3D Printing Technology Enables Precise Fabrication of Delayed-Release Regorafenib Tablets

Strategic Insights -

Researchers from the Tehran University of Medical Sciences have successfully developed a 3D printing technology to create once-daily, delayed-release regorafenib tablets for the treatment of colorectal cancer. The innovative approach uses a hydrogel containing 80 mg of the drug in a matrix of hyaluronic acid, carboxymethyl cellulose, Pluronic F127, and glycerol, which is then incorporated into the shell cavity of the tablet. The shell is printed from an optimized ink formulation of Soluplus, Eudragit RS-100, corn starch 1500, propylene glycol 4000, and talc through melt extrusion-based 3D printing. The results show a drug release rate of 91.1% in the phosphate buffer medium at 8 h and only 8.5% in the acidic medium, demonstrating controlled-release kinetics and accurate dosing tailored for patients in intensive care units.

Key Takeaways:

  • Researchers have successfully developed a 3D printing technology to create once-daily, delayed-release regorafenib tablets for colorectal cancer treatment.
  • The hydrogel matrix used in the tablets combines hyaluronic acid, carboxymethyl cellulose, Pluronic F127, and glycerol to incorporate 80 mg of the drug.
  • The shell of the tablet is printed from a customized ink formulation of Soluplus, Eudragit RS-100, corn starch 1500, propylene glycol 4000, and talc through melt extrusion-based 3D printing.
  • The drug release rate is 91.1% in the phosphate buffer medium at 8 h and only 8.5% in the acidic medium, demonstrating controlled-release kinetics.
  • The tablets' mechanical strength testing reveals a Young's modulus of 5.18 MPa.
  • The results adhere to USP standards for weight variation and assay.
  • The technology offers controlled-release kinetics and accurate dosing tailored for patients in intensive care units.
  • The research was conducted by Mohammad Akrami and a team of researchers from the Tehran University of Medical Sciences, including Fatemeh Safari, Azin Goudarzi, Hossein Abolghasemi, Hussein Abdelamir Mohammad, Ismaeil Haririan, and Saeid Mohammadi.

Statistics:

  • 91.1%: the percentage of drug released in the phosphate buffer medium at 8 h.
  • 8.5%: the percentage of drug released in the acidic medium.
  • 5.18 MPa: the Young's modulus of the tablets' mechanical strength testing.
  • 80 mg: the amount of drug incorporated in the hydrogel matrix.
  • 8 h: the time period for the drug release rate measurement.

Sources:

  • Additive Manufacturing of Regorafenib Tablets: Formulation Strategies and Characterization for Colorectal Cancer. Polymers, 2025;17(17):2302.
  • Polymers can be contacted at: Mdpi, St Alban-Anlage 66, Ch-4052 Basel, Switzerland.
  • NewsRx. Research Data from Tehran University of Medical Sciences Update Understanding of Engineering (Additive Manufacturing of Regorafenib Tablets: Formulation Strategies and Characterization for Colorectal Cancer). Journal of Engineering. October 20, 2025; p 3029.