Excipients Used in Pediatric Oral Dosage Forms: Challenges and Perspectives for Safe Hospital Practice

The pharmacological management of pediatric patients remains a major challenge, particularly in low-resource settings. Oral dosage forms, widely used in children, require appropriate excipients; however, some of these excipients may induce adverse effects. The aim of this study was to identify the excipients used in pediatric oral formulations available in community pharmacies in order to guide the development of safer hospital formulations. A descriptive study was conducted in a community pharmacy located in the suburbs of Dakar over a three-month period. Pediatric oral pharmaceutical products were surveyed, and for each product, the international nonproprietary name (INN), dosage form, packaging volume, therapeutic indication, and list of excipients were collected. Data were entered and analyzed using Microsoft Excel 2016. A total of 200 pharmaceutical products corresponding to 96 international nonproprietary names were identified. Solutions were the most frequent dosage forms (46.5%), followed by powders (31.8%) and suspensions (21.7%). The most common packaging volumes ranged from 51 to 100 mL, and antibiotics were the most frequently encountered therapeutic class. The most commonly used excipients were sucrose, sodium benzoate, and citric acid. Sucrose served as the main sweetener to mask the bitter taste of active ingredients, sodium benzoate acted as a preservative, and citric acid was used as a pH regulator. Flavoring agents and preservatives were the most represented categories. The findings highlight the widespread use of sweeteners and preservatives, which are essential for the acceptability and stability of liquid formulations, although several of these excipients may pose potential risks for infants. A better understanding of these substances is therefore necessary to optimize pediatric hospital formulations. The development of locally adapted formulations using safe and available excipients appears essential to improve the safety and efficacy of pediatric treatments in Senegal. Overall, excipients play a crucial role in pediatric drug formulation by influencing stability, preservation, and palatability, and this study underscores the need for increased vigilance regarding excipients with known effects while supporting the development of hospital preparations tailored to local needs. Keywords: Pediatric oral dosage forms; Excipients; Pharmaceutical formulation; Hospital preparations; Drug safety