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Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion,
Julian Quodbach1, Malte Bogdahn2, Jörg Breitkreutz3
1Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany. julian.quodbach@hhu.de.
Therapeutic Innovation & Regulatory Science
|November 26, 2021
Summary
3D printing enables personalized pediatric medicines by creating customized dosages and release profiles. Further research is needed to establish quality control and validation for this innovative pharmaceutical manufacturing technology.
Area of Science:
- Pharmaceutical Technology
- Precision Medicine
- Additive Manufacturing
Background:
- Pediatric medicine requires individualized dosing, often unmet by traditional dosage forms.
- Precision medicine aims to tailor treatments based on individual patient characteristics.
- 3D printing offers a novel approach for manufacturing customized medications.
Purpose of the Study:
- To explore the quality aspects and control measures for 3D printed medicines.
- To present engineering approaches for quality assurance in 3D printing pharmaceuticals.
- To discuss considerations for Good Manufacturing Practice (GMP)-compliant 3D printer design.
Main Methods:
- Development of novel polymers and drug-loaded filaments for fused deposition modeling (FDM) 3D printing.
- Optimization of the FDM 3D printing process for pharmaceutical applications.
- Investigation of quality attributes and process parameters for 3D printed dosage forms.
Main Results:
- 3D printing allows for individualized dosages, sizes, release profiles, and drug combinations in small batches.
- Critical quality attributes and process parameters require further understanding and improvement.
- Analytical methods for in-process control and final product quality are essential.
Conclusions:
- 3D printing holds significant potential for personalized pediatric medicine and precision therapies.
- Establishing robust quality assurance, validation, and GMP-compliant manufacturing is crucial for clinical translation.
- Continued development in materials, processes, and printer design will advance the field of pharmaceutical 3D printing.
