Extemporaneous drug formulations.

BACKGROUND: Access to a special dosage form of a medication is essential when administration to infants and children and selected other populations is required. Some drugs necessary for pediatric patients are not commercially available in dosage forms appropriate for use in this population. These drugs may be prepared extemporaneously for use in individual patients. Physical and chemical properties of drugs and excipients should be considered when preparing extemporaneous formulations. These formulations, however, may lack studies to document stability, bioavailability, pharmacokinetics, pharmacodynamics, efficacy, and tolerability.
OBJECTIVE: The goal of this article was to discuss factors involved in extemporaneous compounding of pediatric dosage forms.
METHODS: The proceedings from a Pediatric Formulation Initiative workshop sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, held December 6 and 7, 2005, in Bethesda, Maryland, were used as a source of information for this article. A literature search of PubMed/ MEDLINE (1966-October 2008) was also conducted, using the search terms extemporaneous, drug formulations, and pediatric.
RESULTS: Access to age-appropriate drug formulations is critical to provide effective and well-tolerated medications to patients. There continues to be a need for extemporaneous formulations of brand and generic drugs for neonates, infants, and children. Potential solutions to current limitations include the need to develop a prioritized list of essential formulations, increased funding of research, dissemination of data, and monitoring of clinical effectiveness and tolerability during use in various age groups of pediatric patients and the sharing of these clinical experiences.
CONCLUSION: To achieve desired therapeutic outcomes in pediatric patients, access to age-appropriate, stable, effective, and well-tolerated drug formulations is essential.