Triastek Drug T21: Source: Triastek
Triastek, a Chinese 3D printing company, has finished the FIH phase of its innovative 3D printed medication T21. This medication is approved for the treatment of UC in its moderate to severe forms.
The study’s imaging results show that T21 tablets go to the colon and release their contents steadily and precisely where they’re supposed to have an effect. To control the rate at which the medicine is absorbed by the body, the business uses a 3D printing technology called Melt Extrusion Deposition (MED). Thus, this approach guarantees a more targeted and efficient method of medication distribution.
According to Professor Xiaoling Li, Co-Founder and Chief Scientific Officer of Triastek, “the first human study data with T21 verifies the precise colon delivery capability of the MED process,” and this platform is set to become the novel drug delivery system of choice for new colon-targeted products with either local efficacy or systemic absorption. In order to supply patients with more clinically beneficial medications, “we hope to continue showcasing how Triastek’s 3D printing processes can bring technical solutions to pharmaceutical companies for efficient product development of optimised drug delivery.”
Targeted and effective drug delivery of T21
The business claims that oral medicine is preferable for UC patients owing to safety, pain avoidance, and patient compliance. The T21 from Triastek allows for focused and accurate medication administration in the gastrointestinal system.
As the third 3D printed medicinal product from the business, T21 is an oral medication with three distinct components: an enteric layer, a delay layer, and the drug core itself. The enteric coating keeps the tablet together in the stomach’s acidic environment, preventing the early release of the active components. Time-delayed medication release is accomplished via the gradual erosion of the delay layer in the gut. After entering the colon, the delay layer completely breaks down, allowing the active chemicals to be released in a controlled fashion.
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On November 18, 2022, the FDA granted T21 approval for its Investigational New Drug (IND) application under the 505(B)(2) pathway. Tofacitinib (T21) is an orally bioavailable Janus kinase (JAK) inhibitor, and its approval allowed Triastek to launch FIH studies in the first quarter of 2023. T21 was orally administered, and the FIH research attempted to track where it went in the body, how it eroded, and where it was released.
Triastek’s mission is to form strategic partnerships with pharmaceutical corporations so that they may reap the benefits of 3D printing in the pharmaceutical manufacturing process. Recent collaborations include major pharmaceutical companies including Boehringer Ingelheim, Eli Lilly, and Merck KGaA.
Chemical medications, biological pharmaceuticals, and peptides may all supposedly benefit from Triastek’s 3D printing technology for drugs. Novel dosage form design (multi-layered, honeycomb/weave and multi-compartments, etc.), FbD product development, and continuous manufacture at commercial scale are just a few of the services that Triastek’s MED technology provides. In order to achieve the desired Pharmacokinetic (PK) profiles, the business uses its 3D printing formulation platform, 3DFbD, to convert these profiles into release profiles. It allows for the controlled release of API at the appropriate onset time, rate, and quantity, and allows for accurate tablet design for specific, hard-to-reach GI areas like the colon.
Triastek Reports Positive FIH Results from Study of T21/ Source: Globenewswire
In under seven seconds, researchers from the MERLN Institute, University of Santiago de Compostela, University College London (UCL), and the UCL spin-out FabRx have developed a method to 3D print tablets. The researchers developed a volumetric 3D printing technique that cured whole vats of resin in a single run, rather than the conventional vat photopolymerization procedure used for layer-by-layer printing of pills. An important step towards realising clinical 3D printing for final applications, this development might significantly speed up the manufacturing of personalised drugs.
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