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Drug Stability For Pharmaceutical Scientists

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Drug Stability for Pharmaceutical Scientists

Drug Stability for Pharmaceutical Scientists Book
Author : Thorsteinn Loftsson
Publisher : Academic Press
Release : 2014-01-25
ISBN : 0124115624
Language : En, Es, Fr & De

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Book Description :

Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries. Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material Provides answers and explanations to test your knowledge Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability

Pharmaceutical Stress Testing

Pharmaceutical Stress Testing Book
Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1439801800
Language : En, Es, Fr & De

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Book Description :

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

Drug Stability and Chemical Kinetics

Drug Stability and Chemical Kinetics Book
Author : Muhammad Sajid Hamid Akash,Kanwal Rehman
Publisher : Springer Nature
Release : 2020-11-01
ISBN : 9811564264
Language : En, Es, Fr & De

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Book Description :

This book comprehensively reviews drug stability and chemical kinetics: how external factors can influence the stability of drugs, and the reaction rates that trigger these effects. Explaining the important theoretical concepts of drug stability and chemical kinetics, and providing numerous examples in the form of illustrations, tables and calculations, the book helps readers gain a better understanding of the rates of reactions, order of reactions, types of degradation and how to prevent it, as well as types of stability studies. It also offers insights into the importance of the rate at which the drug is degraded and/or decomposed under various external and internal conditions, including temperature, pH, humidity and light. This book is intended for researchers, PhD students and scientists working in the field of pharmacy, pharmacology, pharmaceutical chemistry, medicinal chemistry and biopharmaceutics.

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development Book
Author : Kim Huynh-Ba
Publisher : Springer
Release : 2010-11-23
ISBN : 9781441927569
Language : En, Es, Fr & De

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Book Description :

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

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

Chemical Stability of Pharmaceuticals

Chemical Stability of Pharmaceuticals Book
Author : Kenneth A. Connors,Gordon L. Amidon,Valentino J. Stella
Publisher : John Wiley & Sons
Release : 1986-10-13
ISBN : 9780471879558
Language : En, Es, Fr & De

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Book Description :

Provides a sound theoretical basis for understanding chemical kinetics and its uses in studying drug stability. Treats the calculations, approximations, and estimates that are useful to the pharmacist in professional practice, and presents a collection of selected drug-stability data from the pharmaceutical literature. This Handbook makes accessible to the pharmacist much of the information necessary to make pharmaceutical decisions about drug stability. Changes in this edition include thorough revision of the chapter on oxidation, addition of a new chapter on solid-state stability, and a tripling of the number of stability monographs. All monographs figures have been redrawn, most of them from published data, and all sources are cited.

Pharmaceutical Stability Testing to Support Global Markets

Pharmaceutical Stability Testing to Support Global Markets Book
Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Release : 2009-12-04
ISBN : 9781441908896
Language : En, Es, Fr & De

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Book Description :

The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.

Analytical Techniques in the Pharmaceutical Sciences

Analytical Techniques in the Pharmaceutical Sciences Book
Author : Anette Müllertz,Yvonne Perrie,Thomas Rades
Publisher : Springer
Release : 2016-08-30
ISBN : 1493940295
Language : En, Es, Fr & De

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Book Description :

The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Stability of Drugs and Dosage Forms

Stability of Drugs and Dosage Forms Book
Author : Sumie Yoshioka,Valentino J. Stella
Publisher : Springer Science & Business Media
Release : 2007-05-08
ISBN : 0306468298
Language : En, Es, Fr & De

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Book Description :

Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry.

Analytical Scientists in Pharmaceutical Product Development

Analytical Scientists in Pharmaceutical Product Development Book
Author : Kangping Xiao
Publisher : John Wiley & Sons
Release : 2020-10-06
ISBN : 1119547857
Language : En, Es, Fr & De

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Book Description :

This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment. This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment.

Drug Stability

Drug Stability Book
Author : Jens Thurø Carstensen
Publisher : Marcel Dekker Incorporated
Release : 1990
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Practical advice on the problems of carrying out a testing program, written with the stability scientist in mind. Presents basic theory, industrial practice, and regulatory aspects, taking the reader from stability principles of the drug in dissolved, dispersed, and solid states through data analysis of the packaged drug's stability and experimental methods for achieving stable marketed products. Features computer programs, many diagrams and tables, and some 500 references. Annotation(c) 2003 Book News, Inc., Portland, OR (booknews.com)

Accelerated Predictive Stability APS

Accelerated Predictive Stability  APS  Book
Author : Fenghe Qiu,Garry Scrivens
Publisher : Academic Press
Release : 2018-06-28
ISBN : 0128027851
Language : En, Es, Fr & De

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Book Description :

Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly. Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studies Covers up-to-date regulatory experience

Stability indicating HPLC Methods for Drug Analysis

Stability indicating HPLC Methods for Drug Analysis Book
Author : Quanyun A. Xu,Lawrence A. Trissel,American Pharmacists Association
Publisher : Amer Pharmacists Assn
Release : 2003
ISBN : 9781582120461
Language : En, Es, Fr & De

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Book Description :

Stability-Indicating HPLC Methods for Drug Analysis compiles summaries of stability-indicating HPLC analytical methods that have appeared in the published literature. A first stop for pharmaceutical scientists, analytical chemists, and librarians in the quest for information about the stability of drugs. Co-published by the American Pharmaceutical Association and the Pharmaceutical Press, a division of the Royal Pharmaceutical Society of Great Britain.

