A Comprehensive Review of Pediatric Drug Development: An Extensive Analysis of Present Difficulties and Prospects for the Future

Creating a suitable dosage form for pediatric medical treatment can be challenging, considering factors like body weight, taste masking, excipient safety, and dosage form size. Potential options such as mini-tablets, soluble films, and oral disintegrating tablets have shown promise. However, pediatric dosage forms face challenges such as age-related physiological changes, excipient safety concerns, technical demands, limited profitability, clinical trial constraints, and unclear legislation. Recent advancements have increased pediatric formulation acceptance, providing parents with easier administration and greater dosing flexibility. Key considerations include acceptability, palatability, pediatric compatibility, excipient selection, and modified drug release formulations or fixed-dose combinations. Machine learning classifiers to predict bitterness in pediatric formulations could be explored. The shift in the paradigm of pediatric medication development involves a "carrotand-stick" strategy, addressing population-specific issues. This includes leveraging nanotechnologybased delivery systems encompassing lipid-based, polymeric, and inorganic nanoparticles. An essential aspect is involving a diverse workforce, including pediatric patients, caregivers, healthcare stakeholders, drug developers, and physicians, to establish standard criteria for pediatric drug development. This paper aims to compile information on the current status of pediatric drug development by providing an overview of the historical regulatory environment, summarizing challenges in pediatric drug formulation, and analyzing the pros and cons of innovative methodologies in pediatrics.