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.
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.
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.
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:
MED® 3DP Pharmaceuticals R&D Printer can be used for development and early-stage clinical batch production.
Triastek has constructed GMP compliant continuous 3D printing pharmaceutical production center with a maximum annual capacity of 75 million units in the initial continuous production line. This production line is dedicated to phase Ⅱ/Ⅲ clinical batch production and commercial production with flexible scalability.
3D Printing Formulation by Design (3DFbD®)
A digital formulation process that changes the traditional trial-and-error formulation development method can considerably increase the efficiency and success rate of drug product development and reduce development time and cost. Once the target PK profile is defined, it can be translated into the corresponding release profile that can then be used to design tablet structures and identify appropriate polymeric materials and excipients to fabricate the prototype.
Structural design and data-based material allow an expedite formulation development, approximately 8-12 weeks to complete the proof of concept of complicate formulation development and enter the IND preparation phase.
Simplified continuous fabrication process from raw materials to tablets without requiring pre- or post-production processing.
Flexible Product Supply
Modular design supports flexible adjustment of production capacity to meet the production needs of millions of rare disease drugs to hundreds of millions of blockbuster products.
The PAT is used to ensure quality control and consistency.
Solid dosage forms for various routes of administration, including oral, implants, dermal, etc. to provide delivery solutions for different drugs, including chemical drug and oral peptide.
Programmable release control
3DFbD® digital formulation development
Digital and continuous manufacturing
Agile and flexible manufacturing system