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How to Scale-Up a Wet Granulation End Point Scientifically

Author: Michael Levin

Publisher: Academic Press

Published: 2015-10-07

Total Pages: 88

ISBN-13: 0128035609

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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

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

Published: 2018-08-31

Total Pages: 890

ISBN-13: 0323481035

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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

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

Published: 2018-07-28

Total Pages: 820

ISBN-13: 0128144246

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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

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

Published: 2015-07-20

Total Pages: 508

ISBN-13: 0470710551

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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.

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

Published: 2019-11-27

Total Pages: 383

ISBN-13: 0128173009

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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

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

Published: 2016-10-05

Total Pages: 190

ISBN-13: 0128047321

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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

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

Published: 2017-04-04

Total Pages: 210

ISBN-13: 0128047283

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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

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

Handbook of Pharmaceutical Granulation Technology

Author: Dilip M. Parikh

Publisher: CRC Press

Published: 2021-05-11

Total Pages: 905

ISBN-13: 1000366383

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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

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

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

Author: Bhavishya Mittal

Publisher: Academic Press

Published: 2019-08-24

Total Pages: 274

ISBN-13: 0128173041

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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

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

The Science and Engineering of Granulation Processes

Author: Jim Litster

Publisher: Springer Science & Business Media

Published: 2013-06-29

Total Pages: 258

ISBN-13: 9401705461

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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.

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 258 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.