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Aspartame

Oral

Phenylketonuria

Fructose

Oral, parenteral

Hereditary fructose intolerance

Lactose

Oral

Lactose intolerance, diarrhea

Sorbitol

Oral

Hereditary fructose intolerance

Sucrose

Oral, parenteral

Hereditary fructose intolerance

Source: From Ref. 1.

Source: From Ref. 1.

metabolic acidosis, cardiovascular collapse, and death in low birth weight premature neonates and infants. The cumulative dose of benzyl alcohol ranged from 99 to 234 mg/ kg/day in these patients (48,49). Dose-related adverse effects to excipients are of particular concern in the preterm, low birth weight infant because of the known immaturity of hepatic and renal function in this population. Dose-related reversible CNS effects have also been reported in children receiving long-term therapy in which propylene glycol was a cosolvent (50).

Dyes Dose does not appear to be a factor in patient reaction to dyes. The mandatory labeling of the azo dye tartrazine (FD&C Yellow No. 5) in over-the-counter (OTC) and prescription medications (51) has focused the attention of pharmaceutical manufacturers and the consumer on the potential danger of dyes in susceptible individuals. Hypersensitivity reactions have been reported with several azo dyes, particularly FD&C Yellow No. 5 and No. 6. Tartrazine-induced bronchoconstriction is commonly considered a cross-reaction to aspirin in sensitive asthmatics, although urticaria has been reported in other patient populations (52). In a double-blind challenge involving aspirin-sensitive asthmatics, hypersensitivity to dyes was only 2% (53); however, numerous case reports involving azo dyes suggest caution when using a drug containing an azo dye in asthmatics (54). Non-azo dyes are considered to be weak sensitizers.

In a recent study (55), two combinations of Tartrazine (E102), Quinoline Yellow (E104), Sunset Yellow FCF (El 10), Ponceau 4R (E124), Allura Red AC (E129), Carmoisine (E122), and the preservative, sodium benzoate (E211), contained in drinks, were studied on the behavior of 153 three-year old and 144 eight- to nine-year old children. (All synthetic azo dyes except for Quinoline Yellow (El04), which is a quinophthalone.) In 2008, The European Food Safety Agency reported that the study carried considerable uncertainties, such as the lack of consistency and relative weakness of the effect and the absence of information on the clinical significance of the behavioral changes observed. The association of dye content (especially in medicines) with hyperactivity in children remains controversial and unproved.

Sweeteners Sweeteners are commonly included in pediatric formulations to increase palatability.

Sucrose is the most popular sweetener due to its combination of sweetness, solubility, viscosity-enhancing, texture, and preservation properties. Chewable tablets may contain 20% to 60% sucrose, and liquid preparations may contain up to 85% sucrose. In a survey of sweetener content of 107 pediatric antibiotic liquid preparations in 1988, only 4 were sucrose free (56). Nevertheless sugar-free formulations have been largely promoted and are more readily available these days. In a recent review (57), only 14 of the 32 pediatric oral liquids (e.g., solutions, suspensions, or syrups) commercially available in the United States were not sugar free, although five of the eight syrups did contained sucrose. The sucrose content of oral liquids may cause significant problems when these products are prescribed for long-term therapy (e.g., asthma, seizure control, recurrent infections). Oral liquid preparations can represent a substantial carbohydrate load to children with labile diabetes, particularly if a child is ingesting more than one liquid medication with a high sugar content or/and have a parallel poor controlled diet. Nevertheless a wider problem exists with the possible role of these liquid medications in dental caries formation (58). The extent of acid production from sucrose by the buccal bacteria in the oral cavity is closely related to caries formation. In a study of liquid medication, investigators have observed that medications with sucrose concentrations higher than 15% were able to significantly lower pH; there was an inverse relation between sucrose content and a decrease in oral cavity pH (59). In a comparison of sorbitol and sucrose-sweetened liquid iron preparations, only sucrose-containing products produced a significant decrease in oral cavity pH (60). Viscous formulations with high sucrose content are especially prone to contribute to caries formation because of their prolonged contact time in the oral cavity. This can be improved by rinsing the mouth after intake of such formulations.

To achieve sugar-free preparations, polyols (sugar alcohol) are replacing sucrose as bulk sugar substitutes. They are not fermented by oral bacteria, hence noncariogenic. However, they are slowly hydrolyzed by the enzymes of the small intestine into their constituent monomers, which are only slowly and incompletely absorbed compared with

Table 4 A Brief Summary of the Characteristics of Common Polyols

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