Pediatric orodispersible nanoparticle delivery: recent innovations and practical challenges

Background Designing age-appropriate oral drug-delivery systems remains a major challenge in pharmaceutical sciences. Conventional solid dosage forms are often unsuitable for pediatric patients because of limited swallowing ability, variable dose requirements across age groups, excipient-related safety concerns, and poor taste acceptability. Consequently, extemporaneous compounding is frequently used in clinical practice, despite its association with dose inaccuracy, instability, medication errors, and potentially suboptimal therapeutic outcomes. Scope and approach This review critically evaluates the current landscape of pediatric oral drug-delivery platforms, including liquids, minitablets, multiparticulates, orodispersible tablets, oral films, and chewable dosage forms. Unlike reviews that address these formulations primarily from a technological perspective, the present review integrates formulation design with patient-centric factors, including age-specific acceptability, palatability, dose flexibility, excipient safety, caregiver usability, manufacturing feasibility, regulatory requirements, and global accessibility. It also highlights the emerging role of administration devices, smart packaging, and adherence-supporting strategies in improving real-world treatment outcomes. Key findings and translational gaps The need for this review arises from the persistent gap between advances in formulation technologies and the limited availability of licensed, affordable, and child-acceptable medicines. Current approaches exhibit distinct strengths and limitations related to acceptability, dose precision, safety, and scalability, but face common translational barriers, including limited pediatric clinical data, regulatory complexity, and economic constraints, particularly in low- and middle-income settings. Conclusions and framework By identifying the strengths, limitations, and translational barriers of currently available approaches, this review proposes a framework for balancing innovation, safety, manufacturability, and cost-effectiveness in pediatric oral formulation development. Greater collaboration among academia, industry, healthcare professionals, and regulatory authorities is essential to accelerate the development and equitable availability of safe, effective, and acceptable oral medicines for children worldwide. Clinical trial number Not applicable.