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Dosage Form Design Considerations

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Dosage Form Design Considerations

Dosage Form Design Considerations Book
Author : Anonim
Publisher : Academic Press
Release : 2018-07-28
ISBN : 0128144246
Language : En, Es, Fr & De

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Book Description :

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Dosage Form Design Parameters

Dosage Form Design Parameters Book
Author : Anonim
Publisher : Academic Press
Release : 2018-07-25
ISBN : 012814422X
Language : En, Es, Fr & De

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Book Description :

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms Book
Author : Bhavishya Mittal
Publisher : Academic Press
Release : 2016-10-05
ISBN : 0128047321
Language : En, Es, Fr & De

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Book Description :

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research Book
Author : Anonim
Publisher : Academic Press
Release : 2020-08-19
ISBN : 0128144564
Language : En, Es, Fr & De

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Book Description :

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design Book
Author : Sarwar Beg,Md Saquib Hasnain
Publisher : Academic Press
Release : 2019-03-27
ISBN : 0128163720
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Biopharmaceutics and Pharmacokinetics Considerations

Biopharmaceutics and Pharmacokinetics Considerations Book
Author : Anonim
Publisher : Academic Press
Release : 2021-07-07
ISBN : 0128144262
Language : En, Es, Fr & De

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Book Description :

Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce. Examines the most recent developments in biopharmaceutics and pharmacokinetics for pharmaceutical sciences Covers the principles, methodologies and technologies of biopharmaceutics and pharmacokinetics Focuses on the pharmaceutical sciences, but also encompasses aspects of toxicology, neuroscience, environmental sciences and nanotechnology

Pharmacokinetics and Toxicokinetic Considerations Vol II

Pharmacokinetics and Toxicokinetic Considerations   Vol II Book
Author : Rakesh Kumar Tekade
Publisher : Academic Press
Release : 2022-02-17
ISBN : 0323913164
Language : En, Es, Fr & De

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Book Description :

Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices. Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists. Allows readers to systematically integrate up-to-date research findings into their laboratory work Presents focused explorations of bioanalytical methods for bioavailability and bioequivalence assessment Provides clinical applications of concepts

Biomaterials and Bionanotechnology

Biomaterials and Bionanotechnology Book
Author : Anonim
Publisher : Academic Press
Release : 2019-05-29
ISBN : 0128144289
Language : En, Es, Fr & De

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Book Description :

Biomaterials and Bionanotechnology examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields. Examines the most recent developments in biomaterials and nanomaterials for pharmaceutical sciences Covers important topics, such as the fundamentals of polymers science, transportation and bio interaction of properties in nanomaterials across biological systems, and nanotechnology in tissue engineering as they pertain specifically to pharmaceutical sciences Contains extensive references for further discovery on the role of biomaterials and nanomaterials in the drug discovery process

Sample Preparation of Pharmaceutical Dosage Forms

Sample Preparation of Pharmaceutical Dosage Forms Book
Author : Beverly Nickerson
Publisher : Springer Science & Business Media
Release : 2011-08-05
ISBN : 9781441996312
Language : En, Es, Fr & De

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Book Description :

This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publisher : Academic Press
Release : 2009-03-10
ISBN : 9780080932729
Language : En, Es, Fr & De

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Book Description :

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Innovative Dosage Forms

Innovative Dosage Forms Book
Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Release : 2019-12-04
ISBN : 3527343962
Language : En, Es, Fr & De

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Book Description :

Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Pharmaceutical Drug Product Development and Process Optimization

Pharmaceutical Drug Product Development and Process Optimization Book
Author : Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda
Publisher : CRC Press
Release : 2020-05-01
ISBN : 1000731588
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

Basic Fundamentals of Drug Delivery

Basic Fundamentals of Drug Delivery Book
Author : Anonim
Publisher : Academic Press
Release : 2018-11-30
ISBN : 0128179104
Language : En, Es, Fr & De

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Book Description :

Basic Fundamentals of Drug Delivery covers the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable drug delivery system. The book also covers various approaches involved in optimizing the therapeutic performance of a biomolecule while designing its appropriate advanced formulation. Provides up-to-date information on translating the physicochemical properties of drugs into drug delivery systems Explores how drugs are administered via various routes, such as orally, parenterally, transdermally or through inhalation Contains extensive references and further reading for course and self-study

Sterile Product Development

Sterile Product Development Book
Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
Publisher : Springer Science & Business Media
Release : 2013-10-12
ISBN : 1461479789
Language : En, Es, Fr & De

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Book Description :

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Aulton s Pharmaceutics

Aulton s Pharmaceutics Book
Author : Michael E. Aulton,Kevin Taylor
Publisher : Elsevier Health Sciences
Release : 2013
ISBN : 0702042900
Language : En, Es, Fr & De

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Book Description :

"Pharmaceutics is the art of pharmaceutical preparations. It encompasses design of drugs, their manufacture and the elimination of micro-organisms from the products. This book encompasses all of these areas."--Provided by publisher.

