Practical Guide to Hot-Melt Extrusion : Continuous Manufacturing and Scale-up
Langue : Anglais
Auteur : MANIRUZZAMAN Mohammed
Over the past few decades, hot-melt extrusion (HME) techniques have been
shown to exhibit remarkable potential for the manufacture of various
pharmaceutical products. HME is an emerging processing technology used
primarily for the manufacture of pharmaceutical solid dispersions,
combining the advantages of a solvent-free process with fewer production
steps making it suitable for easy to scale-up and continuous manufacturing
applications. A single unit HME based operation, employing heat and
mechanical shear, has displayed a significant potential to retain the
stability even of thermo-labile therapeutics e.g., proteins. HME has now
explicitly been established from a quality-by-design viewpoint for in-line
data monitoring as per the recent guidelines issued by the US Food and
Drugs Administration (FDA).
This book will focus primarily on the foregoing subject areas and will be of
significant interest to a broad/interdisciplinary readership across the
industries and academia for, (but not limited to) the following reasons:
• Emerging HME processes and applications for multiple drug delivery.
• Solid-state engineering, solubility enhancement, controlled release, taste
masking and sustained release case studies from a continuous manufacturing
view-point.
• Means to explore the potential of continuous manufacture of co-crystals for
promoting solvent free production methods.
• Scale-up case study and issue considerations and studies on the regulatory
guidelines (FDA) for continuous manufacturing involving emerging HME
techniques.
Date de parution : 07-2015
Ouvrage de 232 p.
Disponible chez l'éditeur (délai d'approvisionnement : 15 jours).
Prix indicatif 128,80 €
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