Melt Extrusion
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Melt Extrusion
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Author : Michael A. Repka
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-10-11
Melt Extrusion written by Michael A. Repka and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-11 with Medical categories.
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
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Author : Dennis Douroumis
language : en
Publisher: John Wiley & Sons
Release Date : 2012-04-24
Hot Melt Extrusion written by Dennis Douroumis and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-24 with Science categories.
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.
Practical Guide To Hot Melt Extrusion
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Author : Mohammed Maniruzzaman
language : en
Publisher: Smithers Rapra
Release Date : 2015-07-22
Practical Guide To Hot Melt Extrusion written by Mohammed Maniruzzaman and has been published by Smithers Rapra this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-22 with Science categories.
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.
Practical Guide To Hot Melt Extrusion
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Author : Mohammed Maniruzzaman
language : en
Publisher:
Release Date : 2015
Practical Guide To Hot Melt Extrusion written by Mohammed Maniruzzaman and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with Drugs categories.
Pharmaceutical Extrusion Technology
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Author : Isaac Ghebre-Selassie
language : en
Publisher: CRC Press
Release Date : 2003-05-14
Pharmaceutical Extrusion Technology written by Isaac Ghebre-Selassie and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-05-14 with Medical categories.
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 With Poorly Soluble Drugs
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Author : Jessica Albers
language : en
Publisher: Cuvillier Verlag
Release Date : 2008-08-22
Hot Melt Extrusion With Poorly Soluble Drugs written by Jessica Albers and has been published by Cuvillier Verlag this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-08-22 with Philosophy categories.
Hot-melt extrusion with poorly soluble drugs is a challenging method to enhance the solubility. The formation of solid dispersions, specifically of glassy solid solutions, wherein the drug is dispersed on a molecular basis in an inert carrier, leads to metastable systems that have advantageous dissolution behaviour but suffer from physical stability problems. To date, there is poor understanding of the solid state structure, the mechanism by which dissolution enhancement occurs, the stability on storage and in dissolution, and the processing to solid dosage forms. The hot-melt extrusion process is influenced by several parameters. The right coordination of these parameters is decisive for the production of solid dispersions and thus, the success in solubility enhancement. The solid state and the viscosity of the extrudates can be controlled by the temperature of the barrels. Besides the configuration of the screw and the temperature profile of the barrel, the design of the die plate represents the third important extrusion parameter. By keeping the dead storage capacity at a minimum, an early solidification and thus a blockage of the dies can be prevented. Due to shear forces evolving in the extruder barrel and the ability of the drug to dissolve in the molten carrier before reaching the melting temperature, the process temperature can be kept below the melting point of the substances. Basic butylated methacrylate copolymer is a suitable carrier to enhance the solubility of the poorly water-soluble drug celecoxib in a hot-melt extrusion process. The best solubility enhancement can be obtained by dispersing the drug in the molten carrier on a molecular basis and thus, to form glassy solid solutions. The solid state characteristics of the solid dispersion can be revealed by DSC analysis and interpretation of the corresponding glass transitions. Such systems may contain a drug load of up to 60% and are stable at increased temperature and humidity which is due to the very low water uptake of the components. Glassy solid solutions of celecoxib and basic butylated methacrylate copolymer have a fast dissolution rate and result in a 58 fold supersaturated solution. The mechanism of drug release from these glassy solid solutions is carrier-controlled and governed by dissolution. The enhancement of the dissolution rate is based on improved solubility and wettability. Basic butylated methacrylate copolymer interacts chemically with celecoxib in an acid-base reaction. The hot-melt extrusion process is highly dependent on the physicochemical properties of the compounds and their miscibility in the molten state. The use of basic butylated methacrylate copolymer as solubility enhancing carrier in hot-melt extrusion cannot be transferred easily to all drugs. Depending on the properties of the drug, specifically the melting point and the pKa, basic butylated methacrylate copolymer can be a useful carrier in glassy solid solution formation, but might be insufficient for solubility improvement. The formation of a glassy solid solution evolves