Posted by Pediatric drug development faces notable challenges due to age-related physiological differences, with limited approved formulations often leading to off-label or extemporaneous use. Oral administration is the predominant route in children, necessitating formulations that offer flexible dosing and good taste. Cyclodextrins (CDs) have gained attention as excipients for pediatric use because they can enhance drug solubility in water, improve chemical stability, and mask unpleasant tastes. Although widely utilized in adult medications, their use in pediatric formulations remains limited. Pharmacokinetic studies in young animals show that the clearance of CDs varies with age, with neonates experiencing slower elimination. Clinical data suggest that hydroxypropyl-β-cyclodextrin and sulfobutylether-β-cyclodextrin are generally well tolerated in children, though neonatal use warrants caution due to the risk of accumulation linked to immature renal function. Despite limited regulatory approval, CD-based systems have successfully improved pediatric formulations. Recent advances in child-friendly dosage forms—such as orodispersible tablets, mucoadhesive films, and 3D-printed mini-tablets—demonstrate the versatility of CDs. However, more comprehensive safety data and clear regulatory frameworks are needed to facilitate wider clinical use. This review discusses the application of CD complexation in pediatric drug delivery, summarizes relevant pharmacokinetic and toxicity findings, and provides examples of CD-based formulations for children.
Theingi Tun, Hay Marn Hnin, Vu Minh Triet, Thorsteinn Loftsson, Phatsawee Jansook, Cyclodextrin-based formulations for pediatric patients: pharmaceutical prospectives and toxicological evaluation, Journal of Pharmacy and Pharmacology, 2025;, rgaf088, https://doi.org/10.1093/jpp/rgaf088