Pharmaceutical Crystals

Pharmaceutical Crystals Book
Author : Tonglei Li,Alessandra Mattei
Publisher : John Wiley & Sons
Release : 2018-10-16
ISBN : 1119046297
Language : En, Es, Fr & De

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Book Description :

An important resource that puts the focus on understanding and handling of organic crystals in drug development Since a majority of pharmaceutical solid-state materials are organic crystals, their handling and processing are critical aspects of drug development. Pharmaceutical Crystals: Science and Engineering offers an introduction to and thorough coverage of organic crystals, and explores the essential role they play in drug development and manufacturing. Written contributions from leading researchers and practitioners in the field, this vital resource provides the fundamental knowledge and explains the connection between pharmaceutically relevant properties and the structure of a crystal. Comprehensive in scope, the text covers a range of topics including: crystallization, molecular interactions, polymorphism, analytical methods, processing, and chemical stability. The authors clearly show how to find solutions for pharmaceutical form selection and crystallization processes. Designed to be an accessible guide, this book represents a valuable resource for improving the drug development process of small drug molecules. This important text: Includes the most important aspects of solid-state organic chemistry and its role in drug development Offers solutions for pharmaceutical form selection and crystallization processes Contains a balance between the scientific fundamental and pharmaceutical applications Presents coverage of crystallography, molecular interactions, polymorphism, analytical methods, processing, and chemical stability Written for both practicing pharmaceutical scientists, engineers, and senior undergraduate and graduate students studying pharmaceutical solid-state materials, Pharmaceutical Crystals: Science and Engineering is a reference and textbook for understanding, producing, analyzing, and designing organic crystals which is an imperative skill to master for anyone working in the field.

HPLC for Pharmaceutical Scientists

HPLC for Pharmaceutical Scientists Book
Author : Yuri V. Kazakevich,Rosario LoBrutto
Publisher : John Wiley & Sons
Release : 2007-02-16
ISBN : 0470087943
Language : En, Es, Fr & De

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Book Description :

HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publisher : Academic Press
Release : 2016-11-08
ISBN : 0128026375
Language : En, Es, Fr & De

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Book Description :

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Essential Chemistry for Formulators of Semisolid and Liquid Dosages

Essential Chemistry for Formulators of Semisolid and Liquid Dosages Book
Author : Vitthal S. Kulkarni,Charles Shaw
Publisher : Academic Press
Release : 2015-10-15
ISBN : 012801072X
Language : En, Es, Fr & De

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Book Description :

A needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemistry of mixing different phases and test methods for the stability study of nonsolid formulations. The book covers foundational surface/colloid chemistry, which forms the necessary background for making emulsions, suspensions, solutions, and nano drug delivery systems, and the chemistry of mixing, which is critical for further formulation of drug delivery systems into semisolid (gels, creams, lotions, and ointments) or liquid final dosages. Expanding on these foundational principles, this useful guide explores stability testing methods, such as particle size, rheological/viscosity, microscopy, and chemical, and closes with a valuable discussion of regulatory issues. Essential Chemistry for Formulators of Semisolid and Liquid Dosages offers scientists and students the foundation and practical guidance to make and analyze semisolid and liquid formulations. Unique coverage of the underlying chemistry that makes possible stable dosages Quality content written by experienced experts from the drug development industry Valuable information for academic and industrial scientists developing topical and liquid dosage formulations for pharmaceutical as well as skin care and cosmetic products

Drug Stability Third Edition Revised and Expanded

Drug Stability  Third Edition  Revised  and Expanded Book
Author : Jens T. Carstensen,Christopher Rhodes
Publisher : CRC Press
Release : 2000-07-28
ISBN : 9780824703769
Language : En, Es, Fr & De

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Book Description :

Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.

Food and Beverage Stability and Shelf Life

Food and Beverage Stability and Shelf Life Book
Author : David Kilcast,Persis Subramaniam
Publisher : Elsevier
Release : 2011-04-08
ISBN : 0857092545
Language : En, Es, Fr & De

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Book Description :

Ensuring that foods and beverages remain stable during the required shelf life is critical to their success in the market place, yet companies experience difficulties in this area. Food and beverage stability and shelf life provides a comprehensive guide to factors influencing stability, methods of stability and shelf life assessment and the stability and shelf life of major products. Part one describes important food and beverage quality deterioration processes, including microbiological spoilage and physical instability. Chapters in this section also investigate the effects of ingredients, processing and packaging on stability, among other factors. Part two describes methods for stability and shelf life assessment including food storage trials, accelerated testing and shelf life modelling. Part three reviews the stability and shelf life of a wide range of products, including beer, soft drinks, fruit, bread, oils, confectionery products, milk and seafood. With its distinguished editors and international team of expert contributors, Food and beverage stability and shelf life is a valuable reference for professionals involved in quality assurance and product development and researchers focussing on food and beverage stability. A comprehensive guide to factors influencing stability, methods of stability and shelf life assessment and the stability and shelf life of major products Describes important food and beverage quality deterioration processes exploring microbiological spoilage and physical instability Investigate the effects of ingredients, processing and packaging on stability and documents methods for stability and shelf life assessment

Drug Design and Development

Drug Design and Development Book
Author : Chris Rostron
Publisher : Unknown
Release : 2020-05-15
ISBN : 0198749317
Language : En, Es, Fr & De

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Book Description :

Drug Design and Development outlines the processes involved in the design and development of new drugs and emphasises the significance of these processes to the practice of pharmacy.