Department of Pharmaceutical Analysis

Dr. Lien Saerens

Obtained degree of Doctor in Pharmaceutical Sciences in 2013 at:

Laboratory of Pharmaceutical Process Analytical Technology
Ottergemsesteenweg 460
B-9000 Gent (Belgium)

Education: Pharmacist (Master in Pharmaceutical Care)

Implementation of PAT systems in pharmaceutical hot-melt extrusion processes.

Hot-melt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry, and has significant potential as a continuous process in the pharmaceutical industry. Extrusion is the process of converting a raw material into a product of uniform shape and density by forcing it through a die under controlled conditions. Hot-melt extrusion offers several advantages over traditional processing techniques for pharmaceutical applications. The process is anhydrous and requires no solvents, entails a continuous operation necessitating fewer processing steps, requires no compression of the actives, offers the possibility of the formation of solid dispersions and solid solutions and improves bioavailability of poorly soluble drugs.

The purpose of this research is to implement PAT systems in pharmaceutical hot-melt extrusion processes. In first instance, innovative processes sensors will be used for in-line critical process and formulation variables monitoring. This should lead to increased process understanding as hot-melt extrusion processes are mainly black boxes.

International Mobility
April - June 2011:
IRC in Polymer Science and Technology
School of Engineering, Design and Technology University of Bradford

Download PhD Thesis

Publications

  • Saerens, L.; Vervaet, C.; Remon, J.P., De Beer, T. (2014). Process monitoring and visualization solutions for hot-melt extrusion: A review. Journal of Pharmacy and Pharmacology, 66, 180-203.
  • Saerens, L.; Segher, N.; Vervaet, C.; Remon, J.P.; De Beer, T. (2014). Validation of an in-line Raman spectroscopic method for continuous active pharmaceutical ingredient quantification during pharmaceutical hot-melt extrusion. Analytica Chimica Acta, 806, 180-187.
  • Saerens, L.; Vervaet, C.; Remon, J.P.; De Beer, T. (2013). Visualization and understanding of material behaviour in the extrusion barrel during a pharmaceutical hot-melt extrusion process using Raman spectroscopy. Analytical Chemistry, 85, 5420-5429.
  • Vervaeck, A.; Saerens, L.; De Geest, B.G.; De Beer, T.; Carleer, R.; Adriaensens, P.; Remon, J.P.; Vervaet, C. (2013). Prilling of fatty acids as a continuous process for the development of controlled release of multiparticulate dosage forms. European Journal of Pharmaceutics and Biopharmaceutics, 85, 587-596.
  • Saerens, L.; Dierickx, L.; Quinten, T.; Adriaensens, P.; Carleer, R.; Vervaet, C.; Remon, J.P.; De Beer, T. (2012). In-line NIR spectroscopy for the understanding of polymer-drug interaction during pharmaceutical hot-melt extrusion. European Journal of Pharmaceutics and Biopharmaceutics, 81, 230-237.
  • Dierickx, L.; Saerens, L.; Almeida, A.; De Beer, T.; Remon, J.P.; Vervaet, C. (2012). Co-extrusion as manufacturing technique for fixed-dose combination mini-matrices. European Journal of Pharmaceutics and Biopharmaceutics, 81, 683-689.
  • Quinten, T.; Andrews, G.P.; De Beer, T.; Saerens, L.; Bouquet, W.; Jones, D.S.; Hornsby, P.; Remon, J.P.; Vervaet, C (2012). Preparation and evaluation of sustained-release matrix tablets based on metoprolol and an acrylic carrier using injection moulding. AAPS PharmSciTech, 13, 1197-1211.
  • Almeida, A.; Saerens, L.; De Beer, T.; Remon, J.P.; Vervaet, C. (2012). Upscaling and in-line process monitoring via spectroscopic techniques of ethylene vinyl acetate hot-melt extruded formulations. International Journal of Pharmaceutics, 439, 223-229.
  • Saerens, L.; Dierickx, L.; Lenain, B.; Vervaet, C.; Remon, J.P.; De Beer, T. (2011). Raman spectroscopy for the in-line polymer-drug quantification and solid-state characterization during a pharmaceutical hot-melt extrusion process. European Journal of Pharmaceutics and Biopharmaceutics, 77, 158-163.
  • De Beer, T.; Burggraeve, A.; Fonteyne, M; Saerens, L.; Vervaet, C.; Remon, J.P. (2011). Near infrared and Raman spectroscopy for the in-process monitoring of Pharmaceutical production processes. International Journal of Pharmaceutics, 417, 32-47.
  • Sacré, P.Y.; Deconinck, E.; Saerens, L.; De Beer, T.; Courselle, P.; Vancauwenberghe, R.; Chiap, P.; Crommen, J.; De Beer, J. (2011). Detection of counterfeit Viagra® by Raman microspectroscopy imaging and multivariate analysis. Journal of Pharmaceutical and Biomedical Analysis, 56, 454-461.