The Development of a Robust Risk-Based Approach to the use of Hot Melt Extrusion for the Manufacture of Amorphous Solid Dispersions

This project builds upon the extensive experience within the Pharmaceutical Engineering team at the School of Pharmacy to develop a risk-based approach to evaluate the suitability of hot melt extrusion as a manufacturing technique for amorphous solid dispersions. 

This project aims to establish and evaluate key risks factors, and hence enabling success/failure prediction, of amorphous solid dispersions (ASDs) using hot-melt extrusion (HME) technology, focusing on a broad range of active pharmaceutical ingredients (APIs) and polymer excipients. The PhD project will build upon the risk assessment classification system proposed by Kyeremateng et al, 2022 which uses API–polymer phase diagrams for early risk assessment and process optimization. 

Key Objectives of the project include: 

• Develop and characterise ASDs using HME for poorly water-soluble APIs. 
• Construct and analyse API–polymer phase diagrams to identify optimal processing conditions. 
• Implement and validate the HME risk classification system (HCS) for various API–polymer combinations. 
• Utilise advanced analytical techniques such as differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), polarized light microscopy (PLM), and X-ray powder diffraction (XRPD) to develop a deep understanding of these complex systems. 
• Integrate Process Analytical Technology (PAT) tools for real-time monitoring and control of the HME process. 

Subject area 

Pharmaceutics 

Candidate requirements / Key skills required for the post  

Applicants should have a 1st or 2.1 honours degree (or equivalent) in a relevant subject, such as pharmaceutical sciences, chemical engineering, chemistry or pharmacy. Students who have a 2.2 honours degree and a Master’s degree may also be considered 

The following technical skills/knowledge would be beneficial: 

Hot-Melt Extrusion (HME) – twin-screw extrusion, process optimisation and machine configuration. 

Thermal Analysis – Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA). 

Analytical Techniques – polarized light microscopy (PLM), X-ray powder diffraction (XRPD), drug dissolution, UV-Vis, IR and Raman spectroscopy, QbD 

Modeling and Simulation – Applying empirical models and using simulation software. 

Laboratory Techniques – Preparing samples, analysing data, documenting procedures and presenting findings. 

How to apply / contacts 

Postgraduate Research applicants must have applied to Queen’s, via the Direct Applications Portal. 

https://dap.qub.ac.uk/portal/user/u_login.php  

Relevant links / more information   

http://www.qub.ac.uk/schools/SchoolofPharmacy/Research/PostgraduatePositions/ 

http://www.qub.ac.uk/schools/SchoolofPharmacy/Research/ 

Keywords for search filters 

Hot-Melt Extrusion (HME), Amorphous Solid Dispersions (ASDs), API–Polymer Phase Diagrams, Process Analytical Technology (PAT), Risk Assessment Classification System (HCS) 

Training provided through the research project 

The successful student will join a multidisciplinary research team that will equip them to work within the Pharmaceutical Industry or to pursue a career in academia. The student will gain a range of skills in Hot-Melt Extrusion (processing optimisation), thermal Analysis (DSC, TGA), polarized light microscopy (PLM), X-ray powder diffraction (XRPD, and spectroscopic techniques such as UV-Vis, IR, Raman and Solid-Sate NMR. The student will also work alongside academics from other Schools (E.g., Chemistry and Chemical Engineering, and Mathematics) to build appropriate models and simulations to assess risk. 

In addition, the student will develop their ability to critically evaluate scientific literature, formulate research questions, collect and analyse data, and interpret complex data using various statistical and other relevant tools. 

Importantly, the student will also be taught how to manage a research project from conception to completion, including setting objectives and associated timelines. Upon completion of the training, they will enhance their scientific writing and presentation skills, whilst also gaining an opportunity to work in a multidisciplinary team and build professional relationships through conference attendances.