Aluminum contamination

Two studies with raw materials used to prepare parenteral formulations were carried out to show their content of aluminum and arsenic [15,16]. It is possible to see in Figures 2 and 3 that aluminum and arsenic were present in all investigated raw materials. There were also different levels of contamination among the substances. While salts such as NaCl and KC1 presented low aluminum contaminations, phosphates, gluconate, and also citric acid were relatively contaminated. The authors attributed this difference to the affinity of aluminum to the latter substances. Arsenic showed a more uniform distribution of contamination. With the exception of the amino acid tyrosine, the arsenic level in all substances was below 1 qg/g, not exceeding the limits prescribed by pharmacopeias. 

Popinska, K., Kierkus, I, Lyszkowska, M., Socha, I, Pietraszek, E., Kmiotek, W., and Ksiazky, J. (1999), Aluminum contamination of parenteral nutrition additives, amino acid solutions, and lipid emulsions, Nutrition, 15, 683-686. 

Figure 5-1. Frequency of NPL Sites with Aluminum Contamination... 

Dion M, Loranger S, Kennedy G, et al. 1993. Evaluation of black spruce (picea mariana) as a bioindicator of aluminum contamination. Water Air Soil Pollut 71 29-41. 

Koo WWK, Kaplan LA. 1988. Aluminum and bone disorders with specific reference to aluminum contamination of infant nutrients. J Am Coll Nutr 7 199-214. 

Koo WWK, Kaplan LA, Krug-Wispe SK. 1988. Aluminum contamination of infant formulas. J Parenter Enteral Nutr 12 170-173. 

Tennakone BK, Wickramanayake S, Fernando CAN. 1988. Aluminum contamination from fluoride assisted dissolution of metallic aluminum. Environ Pollut 49 133-143. 

Woolfson AD, Gracey GM. 1988. Methods for the determination of trace aluminum contamination in dialysis fluids. J Clin Pharm Ther 13 243-248. 

Fig. 1. Days between the onset of severe symptoms after the end of exposure to aluminum-contaminated dialysate...

LDPE and PTFE are manufactured by processes involving little contact with metals, and should not be a major source of aluminum. On the other hand, HDPE and PP have similar manufacturing processes, based on catalysis, that involve aluminum, among other metals. The contamination risk may therefore be very high. In addition, the manufacture of the container itself can lead to aluminum contamination, considering the use of lubricants, stabilizers and other additives. For example, metal soaps, such as aluminum, magnesium, sodium, and tin, were sanctioned by the FDA to be used as stabilizers in plastic containers for parenteral nutrition solutions [76]. 

Sanz-Medel and coworkers [84] developed a system to avoid aluminum contamination in a chromatographic system, used for studying aluminum bound to serum proteins, by introducing an on-line Al-chelating scavenger pre-column. 

An example of the influence of extraneous aluminum in an in vivo study with animals can be seen in Fig. 16. The graph shows the results of aluminum determination in brain and liver of mice in a study of the effect of aluminum sulfate on delta-aminolevulinate dehydratase from these organs [110], before and after measures to avoid aluminum contamination had been adopted. In a first attempt to check the way to kill the animals and how to digest the samples, the animals were sacrificed with no measures taken to avoid contamination. The results from this experiment, when compared with those after controlling extraneous aluminum as much as possible, show an aluminum level at least 10 times higher. The results also show that, due to the extent and to the randomness of the distribution of the contamination, there are no significant differences between controls and Al-treated animals, when no attempts to avoid contamination are adopted. 

Milliner DS, Shinaberger JH, Shuman P, Coburn JW. Inadvertent aluminum administration during plasma exchange due to aluminum contamination of albumin-replacement solutions. N Engl J Med 1985 312(3) 165-7. 

Advenier E, Landry C, Colomb V, et al. Aluminum contamination of parenteral nutrition and aluminum loading in children on long-term parenteral nutrition. J Pediatr Gastroenterol Nutr 2003 36 448 53. 

Blood sample collection is potentially a major source of contamination. Needles, glass vacuum tubes, plastic syringes, anticoagulants, plastic tubes, and other equipment used in standard venipuncture methods are all suspect as sources of aluminum contamination. Each piece must be checked for aluminum contribution to the specimen. 

Little has been done to examine other transmitter systems although aluminum has been shown to have some inhibitory effects on the synaptosomal uptake of dopamine, norepinephrine, and 5-hydrojtytryptamine. Wenk and Stemmer investigated the effect, in rats, of aluminum in combination with a number of special diets, many of which were deficient in other metals. The various interactions between the metals were complex and difficult to interpret in terms of the norepinephrine and dopamine levels examined. Animals fed an aluminum-contaminated, optimal nutrient diet, showed elevated norepinephrine levels in the cerebral cortex and hippocampus, while animals fed aluminum-contaminated laboratory chow showed reduced norepinephrine levels in the... 

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