A5036727750- Chemistry and Chemical Engineering
- Injection Molding Process and Properties
- Process Optimization and Integration
- Drug Solubulity and Delivery Systems
- Innovative Microfluidic and Catalytic Techniques Innovation
- Analytical Methods in Pharmaceuticals
- Manufacturing Process and Optimization
- Scheduling and Optimization Algorithms
- Flexible and Reconfigurable Manufacturing Systems
- Computational Drug Discovery Methods
- Crystallization and Solubility Studies
Marinus Pharmaceuticals (United States)
2023
Novartis-MIT Center for Continuous Manufacturing
2017
Massachusetts Institute of Technology
2017
The pharmaceutical industry faces multiple challenges (e.g., inefficient manufacturing techniques, quality control issues, and supply chain vulnerabilities) because of its current batch-wise approach to manufacturing. Recent regulatory support for continuous advances in process technologies have caused an increase interest from some drug manufacturers modernize their production processes. However, many these companies focused on hybrid processes, where only certain steps are continuous,...
We report here a fully automated, end-to-end, integrated continuous manufacturing process for small-molecule generic medication with built-in quality assurance. The entire fits into box of 30.7 m2 modular footprint and total residence time less than 30 h, throughput up to 40.3 × 106 tablets per year.
Much less waste was generated by the end-to-end Integrated Continuous Manufacturing (ICM) process compared to batch process.
Abstract A predictive mathematical model for tablet dissolution was developed and implemented in an end‐to‐end integrated continuous manufacturing pilot plant. The tablets were produced immediate release with a proprietary extrusion‐molding‐coating (EMC) unit operation. Besides the mass balance of API solute buffer solution, consisted dissolution, diffusion, population particles swollen tablet, which mainly controlled by swelling erosion polymeric excipient matrix. An equivalence study...