Parenteral nutrition containers

FIGURE 7 Influence of a lipid emulsion and daylight on peroxide levels in freshly prepared solutions of parenteral nutrition containing multivitamins (PN + MVI and PN + Lipid + MVI). (PN = parenteral nutrition MVI = multi vitamin preparation.) The data represent the mean SEM,n = 3 the variations are not depicted because of their small size relative to the symbols. The peroxide content rose significantly over time (P < 0.001), and exposure to daylight had a significant effect on peroxide generation (P < 0.001) [33]. 

Amino acid-glucose solutions used in total parenteral nutrition of humans lack choline. The lipid emulsions that deliver extra calories and essential fatty acids during parenteral nutrition contain choline in the form of lecithin (20% emulsion contains 13.2 mmol 1 ). Humans treated with parenteral nutrition require 1-1.7 mmol of choline-containing phospholipid per day during the first week of parenteral nutrition therapy to maintain plasma choline levels. 

Alimentary biotin deficiency is rare. It may, however, occur in patients on long-term parenteral nutrition lacking biotin or in persons who frequently consume raw egg white. Raw egg white contains a biotin-binding glycoprotein, called avidin, which renders biotin biologically unavailable. Pharmacological doses of the vitamin (1-10 mg/d) are then used to treat deficiency symptoms. There are no reports of toxicity for daily oral doses up to 200 mg and daily intravenous doses of up to 20 mg [2]. 

Other causes include magnesium-containing antacids in patients with renal insufficiency, enteral or parenteral nutrition in patients with multiorgan system failure, magnesium for treatment of eclampsia, lithium therapy, hypothyroidism, and Addison s disease. 

Lipid peroxides are also able to react with other components of parenteral nutrition admixtures (trace elements), causing a drop in pH with the subsequent potential for physical-chemical instability [29]. Table 11 shows the peroxide value and the pH drop in a pure lipid emulsion and a lipid-containing AlO admixture stored in EVA bags under different conditions of temperature and light exposure in the presence and absence of trace elements. 

Peroxide formation has also been observed in multivitamin solutions for parenteral nutrition. Lavoie and co-workers [30] have studied the action of light, air, and composition on the stability of multivitamin formulations, and also total parenteral nutrition (TPN) admixtures containing and not containing vitamins and fatty acids. They analyzed the generation of peroxide in multivitamin solutions and in TPN for adults and neonates. The analysis of multivitamin solutions for enteral use revealed the presence of peroxides at the initial opening of the bottle. The levels were higher in Poly-Vi-Sol (vitamin A, Vitamin D, and vitamin C, vitamin Bb riboflavin, and... 

Acquired biotin deficiency is extremely rare but may occur in special conditions such as long-term parenteral nutrition without biotin supplementation, short bowel syndrome and after excessive intake of raw egg white, which contains the potent bio-tin-binding protein avidin. The main symptoms are alopecia and skin abnormalities which resolve after administration of biotin [2, 30]. 

Their use as an injectable warrants assurance of product sterility. Whereas the FDA-preferred heat-sterilization process is acceptable for total parenteral nutritional (TPN) emulsions, it could affect chemical as well as physical stability of emulsions containing therapeutic agents. Recently, data supporting the Liter sterilization of emulsions have been published. 

Severe negative nitrogen balance may occasionally have to be corrected by hyperalimentation or total parenteral nutrition (TPN). Intravenous solutions used in TPN contain essential and nonessential amino acids, plus a source of calories in the form of fat and carbohydrate. They "spare" the administered amino acids and allow them to be used for tissue repair. The TPN fluid must also contain all other nutritional factors required for life, including essential fatty acids, vitamins, and minerals. Severe metal and essential fatty acid deficiencies have been observed in situations in which such inclusions had not been made. 

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]. 

Persons at risk for EFA deficiency tend to be the same as those at risk for vitamin E deficiency. Some signs are shared by both defidencies. Premature infants may be at risk for EFA deficiency because of their low stores of lipids and their rapid growth, especially when they are fed diets that do not contain EFAs. For example, fats have been omitted from diets used to feed preterm infants (to avoid a variety of complications). EFA deficiency may develop later in life with fat malabsorption syndromes, EFA deficiency has presented in adults fed by total parenteral nutrition for longer periods, where EFAs had not been included in the liquid diet. 

The second type of container is the single-dose container. This container should contain a quantity designed for a single-parenteral preparation (not to exceed 1 L) and should contain a suitable antimicrobial additive. Larger packaging volumes may be used for compounds designed for use with hemofiltration, dialysis, or parenteral nutrition. 

These various reports stress the need to supplement parenteral nutrition with thiamine-containing vitamins unless there is adequate dietary intake, and to monitor serum thiamine and erythrocyte transketolase activity so that supplementary thiamine can be given in good time, if necessary intravenously (45). Giving thiamine will not rectify the various disorders if hepatic function is severely disturbed, because then thiamine is not phosphorylated and hence remains physiologically inactive. 

It is estimated that the minimum daily requirement of folate is 5 micrograms/kg. Liver stores are about 160 micrograms in premature children, and 220 micrograms in full-term infants. Infants who require parenteral nutrition will rapidly become folate deficient unless fohc acid is included in the regimen. Since many multivitamin supplements do not contain folic acid, its inclusion should be ensured by the addition of folic or folinic acid. 

Iron is an essential element in nutrition, and its inclusion in any long-term parenteral nutrition regimen should be mandatory. However, it is not included in all trace element formulations, although this varies from country to country most European products include 20 pmol of iron in trace element formulations. While it might be considered unnecessary to include iron as a daily supplement, because of safety and pharmaceutical considerations, there is ample evidence that the use of iron-containing trace element formulations is both safe and efficacious, with no associated adverse effects. 

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