Process Analytical Technology Approach in Fluid Bed Granulation and Drying PDF Download

Author: Tanja Lipsanen
Publisher:
ISBN: 9789521050114
Category :
Languages : en
Pages :

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Author: Daniela Steigmiller
Publisher:
ISBN:
Category :
Languages : en
Pages : 167

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Author: Dilip M. Parikh
Publisher: CRC Press
ISBN: 9780824798826
Category : Medical
Languages : en
Pages : 532

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Book Description
Integrating the basic principles and industrial practices of pharmaceutical granulation production, this book discusses technologies and demonstrates cost-effective approaches to manufacturing solid-dosage forms with content uniformity and consistent physical properties while complying with regulatory requirements. Specialists from pharmaceutical companies, academia, and the U.S. Drug Regulatory Affairs agency address current and changing practices in industrial drug granulation production. Text, charts, figures, and photographs illustrate the pros and cons of diverse methods and technologies for accurately achieving strong bonding of particles in tablets and capsules.

Author: Katherine A. Bakeev
Publisher: John Wiley & Sons
ISBN: 0470689609
Category : Science
Languages : en
Pages : 576

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Book Description
Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: Implementation of Process Analytical Technologies UV-Visible Spectroscopy for On-line Analysis Infrared Spectroscopy for Process Analytical Applications Process Raman Spectroscopy Process NMR Spectrscopy: Technology and On-line Applications Fluorescent Sensing and Process Analytical Applications Chemometrics in Process Analytical Technology (PAT) On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing NIR Chemical Imaging This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition “The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology.”—Current Engineering Practice

Author: Dilip M. Parikh
Publisher: CRC Press
ISBN: 1000366383
Category : Medical
Languages : en
Pages : 905

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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

Author: Dilip Parikh
Publisher: Academic Press
ISBN: 0128047283
Category : Science
Languages : en
Pages : 211

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Book Description
How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference. This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation. Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation. - Written by an expert in the field with several years of experience in product development, manufacturing, plant operations, and process engineering - Illustrates when fluid bed granulation is needed, when to use less common fluid bed granulation methods, and the advantages of fluid bed granulation when compared to other granulation techniques - Offers troubleshooting tips and practical advice for scientists working with this technique

Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527341129
Category : Medical
Languages : en
Pages : 394

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Book Description
A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

Author: Jim Litster
Publisher: Springer Science & Business Media
ISBN: 9401705461
Category : Science
Languages : en
Pages : 258

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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.

Author: Evangelos Tsotsas
Publisher: John Wiley & Sons
ISBN: 3527643990
Category : Technology & Engineering
Languages : en
Pages : 431

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Book Description
This five-volume series provides a comprehensive overview of all important aspects of modern drying technology, concentrating on the transfer of cutting-edge research results to industrial use. Volume 3 discusses how desired properties of foods, biomaterials, active pharmaceutical ingredients, and fragile aerogels can be preserved during drying, and how spray drying and spray fluidized bed processes can be used for particle formation and formulation. Methods for monitoring product quality, such as process analytical technology, and modeling tools, such as Monte Carlo simulations, discrete particle modeling and neural networks, are presented with real examples from industry and academia.

Author: Ajit S. Narang
Publisher: CRC Press
ISBN: 100080447X
Category : Medical
Languages : en
Pages : 495

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Book Description
Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability. Features: Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies