Aluminum contamination of parenteral nutrition additives, amino acid solutions, and lipid emulsions

Popińska, Katarzyna; Kierkuś, Jarosław; Łyszkowska, M.; Socha, Jerzy; Pietraszek, Ewa; Kmiotek, Witold; Książyk, Janusz

doi:10.1016/s0899-9007(99)00124-0

Cited by 56 publications

(27 citation statements)

References 6 publications

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“…Plastic particle migration during IV infusion is linked to infantile pulmonary hypertension [85]. Other particulate contaminants, such as metallic particles, can be found during IV infusion, e. g. aluminum particles detected in premature babies during total parenteral nutrition resulted in death [86,87]. Indeed, many commonly used IV solutions, especially parenteral nutrition solutions, may be contaminated by traces of aluminum, leading to a high risk of aluminum intoxication in exposed infants.…”

Section: Number and Characteristicsmentioning

confidence: 99%

Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients

Perez

Maiguy-Foinard

Barthélémy

et al. 2016

Pharmaceutical Technology in Hospital Pharmacy

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AbstractOne of the fundamental principles guiding the pharmaceutical quality of parenteral products is to prevent injecting contaminants from microbiological, chemical or physical sources. It is just as difficult to ensure the absence of chemical and particulate contaminants in injectable products as it is to weigh up the microbiological risk. The problem of particulate matter is mainly related to the preparing and administrating of injectable drugs rather than through the contamination of marketed products. Particulate contamination also arises

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Section: Number and Characteristicsmentioning

confidence: 99%

Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients

Perez

Maiguy-Foinard

Barthélémy

et al. 2016

Pharmaceutical Technology in Hospital Pharmacy

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“…Although the most common source of metal particles is processing equipment, they have also been found to contaminate the raw materials used in drug product formulation (43). Lead and chromium are considered among the most dangerous metal contaminants, but serious adverse events related to aluminum ingestion have also been well documented (43)(44)(45)(46). Aluminum toxicity in premature infants has been linked to total parenteral nutrition admixtures (45,46) and contributed to the issuance of FDA regulations regarding the aluminum content of drug products used for total parenteral nutrition (47).…”

Section: Compositionmentioning

confidence: 99%

Particulate Matter in Injectable Drug Products

Langille

2013

PDA Journal of Pharmaceutical Science and Technology

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Clinicians have had concerns about particulate matter contamination of injectable drug products since the development of the earliest intravenous therapeutics. All parenteral products contain particulate matter, and particulate matter contamination still has the potential to cause harm to patients. With tens of millions of doses of injectable drug products administered in the United States each year, it is critical to understand the types and sources of particulate matter that contaminate injectable drug products, the possible effects of injected particulate matter on patients, and the current state of regulations and standards related to particulate matter in injectable drug products. Today, the goal of manufacturers, regulators, and standards-setting organizations should be to continue to minimize the risk of particle-induced sequelae, especially in high-risk patients, without trading unnecessary manufacturing burden for minimal safety gains.

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“…(1) Interrupción del ciclo enterohepático (enfermedad o resección ileal) [47,48] (2) Estasis intestinal con sobrecrecimiento bacteriano intraluminal subsiguiente y/o translocación (endotoxinemia) [49] (3) Sepsis recurrente en relación con el catéter [50,51] (4) Prematurez [51] (5) Ingestión inadecuada de macronutrientes, como infusión de NP continua con ingestión excesiva de glucosa, conducente a hiperinsulinismo y esteatosis [52] , y provisión inadecuada de aminoácidos [49] (6) Ingestión excesiva de ácidos grasos poliinsaturados de cadena larga con su lipoperoxidación asociada [53,54] , y contenido elevado en fi toesteroles de emulsiones basadas en aceite de soja [55] (7) Sobrecarga de aluminio, hierro y/o cromo [56][57][58] . Los lactantes prematuros y/o pequeños para la edad gestacional con enterocolitis necrosante grave presentan un riego especialmente elevado de tener insufi ciencia hepática y fallo hepático terminal prematuro, debido a la combinación de prematuridad, suboclusión, sepsis gramnegativa, reposo intestinal prolongado, infusión de NP continua en lugar de cíclica y sepsis recurrente relacionada con el catéter.…”

Section: Factores Y Tratamiento De La Insufi Ciencia Hepáticaunclassified

Enteropatía congénita y trasplante intestinal

Goulet

2006

Ann Nestlé [Esp]

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La insuficiencia intestinal (II) exige el uso de nutrición parenteral (NP). Entre las causas de II prolongada grave destacan el síndrome del intestino corto, trastornos de la motilidad grave (aganglionosis total o subtotal o síndrome de seudoobstrucción intestinal crónica) y enfermedades congénitas del desarrollo de los enterocitos. Puede aparecer insuficiencia hepática grave en pacientes con II como consecuencia de una enfermedad digestiva subyacente y una NP no adaptada. La sepsis relacionada con el catéter y/o la trombosis vascular extensa pueden impedir el mantenimiento de una NP segura y eficiente. Por tanto, el tratamiento de pacientes con II exige la identificación precoz del proceso y el análisis de su riego de irreversibilidad. La cronología de la derivación para trasplante intestinal continúa siendo una cuestión crucial. En consecuencia, la asistencia debe incluir tratamientos adaptados a cada una de las etapas de la II, basándose en la puesta en práctica de un enfoque multidisciplinario en centros que cuenten con gastroenterología pediátrica, experiencia en NP, programa de NP domiciliaria, cirugía pediátrica y programa de trasplantes de hígado e intestino.

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Aluminum contamination of parenteral nutrition additives, amino acid solutions, and lipid emulsions

Cited by 56 publications

References 6 publications

Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients

Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients

Particulate Matter in Injectable Drug Products

Enteropatía congénita y trasplante intestinal

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