Drug Stability For Pharmaceutical Scientists

Author : Thorsteinn Loftsson
Publisher : Academic Press
Page : 170 pages
File Size : 48,6 Mb
Release : 2014-01-25
Category : Medical
ISBN : 9780124115620

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Drug Stability for Pharmaceutical Scientists by Thorsteinn Loftsson Pdf

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

Author : Jens Thurø Carstensen
Publisher : Marcel Dekker
Page : 624 pages
File Size : 46,6 Mb
Release : 1995
Category : Drug stability
ISBN : UOM:39015034859911

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Drug Stability by Jens Thurø Carstensen Pdf

Combining basic theory, current industrial practice, and useful regulatory aspects in an original overview of pharmaceutical stability, this thoroughly rewritten and enlarged reference/text examines data analysis of the packaged drug's stability, experimental methods for achieving stable marketed products, and the stability principles of drugs in dissolved, dispersed, and solid states.

Author : Muhammad Sajid Hamid Akash,Kanwal Rehman
Publisher : Springer Nature
Page : 284 pages
File Size : 53,9 Mb
Release : 2020-11-01
Category : Medical
ISBN : 9789811564260

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Drug Stability and Chemical Kinetics by Muhammad Sajid Hamid Akash,Kanwal Rehman Pdf

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.

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Page : 261 pages
File Size : 42,9 Mb
Release : 2009-12-04
Category : Medical
ISBN : 9781441908896

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Pharmaceutical Stability Testing to Support Global Markets by Kim Huynh-Ba Pdf

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.

Author : Fenghe Qiu,Garry Scrivens
Publisher : Academic Press
Page : 512 pages
File Size : 48,7 Mb
Release : 2018-06-28
Category : Medical
ISBN : 9780128027851

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Accelerated Predictive Stability (APS) by Fenghe Qiu,Garry Scrivens Pdf

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

Author : Jiben Roy
Publisher : Elsevier
Page : 446 pages
File Size : 53,6 Mb
Release : 2011-07-25
Category : Medical
ISBN : 9781908818041

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An Introduction to Pharmaceutical Sciences by Jiben Roy Pdf

This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences. This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry. A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries

Author : Sumie Yoshioka,Valentino J. Stella
Publisher : Springer Science & Business Media
Page : 270 pages
File Size : 47,6 Mb
Release : 2007-05-08
Category : Medical
ISBN : 9780306468292

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Stability of Drugs and Dosage Forms by Sumie Yoshioka,Valentino J. Stella Pdf

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.

Author : Kenneth A. Connors,Gordon L. Amidon,Valentino J. Stella
Publisher : John Wiley & Sons
Page : 869 pages
File Size : 52,6 Mb
Release : 1986-10-13
Category : Medical
ISBN : 9780471879558

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Chemical Stability of Pharmaceuticals by Kenneth A. Connors,Gordon L. Amidon,Valentino J. Stella Pdf

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.

Author : Christopher T. Rhodes,Jens Thurø Carstensen
Publisher : Unknown
Page : 773 pages
File Size : 41,9 Mb
Release : 2000-01-01
Category : Medical
ISBN : 0585393265

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Drug Stability by Christopher T. Rhodes,Jens Thurø Carstensen Pdf

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.

Author : Michael Henry Rubinstein
Publisher : Unknown
Page : 178 pages
File Size : 48,6 Mb
Release : 1989
Category : Medical
ISBN : UOM:39015014472198

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Pharmaceutical Technology--drug Stability by Michael Henry Rubinstein Pdf

Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
Publisher : CRC Press
Page : 0 pages
File Size : 51,9 Mb
Release : 2011-07-27
Category : Medical
ISBN : 1439801797

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Pharmaceutical Stress Testing by Steven W. Baertschi,Karen M. Alsante,Robert A. Reed Pdf

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).

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Page : 389 pages
File Size : 55,5 Mb
Release : 2008-11-16
Category : Medical
ISBN : 9780387856278

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Handbook of Stability Testing in Pharmaceutical Development by Kim Huynh-Ba Pdf

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.

Author : Yuri V. Kazakevich,Rosario LoBrutto
Publisher : John Wiley & Sons
Page : 1136 pages
File Size : 52,6 Mb
Release : 2007-02-16
Category : Science
ISBN : 9780470087947

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HPLC for Pharmaceutical Scientists by Yuri V. Kazakevich,Rosario LoBrutto Pdf

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.

Author : Anette Müllertz,Yvonne Perrie,Thomas Rades
Publisher : Springer
Page : 838 pages
File Size : 44,8 Mb
Release : 2016-08-30
Category : Medical
ISBN : 9781493940295

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Analytical Techniques in the Pharmaceutical Sciences by Anette Müllertz,Yvonne Perrie,Thomas Rades Pdf

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.

Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
Publisher : CRC Press
Page : 504 pages
File Size : 41,7 Mb
Release : 2005-06-24
Category : Medical
ISBN : 0824740211

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Pharmaceutical Stress Testing by Steven W. Baertschi,Karen M. Alsante,Robert A. Reed Pdf

The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.