[製剤] スプレードライ法によるアモルファス固体分散体の製造：スケールアップについて

Lonza ウェビナー

スプレードライ法によるアモルファス固体分散体の製造：スケールアップについて
Manufacturing Amorphous Solid Dispersions by Spray-Drying: scale-up approaches

Event Overview
Spray-drying is a preferred process for manufacturing amorphous solid dispersions, which provide oral bioavailability enhancement for low-solubility small molecules. High permeability, low-solubility BCS Class II compounds are prevalent, representing approximately 70% of the new chemical entity pipeline, driving continued research and optimization of dispersion technology.

This webinar focuses on manufacturing aspects of amorphous spray-dried dispersions (SDDs) to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges will be presented along with a robust process development strategy to ensure critical-to-quality attributes are maintained. Tools and methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale will also be highlighted.

In a scale-up case study of spray-dried Eudragit L100, a filament particle morphology was observed, leading to poor yields and very low bulk density. By controlling the formulation and process parameters, researchers identified a scale-independent process space where SDDs can be manufactured without filament formation at high product yields and with desired particle properties.

Key Learning Objectives
Spray-drying is a preferred process for manufacturing amorphous solid dispersions, which provide oral bioavailability enhancement for low-solubility small molecules. High permeability, low-solubility BCS Class II compounds are prevalent, representing approximately 70% of the new chemical entity pipeline, driving continued research and optimization of dispersion technology.

This webinar focuses on manufacturing aspects of amorphous spray-dried dispersions (SDDs) to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges will be presented along with a robust process development strategy to ensure critical-to-quality attributes are maintained. Tools and methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale will also be highlighted.

In a scale-up case study of spray-dried Eudragit L100, a filament particle morphology was observed, leading to poor yields and very low bulk density. By controlling the formulation and process parameters, researchers identified a scale-independent process space where SDDs can be manufactured without filament formation at high product yields and with desired particle properties.
 

日時：2020年8月5日（火）3:00pm – 4:00pm (日本標準時)
8月5日のライブウェビナーは終了しましたが、オンデマンド視聴が可能となりました。
下記のリンクより、お申込みと同時にお好きなタイミングでご覧頂けます。

場所：オンライン
演者：Joel Wood, Product Development Engineer Lonza Bend, OR
         Kim Shepard, Ph.D., Associate Principal Engineer Lonza Bend, OR
費用：無料
 
 *本プレゼンテーションの言語は英語になります。
 *ご参加にはお申し込みが必要です。リンクのPharmaceutical Technology 社の申し込みページよりお申込みください。

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Lonza Pharma & Biotech | ロンザ株式会社 受託製造開発部
Tel:03-6264-7630(代表)
Email: pharma-biotech-jp@lonza.com
Web:Pharma.lonza.com

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