Web-Seminar series: Advances In Amorphous Solid Dispersion Technologies: Spray drying

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.

Wednesday 22 September, 3pm CEST, 9am EST

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Spray drying is widely applied technology used in Amorphous Solid Dispersions (ASD). It is a single step process converting ASD solutions, based on the active ingredient, polymer and solvent, into powder for further processing in a dry form.

Looking into the recent FDA approvals of ASDs, more than 60% of the drug products are formulated with HPMCAS (Developed by Shin-Etsu under the brand name Shin-Etsu AQOAT®) via spray drying technology.

However, there is still a need of understanding the impact of the formulation and process parameters on the final ASD powder characteristics.

Shin-Etsu, ProCepT and Xedev will present recent advances in spray drying.

The objective of this web-seminar is to address:

• Spray drying technological advances
• How spray drying parameters influence powder morphology
• Optimization of process parameters
• Applications of HPMCAS in spray drying ASDs technologies

First presentation: Spray drying of amorphous solid dispersions (ASD): small scale screening of batches containing less than 50 mg API

Speaker: 
Elien de Coninck, PhD, Project Manager @ Xedev & Filip Van der Gucht, CEO @ ProCepT/Xedev

Presentation abstract:

As the number of new compounds with poorly water-soluble properties is continuously increasing, the use of amorphous solid dispersions (ASD) has become a common strategy to increase the bioavailability of the active pharmaceutical ingredient (API) during early drug development. However, during early drug development, limited amounts of API (e.g. < 1 g) are available. The ProCepT 4M8-TriX spray dryer provides the opportunity to perform an ASD screening on small batches (i.e. minimum 60 – 100 mg solids). Consequently, with a limited amount of the API, a selection of polymers can be assessed on their capability to form a stable amorphous matrix in combination with the API. Current study illustrates the minimal required batch size on the ProCepT 4M8-TriX spray dryer in order to obtain sufficient material for solid state characterization and an indicative yield for a larger scale process.

Speaker biography:

Elien de Coninck, PhD: Elien obtained her doctoral degree in Pharmaceutical Sciences at Ghent University in 2020. In the laboratory of pharmaceutical technology, she focused on prilling of API/fatty acid suspensions: an innovative pharmaceutical production technique for multiparticulate dosage forms. While she already collaborated with ProCepT/Xedev as a PhD student to scale up the prilling process, she started in January 2020 as a project manager at Xedev. Based on multiple customer projects executed since Xedev was founded in 2012, the Xedev Team became an expert in formulation and process development for ASDs via spray drying.

Filip Van der Gucht: Filip Van der Gucht has a Master in Chemical Engineering BioTechnology and is CEO from ProCepT and Xedev. Filip has built up 25 years hands-on process knowhow in drying, agglomeration, mixing and coating technologies. He is involved in several contract development and scale-up projects for third parties. Filip focuses on Spray Drying/Congealing and he has processed more than 200 compounds and supervised several Master proofs and posters in this area.

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Second presentation: Spray Drying Formulations with HPMCAS (Hypromellose Acetate Succinate)

Speaker:
Shogo Warashina, Technical Sales Manager @ Shin-Etsu

Presentation abstract:

HPMCAS (Shin-Etsu AQOAT®) is the most widely used excipient for spray drying solid dispersion formulation due to its unique properties of improving solubility, maintaining supersaturation, and good stability of the drug product. In this presentation, we investigate the impact of process parameters in medium scale spray dryer (nozzle gas, solid concentration and drying temperature) on powder properties of amorphous solid dispersion based on HPMCAS. as the post drying step is also investigated.

Speaker biography:

Shogo Warashina is a Technical Sales Manager at Shin-Etsu chemical. He studied agricultural and life science at the University of Tokyo in Japan. In 2012 he obtained a Master degree on his study of cellulose chemistry. He joined Shin-Etsu in Japan from 2012 and since then was in charge of development of cellulose derivatives, especially for HPMCAS. His responsibilities included the research of solid dispersion with HPMCAS. In 2019 he changed his role to a Technical Sales Manager in EU and relocated to Wiesbaden, Germany.

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See the first webinar of the webinar series here: Hot Melt Extrusion