Organic Chemistry of Drug Degradation

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Author: Min Li

Publisher: Royal Society of Chemistry

ISBN: 1782625631

Category: Medical

Page: 306

View: 5100

The vast majority of drugs are organic molecular entities. A clear understanding of the organic chemistry of drug degradation is essential to maintaining the stability, efficacy, and safety of a drug product throughout its shelf-life. During analytical method development, stability testing, and pharmaceutical manufacturing troubleshooting activities, one of the frequently occurring and usually challenging events would be the identification of drug degradants and understanding of drug degradation mechanisms and pathways. This book is written by a veteran of the pharmaceutical industry who has first-hand experience in drug design and development, drug degradation mechanism studies, analytical development, and manufacturing process troubleshooting and improvement. The author discusses various degradation pathways with an emphasis on the mechanisms of the underlying organic chemistry, which should aid greatly in the efforts of degradant identification, formulation development, analytical development, and manufacturing process improvement. Organic reactions that are significant in drug degradation will first be reviewed and then illustrated by examples of drug degradation reported in the literature. The author brings the book to a close with a final chapter dedicated to the strategy for rapid elucidation of drug degradants with regard to the current regulatory requirements and guidelines. One chapter that should be given special attention is Chapter 3, Oxidative Degradation. Oxidative degradation is one of the most common degradation pathways but perhaps the most complex one. This chapter employs more than sixty drug degradation case studies with in-depth discussion in regard to their unique degradation pathways. With the increasing regulatory requirements on the quality and safety of pharmaceutical products, in particular with regard to drug impurities and degradants, the book will be an invaluable resource for pharmaceutical and analytical scientists who engage in formulation development, analytical development, stability studies, degradant identification, and support of manufacturing process improvement. In addition, it will also be helpful to scientists engaged in drug discovery and development as well as in drug metabolism studies.

Modern Pharmaceutics, Fourth Edition

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Author: Gilbert S. Banker,Juergen Siepmann,Christopher Rhodes

Publisher: CRC Press

ISBN: 9780824744694

Category: Medical

Page: 860

View: 4597

"Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the pharmacodynamic and physicochemical factors influencing drug action through various routes of administration."

Pharmaceutical Stress Testing

Predicting Drug Degradation, Second Edition

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Author: Steven W. Baertschi,Karen M. Alsante,Robert A. Reed

Publisher: CRC Press

ISBN: 1439801800

Category: Medical

Page: 612

View: 7267

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).

The Organic Chemistry of Drug Design and Drug Action

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Author: Richard B. Silverman

Publisher: Elsevier

ISBN: 0080571239

Category: Science

Page: 422

View: 7065

This is a new approach to the teaching of medicinal chemistry. The knowledge of the physical organic chemical basis of drug design and drug action allows the reader to extrapolate to the many related classes of drugs described in standard medicinal chemistry texts. Students gain a solid foundation to base future research endeavors upon: drugs not yet developed are thus covered! n Emphasizes the use of the principles of physical organic chemistry as a basis for drug design n Discusses organic reaction mechanisms of clinically important drugs with mechanistic schemes n Uses figures and literature references extensively throughout n This text is not merely a "compilation of drugs and uses," but features selected drugs as examples of the organic chemical basis for any and all drug design applications

Drugs, Photochemistry and Photostability

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Author: Angelo Albini,Elisa Fasani,Royal Society of Chemistry (Great Britain)

Publisher: Royal Society of Chemistry

ISBN: 9780854047437

Category: Medical

Page: 326

View: 6207

Since Pasteur in 1846, scientists have been aware that many drugs are photoreactive, but until recently research in this area had been somewhat limited. However, since the introduction of acutely sensitive analytical methods, the realisation of the need to identify the photochemical properties of a potential drug as early in its development as possible and the increased attention to the phototoxic effect of drugs, more details are becoming available. Drugs: Photochemistry and Photostability presents the basic elements of the science, and serves as an excellent introduction to this emerging field of photochemistry. Detailed experimental conditions for photostability studies are given, along with a discussion of the recently implemented ICH Guidelines for drug photostability. With contributions from international experts in the field and including a comprehensive literature review, this book provides all the up-to-date information needed by researchers in many fields, especially medicinal and pharmaceutical chemistry.

