Practical Guide to Hot-Melt Extrusion
Practical Guide to Hot-Melt Extrusion

Author: Mohammed Maniruzzaman

Publisher: Smithers Rapra

Published: 2015-07-22

Total Pages: 249

ISBN-13: 1910242128

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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, 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.

Hot-Melt Extrusion
Hot-Melt Extrusion

Author: Dennis Douroumis

Publisher: John Wiley & Sons

Published: 2012-04-24

Total Pages: 404

ISBN-13: 1118307879

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Hot-melt extrusion (HME) - melting a substance and forcing it through an orifice under controlled conditions to form a new material - is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.

Melt Extrusion
Melt Extrusion

Author: Michael A. Repka

Publisher: Springer Science & Business Media

Published: 2013-10-11

Total Pages: 472

ISBN-13: 1461484324

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This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

Basics of Troubleshooting in Plastics Processing
Basics of Troubleshooting in Plastics Processing

Author: Muralisrinivasan Natamai Subramanian

Publisher: John Wiley & Sons

Published: 2011-04-20

Total Pages: 269

ISBN-13: 1118071719

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The Basics of Troubleshooting in Plastics Processing is a condensed practical guide that gives the reader a broad introduction to properties of thermoplastics plastics, additives, the major processes (extrusion, injection molding, rotational molding, blow molding, and thermoforming), as well as troubleshooting. The main goal is to provide the plastics processor with an improved understanding of the basics by explaining the science behind the technology. Machine details are minimized as the emphasis is on processing problems and the defects in an effort to focus on basic root causes to problems and how to solve them. The book’s framework is troubleshooting in plastics processing because of the importance it has to the eventual production of high quality end products. Each chapter contains both practical and detailed technical information. This basic guide provides state-of-the-art information on: Processing problems and defects during manufacturing Plastics materials, their properties and characterization The plastics processing techniques Plastics additives Troubleshooting of the 5 main plastics processes References for further reading

Diffusion Foundations Vol. 23
Diffusion Foundations Vol. 23

Author: Dr. Inamuddin

Publisher: Trans Tech Publications Ltd

Published: 2019-08-07

Total Pages: 241

ISBN-13: 303573271X

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Thermo-Mechanical Properties of Polymer Composites Special topic volume with invited peer reviewed papers only

Extrusion
Extrusion

Author: Harold F. Giles Jr

Publisher: William Andrew

Published: 2013-09-21

Total Pages: 638

ISBN-13: 1437734820

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The second edition of Extrusion is designed to aid operators, engineers, and managers in extrusion processing in quickly answering practical day-to-day questions. The first part of the book provides the fundamental principles, for operators and engineers, of polymeric materials extrusion processing in single and twin screw extruders. The next section covers advanced topics including troubleshooting, auxiliary equipment, and coextrusion for operators, engineers, and managers. The final part provides applications case studies in key areas for engineers such as compounding, blown film, extrusion blow molding, coating, foam, and reprocessing. This practical guide to extrusion brings together both equipment and materials processing aspects. It covers basic and advanced topics, for reference and training, in thermoplastics processing in the extruder. Detailed reference data are provided on such important operating conditions as temperatures, start-up procedures, shear rates, pressure drops, and safety. - A practical guide to the selection, design and optimization of extrusion processes and equipment - Designed to improve production efficiency and product quality - Focuses on practical fault analysis and troubleshooting techniques

Developing Solid Oral Dosage Forms
Developing Solid Oral Dosage Forms

Author: Yihong Qiu

Publisher: Academic Press

Published: 2009-03-10

Total Pages: 976

ISBN-13: 008093272X

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Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: - Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms - Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies - New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development - The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards - It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter - A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Practical Guide to Water-Blown Cellular Polymers
Practical Guide to Water-Blown Cellular Polymers

Author: Chris Defonseka

Publisher: Smithers Rapra

Published: 2016-05-10

Total Pages: 183

ISBN-13: 1910242691

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Cellular polymers or foamed polymers are an important branch of plastics and are an essential part of daily life. Some of the major sectors of use are bedding, automotive, building construction, furniture, sound/thermal insulation, and packaging.Due to growing global concerns with regard to air pollution, research has led to the fascinating concept of using water as the sole blowing agent to create cellular foams as an alternative to traditional petroleum-based blowing agents (which contribute to air pollution). This strategy has created other possibilities of better and safer foams, and reduced costs are also considerable.With over 45 years of hands-on experience, the author provides in-depth knowledge of water-blown cellular polymers, from their chemistry to formulation and process methodology to produce quality foams. This exciting new phase of the polymer industry is presented in detail with regard to manufacture of standard foams as well as specialty foams. Such descriptions are based on new and emerging technologies, including the challenges and solutions foam producers must face with formulations as well as recommendations for machinery and equipment.This is a comprehensive presentation of all aspects of the technology required to produce water-blown cellular foams with different polymers to meet market demands. This book provides theoretical and practical information as well as guidance, and is an ideal source of information for libraries, students, teachers, foam producers and entrepreneurs.

Amorphous Solid Dispersions
Amorphous Solid Dispersions

Author: Navnit Shah

Publisher: Springer

Published: 2014-11-21

Total Pages: 702

ISBN-13: 1493915983

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This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol®, and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems. Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.