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Author : Louis Rey,Joan Christine May
Publisher : Unknown
Page : 613 pages
File Size : 50,9 Mb
Release : 2004
Category : Biological products
ISBN : 0824748689
Author : Louis Rey
Publisher : CRC Press
Page : 580 pages
File Size : 41,8 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781439825761
Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulatio
Author : Louis Rey,Joan C. May
Publisher : CRC Press
Page : 634 pages
File Size : 44,9 Mb
Release : 2004-01-21
Category : Medical
ISBN : 9780203021323
Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.
Author : Henry R. Costantino,Michael J. Pikal
Publisher : Springer Science & Business Media
Page : 726 pages
File Size : 47,5 Mb
Release : 2005-12-05
Category : Medical
ISBN : 0971176760
Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.
Author : Peter Haseley,Georg-Wilhelm Oetjen
Publisher : John Wiley & Sons
Page : 434 pages
File Size : 54,7 Mb
Release : 2018-05-07
Category : Science
ISBN : 9783527343065
This completely updated and enlarged third edition of the classic text adopts a practical approach to describe the fundamentals of freeze-drying, backed by many explanatory examples. Following an introduction to the fundamentals, the book goes on to discuss process and plant automation as well as methods to transfer pilot plant qualifications and process data to production. An entire section is devoted to a large range of different pharmaceutical, biological, and medical products. New to this edition are chapters on antibodies, freeze-dry microscopy, TEMPRIS, microwave freeze-drying, spray freeze-drying, and PAT. Their many years of experience in freeze-drying enable the authors to supply valuable criteria for the selection of laboratory, pilot and production plants, discussing the advantages, drawbacks and limitations of different plant designs. Alongside guidelines for the evaluation and qualification of plants and processes, the author also includes a troubleshooting section.
Author : Davide Fissore,Roberto Pisano,Antonello Barresi
Publisher : CRC Press
Page : 201 pages
File Size : 46,6 Mb
Release : 2019-10-24
Category : Medical
ISBN : 9780429664014
Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.
Author : Tse-Chao Hua,Bao-Lin Liu,Haimei Zhang
Publisher : Elsevier
Page : 280 pages
File Size : 45,7 Mb
Release : 2010-07-30
Category : Technology & Engineering
ISBN : 9781845697471
Freeze-drying is an important preservation technique for heat-sensitive pharmaceuticals and foods. Products are first frozen, then dried in a vacuum at low temperature by sublimation and desorption, rather than by the application of heat. The resulting items can be stored at room temperature for long periods. This informative text addresses both principles and practice in this area. The first chapter introduces freeze-drying. The authors then review the fundamentals of the technique, heat-mass transfer analyses, modelling of the drying process and the equipment employed. Further chapters focus on freeze-drying of food, freeze-drying of pharmaceuticals and the protective agents and additives applied. The final chapter covers the important subjects of disinfection, sterilization and process validation. Freeze-drying of pharmaceutical and food products is an essential reference for food, pharmaceutical and refrigeration engineers and scientists with an interest in preservation techniques. It will also be of use to students in these fields. Addresses the principles and practices used in this important preservation technique Explains the fundamentals of heat-mass transfer analysis, modelling and the equipment used Discusses the importance of disinfection, sterilization and process validation
Author : Felix Franks,Tony Auffret
Publisher : Royal Society of Chemistry
Page : 220 pages
File Size : 49,9 Mb
Release : 2008
Category : Medical
ISBN : 9780854041510
Aimed at product and process developers in the biopharmaceutical industry and academia, this is the first book to describe freeze-drying, as related to the pharmaceutical industry.
Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Publisher : John Wiley & Sons
Page : 394 pages
File Size : 46,8 Mb
Release : 2020-06-02
Category : Medical
ISBN : 9783527341122
A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Author : Chilukuri Dakshina Murthy,Gangadhar Sunkara,David Young
Publisher : CRC Press
Page : 228 pages
File Size : 45,5 Mb
Release : 2007-02-12
Category : Medical
ISBN : 9781000611540
During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and phar
Author : Michael J. Akers
Publisher : CRC Press
Page : 517 pages
File Size : 49,7 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420020564
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
Author : Joseph T. Piechocki,Karl Thoma
Publisher : CRC Press
Page : 445 pages
File Size : 52,7 Mb
Release : 2006-09-18
Category : Medical
ISBN : 9781420014136
Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background
Author : Anthony Kennedy
Publisher : CRC Press
Page : 274 pages
File Size : 48,9 Mb
Release : 2008-03-17
Category : Medical
ISBN : 9781040062920
Encompassing the full spectrum of project management's role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration
Author : Alexander T. Florence,Juergen Siepmann
Publisher : CRC Press
Page : 1216 pages
File Size : 50,6 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420065718
This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current
Author : Alexander T. Florence,Juergen Siepmann
Publisher : CRC Press
Page : 656 pages
File Size : 46,6 Mb
Release : 2009-05-28
Category : Medical
ISBN : 9781420065657
With over 100 illustrations, Volume 1 addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics. Key topics in Volume 1 include: • principles of drug absorption, chemical kinetics, and drug stability • pharmacokinetics • the effect of route of administration and distribution on drug action • in vivo imaging of dose forms: gamma scintigraphy, PET imaging NMR, MRI, etc. • powder technology • excipient design and characterization • preformulation • optimization techniques in pharmaceutical formulation and processing • disperse and surfactant systems • the solid state, tablet dosage forms, coating processes, and hard and soft shell capsules • parenteral products
