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Author: Reynir Eyjolfsson
Publisher: Academic Press
ISBN: 012802187X
Category : Medical
Languages : en
Pages : 68
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Book Description
Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets. This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing. It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics. In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients. Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book. - Incorporates important mathematical models and computational applications - Includes unique content on central composite design and augmented simplex lattice - Provides background on important design principles with emphasis on quality-based design (QBD) of pharmaceutical dosage forms
Author: Reynir Eyjolfsson
Publisher: Academic Press
ISBN: 012802187X
Category : Medical
Languages : en
Pages : 68
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Book Description
Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets. This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing. It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics. In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients. Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book. - Incorporates important mathematical models and computational applications - Includes unique content on central composite design and augmented simplex lattice - Provides background on important design principles with emphasis on quality-based design (QBD) of pharmaceutical dosage forms
Author: Michael E. Aulton
Publisher: Elsevier Health Sciences
ISBN: 0702042900
Category : Medical
Languages : en
Pages : 909
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Book Description
"Pharmaceutics is the art of pharmaceutical preparations. It encompasses design of drugs, their manufacture and the elimination of micro-organisms from the products. This book encompasses all of these areas."--Provided by publisher.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386
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Book Description
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128163720
Category : Medical
Languages : en
Pages : 450
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Book Description
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Author: Gintaras V. Reklaitis
Publisher: John Wiley & Sons
ISBN: 0470942371
Category : Science
Languages : en
Pages : 418
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Book Description
Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.
Author: Peter Kleinebudde
Publisher: John Wiley & Sons
ISBN: 1119001323
Category : Science
Languages : en
Pages : 645
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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.
Author:
Publisher: Academic Press
ISBN: 012814422X
Category : Medical
Languages : en
Pages : 816
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Book Description
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Author: Abdul W. Basit
Publisher: Springer
ISBN: 3319907557
Category : Medical
Languages : en
Pages : 246
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Book Description
3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.
Author: Walkiria S. Schlindwein
Publisher: John Wiley & Sons
ISBN: 1118895215
Category : Science
Languages : en
Pages : 319
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Book Description
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Author: Jack Zheng
Publisher: John Wiley & Sons
ISBN: 0470056096
Category : Medical
Languages : en
Pages : 506
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Book Description
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
