Freeze Drying Lyophilization Of Pharmaceutical And Biological Products Third Edition

Author : Louis Rey
Publisher : CRC Press
Page : 580 pages
File Size : 50,9 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781439825761

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Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products by Louis Rey Pdf

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 : 47,5 Mb
Release : 2004-01-21
Category : Medical
ISBN : 9780203021323

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Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded by Louis Rey,Joan C. May Pdf

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 : Louis Rey,Joan Christine May
Publisher : Unknown
Page : 613 pages
File Size : 49,9 Mb
Release : 2004
Category : Biological products
ISBN : 0824748689

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Freeze-drying/lyophilization of Pharmaceutical and Biological Products by Louis Rey,Joan Christine May Pdf

Author : Peter Haseley,Georg-Wilhelm Oetjen
Publisher : John Wiley & Sons
Page : 434 pages
File Size : 46,6 Mb
Release : 2018-05-07
Category : Science
ISBN : 9783527343065

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Freeze-Drying by Peter Haseley,Georg-Wilhelm Oetjen Pdf

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 : Henry R. Costantino,Michael J. Pikal
Publisher : Springer Science & Business Media
Page : 726 pages
File Size : 42,5 Mb
Release : 2005-12-05
Category : Medical
ISBN : 0971176760

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Lyophilization of Biopharmaceuticals by Henry R. Costantino,Michael J. Pikal Pdf

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 : Tse-Chao Hua,Bao-Lin Liu,Haimei Zhang
Publisher : Elsevier
Page : 280 pages
File Size : 41,6 Mb
Release : 2010-07-30
Category : Technology & Engineering
ISBN : 9781845697471

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Freeze-Drying of Pharmaceutical and Food Products by Tse-Chao Hua,Bao-Lin Liu,Haimei Zhang Pdf

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 : Davide Fissore,Roberto Pisano,Antonello Barresi
Publisher : CRC Press
Page : 201 pages
File Size : 41,8 Mb
Release : 2019-10-24
Category : Medical
ISBN : 9780429664014

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Freeze Drying of Pharmaceutical Products by Davide Fissore,Roberto Pisano,Antonello Barresi Pdf

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 : Felix Franks,Tony Auffret
Publisher : Royal Society of Chemistry
Page : 220 pages
File Size : 44,6 Mb
Release : 2008
Category : Medical
ISBN : 9780854041510

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Freeze-drying of Pharmaceuticals and Biopharmaceuticals by Felix Franks,Tony Auffret Pdf

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 : Linda A. Felton,James W. McGinity
Publisher : CRC Press
Page : 510 pages
File Size : 49,5 Mb
Release : 2008-01-09
Category : Medical
ISBN : 9780849387883

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Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition by Linda A. Felton,James W. McGinity Pdf

Thoroughly updated and expanded, this new Third Edition provides the latest information on dosage, forms, film defects, and polymer characterization. Written by renowned leaders in the field, Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms is easily the most comprehensive book available on the market today. New to the Third Edition: the interaction of drugs with functional polymers the influence of processing parameters on coating quality the stabilization of polymeric film coats plasticizers and their applications in pharmaceutical coatings adhesion of polymeric films to solid substrates basic properties of latex and pseudolatex colloidal dispersions Key topics included: polymer interactions with drugs and excipients physical aging of polymeric films a complete overview and in-depth analysis of recent advances in the field, which includes information on the latest equipment used to apply polymers to a pharmaceutical system illustrated examples explaining the appropriate steps to be taken in order to solve formulation, processing, and stability problems to achieve an optimized dosage form

Author : Graham P. Bunn
Publisher : CRC Press
Page : 371 pages
File Size : 52,5 Mb
Release : 2019-02-04
Category : Medical
ISBN : 9781498732079

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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition by Graham P. Bunn Pdf

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.

Author : Terry Jacobs,Andrew A. Signore
Publisher : CRC Press
Page : 674 pages
File Size : 42,7 Mb
Release : 2016-08-19
Category : Medical
ISBN : 9781315355023

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Good Design Practices for GMP Pharmaceutical Facilities by Terry Jacobs,Andrew A. Signore Pdf

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Author : Leon Shargel,Isadore Kanfer
Publisher : CRC Press
Page : 400 pages
File Size : 55,7 Mb
Release : 2013-10-24
Category : Medical
ISBN : 9781420086355

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Generic Drug Product Development by Leon Shargel,Isadore Kanfer Pdf

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

Author : Isaac Ghebre-Sellassie,Charles E. Martin,Feng Zhang,James DiNunzio
Publisher : CRC Press
Page : 433 pages
File Size : 51,7 Mb
Release : 2018-03-05
Category : Medical
ISBN : 9781498704922

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Pharmaceutical Extrusion Technology by Isaac Ghebre-Sellassie,Charles E. Martin,Feng Zhang,James DiNunzio Pdf

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 1012 pages
File Size : 51,6 Mb
Release : 2014-10-29
Category : Medical
ISBN : 9781482226379

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Handbook of Bioequivalence Testing, Second Edition by Sarfaraz K. Niazi Pdf

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.

Author : Linda A. Felton
Publisher : CRC Press
Page : 407 pages
File Size : 40,9 Mb
Release : 2016-09-19
Category : Medical
ISBN : 9781498732093

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Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms by Linda A. Felton Pdf

Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of commercially marketed coatings are used throughout the text to help familiarize the reader with the various materials available for pharmaceutical applications. This book will be a valuable resource for anyone in the pharmaceutical industry working in the area of aqueous-based film coating.