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With the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products. This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products. Key Features: Presents current advancements including new technologies of transdermal and topical dosage forms. Presents challenges in the development of the new generation of transdermal and topical dosage forms. Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies. Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality. Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.
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
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.
Presents authoritative state-of-the-art discussions of the key issues pertinent to transdermal drug delivery, examining those topics necessary to enable a critical evaluation of a drug candidate's potential to be delivered across the skin; from physical chemistry and assessment of drug permeability to available enhancement technolgies, to regulator
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 authors show how the pharmaceutical industry faces the development of dermal drugs and provide the only book of its kind that describes how the industry develops and selects dermal drugs, complete with the challenges and opportunities of the field. Delivery of drugs through the skin has been an attractive and challenging area for research, and advances in modern technologies have resulted in a larger number of drugs being delivered transdermally, including conventional hydrophobic small molecule drugs, hydrophilic drugs and macromolecules. Offering the perspective from the industrial side of selection and development of drugs, the primary audience is geared towards the pharmaceutical industry but can also offer valuable information to clinicians, compounding pharmacists, and similarly pharmacy students. Dermal Drug Selection and Development covers the scientific gaps that exist in terms of dermal pharmacokinetics and the resulting uncertainty by clinicians when choosing a drug candidate.
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.
This book reviews skin permeation and disposition of chemical compounds. Skin is utilized as an administration site for transdermal drug delivery systems, topical drug formulations, cosmeceuticals, and cosmetics. Their usefulness is closely related to the permeation and disposition of entrapped active ingredients through and into the skin. Skin permeation, disposition, and metabolism of chemicals are first summarized in the general introduction. Then primary topical formulations are explained in the second part, “Basic Formulations Applied to Skin”. The explanation for the active compounds and formulations are of the most important parts required to fabricate these formulations. Skin absorption of chemicals is generally much lower than oral and the other mucosal absorptions, so that skin-penetration enhancement is a key issue to have good formulations topically applied. Part 3 presents “Skin Penetration Enhancement”. In addition, Part 4, “Selection of Topically Applied Chemical Candidates”, deals with selection methods of topically applied ingredients for transdermal drug delivery systems, topical drug formulations, cosmeceuticals, and cosmetics. Parts 5 and 6, “Safety Assessment of Topically Applied Compounds“ and “Experimental Methods of Skin Permeation“, respectively, show safety issues and experimental methods for topical formulations. The final part consists of comments on therapeutic and cosmetic formulations by medical doctors and pharmacists. Their comments are especially helpful for pharmaceutical and cosmetic researchers who study dermatopharmacokinetics and topical formulations. This volume is particularly useful for those working in R&D, graduate students, and educators in the area of pharmaceutics, cosmetic sciences, dermatological sciences, pharmacology, toxicology, biopharmacy, pharmacokinetics, physical pharmacy, chemical engineering, and related fields.
Microneedles can be used for delivery of a wide range of drug substances for practically any medical condition and present a real opportunity for vaccines and medicines that are unsuitable for oral administration or conventional patch delivery. Microneedle-mediated Transdermal and Intradermal Drug Delivery covers the major aspects relating to the use of microneedle arrays in enhancing drug delivery applications. It provides an overview of the various methods employed to design and produce microneedles, from the different materials involved to the importance of application methods. It carefully and critically reviews ongoing transdermal and intradermal delivery research using microneedles and includes the outcomes of in vivo animal and human studies. Importantly, it also discusses the safety and patient acceptability studies carried out to date. Finally, the book reviews the recent patents in microneedle research and describes the ongoing developments within industry that will determine the future of microneedle-mediated transdermal and intradermal drug delivery. By an expert author team with practical experience in the design and development of drug delivery systems this is the only text that provides a comprehensive review of microneedle research in transdermal and intradermal drug delivery.
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.