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Author: Mohammed Maniruzzaman
Publisher: Smithers Rapra
ISBN: 1910242128
Category : Science
Languages : en
Pages : 249
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Book Description
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.
Author: Mohammed Maniruzzaman
Publisher: Smithers Rapra
ISBN: 1910242128
Category : Science
Languages : en
Pages : 249
Get Book Here
Book Description
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.
Author: Mohammed Maniruzzaman
Publisher:
ISBN: 9781680158939
Category : Drugs
Languages : en
Pages :
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Book Description
Author: Dennis Douroumis
Publisher: John Wiley & Sons
ISBN: 1118307879
Category : Science
Languages : en
Pages : 404
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Book Description
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.
Author: Michael A. Repka
Publisher: Springer Science & Business Media
ISBN: 1461484324
Category : Medical
Languages : en
Pages : 472
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Book Description
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.
Author: N. C. Lee
Publisher: iSmithers Rapra Publishing
ISBN: 9781859575130
Category : Science
Languages : en
Pages : 218
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Book Description
Blow moulding is a manufacturing process used to form hollow plastic parts. It evolved from the ancient art of glass blowing and it is used to particular advantage with plastic materials. Celluloid was used first to blow mould baby rattles and novelties in the 1930s, linear low-density polyethylene was used in the 1940s for high production bottles and these days polyethylene terephthalate is used to make anything from soda bottles, to highly sophisticated multilayered containers and automotive fuel tanks in the last decade. When designing a product it is important to consider aspects such as a material's characteristics, the processing methods available, the assembly and finishing procedures, and the life cycle and expected performance of the product. This book presents the basics of blow moulding as well as the latest state-of-the-art and science of the industry. A key feature is the approach of discussing the 'basics' and then taking the reader through the entire process from design development through to final production.
Author: Harold F. Giles Jr
Publisher: William Andrew
ISBN: 0815517114
Category : Technology & Engineering
Languages : en
Pages : 575
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Book Description
Why is it important to get to equilibrium and how long does it take? Are there problems running polypropylene profiles on a single screw extruder? Does the job involve compounding color concentrates on a corotating twin screw extruder? This unique reference work is designed to aid operators, engineers, and managers in quickly answering such practical day-to-day questions in extrusion processing. This comprehensive volume is divided into 7 Parts. It contains detailed reference data on such important operating conditions as temperatures, start-up procedures, shear rates, pressure drops, and safety. This reference is a practical guide to extrusion bringing together both the equipment and materials processing aspects. It provides basic and advanced topics about the thermoplastics processing in the extruder, for reference and training. Parts 1 û 3, emphasize the fundamentals, for operators and engineers, of polymeric materials extrusion processing in single and twin screw extruders. Parts 4 û 7 treat advanced topics including troubleshooting, auxiliary equipment, and coextrusion for operators, engineers, and managers. Extensive applications in Part 7 cover such contemporary areas as compounding, blown film, extrusion blow molding, coating, foam, and reprocessing. Each chapter includes review topics.
Author: Yihong Qiu
Publisher: Academic Press
ISBN: 008093272X
Category : Medical
Languages : en
Pages : 976
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Book Description
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
Author: Muralisrinivasan Natamai Subramanian
Publisher: John Wiley & Sons
ISBN: 1118071719
Category : Technology & Engineering
Languages : en
Pages : 269
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Book Description
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
Author: Dr. Inamuddin
Publisher: Trans Tech Publications Ltd
ISBN: 303573271X
Category : Technology & Engineering
Languages : en
Pages : 244
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Book Description
This volume contains papers describing the results of some research in the area of application diffusion and transport phenomena in polymer composite materials and substances for the industrial and engineering goals. We hope that the presented papers will be interesting and useful for many engineers and researchers.
Author: Harold F. Giles Jr
Publisher: William Andrew
ISBN: 1437734820
Category : Technology & Engineering
Languages : en
Pages : 638
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Book Description
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
