From concept to clinic: 3D-printed personalized medication at the point-of-care

Abstract

This thesis explores the implementation of solvent-free semi-solid extrusion (SSE) 3D printing for producing personalized medicines at the point-of-care. Tailoring the drug dose to an individual patient’s need enhances treatment efficacy and reduces toxicity. Especially for children there is an unmet medical need. SSE 3D printing is a promising technique due to its simplicity, suitable excipients and low printing temperature. A proof-of-concept study demonstrated successful 3D printing of furosemide and sildenafil pediatric tablets meeting European Pharmacopoeia quality standards. Minitablets with various diameters and high drug loading were also successfully produced, confirming the technique’s dosing flexibility. Non-destructive analytical methods—NIR and Raman spectroscopy—were investigated for quality control. A GMP-compliant 3D printer was developed using a quality-by-design approach, focusing on critical process parameters such as cartridge temperature. Bioequivalence of 3D-printed sildenafil tablets compared with Revatio® was confirmed in a clinical study. Implementation of 3D-printed tablets in clinic is justified on a small scale, and an increase in clinical data, regulatory guidance, and access to validated formulation data can support widespread implementation. Ultimately, SSE 3D printing holds great potential for safe, precise, and on-demand drug manufacturing at the point-of-care.