Drug Delivery System and Compliance Issues

Inactive Ingredients

Hundreds of excipients have been approved by FDA for use as "inactive ingredients" in drug products. The FDA Division of Drug Information Resources compiles a list of all inactive ingredients in approved prescription drug products in the Inactive Ingredient Guide (available at: http://www.fda.gov/cder/drug/iig/default.htm). The FDA requires the listing of excipients in pharmaceuticals other than oral. The labeling of inactive ingredients in oral drug products is voluntary. The reported incidence of adverse drug reactions to excipients is much lower than the incidence reported with active drug. This may be due to several factors, including the generally safe nature of the excipients, the low concentration found in single doses, or lack of identification of an excipient as a causative agent.

Selecting excipients for incorporation into a drug product for human consumption is complex. In selecting excipients for drug products intended for use in the pediatric population, additional cautions must be taken. Several subgroups of the pediatric population who are likely to be hospitalized and receive both oral and parenteral drug products have been identified as being particularly susceptible to excipient reactions. Serious events have been reported in low birth weight neonates and infants, asthmatics, and diabetics. Reactions have ranged from dermatitis to seizures and death (42-46). Table 3 lists some of the excipients that have been reported to cause adverse events in the pediatric and geriatric population.

Many of these reactions are related to the quantity of excipient found in a dosage form in relation to acute toxicity and repeated cumulative exposure in relation to chronic toxicity. Benzyl alcohol benzalkonium chloride, propylene glycol, lactose, and polysorbates are all associated with dose-related toxic reactions (44,45,47). Large-volume parenterals containing 1.5% benzyl alcohol as a preservative have caused

Table 3 Excipients with Elevated Toxicological Risk for Subpopulations of the Pediatric and Geriatric Patients



Adverse reaction

Preterm and term neonates,

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