Department of Pharmaceutical Analysis

Dr. Anneleen Burggraeve

Obtained degree of Doctor in Pharmaceuticals Sciences in 2012 at:

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

Education: Master in Chemistry

Development of process analytical and control methodologies for pharmaceutical wet granulation processes

Granulation is a general term to describe methods of size enlargement in the pharmaceutical industry. Powder particles are agglomerated into larger, permanent structures (granules) in which the original particles are identifiable. Improvement of one or more powder properties (e.g., flowability, bulk density, dust formation, risk of size segregation, etc.) motivates the pharmaceutical industry to adopt granulation as a key intermediate process step in most solid dosage form production processes.

The traditionally applied granulation control and endpoint determination tools in the pharmaceutical industry do not ensure the consistent production of granules with the desired quality characteristics. Therefore in this thesis, the application of novel process analyzers for fluid bed granulation and extrusion-spheronization, capturing direct granule product information, was evaluated.

Download Phd Thesis

Publications

  • Filipa Tavares da Silva, A.; Burggraeve, A.; Quenten, D.; Van der Meeren, P.; Sandler, N.; Van Den Kerkhof, T.; Hellings, M.; Vervaet, C.; Remon, J.P.; Lopes, J.; De Beer, T. (2013). Particle sizing measurements in pharmaceutical applications: comparison of in-process methods versus offline methods. European Journal of Pharmaceutics and Biopharmaceutics, 85, 1006-1018.
  • Burggraeve, A.; Monteyne, T.; Remon, J.P.; Vervaet, C.; De Beer, T. (2013). Process analytical tools for monitoring, understanding and control of pharmaceutical fluidized bed granulation: a review. European Journal of Pharmaceutics and Biopharmaceutics, 83, 2-15.
  • Burggraeve, A.; Van der Heyden, Y.; Silva, A.F.; Van den Kerkhof, T.; Hellings, M.; Vervaet, C.; Remon, J.P.; De Beer, T. (2012) Development of a fluid bed granulation process control strategy based on real-time process and product measurements. Talanta, 100, 293-302.
  • Fonteyne, M.; Soares, S.; Vercruysse, J.; Peeters, E.; Burggraeve, A.; Vervaet, C.; Remon, J.P.; Sandler, N.; De Beer, T. (2012). Prediction of quality attributes of continuously produced granules using complementary PAT tools. European Journal of Pharmaceutics and Biopharmaceutics, 82, 429-436.
  • Burggraeve, A.; Van Den Kerkhof, T.; Hellings, M.; Remon, J.P.; Vervaet, C.; De Beer, T. (2011). Understanding fluidized-bed granulation using in-line particle-size measurements. Pharmaceutical Technology, 35, 63-67.
  • Burggraeve, A.; Sandler, N.; Heinämäki, J.; Räikkönen, H.; Remon, J.P.; Vervaet,C.; De Beer, T.R.M.; Yliruusi, J. (2011). Real-time investigation of spheronization and drying features of different formulations using digital image information. European Journal of Pharmaceutical Sciences, 44, 635-642.
  • Burggraeve, A.; Van Den Kerkhof, T.; Hellings, M.; Remon, J.P.; Vervaet, C.; De Beer, T. (2011). Batch statistical process control of a fluid bed granulation process using in-line Spatial Filter Velocimetry and product temperature measurements. European Journal of Pharmaceutical Sciences, 42, 584-592.
  • 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.
  • Burggraeve, A.; Van Den Kerkhof, T.; Hellings, M.; Vervaet, C.; Remon, J.P.; De Beer, T. (2010). Evaluation of In-Line Spatial Filter Velocimetry as PAT Monitoring Tool for Particle Growth during Fluid Bed Granulation. European Journal of Pharmaceutics and Biopharmaceutics, 76, 138-146.
  • De Beer, T.R.M.; Wiggenhorn, M.; Veillon, R.; Debacq, C.; Mayeresse, Y.; Moreau, B.; Burggraeve, A.; Quinten, T.; Frieβ, W.; Winter, G.; Vervaet, C.; Remon, J.P.; Baeyens, W.R.G. (2009). The Importance of Using Complementary Process Analyzers for the Process Monitoring, Analysis and Understanding of Freeze Drying. Analytical Chemistry, 81, 7639-7649.
  • De Beer, T.R.M.; Vercruysse, P.; Burggraeve, A.; Quinten, T.; Ouyang, J.; Zhang, X.; Vervaet, C.; Remon, J.P.; Baeyens, W.R.G. (2009). In-line and real-time process monitoring and control of a freeze drying process using Raman and NIR spectroscopy as complementary process analytical technology (PAT) tools. Journal of Pharmaceutical Sciences, 98, 3430-3446.
  • De Beer, T.R.M.; Bodson, C.; Dejaegher, B.; Walczak, B.; Vercruysse, P.; Burggraeve, A.; Lemos, A.; Delattre, L.; Vander Heyden, Y.; Remon, J.P.; Vervaet, C.; Baeyens, W.R.G. (2008). Raman spectroscopy as a process analytical technology (PAT) tool for the in-line monitoring and understanding of a powder blending process. Journal of Pharmaceutical and Biomedical Analysis, 48, 772-779.