Ansel s Pharmaceutical Dosage Forms and Drug Delivery Systems

Ansel s Pharmaceutical Dosage Forms and Drug Delivery Systems Book
Author : Loyd Allen
Publisher : Lippincott Williams & Wilkins
Release : 2014-01-30
ISBN : 1469871947
Language : En, Es, Fr & De

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Book Description :

Long established as a trusted core text for pharmaceutics courses, this gold standard book is the most comprehensive source on pharmaceutical dosage forms and drug delivery systems available today. Reflecting the CAPE, APhA, and NAPLEX® competencies, Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems covers physical pharmacy, pharmacy practice, pharmaceutics, compounding, and dosage forms, as well as the clinical application of the various dosing forms in patient care. This Tenth Edition has been fully updated to reflect new USP standards and features a dynamic new full color design, new coverage of prescription flavoring, and increased coverage of expiration dates.

Pharmaceutical Dosage Forms and Drug Delivery

Pharmaceutical Dosage Forms and Drug Delivery Book
Author : Ram I. Mahato,Ajit S. Narang
Publisher : CRC Press
Release : 2017-11-22
ISBN : 1482253674
Language : En, Es, Fr & De

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Book Description :

Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery – including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery. This book highlights the increased attention that the recent spectacular advances in gene therapy and nanotechnology have brought to dosage form design and drug delivery. With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever. Apart from revising and updating existing chapters on the basic principles, this edition highlights the emerging emphasis on drug discovery, antibodies and antibody-drug conjugates as therapeutic moieties, individualized medicine including patient stratification strategies, targeted drug delivery, and the increasing role of modeling and simulation. Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors and professionals, saving their time and money.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms Book
Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : CRC Press
Release : 2017-10-30
ISBN : 1841849774
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publisher : Academic Press
Release : 2016-11-08
ISBN : 0128026375
Language : En, Es, Fr & De

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Book Description :

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Bioadhesive Drug Delivery Systems

Bioadhesive Drug Delivery Systems Book
Author : Edith Mathiowitz,Donald E. Chickering III,Claus-Michael Lehr
Publisher : CRC Press
Release : 1999-07-13
ISBN : 9781420001341
Language : En, Es, Fr & De

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Book Description :

This invaluable reference presents a comprehensive review of the basic methods for characterizing bioadhesive materials and improving vehicle targeting and uptake-offering possibilities for reformulating existing compounds to create new pharmaceuticals at lower development costs. Evaluates the unique carrier characteristics of bioadhesive polymers and their power to enhance localization of delivered agents, local bioavailability, and drug absorption and transport! Written by over 50 international experts and reflecting broad knowledge of both traditional bioadhesive strategies and novel clinical applications, Bioadhesive Drug Delivery Systems discusses mechanical and chemical bonding, polymer-mucus interactions, the effect of surface energy in bioadhesion, polymer hydration, and mucus rheology analyzes biochemical properties of mucus and glycoproteins, cell adhesion molecules, and cellular interaction with two- and three-dimensional surfaces covers microbalances and magnetic force transducers, atomic force microscopy, direct measurements of molecular level adhesions, and methods to measure cell-cell interactions examines bioadhesive carriers, diffusion or penetration enhancers, and lectin-targeted vehicles describes vaginal, nasal, buccal, ocular, and transdermal drug delivery reviews bioadhesive interactions with the mucosal tissues of the eye and mouth, and those in the respiratory, urinary, and gastrointestinal tracts explores issues of product development, clinical testing, and production and more! Amply referenced with over 1400 bibliographic citations, and illustrated with more than 300 drawings, photographs, tables, and display equations, Bioadhesive Drug Delivery Systems serves as a sound basis for innovation in bioadhesive systems and an excellent introduction to the subject. This unique reference is ideal for pharmaceutical scientists and technologists; chemical, polymer, and plastics engineers; biochemists; physical, surface, and colloid chemists; biologists; and upper-level undergraduate and graduate students in these disciplines.