The Organic Chemistry of Drug Design and Drug Action, Power PDF

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Author: Richard B. Silverman

Publisher: Elsevier

ISBN: 0080575382

Category: Medical

Page: 1275

View: 3491

This CD-ROM edition of Silverman's Organic Chemisry of Drug Design and Drug Action, Second Edition reflects the significant changes in the drug industry in recent years, using an accessible interactive approach. This CD-ROM integrates the author's own PowerPoint slides, indexed and linked to the book pages in PDF format. The three-part structure includes an all-electronic text with full-text search capabilites and nearly 800 powerpoint slides. This is a unique and powerful combination of electronic study guide and full book pages. Users can hyperlink seamlessly from the main text to key points and figures on the outline and back again. It serves as a wonderful supplement for instructors as well as a fully integrated text and study aid for students. * Three-part package includes 1) powerpoint, 2) integrated powerpoint and pdf-based text, and 3) fully searchable PDF-based text with index * Includes new full-color illustrations, structures, schemes, and figures as well as extensive chapter problems and exercises * User-friendly buttons transition from overview (study-guide) format to corresponding book page and back with the click of a mouse * Full-text search capabality an incomparable tool for researchers seeking specific references and/or unindexed phrases

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

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Author: Satinder Ahuja,Karen Mills Alsante

Publisher: Academic Press

ISBN: 9780120449828

Category: Medical

Page: 414

View: 2873

The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.

Stability of Drugs and Dosage Forms

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Author: Sumie Yoshioka,Valentino J. Stella

Publisher: Springer Science & Business Media

ISBN: 0306468298

Category: Medical

Page: 270

View: 5413

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.

Identification and Determination of Impurities in Drugs

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Author: S. Görög

Publisher: Elsevier

ISBN: 9780080534404

Category: Science

Page: 772

View: 2553

Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since this is the best way to characterise the quality and stability of bulk drugs and pharmaceutical formulations, this is the core activity in modern drug analysis. Due to the very rapid development of the analytical methodologies available for this purpose and the similarly rapid increase of the demands as regards the purity of drugs it is an important task to give a summary of the problems and the various possibilities offered by modern analytical chemistry for their solution. That is the aim of this book. The book is methodology-oriented. In the first chapter some important aspects of the background of impurity-related analytical studies (toxicological, pharmacopoeial aspects, the characterisation of the sources of impurities and the role of impurity profiling in various fields of drug research, production and therapeutic use) are summarised. Chapter two deals with related organic impurities, the strategies for impurity profiling, the use of chromatographic and related separation methods, spectroscopic, and hyphenated techniques. The subject of the third chapter is the identification and determination of residual solvents. The determination of inorganic impurities is discussed in chapter four. The special problems of degradation products as impurities are dealt with in chapter five. A separate chapter has been compiled to deal with one of the most up-to-date problems in contemporary pharmaceutical analysis, the estimation of enantiomeric purity of chiral drugs. Chapter seven is devoted to various approaches to solve the problem of polymorphic modifications as impurities. Since in the broader sense of the word the microbiological purity of drugs and drug products also belongs to this circle, the most important information from this field is summarised in chapter eight. After the mainly methodology-oriented chapters, the final one concentrates on four groups of drugs (peptides, biotechnological products, antibiotics and steroids) in order to demonstrate the use of the methods described earlier.

Structure Elucidation in Organic Chemistry

The Search for the Right Tools

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Author: Maria-Magdalena Cid,Jorge Bravo

Publisher: John Wiley & Sons

ISBN: 3527664637

Category: Science

Page: 552

View: 7151

Intended for advanced readers, this is a review of all relevant techniques for structure analysis in one handy volume. As such, it provides the latest knowledge on spectroscopic and related techniques for chemical structure analysis, such as NMR, optical spectroscopy, mass spectrometry and X-ray crystallography, including the scope and limitation of each method. As a result, readers not only become acquainted with the techniques, but also the advantages of the synergy between them. This enables them to choose the correct analytical method for each problem, saving both time and resources. Special emphasis is placed on NMR and its application to absolute configuration determination and the analysis of molecular interactions. Adopting a practical point of view, the author team from academia and industry guarantees both solid methodology and applications essential for structure determination, equipping experts as well as newcomers with the tools to solve any structural problem.

Pharmaceutical Organic Chemistry -E-Book

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Author: S.K. Bhasin,Reena Gupta

Publisher: Elsevier Health Sciences

ISBN: 8131232670

Category: Medical

Page: 812

View: 8498

Pharmaceutical Organic Chemistry has been written keeping in mind the severe need for a comprehensive text to meet the curriculum needs of the undergraduate pharmacy students. It not only provides all the curriculum topics to the students but also contains all the vital reactions/mechanisms that the students look for in an organic chemistry book. Entire subject matter has been written in a systematic and lucid style in simple language. All the basic concepts and fundamentals of organic chemistry have been explained with well-chosen examples. For better understanding of the subject matter, important points have been highlighted in the form of the textboxes titled as Remember, Learning Plus and Noteworthy Points, wherever required. Summary of the topics in the form of Memory Focus has been given at relevant places to help the students to revise the subject matter quickly. Stepwise mechanism of the reactions as per the syllabus has been illustrated, laying emphasis on the reactive intermediates involved. At the end of each chapter, Revision Questions including descriptive questions and short answer questions have been given for the students to practice. Multiple Choice Questions with answers have been included at the end of each chapter.

