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.

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.

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.

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

Presents nanobiotechnology in drug delivery and disease management Featuring contributions from noted experts in the field, this book highlights recent advances in the nano-based drug delivery systems. It also covers the diagnosis and role of various nanomaterials in the management of infectious diseases and non-infectious disorders, such as cancers and other malignancies and their role in future medicine. Nanobiotechnology in Diagnosis, Drug Delivery and Treatment starts by introducing how nanotechnology has revolutionized drug delivery, diagnosis, and treatments of diseases. It then focuses on the role of various nanocomposites in diagnosis, drug delivery, and treatment of diseases like cancer, Alzheimer's disease, diabetes, and many others. Next, it discusses the application of a variety of nanomaterials in the diagnosis and management of gastrointestinal tract disorders. The book explains the concept of nanotheranostics in detail and its role in effective monitoring of drug response, targeted drug delivery, enhanced drug accumulation in the target tissues, sustained as well as triggered release of drugs, and reduction in adverse effects. Other chapters cover aptamer-incorporated nanoparticle systems; magnetic nanoparticles; theranostics and vaccines; toxicological concerns of nanomaterials used in nanomedicine; and more. Provides a concise overview of state-of-the-art nanomaterials and their application like drug delivery in infectious diseases and non-infectious disorders Highlights recent advances in the nano-based drug delivery systems and role of various nanomaterials Introduces nano-based sensors which detect various pathogens Covers the use of nanodevices in diagnostics and theranostics Nanobiotechnology in Diagnosis, Drug Delivery and Treatment is an ideal book for researchers and scientists working in various disciplines such as microbiology, biotechnology, nanotechnology, pharmaceutical biotechnology, pharmacology, pharmaceutics, and nanomedicine.

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

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.