Triastek, a 3D pharmaceutical printing company, has reported positive results for its 3D printed drug, D23 (Budesonide Ileum-Targeted Tablets), designed to treat IgA nephropathy (IgAN).
D23 is a delayed-release budesonide tablet produced using Triastek’s proprietary Melt Extrusion Deposition (MED) process, based on its 3D Microstructure for Intestine Targeting (3DμS-IT) platform. This platform enables precise, site-specific drug release – ensuring that budesonide reaches the ileum, where IgAN originates and where the drug can have the most therapeutic effect. This targeted approach is expected to offer significant advantages over existing treatments.
Clinical study and findings
The D23 clinical trial was a randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover study. Researchers used an innovative labeling method to track D23 tablet components and X-ray imaging to monitor gastrointestinal (GI) transit. This allowed them to analyze both the tablet’s movement through the GI tract and budesonide absorption in the body.
X-ray imaging confirmed that D23 tablets remain intact until they reach the ileum – ensuring maximum drug release precisely where it is needed. Since IgAN originates in the ileum, this targeted delivery method is expected to enhance budesonide’s effectiveness by optimizing its impact on the immune response at the disease site. The study also found a strong correlation between the pharmacokinetics (PK) of budesonide and the X-ray tracking results, demonstrating a consistent and predictable drug release pattern.
Next steps
Following these promising results, D23 will advance to the next phase of clinical trials to assess its effectiveness in treating IgAN patients.
Triastek’s MED 3D printing process and 3D microstructure design allow for precise control over drug release by adjusting factors such as the delay layer material, thickness, and composition – a level of customization not possible with traditional tablet manufacturing. In addition to delayed release, this technology can also enable immediate, sustained, or pulsed drug release, offering flexibility in drug formulation and administration.
By leveraging advanced 3D printing techniques, Triastek aims to redefine targeted drug delivery – improving treatment outcomes for patients with IgAN and other diseases requiring precise site-specific therapy.
