How to Scale-Up a Wet Granulation End Point Scientifically

Author: Michael Levin

Publisher: Academic Press

ISBN: 0128035609

Category: Medical

Page: 88

View: 604

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

Theory and Practice in a Quality by Design Paradigm

Author: Ajit S. Narang,Sherif I.F. Badawy

Publisher: Academic Press

ISBN: 0323481035

Category: Medical

Page: 890

View: 6163

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: N.A

Publisher: Academic Press

ISBN: 0128144246

Category: Medical

Page: 820

View: 7444

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

How to Validate a Pharmaceutical Process

Author: Steven Ostrove

Publisher: Academic Press

ISBN: 0128096535

Category: Medical

Page: 218

View: 5406

How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

How to Develop Robust Solid Oral Dosage Forms

From Conception to Post-Approval

Author: Bhavishya Mittal

Publisher: Academic Press

ISBN: 0128047321

Category: Medical

Page: 190

View: 5119

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

Part of the Expertise in Pharmaceutical Process Technology Series

Author: Dilip Parikh

Publisher: Academic Press

ISBN: 0128047283

Category: Medical

Page: 210

View: 1780

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

Predictive Modeling of Pharmaceutical Unit Operations

Author: Preetanshu Pandey,Rahul Bharadwaj

Publisher: Woodhead Publishing

ISBN: 0081001800

Category: Medical

Page: 464

View: 3083

The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Design and Processing of Particulate Products

Author: Jim Litster

Publisher: Cambridge University Press

ISBN: 1107007372

Category: Science

Page: 328

View: 2055

A unique text providing comprehensive coverage of fundamental particle science, processing and technology. Including quantitative tools, real-world case studies and end-of-chapter problems, it is ideal for students in engineering and applied sciences, as well as for practitioners in a range of industries manufacturing particulate products.

Handbook of Pharmaceutical Granulation Technology, Third Edition

Author: Dilip M. Parikh

Publisher: CRC Press

ISBN: 1616310030

Category: Medical

Page: 676

View: 8812

The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the reader in selecting the ideal technology for his/her company’s particular drug delivery system. This knowledge helps ensure that regulatory guidelines are followed and met in a cost-effective manner. Here are just a few of the new topics discussed in this revised and expanded handbook: spray drying nanotechnology biotechnologically derived drugs nutraceuticals controlled release drugs particle engineering supercritical fluids concepts of design space process optimization regulation harmonization by global health authorities process controlexpert systems Process Analytical Technology (PAT) regulatory issues in granulation In addition, all chapters in the Handbook of Pharmaceutical Granulation Technology explore the fundamentals of powder characterization, granulation, and state-of-the-art technologies, modeling, application of expert systems, and manufacturing optimization.

The Science and Engineering of Granulation Processes

Author: Jim Litster,Bryan Ennis

Publisher: Springer Science & Business Media

ISBN: 9401705461

Category: Science

Page: 250

View: 4355

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.

Pharmaceutical Process Scale-Up, Second Edition

Author: Michael Levin

Publisher: Taylor & Francis US

ISBN: 1420026658

Category: Medical

Page: 576

View: 9088

Keeping pace with the increased influence of PAT in the pharmaceutical industry, this completely updated reference spans the latest research and regulations, technologies, and expert solutions for every significant aspect of pharmaceutical process scale-up-clearly introducing readers to the theoretical concept of dimensional analysis to quantify similar processes on varying scales.

The Anarchist Cookbook

Author: William Powell

Publisher: Lulu Press, Inc

ISBN: 1387589660

Category: Sports & Recreation

Page: N.A

View: 416

The Anarchist Cookbook will shock, it will disturb, it will provoke. It places in historical perspective an era when "Turn on, Burn down, Blow up" are revolutionary slogans of the day. Says the author" "This book... is not written for the members of fringe political groups, such as the Weatherman, or The Minutemen. Those radical groups don't need this book. They already know everything that's in here. If the real people of America, the silent majority, are going to survive, they must educate themselves. That is the purpose of this book." In what the author considers a survival guide, there is explicit information on the uses and effects of drugs, ranging from pot to heroin to peanuts. There i detailed advice concerning electronics, sabotage, and surveillance, with data on everything from bugs to scramblers. There is a comprehensive chapter on natural, non-lethal, and lethal weapons, running the gamut from cattle prods to sub-machine guns to bows and arrows.

