Melt Extrusion Deposition (MED®) 3D printing is an additive manufacturing, end-to-end technology that continuously converts powder feedstocks into softened/molten states followed by precise layer-by-layer deposition to fabricate produce objects with well-designed geometric structures. MED® technology can be used to develop products containing new chemical entities (NCE) as well as highly differentiated lifecycle management products for unmet medical and clinical needs. Versatile scalability and real-time monitoring allow production of medicines tailored to different clinical and commercial quantities.
Principle
The powdered raw materials are directly mixed and fused into a movable semi-solid, then extruded with high precision, printed layer by layer, to form pre-designed three-dimensional structure drug tablets.
Material Research
MED® process broadens the database of APIs and pharmaceutical excipients, encompassing 200+ pharmaceutical excipients and 1000+ compositions for 3D printing formulation development. The established temperature range for printing is from 25℃ to 250℃.
Formulation and Dosage Form Design
The flexibility of 3D printing to produce a wide range of structural designs can be used to achieve the desired release profile, overcome challenges in drug delivery and development.
Process Development
Based on the MED® technology, Triastek has built three pharmaceutical processes, which are named MED® process, MED&MIM process and MED&SSE process, for the development of pharmaceutical products with different needs.
Platform Development
Triastek has developed five 3D microstructure drug delivery technology platforms based on materials, formulation and dosage form designs, and processes research to meet challenges across diverse clinical application scenarios.
Triastek's MED® 3D Printing technology was accepted into the FDA Emerging Technology Program (ETP) in April 2020 based on the following merits:
Use of MED®-based 3D printing technology to manufacture solid oral dosage forms with modified release profiles.
A fully automated and continuous manufacturing process using process analytical technology (PAT) and feedback controls.