Transdermal And Topical Drug Delivery From Theory To Clinical Practice

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Transdermal and Topical Drug Delivery from Theory to Clinical Practice

Author : Adrian Williams
Publisher :
ISBN 13 : 9780853694892
Total Pages : 0 pages
Book Rating : 4.6/5 (948 download)

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Book Synopsis Transdermal and Topical Drug Delivery from Theory to Clinical Practice by : Adrian Williams

Download or read book Transdermal and Topical Drug Delivery from Theory to Clinical Practice written by Adrian Williams and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The therapeutic benefits of administering drugs through the skin have been recognized for many years and have been capitalized upon in commercially successful and important transdermal delivery systems, such as estradiol patches for hormone replacement and nicotine patches as aids to smoking cessation. Transdermal and Topical Drug Delivery addresses all aspects of how to deliver drugs to the skin for local effects or across the skin for systemic therapy. Starting with a discussion of the principles underlying the area, the text expands into strategies used to deliver drugs effectively. This should be a valuable practical guide for the clinical delivery of drugs.

Transdermal and Topical Drug Delivery

Author : Adrian Christopher Williams
Publisher :
ISBN 13 : 9783769232516
Total Pages : 242 pages
Book Rating : 4.2/5 (325 download)

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Book Synopsis Transdermal and Topical Drug Delivery by : Adrian Christopher Williams

Download or read book Transdermal and Topical Drug Delivery written by Adrian Christopher Williams and published by . This book was released on 2003 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Topical and Transdermal Drug Delivery

Author : Heather A. E. Benson
Publisher : John Wiley & Sons
ISBN 13 : 1118140494
Total Pages : 393 pages
Book Rating : 4.1/5 (181 download)

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Book Synopsis Topical and Transdermal Drug Delivery by : Heather A. E. Benson

Download or read book Topical and Transdermal Drug Delivery written by Heather A. E. Benson and published by John Wiley & Sons. This book was released on 2012-02-03 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical drug development approaches presented by leading experts Designed to support the development of new, effective therapeutics, Topical and Transdermal Drug Delivery: Principles and Practice explains the principles underlying the field and then demonstrates how these principles are put into practice in the design and development of new drug products. Drawing together and reviewing the latest research findings, the book focuses on practical, tested, and proven approaches that are backed by industry case studies and the authors' firsthand experience. Moreover, the book emphasizes the mechanistic information that is essential for successful drug product development. Topical and Transdermal Drug Delivery: Principles and Practice is divided into two parts: Part One, Current Science, Skin Permeation, and Enhancement Approaches, offers readers a fundamental understanding of the underlying science in the field. It describes the principles and techniques needed to successfully perform experimental approaches, covering such issues as skin permeation, enhancement, and assessment. Part Two, Topical and Transdermal Product Development, guides readers through the complete product development process from concept to approval, offering practical tips and cautions from experts in the field. This part also discusses regulations that are specific to the development of dermal drug products. The final chapter explores current and future trends, forecasting new development techniques and therapeutics. Throughout the book, the authors clearly set forth the basic science and experimental procedures, making it possible for researchers to design their own experimental approaches and accurately interpret their results. With contributions from experienced drug researchers, this text is highly recommended for all researchers involved in topical and transdermal product development who need to know both the state of the science and the standards of practice.

Fundamentals of Drug Delivery

Author : Heather A. E. Benson
Publisher : John Wiley & Sons
ISBN 13 : 1119769604
Total Pages : 580 pages
Book Rating : 4.1/5 (197 download)

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Book Synopsis Fundamentals of Drug Delivery by : Heather A. E. Benson

Download or read book Fundamentals of Drug Delivery written by Heather A. E. Benson and published by John Wiley & Sons. This book was released on 2021-10-12 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive guide to the current research, major challenges, and future prospects of controlled drug delivery systems Controlled drug delivery has the potential to significantly improve therapeutic outcomes, increase clinical benefits, and enhance the safety of drugs in a wide range of diseases and health conditions. Fundamentals of Drug Delivery provides comprehensive and up-to-date coverage of the essential principles and processes of modern controlled drug delivery systems. Featuring contributions by respected researchers, clinicians, and pharmaceutical industry professionals, this edited volume reviews the latest research in the field and addresses the many issues central to the development of effective, controlled drug delivery. Divided in three parts, the book begins by introducing the concept of drug delivery and discussing both challenges and opportunities within the rapidly evolving field. The second section presents an in-depth critique of the common administration routes for controlled drug delivery, including delivery through skin, the lungs, and via ocular, nasal, and otic routes. The concluding section summarizes the current state of the field and examines specific issues in drug delivery and advanced delivery technologies, such as the use of nanotechnology in dermal drug delivery and advanced drug delivery systems for biologics. This authoritative resource: Covers each main stage of the drug development process, including selecting pharmaceutical candidates and evaluating their physicochemical characteristics Describes the role and application of mathematical modelling and the influence of drug transporters in pharmacokinetics and drug disposition Details the physiology and barriers to drug delivery for each administration route Presents a historical perspective and a look into the possible future of advanced drug delivery systems Explores nanotechnology and cell-mediated drug delivery, including applications for targeted delivery and toxicological and safety issues Includes comprehensive references and links to the primary literature Edited by a team of of internationally-recognized experts, Fundamentals of Drug Delivery is essential reading for researchers, industrial scientists, and advanced students in all areas of drug delivery including pharmaceutics, pharmaceutical sciences, biomedical engineering, polymer and materials science, and chemical and biochemical engineering.

