Pediatric Drug Development Process: A Review

Abstract

This review includes New Formulation approaches to improve Pediatric compliance such as Mini tablets, 3D printing, Orodispersible films, Chewable tablets. Various strategies to improve patient adherence such as ‘nipple shield’ delivery system, dry solid formulations to be converted to liquid at the point of administration, pill swallowing cups, Medicated dosing straw. It is important to formulate pediatric medicines that are tailored to a child’s age, size, physiological condition, and treatment requirements. Legislations for pediatric formulation to ensure that products to treat pediatric patients are appropriately authorized for use in the pediatric population, minimize the worst effect of Off-label medication and to improve the information available on the use of these products in the various pediatric populations. Also, the review consists of Information on legislative obligation and requirement, current State, challenges and effect of regulations. Recent progress has been made in the development of pediatric formulations due to new regulations, additional funding opportunities, and collaborative research initiatives.