How 3D-Printed Tablets Can Optimize IgA Nephropathy Treatment

IgA nephropathy (IgAN) is recognized as a significant contributor to chronic kidney disease and is a primary driver of kidney failure, characterized by progressive, chronic autoimmune damage to the kidneys (1). Effective treatment requires targeted intervention. Budesonide is the first treatment approved by the FDA shown to reduce the rate of kidney function loss in adult patients managing IgAN (2). The mechanism hinges on the drug acting locally on the terminal ileum to reduce the amount of IgA1 antibodies, thereby treating the IgAN. In parallel, three-dimensional (3D) printing is an emerging technology that offers innovative solutions for both patients and the pharmaceutical industry (3). This technology can greatly benefit drug product design by allowing precise construction of the structure of dosage forms. Furthermore, 3D printing facilitates patient-centric treatment, such as personalized dosing, accommodates the treatment of specific disease states or patient populations, and provides versatile release modes to meet clinical requirements.

For a study presented via the poster “3D Printed Ileum Targeted Tablet for the Treatment of IgA Nephropathy” by Xiaoling Li, PhD, professor/CSO at Triastek, Inc., at AAPS PharmSci 360, held Nov 9-12, 2025 in San Antonio, Texas (5), Li and colleagues at Triastek, Inc—Zhaoyao Chu, PhD, scientist, Formulation Development; Aiming Ma, PhD, senior manager, Formulation Development; Lanfang Chen, PhD, senior industry analyst; Fenge Zhang, director, CMC; and Senping Cheng, PhD, founder and CEO—focused on designing a 3D-printed tablet specifically for budesonide delivery to the ileum, aiming to modulate the activity and numbers of B-cells.

A novel 3D-printed tablet was created using 3D microstructure design platforms. Fabrication of this tablet, which featured a coating sheet structure, was achieved utilizing melt extrusion deposition (MED®) 3D printing technology (4). To verify performance in-vivo, X-ray imaging was used to track the gastrointestinal (GI) transition and subsequent budesonide release. Barium sulfate was incorporated into the formulation to serve as the tracking agent during the in-vivo study.

How was the delayed release successfully achieved?

Through the application of 3D micro-structure design coupled with MED 3D printing technology, a functional delayed-release tablet was successfully designed and fabricated. X-ray images captured during the study indicated that the drug release occurred at four hours, confirming the successful targeting of the distal small intestine. Crucially, a human pharmacokinetic study demonstrated a more consistent delivery of budesonide within the ileum when compared against a traditional targeted-release formulation of the drug (Figure). This enhanced consistency was confirmed by observing a measured decrease in the variability of both Tlag (lag time) and Tmax (time to maximum concentration).

What is the long-term impact on drug development variability?

The research validates that MED 3D printing technology and 3D microstructure design can be successfully leveraged to develop drug products with precise, desired release profiles targeted to specific GI locations. Ultimately, these 3D-printed, budesonide delayed-release tablets achieved a more precise delivery of the drug to the lower small intestine area, resulting in a significant reduction of in-vivo variability.

References

1. Le, W; Liang, S; Hu, Y; et al. Long-term Renal Survival and Related Risk Factors in Patients with IgA Nephropathy: Results From a Cohort of 1155 Cases in a Chinese Adult Population. Nephrol Dial Transplant. 2012;27(4):1479-1485.
2. Du, Y; Cheng, T; Liu, C; et al. IgA Nephropathy: Current Understanding and Perspectives on Pathogenesis and Targeted Treatment. Diagnostics. 2023;13(2):303.
3. Tracy, T; Wu, L; Liu, X; et al. 3D Printing: Innovative Solutions for Patients and Pharmaceutical Industry. Int J Pharm. 2023;631:122480.
4. Zheng, Y; Deng, F; Wang, B; et al. Melt Extrusion Deposition (MED™) 3D Printing Technology – A Paradigm Shift in Design and Development of Modified Release Drug Products. Int J Pharm. 2021;602:120639.
5. Li, X; Chu, Z; Ma, A; et al. 3D Printed Ileum Targeted Tablet for the Treatment of IgA Nephropathy. AAPS PharmSci 360 Poster Abstract. Accessed Nov 12, 2025.