from interactions between the drug and the carrier. Bonds can differ in their strength and can be advantageous or disadvantageous for a fast dissolution. Furthermore, decomposition processes can occur, when processing the drug at high temperatures. Thus, each formulation has to be analyzed separately. The interpretation of the chemical structure, the calculation of solubility parameters, the determination of melting temperatures and enthalpies, and the performance of molecular dynamics simulations are tools to predict the miscibility of drugs and carriers for the formulation of solid dispersions. A combined approach of tools predicting miscibility is highly appropriate, as no single technique may yield all the required information. Nevertheless, the evaluation of the melting behaviour via DSC has the highest impact. Hot-melt extruded glassy solid solutions can be processed into solid dosage forms. The mechanical energy input through milling and zabletting has no influence on the solid-state stability. The solution-state stability can be achieved by adding HPMC to the external phase. The filling of capsules with milled hot-melt extrudates is a promising technique to obtain solid dosage forms from glassy solid solutions. By the extensive analysis of the hot-melt extrusion process, the interactions of the compounds, the thermal characteristics, and the dissolution mechanism of the resulting systems, it is possible to predict the extrusion process in an early stage of development and to improve the dissolution of poorly soluble drugs.
Controlled Release Solid Dosage Forms By Melt Extrusion
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Author : Frank Seiler
language : en
Publisher:
Release Date : 2010
Controlled Release Solid Dosage Forms By Melt Extrusion written by Frank Seiler and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with categories.
Pharmaceutical Extrusion Technology
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Author : Isaac Ghebre-Sellassie
language : en
Publisher: CRC Press
Release Date : 2020-12-18
Pharmaceutical Extrusion Technology written by Isaac Ghebre-Sellassie and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-18 with categories.
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
Pharmaceutical Extrusion Technology
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Author : Isaac Ghebre-Sellassie
language : en
Publisher: CRC Press
Release Date : 2003-05-14
Pharmaceutical Extrusion Technology written by Isaac Ghebre-Sellassie and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-05-14 with Medical categories.
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.
Polymer Melt Fracture
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Author : Rudy Koopmans
language : en
Publisher: CRC Press
Release Date : 2010-08-03
Polymer Melt Fracture written by Rudy Koopmans and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-08-03 with Technology & Engineering categories.
The continually growing plastics market consists of more than 250 million tons of product annually, making the recurring problem of polymer melt fracture an acute issue in the extrusion of these materials. Presenting a pictorial library of the different forms of melt fracture and real industrial extrusion melt fracture phenomena, Polymer Melt Fracture provides pragmatic identification and industrial extrusion defect remediation strategies based on detailed experimental and theoretical findings from the last 50 years. Distinct microscopic photos Each chapter in this comprehensive volume covers a different aspect of the science and technology relating to polymer melt fracture. The book begins with a collection of optical and scanning electron microscopy pictures. These photos show distorted capillary die extrudates for a number of commercially available polymers. The authors present a brief introduction to the basic science and technology of polymers. They explain what polymers are, how they are made, and how they can be characterized. They also discuss polymer rheology, review the principles of continuum mechanics, and define linear viscoelastic material functions. Techniques for observing and measuring fracture Next, the book explains how polymer melt fracture is actually experienced in the polymer processing industry. It explains the various ways polymer melt fracture may appear during polymer melt processing in different extrusion processes. The authors provide comprehensive reviews of the polymer melt fracture literature, with chapters on experimental findings and the techniques used to observe and measure polymer melt fracture, and the influence of polymer architecture and polymer processing conditions on the onset and types of polymer melt fracture. Posing a hypothesis about the phenomenon, the book presents the current understanding of polymer melt fracture. Mathematical equations Recognizing the importance of models for simulations that may indicate potential solutions, the book discusses aspects of non-linear constitutive equations and microscopic theory and develops a macroscopic model, explaining the capabilities and limitations of this approach. The book presents an overview of pragmatic tools and methods that have been used to prevent the appearance of polymer melt fracture and explains how to use them to suppress defects.