Can Hot-Melt Extrusion Displace Spray Drying in Solubility Enhancement?

Access an inside view of the future of hot-melt extrusion (HME). The process has long been used in the pharmaceutical industry for improving drug solubility and bioavailability in the manufacture of amorphous solid dispersions (ASDs) for oral solid dosage (OSD) forms.  

An interview with Dr. Thomas Quinten, Principal Scientist, Janssen Pharmaceutical Companies, and Dirk Leister, Technical Marketing Manager, Thermo Fisher Scientific, explores the advantages, challenges, and outlook for this important technology:

  • Conquering solubility issues
  • Reaping the environmental advantages of HME
  • Overcoming the temperature roadblock
  • Changing the mindset of an industry slow to adopt alternative technologies
  • The outlook for wider use of HME on a commercial scale
Thomas Quinten

Dr. Thomas Quinten, Principal Scientist, The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson

Thomas Quinten earned a Ph.D. in Pharmaceutical Technology and a Master in Pharmaceutical Sciences at the University of Ghent, Belgium. His knowledge of different excipients, formulations and processes was broadened during his Ph.D. focusing on the development of sustained-release matrix tablets manufactured via hot melt extrusion/injection molding. In addition, this provided him a multidisciplinary background in formulation and drug product development including enabling technologies and innovative advanced drug delivery systems focusing on small molecules.

Thomas joined Janssen in 2016 as Senior Scientist within OSD. He has focused on enabling technologies and contributed to multiple projects including technology transfer activities. He is responsible for end-to-end formulation and process development activities for oral solid dosage forms with a specific focus on Enabling Advanced Drug Delivery.

Dirk Leister

Dirk Leister, Technical Marketing Manager, Thermo Fisher Scientific

Dirk Leister is a marketing manager for extruders and compounders at Thermo Fisher Scientific in Karlsruhe, Germany. Together with the product line team he focuses on applications for extrusion-based processes used in the pharmaceutical, food, and polymer industries. Dirk holds an engineering degree in biotechnology and started his professional career in pharmaceutical research and development. After moving to the instrument manufacturing side of the industry, he had several positions in technical sales and product management. His expertise is developing applications for process equipment used to conduct formulation research, process development and manufacturing scale-up for pharmaceutical and bulk material handling. Dirk is adept at helping companies minimize optimization time, costs, and efforts of their continuous process scale-up.

"HME is also a completely solvent-free process, unlike spray-drying. That makes HME the obvious chose for compounds that are unstable in solvents."


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