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Cyclodextrin-based formulations for pediatric patients: pharmaceutical prospectives and toxicological evaluation
Theingi Tun1, Hay Marn Hnin1, Vu Minh Triet1
1Faculty of Pharmaceutical Sciences, Chulalongkorn University, Pathumwan, Bangkok 10330, Thailand.
The Journal of Pharmacy and Pharmacology
|September 23, 2025
Summary
Cyclodextrins (CDs) improve pediatric drug formulations by enhancing solubility and taste. While generally safe, caution is advised for neonates due to immature kidney function, necessitating further safety data and guidelines.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Pharmacology
- Drug Delivery Systems
Background:
- Pediatric drug development faces challenges with age-specific physiology, leading to limited approved formulations.
- Oral administration is preferred for children, requiring flexible and palatable dosage forms.
- Cyclodextrins (CDs) are excipients that enhance solubility, stability, and taste-masking for drug formulations.
Purpose of the Study:
- To review the role of cyclodextrin complexation in pediatric drug delivery.
- To summarize pharmacokinetic and toxicity data of CDs in pediatric populations.
- To present examples of cyclodextrin-based pediatric formulations.
Main Methods:
- Literature review of pharmacokinetic studies in juvenile animals and clinical findings.
- Analysis of safety and tolerability data for cyclodextrins in children.
- Identification and summary of advanced pediatric dosage forms utilizing cyclodextrins.
Main Results:
- Cyclodextrins enhance solubility, stability, and palatability of pediatric drug formulations.
- Juvenile animal studies show age-dependent renal clearance of CDs, with delayed elimination in neonates.
- Hydroxypropyl-β-cyclodextrin and sulfobutylether-β-cyclodextrin are generally well-tolerated, but neonatal use requires caution due to potential accumulation.
Conclusions:
- Cyclodextrin-based systems have improved pediatric formulations despite limited regulatory approval.
- Pediatric-friendly dosage forms like orodispersable tablets and 3D-printed mini-tablets showcase CD versatility.
- Comprehensive safety data and regulatory guidelines are crucial for wider clinical application of cyclodextrins in pediatrics.
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