How To Scale Up A Wet Granulation End Point Scientifically

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How to Scale-Up a Wet Granulation End Point Scientifically

Author : Michael Levin
Publisher : Academic Press
ISBN 13 : 0128035609
Total Pages : 88 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis How to Scale-Up a Wet Granulation End Point Scientifically by : Michael Levin

Download or read book How to Scale-Up a Wet Granulation End Point Scientifically written by Michael Levin and published by Academic Press. This book was released on 2015-10-07 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to Scale-Up a Wet Granulation End Point Scientifically provides a single-source devoted to all relevant information on the scale-up of a wet granulation end point. Contents include a general description, problem identification, and theoretical background with supporting literature, case studies, potential solutions, and more. By outlining issues related to scale-up and end-point determination, and then using practical examples and advice to address these issues, How to Scale-Up a Wet Granulation End Point Scientifically is a valuable and essential resource for all those pharmaceutical scientists and technologists engaged in the granulation process. Thoroughly referenced and based on the latest research and literature Part of the Expertise in Pharmaceutical Process Technology Series edited by internationally respected expert, Michael Levin Illustrates the most common problems related to scale-up of a wet granulation end point and provides valuable insights on how to solve these problems in a practical way

Handbook of Pharmaceutical Wet Granulation

Author : Ajit S. Narang
Publisher : Academic Press
ISBN 13 : 0323481035
Total Pages : 890 pages
Book Rating : 4.3/5 (234 download)

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Book Synopsis Handbook of Pharmaceutical Wet Granulation by : Ajit S. Narang

Download or read book Handbook of Pharmaceutical Wet Granulation written by Ajit S. Narang and published by Academic Press. This book was released on 2018-08-31 with total page 890 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Dosage Form Design Considerations

Author :
Publisher : Academic Press
ISBN 13 : 0128144246
Total Pages : 820 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Dosage Form Design Considerations by :

Download or read book Dosage Form Design Considerations written by and published by Academic Press. This book was released on 2018-07-28 with total page 820 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume I, 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

Pharmaceutical Blending and Mixing

Author : P. J. Cullen
Publisher : John Wiley & Sons
ISBN 13 : 0470710551
Total Pages : 508 pages
Book Rating : 4.4/5 (77 download)

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Book Synopsis Pharmaceutical Blending and Mixing by : P. J. Cullen

Download or read book Pharmaceutical Blending and Mixing written by P. J. Cullen and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.

Current Trends and Future Developments on (Bio-) Membranes

Author : Angelo Basile
Publisher : Elsevier
ISBN 13 : 0128173009
Total Pages : 383 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Current Trends and Future Developments on (Bio-) Membranes by : Angelo Basile

Download or read book Current Trends and Future Developments on (Bio-) Membranes written by Angelo Basile and published by Elsevier. This book was released on 2019-11-27 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Current Trends and Future Developments in (Bio-) Membranes: Membranes in Environmental Applications offers an overview of environmental pollution, covering the air, water, waste from agriculture and climate change, and including emerging offenders such as microplastics and electronic waste which can be solved by conventional and advanced membrane techniques. Chapters cover environmental pollution issues followed by specific membrane processes, problems related to environmental pollution, and the different techniques used for solving these problems. For each pollutant, such as CO2 and fuel, water and wastewater, waste from agriculture, etc., specific membrane processes are described. Users will find a comprehensive overview on the environmental problems that influence climate change and aquatic/water preservation, CO2 emission and air pollution, metals, toxic pollutants in water, wastewater problems and treatments, and more. Presents an overview on the interconnections between membrane technology and environmental issues Provides a comprehensive review of the environmental pollution issues tackled by membrane processes Addresses key issues in energy production from renewable sources

How to Develop Robust Solid Oral Dosage Forms

Author : Bhavishya Mittal
Publisher : Academic Press
ISBN 13 : 0128047321
Total Pages : 190 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis How to Develop Robust Solid Oral Dosage Forms by : Bhavishya Mittal

Download or read book How to Develop Robust Solid Oral Dosage Forms written by Bhavishya Mittal and published by Academic Press. This book was released on 2016-10-05 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

