Design And Manufacture Of Pharmaceutical Tablets

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Design and Manufacture of Pharmaceutical Tablets

Reynir Eyjolfsson
Design and Manufacture of Pharmaceutical Tablets Book PDF

Author : Reynir Eyjolfsson
Publisher : Academic Press
Page : 55 pages
File Size : 41,6 Mb
Release : 2014-10-09
Category : Medical
ISBN : 0128021829

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Design and Manufacture of Pharmaceutical Tablets by Reynir Eyjolfsson Pdf

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

Design and Manufacture of Pharmaceutical Tablets

Reynir Eyjolfsson
Design and Manufacture of Pharmaceutical Tablets Book PDF

Author : Reynir Eyjolfsson
Publisher : Academic Press
Page : 68 pages
File Size : 42,8 Mb
Release : 2014-10-15
Category : Medical
ISBN : 9780128021873

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Design and Manufacture of Pharmaceutical Tablets by Reynir Eyjolfsson Pdf

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

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems

Fernando Muzzio,Sarang Oka
How to Design and Implement Powder to Tablet Continuous Manufacturing Systems Book PDF

Author : Fernando Muzzio,Sarang Oka
Publisher : Elsevier
Page : 442 pages
File Size : 50,5 Mb
Release : 2022-04
Category : Medical
ISBN : 9780128134795

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How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems by Fernando Muzzio,Sarang Oka Pdf

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

Aulton's Pharmaceutics

Michael E. Aulton,Kevin Taylor
Aulton s Pharmaceutics Book PDF

Author : Michael E. Aulton,Kevin Taylor
Publisher : Elsevier Health Sciences
Page : 909 pages
File Size : 53,6 Mb
Release : 2013
Category : Medical
ISBN : 9780702042904

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Aulton's Pharmaceutics by Michael E. Aulton,Kevin Taylor Pdf

"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.

Continuous Manufacturing of Pharmaceuticals

Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
Continuous Manufacturing of Pharmaceuticals Book PDF

Author : Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
Publisher : John Wiley & Sons
Page : 632 pages
File Size : 43,6 Mb
Release : 2017-07-14
Category : Science
ISBN : 9781119001355

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Continuous Manufacturing of Pharmaceuticals by Peter Kleinebudde,Johannes Khinast,Jukka Rantanen Pdf

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.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book PDF

Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Page : 416 pages
File Size : 48,5 Mb
Release : 2017-09-01
Category : Science
ISBN : 9781119356172

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Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz Pdf

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.

Pharmaceutical Quality by Design

Walkiria S. Schlindwein,Mark Gibson
Pharmaceutical Quality by Design Book PDF

Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Page : 375 pages
File Size : 49,8 Mb
Release : 2018-03-19
Category : Science
ISBN : 9781118895207

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Pharmaceutical Quality by Design by Walkiria S. Schlindwein,Mark Gibson Pdf

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.

Pharmaceutical Quality by Design

Sarwar Beg,Md Saquib Hasnain
Pharmaceutical Quality by Design Book PDF

Author : Sarwar Beg,Md Saquib Hasnain
Publisher : Academic Press
Page : 448 pages
File Size : 41,8 Mb
Release : 2019-03-27
Category : Business & Economics
ISBN : 9780128163726

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Pharmaceutical Quality by Design by Sarwar Beg,Md Saquib Hasnain Pdf

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

Pharmaceutical Dosage Forms - Tablets, Third Edition

Larry L. Augsburger,Stephen W. Hoag
Pharmaceutical Dosage Forms Tablets Third Edition Book PDF

Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : CRC Press
Page : 1552 pages
File Size : 44,6 Mb
Release : 2008-06-03
Category : Medical
ISBN : 1420063456

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Pharmaceutical Dosage Forms - Tablets, Third Edition by Larry L. Augsburger,Stephen W. Hoag Pdf

The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, and with over 700 illustrations it guides pharmaceutical scientists and engineers through difficult and technical procedures in a simple easy-to-follow format. New to the third edition:

