How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems

Fernando Muzzio, Sarang Oka

• Publisher: Academic Press
• Year: 2022
• Print ISBN: 9780128134795
• eBook ISBN: 9780128134801
• Topic: Medicine
• Subtopic: Pharmacology

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.- Discusses the development of strategy blueprints in the design of continuous processes- Shows how to create process flowsheet models from individual unit operation models- Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases- Covers the evolving regulatory expectations for continuous manufacturing- Provides readers with ways to more effectively navigate these expectations

Table of contents

• Title of Book
• Cover image
• Title page
• Table of Contents
• Copyright
• Dedication
• Contributors
• About the Expertise in Pharmaceutical Process Technology Series
• Foreword
• Chapter 1 Introduction
• Chapter 2 Characterization of material properties
• Chapter 3 Loss-in-weight feeding
• Chapter 4 Continuous powder mixing and lubrication
• Chapter 5 Continuous dry granulation
• Chapter 6 A modeling, control, sensing, and experimental overview of continuous wet granulation
• Chapter 7 Continuous fluid bed processing
• Chapter 8 Continuous tableting
• Chapter 9 Continuous film coating within continuous oral solid dose manufacturing
• Chapter 10 Role of process analytical technology in continuous manufacturing
• Chapter 11 Developing process models of an open-loop integrated system
• Chapter 12 Integrated process control
• Chapter 13 Applications of optimization in the pharmaceutical process development
• Chapter 14 Regulatory considerations for continuous solid oral dose pharmaceutical manufacturing
• Chapter 15 Continuous manufacturing process development case study
• Chapter 16 Orkambi: a continuous manufacturing approach to process development at Vertex
• Chapter 17 Outlook—what comes next in continuous manufacturing (and in advanced pharmaceutical manufacturing)
• Index