How to Optimize Fluid Bed Processing Technology

Author : Dilip Parikh
Publisher : Academic Press
ISBN 13 : 0128047283
Total Pages : 210 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis How to Optimize Fluid Bed Processing Technology by : Dilip Parikh

Download or read book How to Optimize Fluid Bed Processing Technology written by Dilip Parikh and published by Academic Press. This book was released on 2017-04-04 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

How to Integrate Quality by Efficient Design (QbED) in Product Development

Author : Bhavishya Mittal
Publisher : Academic Press
ISBN 13 : 0128173041
Total Pages : 274 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis How to Integrate Quality by Efficient Design (QbED) in Product Development by : Bhavishya Mittal

Download or read book How to Integrate Quality by Efficient Design (QbED) in Product Development written by Bhavishya Mittal and published by Academic Press. This book was released on 2019-08-24 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

Handbook of Pharmaceutical Granulation Technology

Author : Dilip M. Parikh
Publisher : CRC Press
ISBN 13 : 1000366383
Total Pages : 905 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Handbook of Pharmaceutical Granulation Technology by : Dilip M. Parikh

Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2021-05-11 with total page 905 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Principles of Parenteral Solution Validation

Author : Igor Gorsky
Publisher : Academic Press
ISBN 13 : 0128094125
Total Pages : 298 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Principles of Parenteral Solution Validation by : Igor Gorsky

Download or read book Principles of Parenteral Solution Validation written by Igor Gorsky and published by Academic Press. This book was released on 2019-04-15 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Chemical Engineering in the Pharmaceutical Industry

Author : David J. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 1118088107
Total Pages : 1431 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : David J. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2011-03-10 with total page 1431 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

Developing Solid Oral Dosage Forms

Author : Yihong Qiu
Publisher : Academic Press
ISBN 13 : 9780080932729
Total Pages : 978 pages
Book Rating : 4.9/5 (327 download)

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Book Synopsis Developing Solid Oral Dosage Forms by : Yihong Qiu

Download or read book Developing Solid Oral Dosage Forms written by Yihong Qiu and published by Academic Press. This book was released on 2009-03-10 with total page 978 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

The Science and Engineering of Granulation Processes

Author : Jim Litster
Publisher : Springer Science & Business Media
ISBN 13 : 9401705461
Total Pages : 250 pages
Book Rating : 4.4/5 (17 download)

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Book Synopsis The Science and Engineering of Granulation Processes by : Jim Litster

Download or read book The Science and Engineering of Granulation Processes written by Jim Litster and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Continuous Manufacturing of Pharmaceuticals

Author : Peter Kleinebudde
Publisher : John Wiley & Sons
ISBN 13 : 1119001358
Total Pages : 632 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Continuous Manufacturing of Pharmaceuticals by : Peter Kleinebudde

Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-07-14 with total page 632 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Scale-Up, Third Edition

Author : Michael Levin
Publisher : CRC Press
ISBN 13 : 9781616310011
Total Pages : 0 pages
Book Rating : 4.3/5 (1 download)

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Book Synopsis Pharmaceutical Process Scale-Up, Third Edition by : Michael Levin

Download or read book Pharmaceutical Process Scale-Up, Third Edition written by Michael Levin and published by CRC Press. This book was released on 2011-02-02 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

Encyclopedia of Pharmaceutical Technology

Author : James Swarbrick
Publisher : CRC Press
ISBN 13 : 1439808236
Total Pages : 880 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Encyclopedia of Pharmaceutical Technology by : James Swarbrick

Download or read book Encyclopedia of Pharmaceutical Technology written by James Swarbrick and published by CRC Press. This book was released on 2013-07-01 with total page 880 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to com

Pharmaceutical Blending and Mixing

Author : P. J. Cullen
Publisher : John Wiley & Sons
ISBN 13 : 1118682807
Total Pages : 512 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Pharmaceutical Blending and Mixing by : P. J. Cullen

Download or read book Pharmaceutical Blending and Mixing written by P. J. Cullen and published by John Wiley & Sons. This book was released on 2015-05-11 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.