How To Design And Implement Powder To Tablet Continuous Manufacturing Systems
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How To Design And Implement Powder To Tablet Continuous Manufacturing Systems
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Author : Fernando Muzzio
language : en
Publisher: Academic Press
Release Date : 2022-03-29
How To Design And Implement Powder To Tablet Continuous Manufacturing Systems written by Fernando Muzzio and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-03-29 with Medical categories.
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing. - Discusses the development of strategy blueprints in the design of continuous processes - Shows how to create process flowsheet models from individual unit operation models - Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases - Covers the evolving regulatory expectations for continuous manufacturing - Provides readers with ways to more effectively navigate these expectations
Sustainable Pharmaceutical Product Development And Optimization Processes
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Author : Bancha Yingngam
language : en
Publisher: Springer Nature
Release Date : 2025-01-30
Sustainable Pharmaceutical Product Development And Optimization Processes written by Bancha Yingngam and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-01-30 with Science categories.
This book offers unparalleled insight into the convergence of sustainability and pharmaceutical product development, with a specific focus on optimization processes. By addressing the urgent demand for more environmentally conscious and efficient strategies in the drug development industry, particularly in an era where the world faces the mounting challenges posed by climate change, the book provides a comprehensive guide for integrating sustainability principles throughout the pharmaceutical product lifecycle, directly contributing to the United Nations Sustainable Development Goals (SDGs), such as SDG 12 (Responsible Consumption and Production) and SDG 13 (Climate Action). The chapters cover key topics, including the application of green chemistry, eco-design principles, sustainable sourcing of raw materials, waste reduction strategies, and the use of renewable energy in pharmaceutical manufacturing processes. Throughout the book, case studies are integrated, offering practical insights and concurrently highlighting the economic and environmental advantages of sustainable practices, thereby addressing skepticism regarding the feasibility and profitability of such initiatives. The book also discusses regulatory considerations, ethical implications, and the challenges and opportunities associated with moving toward more sustainable practices in pharmaceutical development. Importantly, this book seeks to solve the problem of the knowledge gap and lack of practical resources for professionals in the pharmaceutical industry who aspire to implement sustainable and optimized processes. This work consolidates a network of professionals and scholars keenly focused on future sustainability challenges, developing enhancement methodologies, and sharing successful strategies for implementing eco-friendly practices in pharmaceutical sectors worldwide, ultimately contributing to the global effort to achieve the SDGs by 2030. With a focus on pharmaceutical professionals, researchers, academicians, and students, the book serves as a valuable reference for those involved in drug development and process optimization. Policymakers and regulatory bodies might also find it insightful, as it addresses current landscapes, challenges, and future directions in sustainable pharmaceutical product development.
Co Crystals In Pharmaceutical Sciences
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Author : Inderbir Singh Bakshi
language : en
Publisher: John Wiley & Sons
Release Date : 2025-05-20
Co Crystals In Pharmaceutical Sciences written by Inderbir Singh Bakshi 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 2025-05-20 with Technology & Engineering categories.
The book is essential for anyone in the pharmaceutical field, as it offers invaluable insights into the innovative world of cocrystals, their design principles, experimental techniques, and practical applications that can significantly enhance drug development and address critical industry challenges. Co-Crystals in Pharmaceutical Sciences: Design to Applications is a comprehensive exploration of pharmaceutical cocrystals that introduces their scope and potential impact on drug development. This volume highlights the structural characteristics influencing cocrystals and delves into design principles and molecular interactions. Focus is placed on the advantages and challenges of integrating in-silico techniques for screening, which accelerates cocrystal discovery. Detailed coverage of experimental techniques, validation, and process optimization provides a solid foundation for readers. The book uniquely explores herbal and drug-drug cocrystals, showcasing synergies between traditional herbal medicine and modern pharmaceuticals. Scaling up cocrystal synthesis and potential commercial opportunities are examined in depth. Chapters on pharmaceutical applications emphasize how cocrystals address solubility, stability, and therapeutic challenges, with real-world examples illustrating their impact. The role of cocrystals in enhancing mechanical properties for more efficient formulations is discussed, and insights into the patent landscape and regulatory considerations round out the book, making it an indispensable resource for researchers and industry professionals alike. Audience Botanists, biologists, pharmaceutical professionals, drug delivery experts, and materials scientists studying pharmaceutical sciences.
