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Hot Melt Extrusion (HME) - First webinar of the Amorphous Solid Dispersion (ASD) Webinar Series
Hot Melt Extrusion is a well established technology used in ASDs. Besides the advantage of being a solvent free method some attributes of the API and polymer have to be considered like glass transition temperature and decomposition temperature.

Shin-Etsu, Leistritz, and Prof. Serajuddin from St. John‘s University will give you more insights into this technology.

The objectives of this webinar is to address:
- How the extruder configuration can impact the ASD
- The advantages of HPMCAS in ASD
- How to optimize the extrusion process of HPMCAS

First presentation: Hot melt extrusion for amorphous solid dispersion-Process Design and Applications
by Kathrin Reusch, Leistritz GmbH
The presentation will give a short background on solid dispersion by Hot Melt Extrusion showing specific process layouts of marketed extruded products.
Based on the case study: "Hot Melt Extrusion of Ritonavir/Lopinavir" process relevant parameters and their impact on the final product quality including scalability will be discussed.

Second presentation: Development of HPMCAS-based amorphous solid dispersions by melt extrusion
by Abu Serajuddin, PhD, Professor of Industrial Pharmacy, College of Pharmacy and Health Sciences, St. John’s University, Queens, New York, USA
Abstract:
Despite the recent interest in the use of solvent-free hot-melt extrusion (HME) method for the development of HPMCAS-based ASDs, its application in the development of marketed products has rather been limited. Indeed, out of 7 ASDs containing HPMCAS that have been marketed in recent years, only one was manufactured by HME. HME is not generally used as it requires very high temperature to extrude HPMCAS (≥170°C), where the polymer and drug may degrade. In order to optimize the processability, we studied the effects of three solid surfactants (poloxamer 188, poloxamer 407 and TPGS) and a model drug (itraconazole) in reducing complex viscosity and thus processing temperature of HPMCAS-based ASDs.
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Speakers

Kathrin Reusch
@Leistritz GmbH
Kathrin obtained her degree as Master of Science at the University of Applied Science Fulda/Germany in 2014. The same year she joined Leistritz as a process engineer (Pharma) responsible for i) preparation, conduction and follow-up of extrusion trials ii) definition of process layouts iii) process optimization, customer support & training iv) scale-up experience v) installation support (FAT, SAT) vi) organization of extrusion events (Pharma extrusion academy) and marketing tasks (website, publication, seminars). In 2019 she took over the responsibility of product manager.
Abu Serajuddin
PhD, Professor of Industrial Pharmacy @College of Pharmacy and Health Sciences, St. John’s University, Queens, New York, USA
Abu Serajuddin, PhD, is Professor of Industrial Pharmacy at St. John’s University, Queens, New York, USA. Prior to joining academia in 2008, Dr. Serajuddin worked in the pharmaceutical industry for 32 years in scientific and managerial positions at Sanofi-Aventis, BMS, and Novartis. In his latest positions in the industry, he served as Executive Director and the US Head of Pharmaceutical R&D at Novartis Pharmaceutical Corp. He also headed Science and Technology (S&T) Forum at Novartis, responsible for fostering innovation in the company globally. He has published over 125 papers and book chapters, and he is a co-inventor in 13 patents. In recognition of his scientific and professional achievements, he was elected Fellow of American Pharmacists Association (APhA) and American Association of Pharmaceutical Scientists (AAPS). Dr. Serajuddin’s work has been awarded by several organisations (AAPS, IPEC).