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
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.