminoácidos para adultos y pediátricos; lípidos; cloruro de potasio; cloruro de sodio, sulfato de magnesio; fosfato de sodio; gluconato de calcio; glicerofosfato de sodio; sulfato de zinc; elementos multitraza; agua estéril en ampollas y de gran volumen. Resultados: Todos los componentes de gran volumen, excepto el agua, contenían entre 249 y 1.580 µg/L, superando entre 4 y 180 veces mas que los niveles establecidos por la FDA (25 µg/L). Los componentes de pequeño volumen contenían entre 85 y 4.909 µg/L, no declarados en los rótulos. Conclusiones: 1) La mayor cantidad de aluminio se encontró en el gluconato de calcio, fosfato de sodio y elementos multitraza. 2) Las mezclas de uso habitual para NP presentan niveles de Al mayores al límite de FDA. Los componentes que aportan mayor cantidad de aluminio en las mezclas de NP para adultos son: glucosa, aminoácidos y lípidos, pero en las de neonatos, el mayor aporte proviene de la dextrosa y gluconato de calcio. 3) En las mezclas de NP para neonatos, niños y adultos la cantidad de aluminio administrado por kg de peso supera la recomendación de FDA (5 µg/kg de peso /día). Los productos comerciales deberían declarar el contenido de Al para no comprometer la evolución de los pacientes graves.

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OBJECTIVES: 1) to determine zinc and copper levels of contamination in the individual component solutions used to prepare the pediatric total parenteral nutrition mixtures in Argentina; 2) to compare zinc and copper amounts prescribed by the physician with the true amount given to a neonate weighing 1.2 kg and to a child weighing 10 kg, who would receive total parenteral nutrition formulas prepared with those component solutions. MATERIALS AND METHODS: Zn and Cu were determined by atomic absorption spectrophotometry in 59 individual solutions belonging to 14 components chosen between the commercial products available in Argentina. RESULTS: zinc and copper, as contaminants, were found neither in the sterile water, nor in the potassium chloride or in the vitamin solutions. Zinc, but no copper, was detected in sodium chloride, manganese sulfate, chromium chloride and seleniose acid solutions. Zinc and copper were detected in dextrose, amino acids, calcium gluconate and lipid solutions at variable levels. Zinc sulfate solutions contained between 90.4% and 140% of the declared content and a variable contamination with copper. Copper sulfate solutions presented between 4% and 18% less the declared copper concentration and a variable contamination with zinc. Dextrose and lipid solutions presented the highest amount of zinc and copper. Therefore, the total parenteral mixtures prepared with the analyzed solutions must have had an excess of zinc and copper in relation to the prescription: ranging between 103% and 161% and between 7%-426% higher than the Zn and Cu amounts prescribed for neonates, respectively; the excess in the total parenteral nutrition for a child weighing 10 kg would ranged between 105% and 189% and between 7%-365% higher than the prescribed for Zn and Cu, respectively. CONCLUSIONS: 1) Nine components presented Zn and five Cu, both of them not declared in the label; 2) the usually prescribed total parenteral nutrition mixtures must have had a zinc and copper amount higher than the prescribed one according to international recommendations; 3) those figures would be safe in patients without complications, but it would be harmful in renal failure, hepatic compromise or colestasis mainly in pediatric patients; 4) It would be advisable to declare in the label the true content of zinc and copper, with the aim to avoid deficiencies and excess which would compromise the evolution of pediatric patients.

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OBJECTIVE: To study, in healthy women, the correlation between the basal urinary zinc/creatinine ratio and dietary zinc intake. SUBJECTS: A group of 36 healthy female University students was evaluated. Mean age and body weight were, respectively, 25.6+/-3.3 years and 54.4+/-7.0 kg. METHODS: Basal urine was collected; Zn was determined by AAS and Creatinine (Creat) by the Jaffe method. A nutritional survey of seven days was recorded. Mean daily dietary intake of energy (DE) and zinc (DZn) were calculated according to the INCAP and English or German Food Composition Tables, respectively. RESULTS: Mean dietary daily intake were as follows (x +/- SD): Energy (kcal): 1606+/-570; zinc (mg): 9.1+/-3.8; basal urine Zn/Creat ratio: 0.41+/-0.24. Individual values of the Zn/Creat ratio correlated with dietary Zn (r=0.481, p=0.0339); data grouped according to ranges of dietary Zn fit the following equation: Zn/Creat=0.160+/-0.034 DZn (mg/day); (r=0.870, p=0.00497). CONCLUSIONS: These results showed that the basal urinary Zn/Creat ratio could be a useful indicator of dietary Zn intake in healthy adult women.

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