Department of Pharmaceutical Analysis

Li Wang

Laboratory of Pharmaceutical Process Analytical TechnologyLi Wang

Ottergemsesteenweg 460
B-9000 Gent (Belgium) 
Tel.: +32-9-264.8068
E-mail: lwangwan.Wang@UGent.beEducation: Master of Medicine (Pharmaceutical Analysis)

Development and optimization of amorphous solid dispersions using twin screw melt granulation

As the pharmaceutical industry advances with the development of new molecular entities, the complexity of drug molecules is increasing, often leading to challenges with solubility and stability. Amorphous solid dispersions (ASDs) have emerged as a promising strategy to address these challenges by improving the solubility and bioavailability of poorly soluble drugs. This research proposal focuses on optimizing the production of ASDs using twin-screw melt granulation (TSMG), an advanced manufacturing technique recognized for its efficiency in processing complex formulations.

TSMG is a continuous, high-shear granulation process that utilizes a twin-screw extruder to melt and mix drug and polymer components. This method provides precise control over key parameters such as temperature, screw speed, and feed rate, which are critical for achieving high-quality granules.

The project aims to gain a thorough understanding of TSMG’s effectiveness in producing high-quality ASDs. It will focus on developing a continuous TSMG process to ensure consistent granule quality and evaluate the granules' suitability for tablet formulation. This includes assessing the stability and performance of the tablets produced.

Additionally, the research will investigate the long-term physical stability of the formulated tablets and their in vitro drug release profiles. This approach is designed to improve pharmaceutical manufacturing and contribute to the development of more effective and reliable drug products.