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Design And Manufacture Of Pharmaceutical Tablets

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Design and Manufacture of Pharmaceutical Tablets

Design and Manufacture of Pharmaceutical Tablets Book
Author : Reynir Eyjolfsson
Publisher : Academic Press
Release : 2014-10-15
ISBN : 012802187X
Language : En, Es, Fr & De

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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

Aulton s Pharmaceutics

Aulton s Pharmaceutics Book
Author : Michael E. Aulton,Kevin Taylor
Publisher : Elsevier Health Sciences
Release : 2013
ISBN : 0702042900
Language : En, Es, Fr & De

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Book Description :

Pharmaceutics is one of the most diverse subject areas in all of pharmaceutical science. In brief, it is concerned with the scientific and technological aspects of the design and manufacture of dosage forms or medicines. An understanding of pharmaceutics is therefore vital for all pharmacists and those pharmaceutical scientists who are involved with converting a drug or a potential drug into a medicine that can be delivered safely, effectively and conveniently to the patient. Now in its fourth edition, this best-selling textbook in pharmaceutics has been brought completely up to date to reflect the rapid advances in delivery methodologies by eye and injection, advances in drug formulations and delivery methods for special groups (such as children and the elderly), nanomedicine, and pharmacognosy. At the same time the editors have striven to maintain the accessibility of the text for students of pharmacy, preserving the balance between being a suitably pitched introductory text and a clear reflection of the state of the art. provides a logical, comprehensive account of drug design and manufacture includes the science of formulation and drug delivery designed and written for newcomers to the design of dosage forms New to this edition New editor: Kevin Taylor, Professor of Clinical Pharmaceutics, School of Pharmacy, University of London. Twenty-two new contributors. Six new chapters covering parenteral and ocular delivery; design and administration of medicines for the children and elderly; the latest in plant medicines; nanotechnology and nanomedicines, and the delivery of biopharmaceuticals. Thoroughly revised and updated throughout.

Aulton s Pharmaceutics E Book

Aulton s Pharmaceutics E Book Book
Author : Michael E. Aulton,Kevin M.G. Taylor
Publisher : Elsevier Health Sciences
Release : 2017-08-26
ISBN : 0702070017
Language : En, Es, Fr & De

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Book Description :

From a review of the previous edition: ‘For all the pharmacy students out there part of your pharmacy degree will be to study formulation design and pharmaceutics. This is the holy grail of pharmaceutical technology books. The text reads well and introduces difficult concepts in a more easy-to-understand way, it is definitely worth the money to help you get through the module, if you’re doing a research project in pharmaceutical design then this would also be an excellent buy...This is essential for passing exams and developing professional competence.’ This is the best known text on pharmaceutics. Its strength lies mainly in being a complete course in one book. Reviewers consistently praise its comprehensiveness and its extremely high quality-quality content. Pharmaceutics is one of the most diverse subject areas in pharmaceutical science and an understanding of it is vital for all pharmacists and scientists involved in converting drugs to medicines that can be safely delivered to a patient. The editorial and author team deliver a tour de force of accessibility, coverage and currency in this new edition of a world-class textbook. Relevant chemistry covered throughout Reflects current and future use of biotechnology products throughout Covers ongoing changes in our understanding of biopharmaceutics, certain areas of drug delivery and the significance of the solid state Includes the science of formulation and drug delivery Designed and written for newcomers to the design of dosage forms Key points boxes throughout Summaries at the end of each chapter Fully updated throughout, with particular focus on delivery of biopharmaceuticals, nanotechnology and nanomedicines, parenteral and ocular drug delivery mechanisms. Now comes with online access on StudentConsult.

Pharmaceutical Dosage Forms Tablets

Pharmaceutical Dosage Forms   Tablets Book
Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420063863
Language : En, Es, Fr & De

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Book Description :

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

Aulton s Pharmaceutics E Book

Aulton s Pharmaceutics E Book Book
Author : Kevin M.G. Taylor,Michael E. Aulton
Publisher : Elsevier Health Sciences
Release : 2021-04-23
ISBN : 0702081566
Language : En, Es, Fr & De

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Book Description :

The essential pharmaceutics textbook One of the world’s best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees. Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor and Michael Aulton, this new edition includes the science of formulation, pharmaceutical manufacturing and drug delivery. All aspects of pharmaceutics are covered in a clear and readily accessible way and extensively illustrated throughout, providing an essential companion to the entire pharmaceutics curriculum from day one until the end of the course. Fully updated throughout, with the addition of new chapters, to reflect advances in formulation and drug delivery science, pharmaceutical manufacturing and medicines regulation Designed and written for newcomers to the design and manufacture of dosage forms Relevant pharmaceutical science covered throughout Includes the science of formulation and drug delivery Reflects current practices and future applications of formulation and drug delivery science to small drug molecules, biotechnology products and nanomedicines Key points boxes throughout Over 400 online multiple choice questions

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design Book
Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Release : 2018-03-19
ISBN : 1118895207
Language : En, Es, Fr & De

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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.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-03-21
ISBN : 0470259809
Language : En, Es, Fr & De

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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.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book
Author : Gintaras V. Reklaitis
Publisher : John Wiley & Sons
Release : 2017-10-09
ISBN : 0470942371
Language : En, Es, Fr & De

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Book Description :

This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.

