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Emerging 3D printing technologies for solid oral dosage forms: Processes, materials and analytical tools for
Nobel O Sierra-Vega1, Muhammad Ashraf1, Thomas O'Connor1
1Office of Pharmaceutical Quality Research, CDER, U.S. FDA, USA.
International Journal of Pharmaceutics
|March 1, 2025
Summary
Three-dimensional (3D) printing offers personalized drug delivery by creating tailored tablets. Ensuring quality requires understanding critical process parameters and real-time monitoring in pharmaceutical additive manufacturing.
Area of Science:
- Pharmaceutical Sciences
- Manufacturing Technology
Background:
- Three-dimensional (3D) printing enables personalized drug delivery and manufacturing flexibility.
- Layer-by-layer material deposition allows tailored solid oral dosage forms and modified drug release profiles.
- Quality assurance remains a challenge in monitoring and controlling critical 3D printing steps.
Purpose of the Study:
- To review advances in 3D printing for solid oral dosage forms.
- To emphasize critical process parameters and material attributes for optimizing printing.
- To explore real-time analytical tools for quality assurance in pharmaceutical additive manufacturing.
Main Methods:
- Literature review of recent advances in 3D printing technologies for pharmaceuticals.
- Analysis of critical process parameters and material attributes impacting tablet performance.
- Discussion of real-time analytical tools and quality assurance considerations.
Main Results:
- 3D printing allows for precise control over tablet geometry and drug release.
- Understanding material attributes and process parameters is key to optimizing 3D printing.
- Real-time monitoring is crucial for ensuring the quality of 3D-printed drug products.
Conclusions:
- 3D printing holds significant potential for personalized pharmaceutical manufacturing.
- Quality assurance is paramount throughout the additive manufacturing process for drug products.
- Further research into process control and material science is needed to fully realize 3D printing's potential in pharmaceuticals.

