Pharmaceutical excipients: Special focus on adverse interactions

A primary concern in treating pediatrics with formulations is the lack of standard specifications for marketing the products for children. The shortage of pediatric medicines motivates health professionals to use marketed adult formulations in an off-labeled way. As many reports revealed, excipients used in off-labeled formulations in pediatric populations pose severe harmful effects. Hence, the thorough investigation of the toxic nature of the excipients used in the formulations for treating pediatric patients must be evaluated with utmost care to avoid toxic reactions in children. On the other side, guidelines provided by various regulatory agencies on drugs and excipients should be followed to meet the acceptable criteria for the safety and quality of pharmaceutical drug products. In addition, any novel excipient used in formulation development should have comprehensive safety and toxicity profile data. So that interaction assessment is easy to understand, which further helps determine the adverse drug event in the formulation.