Sustainable Global Health Systems And Pharmaceutical Development
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Author : Bhavishya Mittal
language : en
Publisher: Springer Nature
Release Date : 2024-09-02
Sustainable Global Health Systems And Pharmaceutical Development written by Bhavishya Mittal and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-02 with Medical categories.
Strategic decision-making focusing on economics is the fundamental requirement to generate efficiency and improve productivity in any manufacturing environment. In the 21st century, the science of drug development is an established field that requires a dedicated and synergistic partnership between various subject matter experts. Unfortunately, pharmaceutical research is complicated, time-consuming, attritive, and costly, with development costs ranging from $4 billion to $11 billion per commercialized drug. There are more than 750 biotech and big pharma companies in the US that are developing new drug products for a vast number of therapeutic indications. Due to the high attrition rate in clinical trials, a small percentage of these drugs get commercialized. Still, a very high amount of resources are being spent on drug development from a societal perspective. Despite being an economically intense activity, the current state of drug product development makes a limited effort to integrate economics into product design and development. For example, pharmaceutical scientists are excellent at a data-driven decision-making process that requires technical elements and a few strategic elements. However, there is minimal integration of financial valuation elements (commonly employed in other high-tech industries such as fine chemicals, automotive, aerospace, etc.) into pharmaceutical drug development. Unfortunately, this hurts the sustainability of the health system of which these products will be a part in the future. A desirable future state integrates fundamentals of economics in product design and development so that the decision-making is parameterized, the cost of goods can be lowered, wastage can be reduced, patient-centricity is built into the design, and manufacturing/distribution efficiencies can be gained. The financial benefits of such an approach could allow for these savings to be passed on to the stakeholders and improve the value proposition of pharmaceuticals, which is critical to maintaining the innovation potential. This book hopes to introduce the reader to this desired future state of pharmaceutical drug development.
Continuous Manufacturing Of Pharmaceuticals
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Author : Peter Kleinebudde
language : en
Publisher: John Wiley & Sons
Release Date : 2024-10-28
Continuous Manufacturing Of Pharmaceuticals written by Peter Kleinebudde 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 2024-10-28 with Science categories.
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.
Pharmaceutical Process Development
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Author : A. John Blacker
language : en
Publisher: Royal Society of Chemistry
Release Date : 2011
Pharmaceutical Process Development written by A. John Blacker and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Medical categories.
This book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry and informs them about the breadth of the work carried out in chemical research and development departments. It is also of value to academics wishing to advise students on the merits of careers in chemical development versus discovery.
Advanced Control Foundation
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Author : Terrence Blevins
language : en
Publisher: International Society of Automation
Release Date : 2012-09-01
Advanced Control Foundation written by Terrence Blevins and has been published by International Society of Automation this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-01 with Science categories.
In this book, the authors address the concepts and terminology that are needed to apply advanced control techniques in the process industry. The book is written for the process or control engineer that is familiar with traditional control but has little or no experience in designing, installing, commissioning and maintaining advanced control applications. Each chapter of the book is structured to allow a person to quickly understand the technology and how it is applied. Application examples are used to show what is required to address an application. Also, a section of each chapter is dedicated to a more in-depth discussion of the technology for the reader that is interested in understanding the mathematical basis for the technology. A workshop is provided at the end of each chapter that explores the technology. The reader may view the workshop solution by going to the web site that accompanies the book. The book provides comprehensive coverage of the major advanced control techniques that are most commonly used in the process industry. This includes tools for monitoring control system performance, on-demand and adaptive tuning techniques, model predictive control, LP optimization, data analytics for batch and continuous processes, fuzzy logic control, neural networks and advancements in PID to use with wireless measurements. Since many readers may work with an existing DCS that does not support advanced control, a chapter of the book is dedicated to tools and techniques that the authors have found useful in integrating advanced control tools into an existing control system. Also, one chapter of the book addresses how dynamic process simulations may be easily created in a DCS to support checkout and operator training on the use of advanced control.
Pharmaceutical Quality By Design
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Author : Sarwar Beg
language : en
Publisher: Academic Press
Release Date : 2019-03-27
Pharmaceutical Quality By Design written by Sarwar Beg and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-27 with Medical categories.
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
Thomas Register
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Author :
language : en
Publisher:
Release Date : 2004
Thomas Register written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Industries categories.
Handbook Of Pharmaceutical Manufacturing Formulations
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Author : Safaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Handbook Of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster