Contenido de aluminio en componentes individuales utilizados para preparar mezclas de nutrición parenteral en Argentina, y su comparación con la legislación internacional - Aluminum content in individual components, used to prepare adult total parenteral nutrition mixtures in argentine, and in comparison with international regulation

Introduction: Aluminum (Al) is a toxic element which may contaminate pharmaceutical products used as indi-vidual 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 detecte...

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Detalles Bibliográficos
Autores principales: Menéndez, A. M., Farías, S. S., Servant, R., Morisio, Y., Misischia, Y., Simon, S., Weisstaub, A. R., Pita Martín de Portela, M. L.
Lenguaje:Español
Publicado: Universidad de Belgrano - Facultad de Ciencias Exactas y Naturales - Proyectos de Investigación 2014
Materias:
Aluminio
Componentes individuales para nutrición parenteral
Mezclas de nutrición parenteral
Legislación internacional
Legislación argentina
Aluminum
Individual products for parenteral nutrition
Parenteral nutrition mixtures
International regu-lations (FDA)
Argentine legislation
Acceso en línea:http://repositorio.ub.edu.ar/handle/123456789/2760
Aporte de:
Repositorio Institucional - Universidad de Belgrano (UB) de Universidad de Belgrano
Descripción
Sumario:Introduction: Aluminum (Al) is a toxic element which may contaminate pharmaceutical products used as indi-vidual 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 inter-national regulations (FDA); 3) to calculate the total amount of Al administered to adult and children recei-ving 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 compo-nents 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.

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