Pharmaceutical manufacturing of the future: a continuous 3D printing approach for personalized medicine

Background

Driven by personalized medicine, 3D printing has emerged as a promising technology for creating tailored pharma­ceutical dosage forms. One of its methods, Fused Deposition Modeling (FDM), is particularly notable for its ability to produce complex geometries using thermoplastic polymers. However, current FDM processes face significant challenges. These include significant lag times in pre-print and post-print stages due to nozzle heating and cooling, need for manual removal of printed forms, and a confined print bed area that restricts continuous production. These issues limit the efficiency and scalability of the technology, making it difficult to meet the growing demand for 3D printed products.

Further, the orientation of printed layers affects the mechanical strength and drug release profiles of the dosage forms, adding complexity to the process. Current approaches also struggle to integrate real-time quality control measures and maintain consistent drug-polymer interactions, which are crucial for the stability and effectiveness of the final pharma­ceutical products. The development of more efficient and automated continuous printing systems is needed to overcome these limitations.

Technology overview

A patent-pending technology from UT Austin presents a novel continuous manufacturing method to address these limitations. It integrates hot-melt extrusion to produce drug-loaded filaments for a Fused Deposition Modeling (FDM) 3D printer. The printer uses a dynamic platform, like a conveyor belt, for continuous printing, reducing lag time and manual intervention. This method allows precise control over drug load and composition, allowing the injection of additional active ingredient. The system can also integrate in-line measurement devices for quality monitoring.

The oblique angle of the extrusion nozzle further minimizes the need for support structures during printing, enhancing the structural integrity and uniformity of the final products. This continuous approach significantly enhances manu­facturing efficiency and scalability, paving the way for large-scale manufacturing of personalized, complex pharmaceutical dosage forms.

Benefits/competitive advantage

  • 3D printing efficiency: Eliminates pre-print and post-print lag times, manual intervention
  • Automated collection: Automatically detaches and collects printed products, reducing manual intervention and potential deformation
  • Enhanced print quality: Produces printlets with smoother and more regular surfaces
  • High throughput: Allows for uninterrupted, sequential production of multiple products
  • Scalability: More favorable for scaling up production, addressing a major limitation of FDM-based 3D printing in the pharmaceutical industry
  • Improved mechanical strength: Printlets exhibit higher breaking force and structural integrity, especially at higher infill densities
  • Consistent drug release: Provides better drug release profiles, especially at higher infill densities
  • Versatility: Supports the production of various pharmaceutical forms, offering greater versatility than traditional FDM printers
  • Real-time quality control: Integrates in-line measurement devices for real-time quality monitoring
  • Regulatory compliance: Facilitates compliance with regulatory guidelines through automated processes and in-line quality control

Opportunity

The healthcare industry is the major beneficiary of this technology, enabling mass production of customized, personalized, and or on-demand 3D printed pharmaceuticals. Other industries that can find this useful include aerospace and defense, consumer goods and research institutions.