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How To Scale Up A Wet Granulation End Point Scientifically

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How to Scale Up a Wet Granulation End Point Scientifically

How to Scale Up a Wet Granulation End Point Scientifically Book
Author : Michael Levin
Publisher : Academic Press
Release : 2015-10-01
ISBN : 9780128035221
Language : En, Es, Fr & De

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Book Description :

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 Volume 1

How to Scale Up a Wet Granulation End Point Scientifically  Volume 1 Book
Author : Anonim
Publisher : Unknown
Release : 2021-12-08
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download How to Scale Up a Wet Granulation End Point Scientifically Volume 1 book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

How to Scale Up a Wet Granulation End Point Scientifically

How to Scale Up a Wet Granulation End Point Scientifically Book
Author : Michael Levin
Publisher : Academic Press
Release : 2015-10-07
ISBN : 0128035609
Language : En, Es, Fr & De

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Book Description :

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

Handbook of Pharmaceutical Wet Granulation Book
Author : Ajit S. Narang,Sherif I.F. Badawy
Publisher : Academic Press
Release : 2018-08-31
ISBN : 0323481035
Language : En, Es, Fr & De

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Book Description :

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

Dosage Form Design Considerations Book
Author : Anonim
Publisher : Academic Press
Release : 2018-07-28
ISBN : 0128144246
Language : En, Es, Fr & De

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Book Description :

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

Current Trends and Future Developments on  Bio   Membranes Book
Author : Angelo Basile,Alberto Figoli,Yongdan Li
Publisher : Elsevier
Release : 2019-11-27
ISBN : 0128173009
Language : En, Es, Fr & De

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Book Description :

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

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

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Book Description :

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

How to Optimize Fluid Bed Processing Technology

How to Optimize Fluid Bed Processing Technology Book
Author : Dilip Parikh
Publisher : Academic Press
Release : 2017-04-04
ISBN : 0128047283
Language : En, Es, Fr & De

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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

How to Integrate Quality by Efficient Design QbED in Product Development

How to Integrate Quality by Efficient Design  QbED  in Product Development Book
Author : Bhavishya Mittal
Publisher : Academic Press
Release : 2019-08-24
ISBN : 0128173041
Language : En, Es, Fr & De

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Book Description :

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

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation Book
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release : 2019-04-15
ISBN : 0128094125
Language : En, Es, Fr & De

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Book Description :

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

Chemical Engineering in the Pharmaceutical Industry Book
Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Release : 2019-04-08
ISBN : 111928550X
Language : En, Es, Fr & De

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Book Description :

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publisher : Academic Press
Release : 2009-03-10
ISBN : 9780080932729
Language : En, Es, Fr & De

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Book Description :

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

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

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Book Description :

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Pharmaceutical Blending and Mixing

Pharmaceutical Blending and Mixing Book
Author : P. J. Cullen,Rodolfo J. Romañach,Nicolas Abatzoglou,Chris D. Rielly
Publisher : John Wiley & Sons
Release : 2015-05-11
ISBN : 1118682807
Language : En, Es, Fr & De

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Book Description :

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.

Advances in Food and Nutrition Research

Advances in Food and Nutrition Research Book
Author : Anonim
Publisher : Academic Press
Release : 2013-03-21
ISBN : 0124115004
Language : En, Es, Fr & De

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Book Description :

Advances in Food and Nutrition Research recognizes the integral relationship between the food and nutritional sciences and brings together outstanding and comprehensive reviews that highlight this relationship. Contributions detail scientific developments in the broad areas of food science and nutrition and are intended to provide those in academia and industry with the latest information on emerging research in these constantly evolving sciences. The latest important information for food scientists and nutritionists Peer-reviewed articles by a panel of respected scientists The go-to series since 1948

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations Book
Author : WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization
Publisher : World Health Organization
Release : 2014
ISBN : 9241209860
Language : En, Es, Fr & De

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Book Description :

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

5th International Symposium on Agglomeration

5th International Symposium on Agglomeration Book
Author : Anonim
Publisher : Unknown
Release : 1989
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download 5th International Symposium on Agglomeration book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Oral Controlled Release Formulation Design and Drug Delivery

Oral Controlled Release Formulation Design and Drug Delivery Book
Author : Hong Wen,Kinam Park
Publisher : John Wiley & Sons
Release : 2011-01-14
ISBN : 9781118060322
Language : En, Es, Fr & De

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Book Description :

This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.

Integrated Pharmaceutics

Integrated Pharmaceutics Book
Author : Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
Publisher : John Wiley & Sons
Release : 2013-02-11
ISBN : 0470596929
Language : En, Es, Fr & De

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Book Description :

Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.

Handbook of Near Infrared Analysis

Handbook of Near Infrared Analysis Book
Author : Emil W. Ciurczak,Benoît Igne,Jerome Workman, Jr.,Donald A. Burns
Publisher : CRC Press
Release : 2021-05-20
ISBN : 1351269860
Language : En, Es, Fr & De

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Book Description :

Rapid, inexpensive, and easy-to-deploy, near-infrared (NIR) spectroscopy can be used to analyze samples of virtually any composition, origin, and condition. The Handbook of Near Infrared Analysis, Fourth Edition, explores the factors necessary to perform accurate and time- and cost-effective analyses across a growing spectrum of disciplines. This updated and expanded edition incorporates the latest advances in instrumentation, computerization, chemometrics applied to NIR spectroscopy, and method development in NIR spectroscopy, and underscores current trends in sample preparation, calibration transfer, process control, data analysis, instrument performance testing, and commercial NIR instrumentation. This work offers readers an unparalleled combination of theoretical foundations, cutting-edge applications, and practical experience. Additional features include the following: Explains how to perform accurate as well as time- and cost-effective analyses. Reviews software-enabled chemometric methods and other trends in data analysis. Highlights novel applications in pharmaceuticals, polymers, plastics, petrochemicals, textiles, foods and beverages, baked products, agricultural products, biomedicine, nutraceuticals, and counterfeit detection. Underscores current trends in sample preparation, calibration transfer, process control, data analysis, and multiple aspects of commercial NIR instrumentation. Offering the most complete single-source guide of its kind, the Handbook of Near Infrared Analysis, Fourth Edition, continues to offer practicing chemists and spectroscopists an unparalleled combination of theoretical foundations, cutting-edge applications, and detailed practical experience provided firsthand by more than 50 experts in the field.