2023-08-06 22:02:29
3D printing is becoming more and more important in the health sector, including in pharmaceutical products. Indeed, some laboratories are exploring the use of additive manufacturing to create personalized drugs to better treat diseases. Now one of China’s largest manufacturers, Triastek recently announced a successful first-in-human study for its third 3D-printed drug, T21. It has been proven to deliver the drug directly to the colon, dedicated to the treatment of moderate to severe ulcerative colitis. This is the first time this colon-targeting system has been validated in human testing, according to Triastek.
Ulcerative colitis, or ulcerative colitis, is a chronic inflammatory bowel disease. According to the Mayo Clinic, it causes inflammation and ulcers in the innermost lining of the large intestine, otherwise known as the colon. Although there is no cure, treatment is imperative to avoid life-threatening complications such as a perforated colon, increased risk of blood clots, severe bleeding, severe dehydration, and other effects.
Triastek is one of the leading manufacturers of 3D printed drugs (photo credits: Triastek)
The disease often develops in adulthood. In France, ulcerative colitis affects around one person in a thousand according to Vidal. However, as with other gastrointestinal diseases, although taking medication by mouth is the preferred method of drug administration, its effectiveness varies greatly from patient to patient. Indeed, the transport mechanisms of the digestive environment and mucous membranes through the gastrointestinal tract can differ considerably. As a result, it can lead to complications such as drug release in other parts of the gastrointestinal system. Additionally, it is difficult to target specific areas for drug delivery. This is precisely the problem that Triastek hopes to solve with T21, a drug administered orally in the colon, which has already received IND clearance from the FDA.
Triastek’s latest 3D-printed drug, T21, may target the colon
To create the T21, Triastek turned to its self-developed process, titled 3D Microstructure, for Colon Targeting (3DµS-CT) to develop a 3D-printed prototype with various combinations of multiple release control mechanisms. This allowed them to test various effects of time and pH and achieve more precise delivery of the drug to the colon, as they were able to reduce the impact of individual gastrointestinal differences. The technique leverages Triastek’s proprietary 3D Melt Extrusion Deposition (MED) technology, which has also been used to create other 3D-printed drugs by the company. The process is carried out with a specially designed 3D printer, which mixes and fuses powdered raw materials into a moving semi-solid before being extruded and printed layer by layer, resulting in three-dimensional drug tablets .
The way the T1 is designed (left) as well as the different additive manufacturing processes used (right) (photo credits: Triastek).
The T21 tablet tested by the FIH consists of several layers in order to achieve the precise targeting of the colon. According to Triastek, it is made up of three layers: an enteric layer, a delay layer, and a drug core. The outer layer is the enteric layer, which maintains the overall structure of the tablet in the stomach acid environment. Thus, it depends on the pH. Once the tablet has passed through the pylorus into the small intestine, it is rapidly eroded to expose the retarding layer. This layer is time dependent and continues to erode at a constant rate in the intestinal tract. This erosion rate can also be adjusted via the thickness of the layer of preselected polymeric material(s) in order to adapt to each patient. The tablet should be totally eroded as it enters or into the ascending colon, releasing the core of the drug. These are the active ingredients that should be most effective because they have reached the targeted area for maximum impact. With this FIH test, the tablet has been proven successful in targeting the desired area, another win for the 3D printed drug market when it comes to treating gastrointestinal diseases. Professor Xiaoling Li, co-founder and chief scientific officer of Triastek, concluded: “Early human study data with T21 verifies the precise ability to deliver the MED process to the colon, and this mechanism is fast becoming the new drug delivery system of choice for new products targeting the colon with local efficacy or systemic absorption. We hope to continue to show how Triastek’s 3D printing processes can provide technical solutions to pharmaceutical companies for the efficient development of products that deliver drugs in an optimized manner, ultimately leading to the ability to deliver drugs to patients with the best clinical outcomes. . You can find out more in Triastek’s press release ICI.
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*Cover photo: Inactive chronic ulcerative colitis in a resection specimen (photo credits: CoRus13, ” target=”_blank” rel=”noopener”>CC BY-SA 4.0 via Wikimedia Commons)
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