Organische Chemie

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Author: Kurt Peter C. Vollhardt,Neil Eric Schore

Publisher: John Wiley & Sons

ISBN: 3527327541

Category: Chemistry, Organic

Page: 1452

View: 3560

Besser Konzepte und Ideen der organischen Chemie verstehen, als eine Vielzahl von Fakten auswendig beherrschen! Diesem Motto bleibt der "Vollhardt/Schore" auch in der neuesten Auflage treu. Das neu gestaltete Layout, beispielhaft gelöste Übungsaufgaben und die deutlich erweiterten Verständnisübungen führen einprägsam an die Methodik zur Lösung organisch-chemischer Probleme heran. So werden nicht nur die stofflichen Grundlagen der organischen Chemie, sondern auch das "Gewusst wie" fast schon spielerisch vermittelt. Nicht nur für Chemiestudenten, auch für Biochemiker, Pharmazeuten, Biologen und Mediziner ist der "Vollhardt/Schore" der fachliche Grundstock für die organische Chemie.

Chemical and Structural Approaches to Rational Drug Design

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Author: David B. Weiner,William V. Williams

Publisher: CRC Press

ISBN: 9780849378188

Category: Medical

Page: 288

View: 5071

This book is the first to provide both a broad overview of the current methodologies being applied to drug design and in-depth analyses of progress in specific fields. It details state-of-the-art approaches to pharmaceutical development currently used by some of the world's foremost laboratories. The book features contributors from a variety of fields, new techniques, previously unpublished data, and extensive reference lists.

The Organic Chemistry of Sugars

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Author: Daniel E. Levy,Péter Fügedi

Publisher: CRC Press

ISBN: 9781420027952

Category: Science

Page: 904

View: 3421

Intrigued as much by its complex nature as by its outsider status in traditional organic chemistry, the editors of The Organic Chemistry of Sugars compile a groundbreaking resource in carbohydrate chemistry that illustrates the ease at which sugars can be manipulated in a variety of organic reactions. Each chapter contains numerous examples demonstrating the methods and strategies that apply mainstream organic chemistry to the chemical modification of sugars. The book first describes the discovery, development, and impact of carbohydrates, followed by a discussion of protecting group strategies, glycosylation techniques, and oligosaccharide syntheses. Several chapters focus on reactions that convert sugars and carbohydrates to non-carbohydrate molecules including the substitution of sugar hydroxyl groups to new groups of synthetic or biological interest, cyclitols and carbasugars, as well as endocyclic heteroatom substitutions. Subsequent chapters demonstrate the use of sugars in chiral catalysis, their roles as convenient starting materials for complex syntheses involving multiple stereogenic centers, and syntheses for monosaccharides. The final chapters focus on new and emerging technologies, including approaches to combinatorial carbohydrate chemistry, the biological importance and chemical synthesis of glycopeptides, and the medicinally significant concept of glycomimetics. Presenting the organic chemistry of sugars as a solution to many complex synthetic challenges, The Organic Chemistry of Sugars provides a comprehensive treatment of the manipulation of sugars and their importance in mainstream organic chemistry. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.

Advanced organic chemistry

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Author: Francis A. Carey,Richard J. Sundberg

Publisher: John Wiley & Sons

ISBN: 9783527292172

Category: Science

Page: 1635

View: 7705

Endlich gibt es ein weiterführendes Lehrbuch der Organischen Chemie in deutscher Sprache! Es wird die Studenten auf den Gebieten Reaktionsmechanismen, Stereochemie und insbesondere Organische Synthese bis zum Diplom begleiten, und darüber hinaus ist es ein äußerst nützliches Nachschlagewerk auch für Diplomanden und Doktoranden. Die deutsche Ausgabe wurde gegenüber dem Original nochmals erweitert und aktualisiert. Erste Dozentenstimmen: 'Die erste deutsche Ausgabe des Carey/Sundberg erfüllt alle Erwartungen an ein modernes Lehrbuch der Organischen Chemie.' - 'Es ist zur Zeit das beste Lehrbuch der Organischen Chemie und unentbehrlich für fortgeschrittene Studenten, Diplomanden und Doktoranden.' - 'Endlich! Ich empfehle dieses Buch bereits seit Jahren fortgeschrittenen Studenten.' - 'Es ist bezeichnend, daß es immer besonders motivierte und leistungsstarke Studenten waren, die mich fragten, ob ich ihnen den Carey/Sundberg empfehlen kann. Ich kann es.' - 'Endlich wird es ein ausgewogenes Lehrbuch zur Organischen Chemie für Fortgeschrittene in deutscher Sprache geben. Die Kompetenz der Herausgeber bürgt für hohen Standard.'

