Pharmaceutical Extrusion Technology

Pharmaceutical Extrusion Technology

Author: Isaac Ghebre-Sellassie

Publisher: CRC Press

Published: 2018-03-05

Total Pages: 433

ISBN-13: 1498704921

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The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields


Book Synopsis Pharmaceutical Extrusion Technology by : Isaac Ghebre-Sellassie

Download or read book Pharmaceutical Extrusion Technology written by Isaac Ghebre-Sellassie and published by CRC Press. This book was released on 2018-03-05 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields


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.


Book Synopsis Melt Extrusion by : Michael A. Repka

Download or read book Melt Extrusion written by Michael A. Repka and published by Springer Science & Business Media. This book was released on 2013-10-11 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


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.


Book Synopsis Hot-Melt Extrusion by : Dennis Douroumis

Download or read book Hot-Melt Extrusion written by Dennis Douroumis and published by John Wiley & Sons. This book was released on 2012-04-24 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Pharmaceutical Extrusion Technology

Pharmaceutical Extrusion Technology

Author: Isaac Ghebre-Sellassie

Publisher: CRC Press

Published: 2003-05-14

Total Pages: 424

ISBN-13: 9781135532161

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Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.


Book Synopsis Pharmaceutical Extrusion Technology by : Isaac Ghebre-Sellassie

Download or read book Pharmaceutical Extrusion Technology written by Isaac Ghebre-Sellassie and published by CRC Press. This book was released on 2003-05-14 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.


Hot-Melt Extrusion

Hot-Melt Extrusion

Author: Dennis Douroumis

Publisher: John Wiley & Sons

Published: 2012-06-25

Total Pages: 404

ISBN-13: 0470711183

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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.


Book Synopsis Hot-Melt Extrusion by : Dennis Douroumis

Download or read book Hot-Melt Extrusion written by Dennis Douroumis and published by John Wiley & Sons. This book was released on 2012-06-25 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Pharmaceutical Pelletization Technology

Pharmaceutical Pelletization Technology

Author: Isaac Ghebre-Selassie

Publisher: CRC Press

Published: 2022-02-24

Total Pages: 0

ISBN-13: 1000148815

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This book serves as a formulation and processing guide during the development of pelletized dosage forms. It provides the pharmaceutical technologist with basic information about the design aspects of the relevant processing equipment.


Book Synopsis Pharmaceutical Pelletization Technology by : Isaac Ghebre-Selassie

Download or read book Pharmaceutical Pelletization Technology written by Isaac Ghebre-Selassie and published by CRC Press. This book was released on 2022-02-24 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book serves as a formulation and processing guide during the development of pelletized dosage forms. It provides the pharmaceutical technologist with basic information about the design aspects of the relevant processing equipment.


Pharmaceutical Extrusion Technology

Pharmaceutical Extrusion Technology

Author: Isaac Ghebre-Selassie

Publisher: CRC Press

Published: 2003-05-14

Total Pages: 383

ISBN-13: 0824755200

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Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.


Book Synopsis Pharmaceutical Extrusion Technology by : Isaac Ghebre-Selassie

Download or read book Pharmaceutical Extrusion Technology written by Isaac Ghebre-Selassie and published by CRC Press. This book was released on 2003-05-14 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.


Pharmaceutical Extrusion Technology

Pharmaceutical Extrusion Technology

Author: Isaac Ghebre-Sellassie

Publisher: CRC Press

Published: 2018-03-05

Total Pages: 464

ISBN-13: 1351129007

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The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields


Book Synopsis Pharmaceutical Extrusion Technology by : Isaac Ghebre-Sellassie

Download or read book Pharmaceutical Extrusion Technology written by Isaac Ghebre-Sellassie and published by CRC Press. This book was released on 2018-03-05 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields


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.


Book Synopsis Amorphous Solid Dispersions by : Navnit Shah

Download or read book Amorphous Solid Dispersions written by Navnit Shah and published by Springer. This book was released on 2014-11-21 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


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.


Book Synopsis Practical Guide to Hot-Melt Extrusion by : Mohammed Maniruzzaman

Download or read book Practical Guide to Hot-Melt Extrusion written by Mohammed Maniruzzaman and published by Smithers Rapra. This book was released on 2015-07-22 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.