Chinese drug 3D printing firm Triastek has announced that its 3D printed drug product, D23, Budesonide Ileum Targeted Tablets for the treatment of IgAN (Immunoglobulin A Nephropathy)—a kidney disorder characterized by the buildup of immunoglobulin A (IgA) deposits in the kidneys—has demonstrated favorable results in a recent clinical study.
D23 is a budesonide delayed-release tablet produced using the Melt Extrusion Deposition (MED®) process, which Triastek has scaled through its proprietary 3D Microstructure for Intestine Targeting (3DμS®-IT) platform. This platform facilitates the precise release and delivery of the drug to the ileum, enhancing the tablet’s effectiveness.
In March 2024, Triastek announced that the Chinese National Medical Products Administration (NMPA) granted clearance for the Investigational New Drug (IND) application for D23, marking it as the third 3D-printed product in China to receive this approval. Triastek now has five 3D-printed products—T19, T20, T21, T22, and D23—that have obtained IND clearance.
D23 Composition and Advantages
D23 includes a multi-granule core and a delay layer to ensure the drug reaches the target tissue before release. The delay layer prevents premature crystallization, allowing the drug to reach the Peyer’s lymph nodes in the ileum, the final section of the small intestine, unaltered. These lymphoid structures are integral to the body’s immune system, acting as a surveillance mechanism to detect and respond to pathogens such as bacteria and viruses.
Targeting the Peyer’s patches in the ileum is critical for this drug, ensuring controlled release of budesonide at a high concentration across the entire target area. This precise delivery enhances absorption and enables the drug to exert its intended immunomodulatory effects. By focusing on the Peyer’s patches, the drug effectively addresses IgA Nephropathy (IgAN) by reducing the production of Gd-IgA—IgA that lacks proper lactose acidification—thus mitigating one of the key contributors to the progression of the disease.
Compared to the original product, D23 simplifies treatment by reducing the number and size of tablets, improving patient adherence. Triastek highlighted that the MED 3D printing process lowers production costs, making the drug more affordable and accessible.
“D23 is developed based on the 3D Microstructure for Modified Release platform and uses the 3D printing process MED. We believe 3D printing technology offers an efficient development platform and a high-quality production process for IgA nephropathy products, enabling the delivery of clinically valuable products to patients,” said Dr. Senping Cheng, Founder and CEO, Triastek.
D23: Clinical Trial
Triastek’s clinical trial followed a randomized, open-label, single-dose, two-sequence, four-period crossover design. X-ray imaging was utilized to monitor the in vivo gastrointestinal (GI) transit of D23 tablets while tracking budesonide pharmacokinetics over time. X-ray results confirmed that the drug is not released until the tablets reach the ileum, optimizing drug exposure at the site of disease origin. The pharmacokinetic profile of budesonide following D23 administration aligned with the imaging data, demonstrating consistent and predictable drug delivery to the ileum.
Building on these results, D23 will proceed to the next phase of clinical trials to further evaluate the clinical effectiveness of targeted budesonide delivery in patients with IgAN.
MED 3D Printing Technology
Since its founding in 2015, Triastek has concentrated on developing 3D-printed solid dosage form drugs. The company holds 213 patent applications related to 3D-printed pharmaceuticals across 10 countries, with 68 patents granted.
Triastek’s MED 3D printing technology, combined with its 3D microstructure design, provides precise control over the drug’s release properties, including the choice of delay layer material, layer thickness, and composition. This capability offers greater flexibility than traditional tablet-making techniques, which typically rely on a drug core and delay layer. As a result, the drug’s release can be tailored for immediate, sustained, or pulsed delivery to meet specific therapeutic needs.
3D Printing Technology in Drug Production
In addition to D23, Triastek has made progress in the 3D-printed pharmaceutical drug delivery field. Last year, in collaboration with Eli Lilly, Triastek worked to research and develop 3D-printed oral drugs for the gastrointestinal tract. This project utilized Triastek’s MED technology to create drug release profiles targeting specific areas of the digestive system.
Elsewhere, researchers from the MERLN Institute, University of Santiago de Compostela, University College London (UCL), and the UCL spin-out FabRx developed a method to 3D print tablets in seven seconds. Unlike traditional layer-by-layer photopolymerization, this team used a volumetric 3D printing technique that cures entire vats of resin in a single run, speeding up the production of customized medications.
Additionally, a team from the Max Planck Institute for Informatics in Saarbrücken, Germany, and the University of California at Davis developed 3D-printed pills that can release drugs at controlled speeds. The team showed how the pills’ shapes can be printed to control the dissolution rate in the body, offering new possibilities for drug delivery.
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Featured image shows Triastek’s 3D printed D23 pharmaceutical product. Image via Triastek.
