Date of Award
1-1-2025
Document Type
Dissertation
Degree Name
Ph.D. in Pharmaceutical Sciences
First Advisor
Michael Repka
Second Advisor
Eman Ashour
Third Advisor
Samir Ross
School
University of Mississippi
Relational Format
dissertation/thesis
Abstract
Hot-melt extrusion (HME) is a solvent-free process that introduces heat flow, pressure, and agitation of the polymer excipients into the screw with continuous rotation. In the HME process, the drug-polymer powder blend was continuously fed into the heated barrel and then thoroughly mixed by the rotating strews inside the barrel. The friction created by the screws and the heat would help to overcome the crystal lattice energy and achieve the molecular mixing of the mixture of drugs and excipients, forming amorphous solid dispersions (ASD). The physical-chemical properties of the formulation such as solubility, bioavailability, and bioadhesive ability could be enhanced through this process by selecting the appropriate polymer excipient. Then, the molten mixture could be customized with different shapes (film, powder, pellets, etc.) right after extrusion by passing through an orifice that ejects the formed extrudates with a predetermined shape for direct administration or further processed to direct compressed tablets, 3D-printed formulations, etc. for controlled-release delivery.
HME provides many advantages among other process technologies, including high efficiency, continuous manufacturing, and low cost. This solvent-free method avoids the difficulties of solvent selection and is favorable for safe manufacturing. There are already various studies using HME for formulation development, however, most of them are using similar traditional polymers (HPC, HPMC, PVP, Eudragit, etc) and the high-temperature process also limits the drug candidate. There is still a need to discover the novelty utilization
Recommended Citation
Zhang, Ziru, "Formulation Development for Controlled Release and Solubility Enhancement using Hot-melt Extrusion" (2025). Electronic Theses and Dissertations. 3412.
https://egrove.olemiss.edu/etd/3412