Pediatric Drug Formulations: A Rate-Limiting Step

Abstract

The majority of drugs approved by the United States Food and Drug Administration (FDA) are not labeled for use in pediatric patients. Infants and young children may often benefit from such medicines; however, lack of an appropriate formulation is a rate-limiting step for clinical use or for conducting important research to develop optimal dosage guidelines. Stability studies on extemporaneous formulations must be performed to assure the delivery of desired doses. The data on bioavailability, efficacy, and safety of these formulations should also be collected, when possible. The funding of research on extemporaneous formulations should be increased. The FDA and the National Institute of Child Health and Human Development (through its Pediatric Pharmacology Research Units) should work with academia and industry to develop pediatric drug formulations and seek labeling for their use.