コンパクトで再構成可能なシステムでの医薬品のオンデマンド連続流量生産

Andrea Adamo¹, Rachel L Beingessner², Mohsen Behnam¹

¹Department of Chemical Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA 02139, USA.

Science (New York, N.Y.)

|April 2, 2016

まとめ

この研究は,薬剤の活性成分を効率的に生産するコンパクトで連続的な製薬プラットフォームを示しています. この新しいアプローチは,従来のバッチ処理の限界を克服し,より迅速な生産とサプライチェーンの信頼性を高めます.

科学分野:

製薬産業
化学工学
プロセス化学

背景:

伝統的な製薬製造業は批量加工に依存しており時間がかかり,サプライチェーンに障害が生じやすい.
分散型製造は薬剤の生産の効率と回復力を高める可能性のある解決策を提供します

研究の目的:

活性薬剤 (API) の連続フロー合成と配列のためのコンパクトで再構成可能な製造プラットフォームを実証する.
伝統的なバッチ処理の代替手段として医薬品の生産を紹介する

主な方法:

冷蔵庫サイズの新しい製造システムで,APIのエンドツーエンドの合成と配列.
連続フロー合成,多段階配列望遠鏡,反応工学,リアルタイム製剤の進歩を利用する.

主要な成果:

このシステムは,十分な量のディフェンヒドラミン水塩化物,リドカイン水塩化物,ディアゼパム,およびフルオキセチン水塩化物を毎日成功裏に生成しました.
合成されたAPIは,経口または局所的な液体用量に対する米国製薬書の基準を満たした.
このプラットフォームは柔軟性のあるプラグ・アンド・プレイのアプローチを薬剤製造に示しました

結論:

コンパクトなプラットフォームでの連続流量製造は,従来のバッチ処理に有効な代替手段を提供します.
このアプローチは生産時間を大幅に短縮し,サプライチェーンのリスクを軽減します.
開発された技術は,厳格な品質基準を満たす複数のAPIの効率的なオンデマンド生産を可能にします.

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