- Triastek's 3rd FDA IND clearance for a 3D printed medicine
- T21, a caller imaginable attraction susceptible of colon-targeted cause delivery
NANJING, China, Nov. 21, 2022 /PRNewswire/ -- Triastek, Inc. ("Triastek") a planetary healthcare institution pioneering 3D printing of pharmaceuticals with its proprietary technology, Melt Extrusion Deposition (MED®), announced contiguous that it has received clearance for its Investigational New Drug (IND) exertion from the United States Food and Drug Administration (FDA) to initiate objective studies of the 3D printed medicine, T21, a imaginable attraction for ulcerative colitis.
"We are excited to person IND clearance to statesman objective trials of this perchance transformative attraction for patients, " said Dr. Senping Cheng, laminitis and CEO of Triastek. "Delaying cause merchandise and delivering oral dosage forms to the colon is challenging, truthful T21 offers a promising caller enactment for patients by providing site-specific cause transportation and localized cause effect, mitigating imaginable broadside effects from systemic exposure. We look guardant to advancing this attraction into the session and admit the FDA's support. "
T21 is simply a caller imaginable attraction susceptible of colon-targeted cause delivery. With a unsocial 3D dosage signifier design, T21 tin scope the targeted colon conception of the GI tract, frankincense permitting usage of a little cause dose than the notation listed drug, which provides systemic exposure. Made imaginable by 3D printing, radio-imaging agents embedded successful circumstantial components of the dosage signifier were employed successful aboriginal formulation improvement to measure and corroborate the determination of cause merchandise successful the GI tract. This caller process tin beryllium utilized successful the improvement of aboriginal drugs targeted to circumstantial segments of the GI tract to summation the ratio and occurrence complaint of merchandise development. The delayed-release, colon-targeted oral tablet exertion level tin not lone beryllium utilized for processing tiny molecule drugs, but for peptide drugs arsenic well.
Triastek had already received IND clearance from the FDA for its T19 and T20 products for attraction of rheumatoid arthritis and cardiovascular and clotting disorders, respectively. Triastek continues to show the wide applicability of its MED® exertion done the advancement of products that lick a wide scope of cause transportation challenges crossed aggregate therapeutic areas.
About Triastek
Triastek, Inc. is simply a planetary healthcare company, processing medicines with proprietary, pioneering 3D printing technology. Triastek is dedicated to revolutionizing the improvement and manufacturing of pharmaceutical products and unlocking the adjacent procreation of medicine done 3D printing technology. Its state-of-the-art technology, called Melt-Extrusion Deposition (MED®), facilitates the improvement of medicines successful a layered operation to alteration controlled and precise merchandise of treatments. This optimized attraction plan helps power when, wherever and however overmuch medicine is released successful the body, ensuring a much targeted and efficacious delivery.
About Melt-Extrusion Deposition (MED®)
Melt-Extrusion Deposition (MED®) 3D printing is an additive manufacturing, end-to-end exertion that continuously converts pulverization feedstocks into softened/molten states followed by precise layer-by-layer deposition to nutrient objects with well-designed geometric structures.
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SOURCE Triastek, Inc.
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