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Three-dimensional (3D) printing offers pharmaceutical manufacturing precision and accuracy for specialized needs, but faces technical and regulatory hurdles. Further research is needed to overcome challenges for broader therapeutic application.

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Area of Science:

  • Pharmaceutical Manufacturing
  • Additive Manufacturing
  • Drug Delivery Systems

Background:

  • Three-dimensional (3D) printing, despite its 1980s origins, sees slow adoption in the pharmaceutical sector.
  • Spiritam® (2015) remains the sole FDA-approved 3D-printed drug, highlighting persistent technical and regulatory barriers.
  • Conventional manufacturing methods for solid dosage forms are well-established, posing competition for 3D printing.

Purpose of the Study:

  • To review 3D printing technologies suitable for pharmaceutical manufacturing.
  • To examine excipient requirements and process understanding for pharmaceutical 3D printing.
  • To identify and discuss technical and regulatory challenges in pharmaceutical 3D printing.

Main Methods:

  • Review of existing literature on 3D printing technologies and their application in pharmaceuticals.
  • Analysis of technical prerequisites for different 3D printing methods regarding materials.
  • Examination of regulatory issues including Current Good Manufacturing Practice (cGMP) and quality control.

Main Results:

  • Not all 3D printing technologies are suitable for pharmaceutical production; material compatibility is key.
  • Technical challenges include process control, in-process testing, and cleaning validation.
  • Potential exists for patient-specific medications in hospital/pharmacy settings with reduced oversight.

Conclusions:

  • 3D printing is best suited for low-volume, high-precision pharmaceutical applications.
  • Understanding manufacturing challenges and quality control is crucial for 3D printing's therapeutic emergence.
  • Addressing technical and regulatory issues is essential for wider pharmaceutical adoption of 3D printing.