Extrusion is a processing technology developed and widely used in polymer and food industries, and now under exploration within the pharmaceutical industry as an alternative to traditional batch processing. This continuous process has the potential to increase efficiency, but in order to meet safety and quality requirements set by regulatory agencies, continuous, accurate and robust Process Analytical Technologies (PAT) are necessary, and a Quality by Design (QbD) approach is required. The need for well-characterized materials and processes is of paramount importance in order to improve scientific understanding, ensure repeatability and reproducibility and reduce failures. This requires measurement of the processes under both well controlled laboratory conditions and within typical production facilities.
Research aims & objectives
The project will explore innovative in-line and on-line analytics, in particular focusing on novel ultrasonic and infra-red spectroscopy measurements during hot melt extrusion (HME) of polymers containing active pharmaceutical ingredients (APIs). Infra-red techniques are now well established in this field and they will be used to validate and assist in explaining the unique ultrasonic response to changes during the process, caused by fundamental and critical variables such as drug loading and drug-polymer miscibility. This experimental study will be conducted within a research team having significant experience of HME and PAT, with state of the art capabilities in processing and analysis. It will build upon previous successful research projects and would suit candidates having an engineering background with an interest in the pharmaceutical industry and the capability of working with academic and industrial collaborators.