Practical Guide to Hot-Melt Extrusion: Continuous Manufacturing and Scale-up by Mohammed ManiruzzamanPractical Guide to Hot-Melt Extrusion: Continuous Manufacturing and Scale-up by Mohammed Maniruzzaman

Practical Guide to Hot-Melt Extrusion: Continuous Manufacturing and Scale-up

EditorMohammed Maniruzzaman

Paperback | July 21, 2015

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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. It combines 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.
Title:Practical Guide to Hot-Melt Extrusion: Continuous Manufacturing and Scale-upFormat:PaperbackDimensions:248 pages, 10 × 7 × 0.52 inPublished:July 21, 2015Publisher:Smithers Rapra TechnologyLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:191024211X

ISBN - 13:9781910242117

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Table of Contents

1-Introduction to Hot-Melt Extrusion, Continuous Manufacturing: Scale-up via Hot-Melt Extrusion; 2-Hot-Melt Extrusion as Continuous Manufacturing Technique, Current Trends and Future Perspectives; 3-Co-extrusion as a Novel Approach in Continuous Manufacturing Compliance; 4-Solid-state Engineering of Drugs using Melt Extrusion in Continuous Process; 5-Continuous Co-crystallisation of Poorly Soluble Active Pharmaceutical Ingredients to Enhance Dissolution; 6-Taste Masking of Bitter Active Pharmaceutical Ingredients for the Development of Paediatric Medicines via Continuous Hot-Melt Extrusion Processing; 7-Continuous Manufacturing of Pharmaceutical Products via Melt Extrusion: A Case Study; 8-Novel Pharmaceutical Formulations Using Hot-Melt Extrusion Processing as a Continuous Manufacturing Technique; 9-Continuous Polymorphic Transformations Study via Hot-Melt Extrusion Process; 10-From Pharma Adapted Extrusion Technology to Brand New Pharma Fitted Extrusion Design: The Concept of Micro-scale Vertical Extrusion and its Impact in Terms of Scale-up Potential; 11-Continuous Manufacturing via Hot-Melt Extrusion and Scale-up: Regulatory Aspects