How to Design and Implement Powder To Tablet Continuous Manufacturing Systems

How to Design and Implement Powder To Tablet Continuous Manufacturing Systems Book
Author : Fernando Muzzio,Sarang Oka
Publisher : Academic Press
Release : 2019-02
ISBN : 9780128134795
Language : En, Es, Fr & De

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Book Description :

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview of the considerations necessary in the design of continuous pharmaceutical manufacturing processes. This book covers both the theory and design of continuous processing of the associated unit operations, along with their characterization and control. It also 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 for design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, 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

How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process Book
Author : Steven Ostrove
Publisher : Academic Press
Release : 2016-06-07
ISBN : 0128096535
Language : En, Es, Fr & De

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Book Description :

How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

Pharmaceutical Dosage Forms Tablets Third Edition

Pharmaceutical Dosage Forms   Tablets  Third Edition Book
Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : CRC Press
Release : 2008-06-03
ISBN : 9781420063455
Language : En, Es, Fr & De

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Book Description :

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:

Continuous Pharmaceutical Processing

Continuous Pharmaceutical Processing Book
Author : Zoltan K Nagy,Arwa El Hagrasy,Jim Litster
Publisher : Springer Nature
Release : 2020-06-10
ISBN : 3030415244
Language : En, Es, Fr & De

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Book Description :

Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.

Essential Chemistry for Formulators of Semisolid and Liquid Dosages

Essential Chemistry for Formulators of Semisolid and Liquid Dosages Book
Author : Vitthal S. Kulkarni,Charles Shaw
Publisher : Academic Press
Release : 2015-10-15
ISBN : 012801072X
Language : En, Es, Fr & De

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Book Description :

A needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemistry of mixing different phases and test methods for the stability study of nonsolid formulations. The book covers foundational surface/colloid chemistry, which forms the necessary background for making emulsions, suspensions, solutions, and nano drug delivery systems, and the chemistry of mixing, which is critical for further formulation of drug delivery systems into semisolid (gels, creams, lotions, and ointments) or liquid final dosages. Expanding on these foundational principles, this useful guide explores stability testing methods, such as particle size, rheological/viscosity, microscopy, and chemical, and closes with a valuable discussion of regulatory issues. Essential Chemistry for Formulators of Semisolid and Liquid Dosages offers scientists and students the foundation and practical guidance to make and analyze semisolid and liquid formulations. Unique coverage of the underlying chemistry that makes possible stable dosages Quality content written by experienced experts from the drug development industry Valuable information for academic and industrial scientists developing topical and liquid dosage formulations for pharmaceutical as well as skin care and cosmetic products

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms Book
Author : Bhavishya Mittal
Publisher : Academic Press
Release : 2016-10-05
ISBN : 0128047321
Language : En, Es, Fr & De

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Book Description :

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms Book
Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : Unknown
Release : 2008
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive treatment of the design, formulation, manufacture and evaluation of the tablet dosage form. Volume 1 is dedicated to unit operations and mechanical properties. To understand the drug interactions it is essential to have a good understanding of the different unit operations involved in making a tablet. Unit operations, ie. drying, milling, granulating, use physical and chemical processes to take the raw materials in a formulation and convert them into a useful product ...

Design of Hot Extrusion Molding Device for the Continuous Production of Pharmaceutical Tablets

Design of Hot Extrusion Molding Device for the Continuous Production of Pharmaceutical Tablets Book
Author : Giorgio Romano Zampierollo
Publisher : Unknown
Release : 2010
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Currently, pharmaceutical tablets are manufactured in large batch operations that have inefficiencies associated with the stopping, re-configuration and testing between batches. Continuous manufacturing has the potential to lower manufacturing costs and energy consumption while enhancing process reliability and flexibility. Although there are many manufacturing processes that could make an impact in this sector, I focused on hot extrusion molding. Hot extrusion molding consists of heat melting a pharmaceutical resin in an extruder and packing it in a mold where it is allowed to solidify until it is ready to be ejected. I designed a hot extrusion molding system after estimating the injection pressure and cooling parameters needed to meet functional requirements. As a result, I realized the importance of using a hot runner system in order to meet criteria and be able to produce the tablets. The hot runner allows for the temperature of the melt to be controlled up until it is to be extruded into the mold, preventing pre-mature solidification and clogging in the system. From the estimations and available hardware I was able to fabricate the components for the hot extrusion molding system. The components were then assembled to be tested.

Developing Drug Products in an Aging Society

Developing Drug Products in an Aging Society Book
Author : Sven Stegemann
Publisher : Springer
Release : 2016-10-20
ISBN : 3319430998
Language : En, Es, Fr & De

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Book Description :

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals Book
Author : Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
Publisher : John Wiley & Sons
Release : 2017-07-14
ISBN : 1119001358
Language : En, Es, Fr & De

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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.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry Book
Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Release : 2019-04-01
ISBN : 1119285518
Language : En, Es, Fr & De

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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.