Three-Dimensionally Printed Paediatric Medicines: Formulation, Process, and Regulatory Considerations.

Area of Science:

• Pharmaceutical Sciences
• Biomedical Engineering
• Pediatric Medicine

Background:

• Pediatric formulations face challenges due to age-dependent physiological and pharmacokinetic variability in children.
• Modifying adult medicines for pediatric use can lead to dosing errors, contamination, and reduced efficacy.
• Existing challenges necessitate innovative approaches for safe and effective pediatric drug delivery.

Purpose of the Study:

• To review the physiological, technological, and regulatory aspects of developing 3D-printed pediatric medicines.
• To discuss critical quality and performance attributes for 3D-printed pediatric dosage forms.
• To explore the evolving regulatory landscape for 3D-printed medicinal products.

Main Methods:

• Review of current literature on pediatric formulations and 3D printing technology.
• Analysis of critical quality and performance attributes for 3D-printed medicines.
• Discussion of regulatory considerations and Good Manufacturing Practice (GMP) for pediatric 3D-printed drugs.

Main Results:

• 3D printing enables personalized pediatric dosage forms with adjustable strengths and controlled release.
• Child-friendly shapes and improved palatability can enhance medication acceptance and adherence.
• Key attributes like dose accuracy, stability, and reproducibility are crucial for 3D-printed pediatric medicines.

Conclusions:

• 3D printing holds transformative potential for personalized pediatric pharmacotherapy.
• Addressing technological and regulatory factors is essential for successful implementation.
• This technology offers a pathway to safer, more effective, and tailored medicines for children.