Triastek’s T21, a medication manufactured using 3D printing, displays potential in the treatment of ulcerative colitis.

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Triastek, a Chinese drug 3D printing firm, has successfully completed its First-in-Human (FIH) study of its new 3D printing drug, known as T21. This drug has been specifically developed to treat moderate to severe ulcerative colitis (UC). The study’s imaging findings have confirmed that T21 tablets are able to accurately deliver the drug to the colon, where it is intended to take effect. The tablets are produced using Triastek’s Melt Extrusion Deposition (MED) 3D printing process, which allows for precise regulation of the drug’s release in the gastrointestinal tract, resulting in a more focused and effective drug delivery mechanism.

Professor Xiaoling Li, Co-Founder and Chief Scientific Officer of Triastek, expressed his confidence in the MED process, stating, “The first human study data with T21 verifies the precise colon delivery capability of the MED process, and this platform is poised to become the novel drug delivery system of choice for new colon-targeted products with either local efficacy or systemic absorption.” He also emphasized the potential of Triastek’s 3D printing processes to provide technical solutions to pharmaceutical companies, leading to more efficient product development of optimized drug delivery and ultimately benefiting patients with more valuable medicines.

The ability of T21 to provide targeted and effective drug delivery is particularly advantageous for UC patients. Oral medication is preferred in these cases due to its safety, pain avoidance, and patient compliance. T21 enables precise drug delivery to the gastrointestinal tract, greatly improving its effectiveness. The drug consists of three layers – the enteric layer, delay layer, and drug core. The enteric layer maintains the tablet’s structure in the stomach’s acidic environment, ensuring that the active ingredients are not released prematurely. The delay layer erodes at a constant rate in the intestine, achieving time-delayed drug release. Finally, upon reaching the colon, the delay layer fully erodes, resulting in the targeted release of active ingredients.

T21 has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) under the 505(B)(2) pathway. Derived from the oral Janus kinase (JAK) inhibitor called tofacitinib, T21 was approved, leading Triastek to commence FIH research in Q1 of 2023. The study aimed to investigate the transport, erosion process, and release site of T21 in the human body after oral administration.

Triastek is actively seeking collaborations with pharmaceutical companies to leverage the advantages of 3D printing in medication production. Some of its recent partnerships include Boehringer Ingelheim, Eli Lilly, and Merck KGaA. Triastek’s MED technology offers end-to-end solutions, including innovative dosage form design, product development, and continuous manufacturing at a commercial scale. The company’s MED 3D printing system is capable of producing up to 50 million tablets per year, catering to both blockbuster and rare disease products and allowing for flexible manufacturing.

The potential market for 3D printed drugs is substantial. Triastek states that 3D printing technology can be applied to produce chemical drugs, biological drugs, and peptides. In addition, the global pharmaceutical market is projected to reach $1,236 billion in 2028, with the small molecule drug market estimated to be $549 billion in the same year. Triastek’s Professor Xiaoling Li envisions a significant portion of the pharmaceutical market being addressable by 3D printing.

In conclusion, Triastek’s successful FIH study of its 3D printing drug, T21, for the treatment of ulcerative colitis highlights the potential of 3D printing technology in revolutionizing drug delivery mechanisms. The precise and targeted delivery capabilities of T21, combined with Triastek’s MED process, hold promise for the development of more efficient and clinically valuable medicines. The company’s dedication to collaboration and the expansion of its MED technology further strengthens its position in the pharmaceutical industry.

Revolutionizing Drug Production: The Potential of 3D Printing Technology

In the world of pharmaceuticals, innovation is key. Companies are constantly seeking new ways to enhance drug delivery, improve patient outcomes, and tackle formulation challenges. One such innovation that has emerged in recent years is 3D printing technology. By utilizing this technology, pharmaceutical companies are able to revolutionize drug production and create customized medication for patients.

Last year, global pharmaceuticals company Eli Lilly and Triastek joined forces to research and develop 3D printed oral drugs for the gastrointestinal tract. Triastek’s proprietary MED technology played a crucial role in the collaboration, allowing them to fabricate programmed drug release profiles that target specific areas of the human digestive system. Dr. Senping Cheng, the Founder and CEO of Triastek, expressed his excitement over the collaboration, highlighting the potential of MED technology to enhance drug delivery via the oral route.

But Triastek isn’t the only player in the 3D printing game. Researchers from the MERLN Institute, University of Santiago de Compostela, University College London (UCL), and UCL spin-out FabRx have recently made significant strides in 3D printing tablets. Unlike traditional layer-by-layer printing methods, they employed a volumetric 3D printing approach that cured full vats of resin in a single run. This breakthrough has the potential to greatly accelerate the production rate of customized medication, making end-use clinical 3D printing more feasible.

So, what does the future hold for 3D printing in the pharmaceutical industry? While it is still premature to estimate the share of 3D printed pharmaceuticals in projected sales, it is clear that this technology is gaining traction in various pharmaceutical areas. Dosing, mass production, API synthesis, implants, and drug-device combinations are just a few of the potential applications. As more companies explore the possibilities of 3D printing, the share of 3D printed pharmaceuticals is expected to steadily increase.

However, this growth won’t come without its challenges. Engineering obstacles will need to be tackled in the additive manufacturing sector over the next decade. Issues such as material selection, quality control, regulatory compliance, and scalability will need to be addressed to unleash the full potential of 3D printing in the pharmaceutical industry.

In conclusion, 3D printing technology has the potential to revolutionize drug production. Through collaborations and advancements in technology, pharmaceutical companies are discovering new ways to enhance drug delivery and tackle formulation challenges. While there are still hurdles to overcome, the future looks bright for 3D printed pharmaceuticals. So, keep an eye on this rapidly evolving field and stay updated with the latest 3D printing news to witness the exciting possibilities that lie ahead.

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