Compounded Topical Pain Creams

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030967218X
Total Pages : 353 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Compounded Topical Pain Creams by : National Academies of Sciences, Engineering, and Medicine

Download or read book Compounded Topical Pain Creams written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-07-21 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

Theory and Applications of Nonparenteral Nanomedicines

Author : Prashant Kesharwani
Publisher : Academic Press
ISBN 13 : 0128204672
Total Pages : 542 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Theory and Applications of Nonparenteral Nanomedicines by : Prashant Kesharwani

Download or read book Theory and Applications of Nonparenteral Nanomedicines written by Prashant Kesharwani and published by Academic Press. This book was released on 2020-09-12 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Theory and Applications of Nonparenteral Nanomedicines presents thoroughly analysed data and results regarding the potential of nanomedicines conceived by diverse non-parenteral routes. In the context of nanotechnology-based approaches, various routes such as oral, pulmonary, transdermal, delivery and local administration of nanomedicine have been utilized for the delivery of nanomedicine. This book discusses the non-parenteral application of nanomedicine, its regulatory implications, application of mucus penetrating nanocarrier, and detailed chapters on development of nanomedicines developed for drug delivery by various route. Beginning with a brief introduction to the non-parenteral delivery of nanomedicine and the safety and regulatory implications of the nanoformulations, further chapters discuss the physiology of the biological barriers, the specificity of the nanocarriers as well as their multiple applications. Theory and Applications of Nonparenteral Nanomedicines helps clinical researchers, researchers working in pharmaceutical industries, graduate students, and anyone working in the development of non-parenteral nanomedicines to understand the recent progress in the design and development of nanoformulations compatible with non-parenteral applications. - Contains a comprehensive review of non-parenteral nanomedicines - Provides analysis of non-parenteral methods of nanomedicines including regulatory implications and future applications - Explores a wide range of promising approaches for non-parenteral drug delivery using the latest advancement in nanomedicine written by experts in industry and academia

Novel Delivery Systems for Transdermal and Intradermal Drug Delivery

Author : Ryan F. Donnelly
Publisher : John Wiley & Sons
ISBN 13 : 1118734513
Total Pages : 290 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Novel Delivery Systems for Transdermal and Intradermal Drug Delivery by : Ryan F. Donnelly

Download or read book Novel Delivery Systems for Transdermal and Intradermal Drug Delivery written by Ryan F. Donnelly and published by John Wiley & Sons. This book was released on 2015-09-28 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: This research book covers the major aspects relating to the use of novel delivery systems in enhancing both transdermal and intradermal drug delivery. It provides a review of transdermal and intradermal drug delivery, including the history of the field and the various methods employed to produce delivery systems from different materials such as device design, construction and evaluation, so as to provide a sound background to the use of novel systems in enhanced delivery applications. Furthermore, it presents in-depth analyses of recent developments in this exponentially growing field, with a focus on microneedle arrays, needle-free injections, nanoparticulate systems and peptide-carrier-type systems. It also covers conventional physical enhancement strategies, such as tape-stripping, sonophoresis, iontophoresis, electroporation and thermal/suction/laser ablation Discussions about the penetration of the stratum corneum by the various novel strategies highlight the importance of the application method. Comprehensive and critical reviews of transdermal and intradermal delivery research using such systems focus on the outcomes of in vivoanimal and human studies. The book includes laboratory, clinical and commercial case studies featuring safety and patient acceptability studies carried out to date, and depicts a growing area for use of these novel systems is in intradermal vaccine delivery. The final chapters review recent patents in this field and describe the work ongoing in industry.

