Active Pharmaceutical Ingredients
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Active Pharmaceutical Ingredients
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Author : Stanley Nusim
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
Active Pharmaceutical Ingredients In Synthesis
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Author : Anthony J. Burke
language : en
Publisher: John Wiley & Sons
Release Date : 2018-11-28
Active Pharmaceutical Ingredients In Synthesis written by Anthony J. Burke and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-28 with Science categories.
Presents the most effective catalytic reactions in use today, with a special focus on process intensification, sustainability, waste reduction, and innovative methods This book demonstrates the importance of efficient catalytic transformations for producing pharmaceutically active molecules. It presents the key catalytic reactions and the most efficient catalytic processes, including their significant advantages over compared previous methods. It also places a strong emphasis on asymmetric catalytic reactions, process intensification (PI), sustainability and waste mitigation, continuous manufacturing processes as enshrined by continuous flow catalysis, and supported catalysis. Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development offers chapters covering: Catalysis and Prerequisites for the Modern Pharmaceutial Industry Landscape; Catalytic Process Design - The Industrial Perspective; Hydrogenation, Hydroformylation and Other Reductions; Oxidation; ; Catalytic Addition Reactions; Catalytic Cross-Coupling Reactions; Catalytic Metathesis Reactions; Catalytic Cycloaddition Reactions: Coming Full-Circle; Catalytic Cyclopropanation Reactions; Catalytic C-H insertion Reactions; Phase Transfer Catalysis; and Biocatalysis. -Provides the reader with an updated clear view of the current state of the challenging field of catalysis for API production -Focuses on the application of catalytic methods for the synthesis of known APIs -Presents every key reaction, including Diels-Alder, CH Insertions, Metal-catalytic coupling-reactions, and many more -Includes recent patent literature for completeness Covering a topic of great interest for synthetic chemists and R&D researchers in the pharmaceutical industry, Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development is a must-read for every synthetic chemist working with APIs.
Active Pharmaceutical Ingredients
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Author : Stanley Nusim
language : en
Publisher:
Release Date : 2010
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Drug development categories.
Handbook On Active Pharmaceutical Ingredients Api Drugs Pharmaceutical Products
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Author : Ashish Dey
language : en
Publisher: NIIR PROJECT CONSULTANCY SERVICES
Release Date : 2023-01-05
Handbook On Active Pharmaceutical Ingredients Api Drugs Pharmaceutical Products written by Ashish Dey and has been published by NIIR PROJECT CONSULTANCY SERVICES this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-05 with Antiques & Collectibles categories.
An active pharmaceutical ingredient (API) is the active substance in a pharmaceutical drug that produces its therapeutic effect. APIs can be synthetic chemicals or natural sources such as plant extracts. APIs are components of drugs, the majority of which are manufactured by pharmaceutical companies. Drugs, on the other hand, are dosage forms that contain an API and are distributed to patients for use. Pharmaceutical products are any compounds used in the medical industry to diagnose, treat, cure, or prevent diseases. These products are typically formulated as drugs, vaccines, biologics, and medical devices, which can either be prescribed by a doctor or bought over-the-counter (OTC). They come in various forms such as tablets, capsules, syrups, ointments, creams, solutions, suspensions, implants, patches, and powders. Pharmaceutical products are manufactured under strict guidelines and must adhere to various regulations such as Good Manufacturing Practices (GMP). The global market for Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products is expected to grow rapidly over the next few years. This growth will be driven by rising demand for improved healthcare services and an increasing number of new treatments. The market for active pharmaceutical ingredients is anticipated to rise at a CAGR of 5.90%. The development in the production of active pharmaceutical ingredients (APIs) as well as the increased incidence of chronic diseases including cancer and cardiovascular conditions are both responsible for the expansion. Government regulations that are supportive of API manufacturing, together with shifting geopolitical conditions, are accelerating market expansion. The pharmaceutical products market has grown steadily in recent years, and is expected to continue to do so. This growth is driven by a number of factors, including increased demand for new drugs, changing disease patterns and aging populations in some countries, as well as the emergence of innovative drugs and technologies. The market is being shaped by the rise of emerging economies and their increasing healthcare needs. This has led to increased investment in drug research and development, as well as an increase in the number of multinational companies setting up operations in various countries. Furthermore, generic drugs are becoming increasingly popular as a way of reducing healthcare costs. Generic drugs are copies of brand-name drugs, which are manufactured by generic drug companies. They offer an effective alternative to branded drugs and are often much cheaper. As a result, generic drugs are increasingly being used in countries across the world, leading to an increase in the global pharmaceutical products market. Overall, the global market for pharmaceutical products and drugs are set to continue to grow in the coming years. New products, innovative technologies and emerging markets will drive growth, and this will bring both opportunities and challenges for the industry. The books' main subjects include Active Pharmaceutical Ingredients (API), Drugs, Aspirin, Paracetamol, IV Fluids, Ointment, Metronidazole, Liquid Glucose, Surgical Cotton, Syrup, Tablet, Excipients, Pharmaceutical Salts with formulations, factory layout, and images of machinery with contact information for suppliers. A thorough guide to manufacturing and business operations in the Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products industry. The Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products manufacturing industry is full with opportunity for producers, traders, and business owners, and this book is your one-stop resource for all the information you require. The only complete manual on the creation of commercial Active Pharmaceutical Ingredients (API), medications, and pharmaceutical products is this one. It offers a wealth of information on how to do things, from concept through equipment acquisition.
