Feng Zhang, PhD
Mechanistic Investigation of Continuous Twin-Screw Melt Granulation
Summary
Continuous manufacturing holds great promise for improving the American drug market. Continuous manufacturing can improve drug quality, address the shortage of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. Continuous manufacturing integrates traditional multi-step batch processes into a single system that is based on modern process monitoring and controls. A steady output of drug products is achieved using a steady input of raw materials. Twin-screw melt granulation (TSMG) is an emerging manufacturing technology that has been proven with a limited number of drug products on the market, and it holds the promise of becoming a leading granulation process. It offers the benefits of both melt granulation processing and continuous processing. This study presents a systematic approach for investigating the applicability and mechanisms of TSMG. This project is the first reported attempt to assess the thermal and mechanical stresses that occur during TSMG. Novel concepts, including pre-plasticization and transient plasticization, as well as split feeding as methods to reduce thermal and mechanical stresses, are investigated. The results from this study can be used to guide a rational formulation and process design to melt granulation in order to improve the flow and compaction properties.
I am grateful for the PhRMA Foundation’s Research Starter Grant. It gave me the financial support to carry out my research plan to gain fundamental knowledge of this novel pharmaceutical processing and to establish my research team as the leader in the field of continuous granulation.