The Art and Science of Dermal Formulation Development

Author : Marc B. Brown
Publisher : CRC Press
ISBN 13 : 0429596065
Total Pages : 248 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis The Art and Science of Dermal Formulation Development by : Marc B. Brown

Download or read book The Art and Science of Dermal Formulation Development written by Marc B. Brown and published by CRC Press. This book was released on 2019-03-01 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes. Key Features: Presents a practical guide for both industry and academia Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery Illustrates the practicalities of formulation design using key case studies Gives an understanding of the skin as a route of delivery and how formulation development for such application differs from that for other administration routes

Transdermal Drug Delivery

Author : Kevin Ita
Publisher : Academic Press
ISBN 13 : 0128225513
Total Pages : 325 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Transdermal Drug Delivery by : Kevin Ita

Download or read book Transdermal Drug Delivery written by Kevin Ita and published by Academic Press. This book was released on 2020-06-12 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transdermal Drug Delivery: Concepts and Application provides comprehensive background knowledge and documents the most recent advances made in the field of transdermal drug delivery. It provides comprehensive and updated information regarding most technologies and formulation strategies used for transdermal drug delivery. There has been recent growth in the number of research articles, reviews, and other types of publications in the field of transdermal drug delivery. Research in this area is active both in the academic and industry settings. Ironically, only about 40 transdermal products with distinct active pharmaceutical ingredients are in the market indicating that more needs to be done to chronicle recent advances made in this area and to elucidate the mechanisms involved. This book will be helpful to researchers in the pharmaceutical and biotechnological industries as well as academics and graduate students working in the field of transdermal drug delivery and professionals working in the field of regulatory affairs focusing on topical and transdermal drug delivery systems. Researchers in the cosmetic and cosmeceutical industries, as well as those in chemical and biological engineering, will also find this book useful. - Captures the most recent advancements and challenges in the field of transdermal drug delivery - Covers both passive and active transdermal drug delivery strategies - Explores a selection of state-of-the-art transdermal drug delivery systems

Aromatherapy Science

Author : Maria Lis-Balchin
Publisher : Pharmaceutical Press
ISBN 13 : 9780853695783
Total Pages : 490 pages
Book Rating : 4.6/5 (957 download)

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Book Synopsis Aromatherapy Science by : Maria Lis-Balchin

Download or read book Aromatherapy Science written by Maria Lis-Balchin and published by Pharmaceutical Press. This book was released on 2006 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aromatherapy is one of the fastest growing forms of alternative medicine in the UK and USA. Essential oils are now sold in pharmacies and aromatherapy is increasingly being used in hospitals and primary care settings.This unique book takes an analytical and scientific approach to aromatherapy practices and principles based on the scientific evidence to date.The monographs cover commonly used essential oils and their therapeutic uses, details of toxicity, bioactivity, contraindications and clinical studies. This book provides pharmacists, GPs, nurses and other healthcare professionals with reliable scientifically based information on this growing discipline.

Drug Delivery in Dermatology

Author : Célia Luiza Petersen Vitello Kalil
Publisher : Springer Nature
ISBN 13 : 3030818071
Total Pages : 212 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Drug Delivery in Dermatology by : Célia Luiza Petersen Vitello Kalil

Download or read book Drug Delivery in Dermatology written by Célia Luiza Petersen Vitello Kalil and published by Springer Nature. This book was released on 2021-09-19 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Skin accounts for approximately 15% of an adult’s total body weight, with a surface of about 2m2. It provides an entry and exit barrier to various substances, offers effective protection against harmful substances, microorganisms and ultraviolet radiation, and is also paramount in immunology and body homeostasis, preventing dehydration and loss of essential minerals. The topical route has a number of advantages over oral and parenteral routes: no first-pass metabolism, greater convenience resulting in better treatment compliance, lower side-effect frequency, and prompt dosing cessation if required. However, the stratum corneum allows penetration of only 1 to 5% of substances applied topically, making this application route much less efficient. Lipophilic and small molecules (up to 500 Da) can cross the stratum corneum, since keratinocytes are covered by a lipid matrix, while it is virtually impossible for hydrophilic and large drugs to cross intact, normal skin, which means that passive topical delivery is restricted. To address this, techniques have been developed aimed at optimizing drug skin penetration by means of chemical, mechanical and physical methods, such as adding permeating active agents and using occlusion, iontophoresis, microneedling, lasers and intense pulsed light, and it is now possible to deliver medication to different skin layers or transdermally to the systemic circulation. Drug delivery is a hot topic in dermatology, with a Pubmed search generating 203431 articles. Offering a detailed review of this emerging therapeutic option, including the various methods available, this unique book guides physicians and doctors in selecting the correct technologies, technique and products for each patient.