Lead Optimization for Medicinal Chemists

Pharmacokinetic Properties of Functional Groups and Organic Compounds

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Author: Florencio Zaragoza Dörwald

Publisher: John Wiley & Sons

ISBN: 3527645659

Category: Science

Page: 622

View: 2390

Small structural modifications can significantly affect the pharmacokinetic properties of drug candidates. This book, written by a medicinal chemist for medicinal chemists, is a comprehensive guide to the pharmacokinetic impact of functional groups, the pharmacokinetic optimization of drug leads, and an exhaustive collection of pharmacokinetic data, arranged according to the structure of the drug, not its target or indication. The historical origins of most drug classes and general aspects of modern drug discovery and development are also discussed. The index contains all the drug names and synonyms to facilitate the location of any drug or functional group in the book. This compact working guide provides a wealth of information on the ways small structural modifications affect the pharmacokinetic properties of organic compounds, and offers plentiful, fact-based inspiration for the development of new drugs. This book is mainly aimed at medicinal chemists, but may also be of interest to graduate students in chemical or pharmaceutical sciences, preparing themselves for a job in the pharmaceutical industry, and to healthcare professionals in need of pharmacokinetic data.

Analysis of Drug Impurities

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Author: Richard J. Smith,Michael L. Webb

Publisher: John Wiley & Sons

ISBN: 0470994223

Category: Science

Page: 288

View: 9827

A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods. Written for both practicing and student analytical chemists, Analysis of Drug Impurities provides a detailed overview of the challenges and the techniques available to permit accurate identification and quantification of drug impurities.

Essentials of Organic Chemistry

For Students of Pharmacy, Medicinal Chemistry and Biological Chemistry

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Author: Paul M. Dewick

Publisher: John Wiley & Sons

ISBN: 1118681967

Category: Science

Page: 704

View: 9950

Essentials of Organic Chemistry is an accessible introduction tothe subject for students of Pharmacy, Medicinal Chemistry andBiological Chemistry. Designed to provide a thorough grounding infundamental chemical principles, the book focuses on key elementsof organic chemistry and carefully chosen material is illustratedwith the extensive use of pharmaceutical and biochemicalexamples. In order to establish links and similarities the book placesprominence on principles and deductive reasoning withcross-referencing. This informal text also places the main emphasison understanding and predicting reactivity rather than syntheticmethodology as well as utilising a mechanism based layout andfeaturing annotated schemes to reduce the need for textualexplanations. * tailored specifically to the needs of students of PharmacyMedical Chemistry and Biological Chemistry * numerous pharmaceutical and biochemical examples * mechanism based layout * focus on principles and deductive reasoning This will be an invaluable reference for students of PharmacyMedicinal and Biological Chemistry.

Pharmaceutical Chemistry E-Book

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Author: David G. Watson

Publisher: Elsevier Health Sciences

ISBN: 070204850X

Category: Medical

Page: 652

View: 2130

This new book, from the editor of the highly successful Pharmaceutical Analysis, sets out to define the area of pharmaceutical chemistry as distinct from medicinal chemistry. It focuses less on prototypes of drugs that perhaps never came to market and more on the drugs currently in use. The emphasis in the book is on the physicochemical properties of drug molecules and, in so far as they are known, the way that these properties govern the interaction of the drug with its target. Important physicochemical properties include pKa and partition coefficient and the properties of the structural elements within the drug which provide interactions with the target via a range of intermolecular forces. The last fifteen years has seen a great advance in the knowledge of protein structures and a strong emphasis is given to the interaction of drugs with proteins which shape the majority of drug mechanisms. Features: Focus on intramolecular actions Mechanisms of action richly illustrated Self-assessment included Comprehensive chapters on vitamins and biotechnological products This new book, from the editor of the highly successful Pharmaceutical Analysis, sets out to define the area of pharmaceutical chemistry as distinct from medicinal chemistry. It focuses less on prototypes of drugs that perhaps never came to market and more on the drugs currently in use. The emphasis in the book is on the physicochemical properties of drug molecules and, in so far as they are known, the way that these properties govern the interaction of the drug with its target. Important physicochemical properties include pKa and partition coefficient and the properties of the structural elements within the drug which provide interactions with the target via a range of intermolecular forces. The last fifteen years has seen a great advance in the knowledge of protein structures and a strong emphasis is given to the interaction of drugs with proteins which shape the majority of drug mechanisms. Features: Focus on intramolecular actions Mechanisms of action richly illustrated Self-assessment included Comprehensive chapters on vitamins and biotechnological products