(W1230-07-42) 3D Printed Ileum Targeted Tablet for the Treatment of IgA Nephropathy

Purpose: IgA nephropathy (IgAN) is a leading cause of chronic kidney disease (CKD) and kidney failure, characterized by chronic, progressive autoimmune kidney damage. Tarpeyo is the first FDA-approved treatment proven to reduce the loss of kidney function in adult patients with IgAN. The drug acts on the terminal ileum, reduces the amount of IgA1 antibodies to achieve the treatment of IgAN. In this study, a 3D printed tablet was designed for the delivery of Budesonide to ileum for modulating B-cell numbers and activity.

Methods: A 3D printed tablet with coating sheet structure was created using 3D microstructure design platforms and fabricated using melt extrusion deposition (MED^®) 3D printing technology. X-ray imaging was used to track the GI transition and budesonide release of 3D printed tablet using BaSO₄ as tracking agent during in-vivo study.

Results: A delayed release tablet was designed and fabricated using 3D micro-structure design and MED^® 3D printing technology. X-ray images captured shown the release occurred at 4 hours in the distal small intestine as shown in Figure 1. The more consistent delivery of Budesonide in ileum was observed with the decrease in variabilityof T_lag and T_max (Figure 2) in human PK study when compared with Nefecon^®.

Conclusion: MED^® 3D printing technology and 3D microstructure design has been successfully used to develop products with desired release profile to targeted GI location. 3D printed budesonide delayed release tablets achieved more precise delivery of budesonide to the lower small intestine area and reduced in-vivo variability.

References: 1. Le W, et al. Nephrol Dial Transplant 2012;27:1479.
2. Tracy T, et al. Int. J. Pharm 2023;631;122480.
3. Zheng Y. et al. Int. J. Pharm 2021;602;120639.
4. Du, Y, et al. Diagnostics (Basel). 2023;13(2):303.

Acknowledgements: All authors are employees of Triastek. This work reflects their research findings and does not necessarily represent the views of the company.


Human PK Study Results


Human X-Ray Imaging Results