Chronotherapeutics

Author : P. H. Redfern
Publisher : Pharmaceutical Press
ISBN 13 : 9780853694885
Total Pages : 456 pages
Book Rating : 4.6/5 (948 download)

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Book Synopsis Chronotherapeutics by : P. H. Redfern

Download or read book Chronotherapeutics written by P. H. Redfern and published by Pharmaceutical Press. This book was released on 2003 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: In nature, many physical processes are governed by the passage of time. The study of these processes - chronobiology - reveals rhythmic patterns which may be yearly, monthly, daily or more frequent. Novel drug delivery systems are currently being delivered that will release varying quantities of a drug at optimum times to coincide with these rhythmic patterns.Chronotherapeutics considers the pharmaceutical and therapeutic implications associated with biological clocks. The book presents a comprehensive discussion of specific diseases that are time dependent, and the drugs and new drug formulations that can be used as treatments.Written by leading international experts in the field, Chronotherapeutics provides up-to-date information on chronobiology for non-chronobiologists in pharmaceutical and medical sciences. Peter Redfern is Professor of Pharmacology at the University of Bath, UK.

Skin Barrier Function

Author : T. Agner
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3318055867
Total Pages : 172 pages
Book Rating : 4.3/5 (18 download)

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Book Synopsis Skin Barrier Function by : T. Agner

Download or read book Skin Barrier Function written by T. Agner and published by Karger Medical and Scientific Publishers. This book was released on 2016-02-04 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although a very fragile structure, the skin barrier is probably one of the most important organs of the body. Inward/out it is responsible for body integrity and outward/in for keeping microbes, chemicals, and allergens from penetrating the skin. Since the role of barrier integrity in atopic dermatitis and the relationship to filaggrin mutations was discovered a decade ago, research focus has been on the skin barrier, and numerous new publications have become available. This book is an interdisciplinary update offering a wide range of information on the subject. It covers new basic research on skin markers, including results on filaggrin and on methods for the assessment of the barrier function. Biological variation and aspects of skin barrier function restoration are discussed as well. Further sections are dedicated to clinical implications of skin barrier integrity, factors influencing the penetration of the skin, influence of wet work, and guidance for prevention and saving the barrier. Distinguished researchers have contributed to this book, providing a comprehensive and thorough overview of the skin barrier function. Researchers in the field, dermatologists, occupational physicians, and related industry will find this publication an essential source of information.

Innovative Dosage Forms

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
ISBN 13 : 3527343962
Total Pages : 470 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Innovative Dosage Forms by : Yogeshwar Bachhav

Download or read book Innovative Dosage Forms written by Yogeshwar Bachhav and published by John Wiley & Sons. This book was released on 2019-12-04 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Enhancement in Drug Delivery

Author : Elka Touitou
Publisher : CRC Press
ISBN 13 : 1420004816
Total Pages : 656 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Enhancement in Drug Delivery by : Elka Touitou

Download or read book Enhancement in Drug Delivery written by Elka Touitou and published by CRC Press. This book was released on 2006-11-27 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a significant cross-fertilization of ideas across several disciplines, Enhancement in Drug Delivery offers a unique comprehensive review of both theoretical and practical aspects of enhancement agents and techniques used for problematic administration routes. It presents an integrated evaluation of absorption enhancers and modes fo

Novel Delivery Systems for Transdermal and Intradermal Drug Delivery

Author : Ryan F. Donnelly
Publisher : John Wiley & Sons
ISBN 13 : 1118734483
Total Pages : 296 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Novel Delivery Systems for Transdermal and Intradermal Drug Delivery by : Ryan F. Donnelly

Download or read book Novel Delivery Systems for Transdermal and Intradermal Drug Delivery written by Ryan F. Donnelly and published by John Wiley & Sons. This book was released on 2015-08-07 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: This research book covers the major aspects relating to the use of novel delivery systems in enhancing both transdermal and intradermal drug delivery. It provides a review of transdermal and intradermal drug delivery, including the history of the field and the various methods employed to produce delivery systems from different materials such as device design, construction and evaluation, so as to provide a sound background to the use of novel systems in enhanced delivery applications. Furthermore, it presents in-depth analyses of recent developments in this exponentially growing field, with a focus on microneedle arrays, needle-free injections, nanoparticulate systems and peptide-carrier-type systems. It also covers conventional physical enhancement strategies, such as tape-stripping, sonophoresis, iontophoresis, electroporation and thermal/suction/laser ablation Discussions about the penetration of the stratum corneum by the various novel strategies highlight the importance of the application method. Comprehensive and critical reviews of transdermal and intradermal delivery research using such systems focus on the outcomes of in vivoanimal and human studies. The book includes laboratory, clinical and commercial case studies featuring safety and patient acceptability studies carried out to date, and depicts a growing area for use of these novel systems is in intradermal vaccine delivery. The final chapters review recent patents in this field and describe the work ongoing in industry.

Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.