How to Scale Up a Wet Granulation End Point Scientifically Book

How to Scale Up a Wet Granulation End Point Scientifically


  • Author : Michael Levin
  • Publisher : Academic Press
  • Release Date : 2015-10-07
  • Genre: Medical
  • Pages : 88
  • ISBN 10 : 9780128035603

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How to Scale Up a Wet Granulation End Point Scientifically 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

How to Scale Up a Wet Granulation End Point Scientifically Book

How to Scale Up a Wet Granulation End Point Scientifically


  • Author : Michael Levin
  • Publisher : Academic Press
  • Release Date : 2015-10-01
  • Genre: Uncategoriezed
  • Pages : 88
  • ISBN 10 : 0128035226

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How to Scale Up a Wet Granulation End Point Scientifically 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 Book

Handbook of Pharmaceutical Wet Granulation


  • Author : Ajit S. Narang
  • Publisher : Academic Press
  • Release Date : 2018-08-31
  • Genre: Medical
  • Pages : 890
  • ISBN 10 : 9780323481038

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Handbook of Pharmaceutical Wet Granulation 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 Book

Dosage Form Design Considerations


  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-28
  • Genre: Medical
  • Pages : 820
  • ISBN 10 : 9780128144244

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Dosage Form Design Considerations 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

Current Trends and Future Developments on  Bio   Membranes Book

Current Trends and Future Developments on Bio Membranes


  • Author : Angelo Basile
  • Publisher : Elsevier
  • Release Date : 2019-11-27
  • Genre: Technology & Engineering
  • Pages : 382
  • ISBN 10 : 9780128173008

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Current Trends and Future Developments on Bio Membranes 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

Chemical Engineering in the Pharmaceutical Industry Book

Chemical Engineering in the Pharmaceutical Industry


  • Author : Mary T. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-08
  • Genre: Technology & Engineering
  • Pages : 688
  • ISBN 10 : 9781119285502

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Chemical Engineering in the Pharmaceutical Industry Excerpt :

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 sc

How to Develop Robust Solid Oral Dosage Forms Book

How to Develop Robust Solid Oral Dosage Forms


  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2016-10-05
  • Genre: Medical
  • Pages : 190
  • ISBN 10 : 9780128047323

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How to Develop Robust Solid Oral Dosage Forms 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 Book

How to Optimize Fluid Bed Processing Technology


  • Author : Dilip Parikh
  • Publisher : Academic Press
  • Release Date : 2017-04-04
  • Genre: Medical
  • Pages : 210
  • ISBN 10 : 9780128047286

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How to Optimize Fluid Bed Processing Technology 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 Book

How to Integrate Quality by Efficient Design QbED in Product Development


  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2019-08-24
  • Genre: Business & Economics
  • Pages : 274
  • ISBN 10 : 9780128173046

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How to Integrate Quality by Efficient Design QbED in Product Development 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 developmen

Principles of Parenteral Solution Validation Book

Principles of Parenteral Solution Validation


  • Author : Igor Gorsky
  • Publisher : Academic Press
  • Release Date : 2019-04-15
  • Genre: Medical
  • Pages : 298
  • ISBN 10 : 9780128094129

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Principles of Parenteral Solution Validation 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

Developing Solid Oral Dosage Forms Book
Score: 5
From 2 Ratings

Developing Solid Oral Dosage Forms


  • Author : Yihong Qiu
  • Publisher : Academic Press
  • Release Date : 2009-03-10
  • Genre: Medical
  • Pages : 978
  • ISBN 10 : 008093272X

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Developing Solid Oral Dosage Forms 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

Continuous Manufacturing of Pharmaceuticals Book

Continuous Manufacturing of Pharmaceuticals


  • Author : Peter Kleinebudde
  • Publisher : John Wiley & Sons
  • Release Date : 2017-07-14
  • Genre: Science
  • Pages : 632
  • ISBN 10 : 9781119001355

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Continuous Manufacturing of Pharmaceuticals 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 manufactur

Handbook of Pharmaceutical Granulation Technology Book

Handbook of Pharmaceutical Granulation Technology


  • Author : Dilip M. Parikh
  • Publisher : CRC Press
  • Release Date : 2021-05-12
  • Genre: Medical
  • Pages : 904
  • ISBN 10 : 9781000366389

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Handbook of Pharmaceutical Granulation Technology Excerpt :

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration, process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more than 50 global subject matter experts who share their years of experience in areas ranging from drug delivery and pharmaceutical technology to advances in nanotechnology. Every pharmaceutical scientist should own a copy of this fourth edition resource. Key Features: 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

Pharmaceutical Blending and Mixing Book

Pharmaceutical Blending and Mixing


  • Author : P. J. Cullen
  • Publisher : John Wiley & Sons
  • Release Date : 2015-05-11
  • Genre: Technology & Engineering
  • Pages : 512
  • ISBN 10 : 9781118682807

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Pharmaceutical Blending and Mixing 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.

Encyclopedia of Pharmaceutical Technology Book

Encyclopedia of Pharmaceutical Technology


  • Author : James Swarbrick
  • Publisher : CRC Press
  • Release Date : 2013-07-01
  • Genre: Medical
  • Pages : 880
  • ISBN 10 : 9781439808238

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Encyclopedia of Pharmaceutical Technology 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