FDA Clearance Granted to Triastek's T22 3D Printed Gastric Retention Drug

Triastek, a Chinese pharmaceutical firm specializing in 3D printing, has reported that the company’s T22 3D-printed gastric retention product has earned the distinction of becoming the first medication of its type to be granted Investigational New Drug (IND) clearance by the US Food and Drug Administration (FDA). Triastek

The FDA’s Federal Food, Drug, and Cosmetic Act’s section 505(B)(2) has received the filings for T22. This drug, which is 3D printed, is developed to cure pulmonary arterial hypertension (PAH) along with chronic thromboembolic pulmonary hypertension (CTEPH).

According to the information provided by Triastek, the newly introduced product significantly reduces the times a patient has to take medication from thrice a day to only once. This simplification in dosage regimen is claimed to augment medication adherence.

The T22 is brought to reality using Triastek’s unique Melt extrusion Deposition plus Micro-Injection Molding (MED&MIM) process that comes inbuilt with its 3D Microstructure for Gastric Retention (3DµS-GR), resulting in optimal drug delivery.

Triastek, a pioneer in the field of 3D printed drugs, has reportedly received FDA clearance for the clinical development of its fourth product, thus expanding its T-Series portfolio that already includes T19, T20 and T21. This accomplishment has solidified Triastek’s position as a global leader in the 3D printed drug arena, especially with respect to product development.

Now, the company is ready to kick-start clinical trials for T22, a move aimed at accelerating the product’s development process.

The company’s CEO, Dr. Senping Cheng, had this to say about their progress: “Our unique 3D Microstructure for Gastric Retention delivery technology platform has spurred the development of T20G and T22. Both products have received IND clearance to proceed from pertinent regulatory bodies in China and the United States this year. This is indeed a positive stride for Triastek’s innovative delivery technology platform as we navigate the regulatory review process.”

Triastek’s T19 drug dedicated to treating rheumatoid arthritis

MED 3D printed pharmaceuticals  

Triastek, established in 2015, devotes itself completely to the creation 3D printed solid dosage pharmaceuticals. It proudly owns 213 patent applications related to its 3D printed drugs, spread across 10 countries, out of which 68 have already been granted. 

Triastek’s unique MED extrusion-based 3D printing technology serves as a complete solution for fabricating a variety of innovative dosage forms. It continuously transitions powder feedstocks into a softened state. The molten material is subsequently layered to create physical medications featuring optimized geometric structures. 

These structures would not be possible to create otherwise. Hence, this 3D printing process affords a level of control over drug release that traditional tablet production methods fail to match. 

Triastek’s latest 3D printed drug: T22

In 2021, a joint development contract was signed by Triastek with Sperogenix Therapeutics. The goal of this agreement was to demonstrate the clinical relevance of 3DµS-GR for the T22 in East Asia.

Dr. Cheng has since reported that the advancement of the T22 has sparked interest from companies in various countries and regions for potential collaborations in product development using the 3DµS-GR drug delivery platform.

Triasktek has recently filed a Patent Cooperation Treaty (PCT) application for both its 3DµS-GR delivery system and the distinct Bloom Structure layout of the T22. 

Once orally consumed, the T22 gastric retention model grows larger than the pylorus- the channel connecting the stomach and small intestine. This increases the time frame of gastric retention. Throughout this gastric retention phase, the T22 unravels APIs, adhering to a predefined drug release behavior.

This method not only simplifies the medication schedule, lessens the medicinal load, and bolster the persistence of long-term medication. It also enhances drug absorption and oral bioavailability.

Triastek has successfully accomplished the development of the T22 gastric retention formulation. This mixture is believed to have garnered favorable outcomes in aspects such as in vitro expansion duration, mechanical fortitude, and dissolution behavior. 

The company has also completed Pharmacokinetic (PK) studies of the T22 prototype on beagle dogs. The PK study assessed how the body interacts with the drug for the duration of exposure. Here the company demonstrated that one daily dose of the T22 prototype gave comparable PK parameters as three times a day dosing of the original product.

Developments in pharmaceutical 3D printing

In recent surveys on the future of 3D printing and 3D printing trends, 3D printing experts highlighted advancements in medical applications as being a key area of current industry growth that will continue in the coming years.

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