Active Pharmaceutical Ingredients
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Author : Stanley Nusim
language : en
Publisher: CRC Press
Release Date : 2005-05-25
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-05-25 with Medical categories.
Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.
Active Pharmaceutical Ingredient Manufacturing
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Author : Girish K. Malhotra
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2022-04-19
Active Pharmaceutical Ingredient Manufacturing written by Girish K. Malhotra and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-19 with Technology & Engineering categories.
The book reviews the history of current brand and generic business in pharmaceuticals manufacturing practices. Based on examples, the reader can interpolate, extrapolate and exploit mutual behavior (physical and chemical properties) of chemicals to design and commercialize processes that fulfi ll the demands, also manipulate chemical unit processes and unit operations to reduce/minimize effl uents and lower environmental impact i.e. reduce global warming. Readers will be able to simplify process development, design and commercialize economic manufacturing processes.
Chemical Engineering In The Pharmaceutical Industry Active Pharmaceutical Ingredients
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Author : David J. am Ende
language : en
Publisher: John Wiley & Sons
Release Date : 2019-03-28
Chemical Engineering In The Pharmaceutical Industry Active Pharmaceutical Ingredients written by David J. am Ende and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-28 with Technology & Engineering categories.
A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: • Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety • Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying • Presents updated and expanded example calculations • Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industry focuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.
Pharmaceutical Biocatalysis
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Author : Peter Grunwald
language : en
Publisher: CRC Press
Release Date : 2019-11-07
Pharmaceutical Biocatalysis written by Peter Grunwald and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-07 with Business & Economics categories.
This volume provides an insight into the future strategies for commercial biocatalysis with a focus on sustainable technologies, together with chemoenzymatic and biotechnological approaches to synthesize various types of approved and new active pharmaceutical ingredients (APIs) via proven and latest synthetic routes using single-step biocatalytic or enzyme cascade reactions. Many of these drugs act as enzyme inhibitors, as discussed in a chapter with a variety of examples. The targeted enzymes are involved in diseases such as different cancers, metastatic and infectious diseases, osteoporosis, and cardiovascular disorders. The biocatalysts employed for API synthesis include hydrolytic enzymes, alcohol dehydrogenases, laccases, imine reductases, reductive aminases, peroxygenases, cytochrome P450 enzymes, polyketide synthases, transaminases, and halogenases. Many of them have been improved with respect to their properties by engineering methods. The book discusses the syntheses of drugs, including alkaloids and antibiotics, non-ribosomal peptides, antimalarial and antidiabetic drugs, prenylated xanthones, antioxidants, and many important (chiral) intermediates required for the synthesis of pharmaceuticals.
Guidelines For The Manufacture Of Active Pharmaceutical Ingredients
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Author :
language : en
Publisher:
Release Date : 1987
Guidelines For The Manufacture Of Active Pharmaceutical Ingredients written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1987 with categories.
Survey Of Active Pharmaceutical Ingredients Excipient Incompatibility
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Author : Tamilvanan Shunmugaperumal
language : en
Publisher: LAP Lambert Academic Publishing
Release Date : 2010-10
Survey Of Active Pharmaceutical Ingredients Excipient Incompatibility written by Tamilvanan Shunmugaperumal and has been published by LAP Lambert Academic Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10 with categories.
To improve physico-chemical properties of an active pharmaceutical ingredient (API) at its preformulation stage, myriad of excipients having defined functional roles like solubility enhancement by co-solvent, micells formation and complexation, intestinal permeability enhancement through the inhibition of efflux transport mechanisms, stability-improvement using pH adjustment, cryo-and lyo-protectants, etc are incorporated into a dosage form containing the API. Although considered primarily as inactive materials, the excipient(s) may react with the API resulting in the development of a detrimental or beneficial substance within the API-loaded dosage form itself. If detrimental substances are formed, then, the issue of API-excipient incompatibility will come up and demand the reformulation of the API, which is costly and time-consuming. This book surveys a comprehensive list of published examples of API-excipient incompatibility relevant to currently or previously marketed drugs. With this coverage, this book also provides first-hand information on the multicomponent nature and complexity of the excipients to the formulation scientist.