Department of Pharmaceutical Analysis

Shana Van de Steene

Laboratory of Pharmaceutical Process Analytical TechnologyShana Van de Steene

Ottergemsesteenweg 460
B-9000 Gent (Belgium) 
Tel.:+32-9-264.81.18 
Fax: +32-9-222.82.36
E-mail: Education: Pharmacist (Master in Drug Development)

 

In pharmaceutical industry, there has been increasing interest in continuous manufacturing for 15 years. Alternative and innovative continuous manufacturing processes are gaining interest in order to improve process efficiency, increase flexibility, reduce costs and decrease the environmental footprint. Therefore, fundamental process understanding is required to apply a switch from batchwise to continuous manufacturing.

Due to its multiple advantages, hot-melt or thermoplastic twin-screw granulation is an interesting innovative technique to perform particle enlargement. Instead of a liquid, a meltable binder is used to achieve agglomeration of powder particles. No drying step is required and therefore, process time and energy consumption can be reduced. Furthermore, the ability to modulate release kinetics of the API, the relatively low processing temperatures and the possibility to develop high-dosed formulations (up to 95% API)  can be added to the extensive list of advantages of melt granulation.

The aim of this research project is:

  • To elucidate the granulation mechanism along the length of the barrel for twin-screw melt granulation
  • To enhance process understanding by evaluating the influence of process parameters and different screw elements on granule properties for twin-screw melt granulation
  • To gain better understanding of the influence and relationship of process parameters and raw material properties during continuous melt granulation
  • To evaluate the influence of formulation and process parameters on downstream processing of melt granules