[PDF] In Vitro Drug Release Testing Of Special Dosage Forms eBook

Author : Nikoletta Fotaki
Publisher : John Wiley & Sons
Page : 314 pages
File Size : 15,28 MB
Release : 2019-10-11
Category : Science
ISBN : 1118675835

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Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.

Author : Nikoletta Fotaki
Publisher : John Wiley & Sons
Page : 312 pages
File Size : 21,15 MB
Release : 2019-12-31
Category : Science
ISBN : 1118341473

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Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.

Author : David B. Young
Publisher : Springer Science & Business Media
Page : 299 pages
File Size : 45,26 MB
Release : 2013-03-08
Category : Medical
ISBN : 1468460366

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This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.

Author : Alexander Taylor Florence
Publisher :
Page : 485 pages
File Size : 11,13 MB
Release : 1988
Category : Biopharmaceutics
ISBN : 9780333449950

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This book provides the physicochemical background to the design and use of pharmaceutical dosage forms. It goes beyond the introductory aspects of the subject to show how basic physicochemical principles are essential to an understanding of every aspect of drug action, from the dosage form to the site of action in the body. This is not a textbook of physical chemistry for pharmacists, but is a book which bridges the gap between basic first-year physical chemistry and the more applied practice of later years. This extensively revised second edition includes much new material, illustrations and references to take into account recent scientific developments and curriculum changes.

Author : Jennifer B. Dressman
Publisher : CRC Press
Page : 432 pages
File Size : 47,34 MB
Release : 2016-04-19
Category : Medical
ISBN : 1420077341

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Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an

Author : Edmund S. Kostewicz
Publisher : John Wiley & Sons
Page : 516 pages
File Size : 11,73 MB
Release : 2022-04-04
Category : Medical
ISBN : 1119772710

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ORAL DRUG DELIVERY FOR MODIFIED RELEASE FORMULATIONS Provides pharmaceutical development scientists with a detailed reference guide for the development of MR formulations Oral Drug Delivery for Modified Release Formulations is an up-to-date review of the key aspects of oral absorption from modified-release (MR) dosage forms. This edited volume provides in-depth coverage of the physiological factors that influence drug release and of the design and evaluation of MR formulations. Divided into three sections, the book begins by describing the gastrointestinal tract (GIT) and detailing the conditions and absorption processes occurring in the GIT that determine a formulation’s oral bioavailability. The second section explores the design of modified release formulations, covering early drug substance testing, the biopharmaceutics classification system, an array of formulation technologies that can be used for MR dosage forms, and more. The final section focuses on in vitro, in silico, and in vivo evaluation and regulatory considerations for MR formulations. Topics include biorelevant dissolution testing, preclinical evaluation, and physiologically-based pharmacokinetic modelling (PBPK) of in vivo behaviour. Featuring contributions from leading researchers with expertise in the different aspects of MR formulations, this volume: Provides authoritative coverage of physiology, physicochemical determinants, and in-vitro in-vivo correlation (IVIVC) Explains the different types of MR formulations and defines the key terms used in the field Discusses the present status of MR technologies and identifies current gaps in research Includes a summary of regulatory guidelines from both the US and the EU Shares industrial experiences and perspectives on the evaluation of MR dosage formulations Oral Drug Delivery for Modified Release Formulations is an invaluable reference and guide for researchers, industrial scientists, and graduate students in general areas of drug delivery including pharmaceutics, pharmaceutical sciences, biomedical engineering, polymer and materials science, and chemical and biochemical engineering.

Author : Leon Shargel
Publisher : CRC Press
Page : 397 pages
File Size : 36,56 MB
Release : 2013-10-24
Category : Medical
ISBN : 1420086367

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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

Author : Hong Wen
Publisher : John Wiley & Sons
Page : 571 pages
File Size : 48,22 MB
Release : 2011-01-14
Category : Science
ISBN : 1118060326

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This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.

Author : Vinod P. Shah
Publisher : Springer
Page : 393 pages
File Size : 22,79 MB
Release : 2015-01-30
Category : Medical
ISBN : 1493912895

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This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.

Author : Rajesh Krishna
Publisher : Springer Science & Business Media
Page : 416 pages
File Size : 21,75 MB
Release : 2007-09-20
Category : Medical
ISBN : 038772379X

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The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.