Green Chemistry and Quality by Design in Process Analytical Technologies and Drug Design
Green Chemistry and Quality by Design in Process Analytical Technologies and Drug Design

Author: Suryakanta Swain

Publisher: Cambridge Scholars Publishing

Published: 2024-04-10

Total Pages: 162

ISBN-13: 1036402576

DOWNLOAD EBOOK

Quality by design (QbD) is becoming an integral element of the modern pharmaceutical and chemical development approach. In this book, the future ramifications of emergent modern applications of QbD and green analytical chemistry in drug design, process analytical technologies, and bioanalytical process development instruments are discussed. It will reveal and improve the QbD principles used in bioanalysis, process development, downstream processing, and the combination of QbD and green analytical chemistry employing eco-friendly and green solvents for product development. In addition, it will provide complete information regarding applying the QbD concept and ideology to quality control and process development. The book will be beneficial to PhD research scholars, researchers, and postgraduate and undergraduate students of pharmacy and chemical sciences for understanding the concept of quality by design and green chemistry for drug design, as it illustrates the necessary inputs that are related to product quality and, ultimately, process sustainability.

Handbook of Analytical Quality by Design
Handbook of Analytical Quality by Design

Author: Sarwar Beg

Publisher: Academic Press

Published: 2021-01-09

Total Pages: 225

ISBN-13: 0128203331

DOWNLOAD EBOOK

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

Pharmaceutical Quality by Design
Pharmaceutical Quality by Design

Author: Sarwar Beg

Publisher: Academic Press

Published: 2019-03-27

Total Pages: 450

ISBN-13: 0128163720

DOWNLOAD EBOOK

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Green Analytical Chemistry
Green Analytical Chemistry

Author: Justyna Płotka-Wasylka

Publisher: Springer

Published: 2019-08-02

Total Pages: 460

ISBN-13: 981139105X

DOWNLOAD EBOOK

The book explains the principles and fundamentals of Green Analytical Chemistry (GAC) and highlights the current developments and future potential of the analytical green chemistry-oriented applications of various solutions. The book consists of sixteen chapters, including the history and milestones of GAC; issues related to teaching of green analytical chemistry and greening the university laboratories; evaluation of impact of analytical activities on the environmental and human health, direct techniques of detection, identification and determination of trace constituents; new achievements in the field of extraction of trace analytes from samples characterized by complex composition of the matrix; “green” nature of the derivatization process in analytical chemistry; passive techniques of sampling of analytes; green sorption materials used in analytical procedures; new types of solvents in the field of analytical chemistry. In addition green chromatography and related techniques, fast tests for assessment of the wide spectrum of pollutants in the different types of the medium, remote monitoring of environmental pollutants, qualitative and comparative evaluation, quantitative assessment, and future trends and perspectives are discussed. This book appeals to a wide readership of the academic and industrial researchers. In addition, it can be used in the classroom for undergraduate and graduate Ph.D. students focusing on elaboration of new analytical procedures for organic and inorganic compounds determination in different kinds of samples characterized by complex matrices composition.Jacek Namieśnik was a Professor at the Department of Analytical Chemistry, Gdańsk University of Technology, Poland. Justyna Płotka-Wasylka is a teacher and researcher at the same department.

Process Analytical Technology
Process Analytical Technology

Author: Katherine A. Bakeev

Publisher: John Wiley & Sons

Published: 2010-04-01

Total Pages: 576

ISBN-13: 0470689609

DOWNLOAD EBOOK

Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: Implementation of Process Analytical Technologies UV-Visible Spectroscopy for On-line Analysis Infrared Spectroscopy for Process Analytical Applications Process Raman Spectroscopy Process NMR Spectrscopy: Technology and On-line Applications Fluorescent Sensing and Process Analytical Applications Chemometrics in Process Analytical Technology (PAT) On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing NIR Chemical Imaging This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition “The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology.”—Current Engineering Practice

Pharmaceutical Quality by Design
Pharmaceutical Quality by Design

Author: Walkiria S. Schlindwein

Publisher: John Wiley & Sons

Published: 2018-03-19

Total Pages: 384

ISBN-13: 1118895207

DOWNLOAD EBOOK

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Pharmaceutical Process Development
Pharmaceutical Process Development

Author: John Blacker

Publisher: Royal Society of Chemistry

Published: 2011-08-17

Total Pages: 375

ISBN-13: 1849733074

DOWNLOAD EBOOK

Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.

