Continuous Manufacturing of Pharmaceuticals


Book Description

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.




Hot-Melt Extrusion


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.




The Science and Engineering of Granulation Processes


Book Description

This book had its origins in a meeting between two (relatively) young particle technology researchers on Rehobeth Beach in Delaware in 1992 near the holiday house of Reg Davies (then Director of the Particle Science and Technology Research Center in Dupont). As we played in the sand, we shared an excitement for developments in particle technology, especially particle characterization, that would lead operations such as granulation to be placed on a sound scientific and engineering footing. The immediate outcome from this interaction was the development of new industry short courses in granulation and related topics which we taught together both in Australia and North America. This book follows closely the structure and approaches developed in these courses, particularly the emphasis on particle design in granulation, where the impact of both formulation properties and process variables on product attributes needs to be understood and quantified. The book has been a long time in the making. We have been actively preparing the book for at least five years. Although the chapters have relatively good bibliographies, this book is not a review of the field. Rather it is an attempt by the authors to present a comprehensive engineering approach to granulator design, scale up and operation. It is exciting for us to see the explosion of research interest around the world in this area in the last five to seven years. Some of the most recent work will have to find its way into the second edition.




Pharmaceutical Extrusion Technology


Book Description

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.




Handbook of Pharmaceutical Granulation Technology


Book Description

Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies




Melt Extrusion


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.







Co-Rotating Twin-Screw Extruder


Book Description

Co-rotating screws and/or extruders are used in many branches of industry for producing, preparing and/or processing highly viscous materials. They find a wide variety of applications especially in the plastics, rubber and food industries. Co-rotating twin-screw machines usually have modular configurations and are thus quite flexible for adapting to changing tasks and material properties. Well-founded knowledge of machines, processes and material behavior are required in order to design twin-screw extruder for economically successful operations. This book provides basic engineering knowledge regarding twin-screw machines; it lists the most important machine-technical requirements and provides examples based on actual practice. Better understanding of the processes is emphasized as this is a prerequisite for optimizing twin-screw designs and operating them efficiently. Besides basic functions, such as compounding, the book focuses on: - the historical development of twin-screws - the geometry of the screw elements (fundamentals, basic patents, patents overview) - material properties and material behavior in the machine - fundamentals of feed behavior, pressure build-up and power input - examples of applications for various processing tasks - compounding: tasks, applications, processing zones - potential and limits of modeling - scaling-up various processes - machine design incl. drives and materials




Chemical Engineering in the Pharmaceutical Industry


Book Description

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.




Extrusion


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