Design Space and Control Strategy for the Manufacturing of Wet Media Milled Drug Nanocrystal Suspensions by Adopting Mechanistic Process Modeling

Design Space and Control Strategy for the Manufacturing of Wet Media Milled Drug Nanocrystal Suspensions by Adopting Mechanistic Process Modeling

Wet media milling is a fully industrialized technology for the manufacturing of drug nanocrystal suspensions. This work describes the development of an advanced control strategy and an associated design space for a manufacturing process at a commercial scale. Full-scale experiments and mechanistic p...

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Bibliographic Details
Main Authors: André Bitterlich, Andrej Mihorko, Michael Juhnke
Format: Article
Language:English
Published: MDPI AG 2024-02-01
Series:Pharmaceutics
Subjects:
design space
control strategy
quality-by-design
risk assessment
mechanistic
modeling
Online Access:https://www.mdpi.com/1999-4923/16/3/328

Internet

https://www.mdpi.com/1999-4923/16/3/328

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