Practical Guide To Hot Melt Extrusion

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 (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.

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.

Worldwide, extrusion lines successfully process more plastics into prod ucts than other processes by consuming at least 36 wt% of all plastics. They continue to find practical solutions for new products and/ or prob lems to meet new product performances. This book, with its practical industry reviews, is a unique handbook (the first of its kind) that covers over a thousand of the potential combina tions of basic variables or problems with solutions that can occur from up-stream to down-stream equipment. Guidelines are provided for maxi mizing processing efficiency and operating at the lowest possible cost. It has been prepared with an awareness that its usefulness will depend greatly upon its simplicity and provision of essential information. It should be useful to: 0) those already extruding and desiring to obtain additional information for their line and/ or prOVide a means of reviewing other lines that can provide their line with operating improvements; (2) those processing or extruding plastics for the first time; (3) those consider ing going into another extrusion process; (4) those desiring additional information about employing the design of various products more effi ciently, with respect to both performance and cost; (5) those contemplat ing entering the business of extrusion; (6) those in new venture groups, materials development, and/ or market development; (7) those in disci plines such as nonplastics manufacturers, engineers, designers, quality control, financial, and management; and (8) those requiring a textbook on extrusion in trade schools and high schools or colleges.

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.

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.

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