Web-Seminar series: Advances In Amorphous Solid Dispersion Technologies: Downstream Processing

In this series of webinars we will discuss the latest developments in the fields of amorphous solid dispersion (ASD) focusing on Excipient Key Attributes linked to the most popular technologies: Hot Melt Extrusion (HME), Spray Drying and their Downstream Processing.

Thursday, 28 October 2021, 3pm CEST, 9am EST

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Formulating spray dried amorphous solid dispersions (ASD) into tablets is a very challenging step. On one hand, the powders obtained have a very low bulk density and low compressibility. On the other hand, the processing into tablets should not affect the stability of the ASD. The most popular downstream processing technology used in pharmaceutical developments is roller compaction. Dry granulation is solvent free and the ribbon obtained can be easily sieved to an optimal free flowing tabletting mass.

Shin-Etsu and Alexanderwerk will give you more insights into downstream processing of ASDs

The objective of this web-seminar is to address:

• Principles and key parameters of the roller compaction process
• Case study on roller compaction and tablet compression of a spray dried ASD with HPMCAS (Shin-Etsu AQOAT®)
• Optimization of roller compaction process parameters
• Application of L-HPC (Low-substituted hydroxypropylcellulose) as alternative to standard binder and disintegrants in tablet formulations based on ASDs

First presentation: Improvement of physical properties of spray dried granules using dry granulation.

Speaker: 
Manfred Felder, Process Development Manager @ Alexanderwerk GmbH

Presentation abstract:

What to do with a fine, low weight, spray dried granule? Just convert it into a more coarser, heavier final granule without loosing too much solubility. Dry granulation offers the most economic, sustainable way of doing this. The presenter will explain why densification is needed, the theory behind dry granulation, a comparison between dry and wet granulation, continuous manufacturing and development of PAT tools as inline process control.

Speaker biography:

Manfred Felder is the Process Development Manager and an authorized officer of Alexanderwerk GmbH in Remscheid in Germany furthermore Vice President Technology of Alexanderwerk Inc. He is a process engineer and finalized his study 1993 at the university of applied sciences in Cologne. In 1994 he started his work life directly at Alexanderwerk and is now 27 years with the company. He was hired as a process engineer with full responsibility for process design of turnkey soda ash plants worldwide and was active part of the commissioning team. In 2000 he switched into the sales group and became responsible for soda ash plants and compaction plants worldwide as well as pharmaceutical roller compactors in Europe. From 2008 to 2018 he took over the responsibility for two daughter companies: Alexanderwerk Inc in the US and Alexanderwerkservice GmbH, here as managing director. Based on his knowledge and long-time experience with roller compactors he was promoted as Process Development Manager, responsible for development of machines, processes and products as well as responsible for technical lab, machine scale up and plant design.

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Second presentation: Downstream Processing HPMCAS SDD – Roller Compaction and Tablet Compression.

Speaker:
Dr. Andreas Sauer, Technical Sales Director @ Shin-Etsu

Presentation abstract:

HPMCAS (Shin-Etsu AQOAT®) is the most popular excipient for ASD formulation due to its unique properties of improving solubility, maintaining supersaturation, and good stability of the drug product. The presentation will include an overview on commercial SDDs with HPMCAS as well as a case study:

Downstream processing of HPMCAS spray dried dispersion. Roller compaction and tablet compression. A head to head comparison of L-HPC (low-substituted hydroxypropyl cellulose) as binder and disintegrant and MCC/croscarmellose blends.

Speaker biography:

Dr. Andreas Sauer studied chemistry at RWTH Aachen University in Aachen, Germany. He then joined Prof. Jun Okuda for his doctoral thesis in organometallic chemistry and polymerization catalysis. He received his doctorate in December 2013 and entered Shin-Etsu as technical manager and head of the application laboratory at Wiesbaden, Germany, in 2014. His responsibilities included the development of solid dosage applications of Shin-Etsu cellulose ether excipients and the technical support of customers with laboratory studies. In 2017 he changed his role within the company to technical sales director responsible for Shin-Etsu’s technical activities in the EU, MEA and LATAM.

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Watch the other two web-seminars of the Advances In Amorphous Solid Dispersion Technologies series: