An Introduction to Pharmaceutical Sciences

Author: Jiben Roy
Publisher: Elsevier
ISBN: 1908818042
Format: PDF, ePub, Mobi
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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

Fed Batch Fermentation

Author: G G Moulton
Publisher: Elsevier
ISBN: 1908818336
Format: PDF, ePub, Mobi
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Fed-batch Fermentation is primarily a practical guide for recombinant protein production in E. coli using a Fed-batch Fermentation process. Ideal users of this guide are teaching labs and R&D labs that need a quick and reproducible process for recombinant protein production. It may also be used as a template for the production of recombinant protein product for use in clinical trials. The guide highlights a method whereby a medium cell density - final Ods = 30-40 (A600) - Fed-batch Fermentation process can be accomplished within a single day with minimal supervision. This process can also be done on a small (2L) scale that is scalable to 30L or more. All reagents (media, carbon source, plasmid vector and host cell) used are widely available and are relatively inexpensive. This method has been used to produce three different protein products following cGMP guidelines for Phase I clinical studies. This process can be used as a teaching tool for the inexperienced fermentation student or researcher in the fields of bioprocessing and bioreactors. It is an important segue from E. coli shake flask cultures to bioreactor The fed-batch fermentation is designed to be accomplished in a single day with the preparation work being done on the day prior The fed-batch fermentation described in this book is a robust process and can be easily scaled for CMO production of protein product

Handbook of Cosmeceutical Excipients and their Safeties

Author: K Y Heng
Publisher: Elsevier
ISBN: 1908818719
Format: PDF, ePub, Docs
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Cosmeceuticals are the latest additions to the health industry and have an ever-expanding market. They are considered to be a marriage between cosmetics and drugs and are defined as preparations applied on the body that may modify the physiological functions of the skin. However, as more cosmeceuticals are being launched in the market and more types of drugs are incorporated into the formulation, the composition of cosmeceuticals is becoming more complex. Handbook of Cosmeceutical Excipients and their Safeties summarises the current evidence relating to cosmeceuticals’ side effects and highlights the important information that practitioners and consumers need to know, as well as ways to avoid the adverse effects of the excipients. Handbook of Cosmeceutical Excipients and their Safeties includes chapters covering topics such as the history of cosmeceuticals and the laws that regulate them, skin permeation, carcinogenicity as a systemic adverse effect and dermatitis as a topical adverse effect. It concludes with an appendix that gives brief information on the potency and permeability of common ingredients in cosmeceuticals. The appendix aims to highlight the maximum allowable quantity of each ingredient to ensure product safety for consumers. The appendix was prepared by compiling the ingredients of 257 products containing more than 500 compounds, collected from a hospital pharmacy in Singapore. Focuses on the practical aspect of adverse effects from cosmeceuticals Explains the regulatory framework of cosmeceuticals Gives an idea of how excipients and drugs in cosmeceuticals enter the skin and methods of control

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Author: Tim Sandle
Publisher: Elsevier
ISBN: 1908818638
Format: PDF, ePub
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Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 9780470259801
Format: PDF, Kindle
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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Porous Silicon for Biomedical Applications

Author: Hélder A. Santos
Publisher: Elsevier
ISBN: 0857097156
Format: PDF, Kindle
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Porous silicon has a range of properties, making it ideal for drug delivery, cancer therapy, and tissue engineering. Porous Silicon for Biomedical Applications provides a comprehensive review of this emerging nanostructured and biodegradable biomaterial. Chapters in part one focus on the fundamentals and properties of porous silicon for biomedical applications, including thermal properties and stabilization, photochemical and nonthermal chemical modification, protein-modified porous silicon films, and biocompatibility of porous silicon. Part two discusses applications in bioimaging and sensing, and explores the optical properties of porous silicon materials; in vivo imaging assessment and radiolabelling of porous silicon; and nanoporous silicon biosensors for DNA sensing and for bacteria detection. Finally, part three highlights drug loading and characterization of porous silicon materials, tumor targeting and imaging, and porous silicon scaffolds for functional tissue engineering, stem cell growth, and osteodifferentiation. With its acclaimed editor and international team of expert contributors, Porous Silicon for Biomedical Applications is a technical resource and indispensable guide for all those involved in the research, development, and application of porous silicon and other biomaterials, while providing a comprehensive introduction for students and academics interested in the field. Comprehensive review of porous silicon focusing on the fabrication and properties of this emerging material Specifically discusses drug delivery and orthopedic applications of porous silicon Aimed at materials researchers and scientists in the biomaterials industry – particularly those concerned with drug delivery and orthopedics

