Semi-solid extrusion 3D printing of milk formula-based paediatric chewable dosage forms

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Pediatric Medicine

Background:

• Limited availability of age-appropriate oral medications for pediatric patients with dysphagia.
• Need for innovative drug delivery systems to improve medication adherence and efficacy in children.

Purpose of the Study:

• To develop and characterize a novel chewable drug delivery platform using milk-based semi-solid extrusion (SSE) 3D printing.
• To evaluate the feasibility of on-demand, dose-flexible medication preparation for pediatric use.

Main Methods:

• Semi-solid extrusion (SSE) 3D printing utilizing milk formula as the primary excipient.
• Formulation and optimization of printable inks containing various active pharmaceutical ingredients (APIs) including paracetamol, sodium valproate, ibuprofen, and carbamazepine.
• Characterization of rheological properties, print fidelity, dose accuracy, drug release profiles, and solid-state properties (DSC, XRD).

Main Results:

• Successfully fabricated high-fidelity, paediatric-friendly chewable dosage forms via cold extrusion.
• Demonstrated linear scalability of dose accuracy with print weight (R²≈1.0), enabling dose personalization.
• Observed varied drug release profiles, with enhanced carbamazepine release and maintained rapid release for highly soluble drugs, influenced by the milk matrix.

Conclusions:

• Milk-based SSE 3D printing offers a viable approach for producing on-demand, dose-flexible chewable medications suitable for children.
• The developed platform shows potential for integration into pharmacy compounding workflows at the point of care.
• This technology addresses a critical need for improved oral medication options for pediatric patients with swallowing impairments.