United States Food and drug administration greenlit Investigational New Drug Application from Chinese company Triastek, Inc. for its 3D printed drug product, T20, for cardiovascular and coagulation disorders.
The Nanjing-based company noted that T20 will offer a once-a-day dosing option for an undisclosed commercial drug currently taken twice daily. Triastek said T20 is designed to provide a formulation that “addresses unmet patient needs by improving compliance and therefore the potential for improved patient outcomes.”
T20 is developed with Triastek’s 3D printing formulation by design method, which begins with a desired sustained-release PK profile. It also uses a predictable live time/location profile of dissolution of the gastrointestinal tract (GIT). This profile was predicted using what Triastek called a “physiologically based biopharmaceutical model (PBBM) of GIT uptake to inform formulation development.” Its approach overcomes the limitations of traditional time-release products, and Triastek said its proof-of-concept has already been demonstrated in animal studies.
With its 3D technology, Triastek said it is able to develop new formulations “difficult to achieve with conventional dosage form technology to address unmet clinical needs and improve drug therapy outcomes.” Its 3D technology for drug development will initially focus on small molecule drugs.
Semping Cheng, founder and CEO of Triastek, noted that 3D printing technology is revolutionizing the pharmaceutical industry. T20 is the second Triastek product to be approved by the FDA for clinical studies. Cheng said the IND clearance for T20 “demonstrates the significant advancements in 3D-printed pharmaceuticals.”
Currently, there is only one FDA-approved 3D printed drug, Aprecia Pharmaceuticals‘ Spritam, which is used to treat partial-onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. Spritam has remained the only FDA-approved 3D-printed drug since it was first green light in 2015.
In addition to Triastek, other companies hope to join Aprecia with an approved 3D-printed drug. Last month, Laxxon Medical secured funding for support its 3D screen printing technology. The company’s technology is designed to control the release of multiple active pharmaceutical ingredients in a single tablet.
Some 3D printed medical devices have been approved by the FDA, including orthopedic implants.
There is a growing global market for 3D printed drugs, devices and implants. In March, the market for 3D printed medical implants was forecast to be expected to reach over $9 billion by 2030. In 2021, the implant market size was less than $2 billion.