Bioresorbable Polymers for Biomedical Applications

Author: Giuseppe Perale
Publisher: Woodhead Publishing
ISBN: 0081002661
Format: PDF, ePub, Mobi
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Bioresorbable Polymers for Biomedical Applications: From Fundamentals to Translational Medicine provides readers with an overview of bioresorbable polymeric materials in the biomedical field. A useful resource for materials scientists in industry and academia, offering information on the fundamentals and considerations, synthesis and processing, and the clinical and R and D applications of bioresorbable polymers for biomedical applications. Focuses on biomedical applications of bioresorbable polymers Features a comprehensive range of topics including fundamentals, synthesis, processing, and applications Provides balanced coverage of the field with contributions from academia and industry Includes clinical and R and D applications of bioresorbable polymers for biomedical applications

Standardisation in Cell and Tissue Engineering

Author: V Salih
Publisher: Elsevier
ISBN: 0857098721
Format: PDF, Kindle
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The increased use of biodegradable synthetic or natural scaffolds combined with cells and/or biological molecules, in order to create functional replacement tissue in a damaged tissue site, has led to the need for the development of ‘best practice’ methods in the area of tissue engineering to help ensure the creation of safe, high quality products. Standardisation in cell and tissue engineering introduces concepts and current practice in the field of cell and tissue engineering to a wide audience and aims to provide awareness of the importance of standardisation in this area while suggesting directions for further investigation. Part one provides an overview of methods for cell and tissue engineering and includes chapters on the fundamentals of cell and matrix biology for tissue engineering, 3D collagen biomatrix development, and control and vascularisation of tissue-engineered constructs. Part two begins with a chapter exploring the methods and protocols of standardisation in cell and tissue engineering before moving on to highlight issues of quality control in cell and tissue engineering, standardised chemical analysis and testing of biomaterials and principles of good laboratory practice (GLP) for in vitro cell culture applications. Standardisation in cell and tissue engineering is a standard reference for leading research groups, government agencies, regulatory bodies, and researchers and technicians at all levels across the whole range of disciplines using cell culture within the pharmaceutical, biotechnology and biomedical industries. Introduces concepts and current practice in the field of cell and tissue engineering Highlights the importance of standardisation in cell and tissue engineering and suggests directions for further investigation Explores methods and protocols of standardisation in cell and tissue engineering and issues of quality control in cell and tissue engineering

Open Source Software in Life Science Research

Author: Lee Harland
Publisher: Elsevier
ISBN: 1908818247
Format: PDF, ePub, Docs
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The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. The book is divided into four parts. Part one looks at laboratory data management and chemical informatics, covering software such as Bioclipse, OpenTox, ImageJ and KNIME. In part two, the focus turns to genomics and bioinformatics tools, with chapters examining GenomicsTools and EBI Atlas software, as well as the practicalities of setting up an ‘omics’ platform and managing large volumes of data. Chapters in part three examine information and knowledge management, covering a range of topics including software for web-based collaboration, open source search and visualisation technologies for scientific business applications, and specific software such as DesignTracker and Utopia Documents. Part four looks at semantic technologies such as Semantic MediaWiki, TripleMap and Chem2Bio2RDF, before part five examines clinical analytics, and validation and regulatory compliance of free/open source software. Finally, the book concludes by looking at future perspectives and the economics and free/open source software in industry. Discusses a broad range of applications from a variety of sectors Provides a unique perspective on work normally performed behind closed doors Highlights the criteria used to compare and assess different approaches to solving problems

Silk

Author: K. Murugesh Babu
Publisher: Elsevier
ISBN: 1782421580
Format: PDF, Kindle
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Silk is a natural, environmentally-friendly fibre with a remarkable range of properties, making it ideal for use in apparel and many other applications. Silk: Processing, properties and applications provides an authoritative reference on sericulture, silk fabric processing, silk properties and its applications. The book begins by looking at key aspects of sericulture, including the range of mulberry and non-mulberry species of silk worm, early and late stage rearing and harvesting of cocoons. Further chapters discuss reeling, weaving and spinning techniques as well as dyeing. The book also discusses the physical and chemical structure of silk as well as its mechanical and thermal properties. Concluding chapters discuss developments in applications and the properties of spider silk. Silk: Processing, properties and applications is useful for textile technologists, fibre scientists and all those with an interest in the characteristics of silk, its production and the varied uses of this important fibre. Provides an in-depth summary of silk production, properties and structure-property relationships Examines the future of silk, including its application in the textile, biomedical, pharmaceutical and cosmetic industries Provides an authoritative reference on sericulture, silk fabric processing, silk properties and its applications