Sun Hongyin

Liaoning University of Traditional Chinese Medicine

Abstract：

Pharmaceutical excipients, as important components of pediatric-specific preparations, have safety that directly affects the safety and therapeutic efficacy of pediatric medications. Furthermore, the rational application of excipients determines the stability, palatability, and medication compliance of the preparations. Children are not "smaller adults"; their physiological development is immature, metabolic functions are incomplete, and they are more sensitive to the toxicity and allergenicity of excipients. Therefore, the safety evaluation and application optimization of pharmaceutical excipients in pediatric-specific preparations have particularity and necessity. This article first outlines the fundamentals related to pediatric-specific preparations, including pediatric physiological and cognitive characteristics, the particularities and core needs of pediatric-specific dosage forms, dosage form design principles, and the classification and characteristics of commonly used pharmaceutical excipients. Subsequently, focusing on pediatric application scenarios, it constructs a safety evaluation system for pharmaceutical excipients, clarifying core evaluation principles, key indicators, procedures and methods, as well as differences from adult safety evaluation. Building on this, optimization strategies for the application of pharmaceutical excipients based on pediatric medication safety and compliance are proposed, covering aspects such as excipient screening, dosage proportioning, palatability and appearance adaptation, convenience for caregivers, and differentiation by age group. Finally, the core viewpoints of the research are summarized, and the future development direction of pharmaceutical excipients in pediatric-specific preparations is discussed, providing theoretical support and practical reference for the research and development, production, and rational clinical application of pediatric-specific preparations.

Key Words：

pharmaceutical excipients; pediatric-specific preparations; safety evaluation; medication compliance; application optimization