Food Analysis

Author: S. Suzanne Nielsen

Publisher: Springer

ISBN: 3319457764

Category: Technology & Engineering

Page: 649

View: 5060

This fifth edition provides information on techniques needed to analyze foods for chemical and physical properties. The book is ideal for undergraduate courses in food analysis and is also an invaluable reference to professionals in the food industry. General information chapters on regulations, labeling, sampling, and data handling provide background information for chapters on specific methods to determine chemical composition and characteristics, physical properties, and objectionable matter and constituents. Methods of analysis covered include information on the basic principles, advantages, limitations, and applications. Sections on spectroscopy and chromatography along with chapters on techniques such as immunoassays, thermal analysis, and microscopy from the perspective of their use in food analysis have been expanded. Instructors who adopt the textbook can contact the editor for access to a website with related teaching materials.

The Resistance of Ships

Author: William Froude

Publisher: N.A

ISBN: N.A

Category: Ship resistance

Page: 107

View: 5492

Leading phenomena of the wave-making resistance of ships.

Scientific American

Supplement

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Science

Page: N.A

View: 6584

Sample Preparation of Pharmaceutical Dosage Forms

Challenges and Strategies for Sample Preparation and Extraction

Author: Beverly Nickerson

Publisher: Springer Science & Business Media

ISBN: 9781441996312

Category: Medical

Page: 397

View: 4176

This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.

Learn to Paint in Watercolor with 50 Paintings

Pick Up the Skills, Put On the Paint, Hang Up Your Art

Author: Wil Freeborn

Publisher: N.A

ISBN: 1631592777

Category: Art

Page: 144

View: 8271

Develop your watercolor skills one painting at a time! Are you a watercolor painter newbie? Have you dabbled in watercolors but wish your paintings looked more polished? Well, it's time to remedy that! Learn to Paint in Watercolor is the patient watercolor instructor you've been waiting for. This unique how-to book offers all you need to know about watercolor painting - perfect for first-time painters or anyone interested in refining their skills. Treat the book as an in-depth class on this medium. With each lesson, you'll be privy to a new watercolor technique or subject. Readers will move through the book subject by subject, course by course, painting all along the way. By the time you reach the end, you'll have fifty paintings showcasing your steady progress. You'll start by painting objects that are important to you and then move on to exploring your immediate environment. By the end of the book, your paintings will start to tell your own story, giving you the confidence to continue painting and discovering watercolors' myriad possibilities. Techniques are introduced throughout the book's projects, from using a simple color wash to learning about ink techniques or letting go with loose, free watercolors. At the same time, concepts such as properties of light (vital for watercolorists) give a solid foundation on which to work. Through fine and vibrant strokes, you'll make expressive watercolors that you can be proud of, all thanks to your instructor, Learn to Paint in Watercolor.

Misconceptions in Chemistry

Addressing Perceptions in Chemical Education

Author: Hans-Dieter Barke,Al Hazari,Sileshi Yitbarek

Publisher: Springer Science & Business Media

ISBN: 3540709894

Category: Science

Page: 294

View: 9602

Over the last decades several researchers discovered that children, pupils and even young adults develop their own understanding of "how nature really works". These pre-concepts concerning combustion, gases or conservation of mass are brought into lectures and teachers have to diagnose and to reflect on them for better instruction. In addition, there are ‘school-made misconceptions’ concerning equilibrium, acid-base or redox reactions which originate from inappropriate curriculum and instruction materials. The primary goal of this monograph is to help teachers at universities, colleges and schools to diagnose and ‘cure’ the pre-concepts. In case of the school-made misconceptions it will help to prevent them from the very beginning through reflective teaching. The volume includes detailed descriptions of class-room experiments and structural models to cure and to prevent these misconceptions.

Pharmaceutical Extrusion Technology

Author: Isaac Ghebre-Selassie,Charles Martin

Publisher: CRC Press

ISBN: 0824755200

Category: Medical

Page: 420

View: 1111

Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.