Green Techniques for Organic Synthesis and Medicinal Chemistry
Green Techniques for Organic Synthesis and Medicinal Chemistry

Author: Wei Zhang

Publisher: John Wiley & Sons

Published: 2012-07-23

Total Pages: 769

ISBN-13: 0470711515

DOWNLOAD EBOOK

Green chemistry is a new way of looking at organic synthesis and the design of drug molecules, offering important environmental and economic advantages over traditional synthetic processes. Pharmaceutical companies are increasingly turning to the principles of green chemistry in an effort to reduce waste, reduce costs and develop environmentally benign processes. Green Techniques for Organic Synthesis and Medicinal Chemistry presents an overview of the established and emerging techniques in green organic chemistry, highlighting their applications in medicinal chemistry. The book is divided into four parts: Introduction: Introduces the reader to the toxicology of organic chemicals,their environmental impact, and the concept of green chemistry. Green Catalysis: Covers a variety of green catalytic techniques including organocatalysis, supported catalysis, biocatalysis, fluorous catalysis, and catalytic direct C-H bond activation reactions. Green Synthetic Techniques: Presents a series of new techniques, assessing the green chemistry aspects and limitations (i.e. cost, equipment, expertise). Techniques include reactions in alternative solvents, atom economic multicomponent reactions, microwave and ultrasonic reactions, solid-supported synthesis, fluorous and ionic liquid-based recycling techniques, and flow reactors. Green Techniques in Pharmaceutical Industry: Covers applications of green chemistry concepts and special techniques for medicinal chemistry, including synthesis, analysis, separation, formulation, , and drug delivery. Process and business case studies are included to illustrate the applications in the pharmaceutical industry. Green Techniques for Organic Synthesis and Medicinal Chemistry is an essential resource on green chemistry technologies for academic researchers, R&D professionals and students working in organic chemistry and medicinal chemistry.

Flow Chemistry in Drug Discovery
Flow Chemistry in Drug Discovery

Author: Jesus Alcazar

Publisher: Springer Nature

Published: 2021-12-08

Total Pages: 501

ISBN-13: 3030855929

DOWNLOAD EBOOK

This book reviews the challenges and opportunities posed by flow chemistry in drug discovery, and offers a handy reference tool for medicinal chemists interested in the synthesis of biologically active compounds. Prepared by expert contributors, the respective chapters cover not only fundamental methodologies and reactions, such as the application of catalysis, especially biocatalysis and organocatalysis; and non-conventional activation techniques, from photochemistry to electrochemistry; but also the development of new process windows, processes and reactions in drug synthesis. Particular attention is given to automatization and library synthesis, which are of great importance in the pharmaceutical industry. Readers will also find coverage on selected topics of general interest, such as how flow chemistry is contributing to drug discovery R&D in developing countries, and the green character of this enabling technology, for example in the production of raw materials for the pharmaceutical industry from waste. Given its scope, the book appeals to medicinal chemistry researchers working in academia and industry alike, as well as professionals involved in scale-up and drug development.

Continuous Pharmaceutical Processing and Process Analytical Technology
Continuous Pharmaceutical Processing and Process Analytical Technology

Author: Ajit S. Narang

Publisher: CRC Press

Published: 2023-03-01

Total Pages: 495

ISBN-13: 100080447X

DOWNLOAD EBOOK

Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability. Features: Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies