Pharmaceutical excipients and pediatric formulations

Pharmaceutical excipients used in pediatric formulations have received significant attention from regulatory agencies worldwide due to the safety concerns. Many excipients have been implicated in interfering with the growth and development process of pediatric population. Excipients require thorough short-term and long-term safety evaluation in pediatric population prior to their incorporation in pediatric formulations. This mini-review will discuss the safety impact of the excipients with reference to the chemical structure, chemical reactivity, and doses used, to the toxicity observed in pediatric population. In addition, the review will highlight the excipients that can be substituted for in pediatric formulations to ensure safety and efficacy of such products.