Pharmaceutical Dosage Forms - Tablets

Larry L. Augsburger,Stephen W. Hoag
Pharmaceutical Dosage Forms Tablets Book PDF

Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : CRC Press
Page : 1558 pages
File Size : 49,6 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420063868

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Pharmaceutical Dosage Forms - Tablets by Larry L. Augsburger,Stephen W. Hoag Pdf

The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, an

Pharmaceutical Manufacturing Handbook

Shayne Cox Gad
Pharmaceutical Manufacturing Handbook Book PDF

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1384 pages
File Size : 54,7 Mb
Release : 2008-03-21
Category : Science
ISBN : 9780470259801

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Pharmaceutical Manufacturing Handbook by Shayne Cox Gad Pdf

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.

Pharmaceutical Process Design and Management

Kate McCormick,D. Wylie McVay Jr
Pharmaceutical Process Design and Management Book PDF

Author : Kate McCormick,D. Wylie McVay Jr
Publisher : Routledge
Page : 288 pages
File Size : 47,6 Mb
Release : 2016-04-22
Category : Business & Economics
ISBN : 9781317081401

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Pharmaceutical Process Design and Management by Kate McCormick,D. Wylie McVay Jr Pdf

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

Handbook of Pharmaceutical Manufacturing Formulations

Sarfaraz K. Niazi
Handbook of Pharmaceutical Manufacturing Formulations Book PDF

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 646 pages
File Size : 54,8 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420081176

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Handbook of Pharmaceutical Manufacturing Formulations by Sarfaraz K. Niazi Pdf

The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first volume, Compressed Solid Products, tackles these challenges head on.Highlights from Compressed Solid Products, Volume One include:formulations for

23 European Symposium on Computer Aided Process Engineering

Ravendra Singh,Marianthi Ierapetritou,Rohit Ramachandran
23 European Symposium on Computer Aided Process Engineering Book PDF

Author : Ravendra Singh,Marianthi Ierapetritou,Rohit Ramachandran
Publisher : Elsevier Inc. Chapters
Page : 1088 pages
File Size : 40,6 Mb
Release : 2013-06-10
Category : Science
ISBN : 9780128086254

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23 European Symposium on Computer Aided Process Engineering by Ravendra Singh,Marianthi Ierapetritou,Rohit Ramachandran Pdf

The direct compaction continuous pharmaceutical tablet manufacturing process considered in this study is highly interactive and has time delays for several process variables due to sensor placements, that indicate that a simple feedback regulatory control system (e.g. PI(D)) by itself may not be sufficient to achieve the tight process control as imposed by regulatory authorities. This process comprises of coupled dynamics involving slow and fast responses indicating the requirement of a hybrid control scheme such as an advanced hybrid MPC-PID control scheme. In this article, an efficient plant-wide hybrid MPC-PID control strategy for an integrated continuous pharmaceutical tablet manufacturing process via direct compaction has been designed in silico. The designed hybrid control system has been implemented in a first principle model-based flowsheet that was simulated in gPROMS (PSE). Results demonstrated enhanced performance of critical quality attributes (CQAs) under the hybrid control scheme compared to only PID or MPC control schemes thus illustrating the potential of hybrid control scheme in improving pharmaceutical manufacturing operations. A systematic methodology for design and implementation of hybrid MPC-PID control system has been also developed that can be employed for other processes.

Pharmaceutical Production Facilities: Design and Applications

Basant Puri,Annie Hall,Roger Ho
Pharmaceutical Production Facilities Design and Applications Book PDF

Author : Basant Puri,Annie Hall,Roger Ho
Publisher : CRC Press
Page : 344 pages
File Size : 52,7 Mb
Release : 1998-02-11
Category : Medical
ISBN : 9781135743550

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Pharmaceutical Production Facilities: Design and Applications by Basant Puri,Annie Hall,Roger Ho Pdf

Pharmaceutical Production Facilities: Design and Applications considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufac