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The Role Of Microstructure In Topical Drug Product Development
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Book Synopsis The Role of Microstructure in Topical Drug Product Development by : Nigel Langley
Download or read book The Role of Microstructure in Topical Drug Product Development written by Nigel Langley and published by Springer. This book was released on 2019-08-07 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content.Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development’ crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.
Book Synopsis Introduction to Cosmetic Formulation and Technology by : Gabriella Baki
Download or read book Introduction to Cosmetic Formulation and Technology written by Gabriella Baki and published by John Wiley & Sons. This book was released on 2022-12-12 with total page 836 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Cosmetic Formulation and Technology An accessible and practical review of cosmetics and OTC drug-cosmetic products In the newly revised second edition of Introduction to Cosmetic Formulation and Technology, veteran educator and researcher Dr. Gabriella Baki delivers a comprehensive discussion of cosmetics and personal care products, including coverage of basic concepts, ingredient selection, formulation technology, and testing. The book offers a clear and easy-to-understand review of cosmetics and over the counter (OTC) drug-cosmetic products available in the United States. In this latest edition, the author expands on general concepts and adds brand-new chapters on the basics of cosmetics testing, ingredients, and skin lightening products. Each chapter includes a summary of common abbreviations with questions provided online, alongside a solutions manual for instructors. Readers will also find: A thorough introduction to the basic definitions, claims, and classifications of cosmetics and OTC drug-cosmetic products Comprehensive explorations of the current rules and regulations for cosmetics and OTC drug-cosmetic products in the United States and European Union Detailed review of cosmetic ingredients, functions, and typical uses both in a dedicated a chapter and included within various others Practical coverage of good manufacturing practices for cosmetics, including documentation, buildings and facilities, equipment, and personnel Fulsome review of a variety of skin and hair care products, color cosmetics, and other personal care products Perfect for undergraduate and graduate students studying cosmetic science in chemistry, chemical engineering, pharmaceutical, biomedical, and biology departments, Introduction to Cosmetic Formulation and Technology will also benefit cosmetic chemists, cosmetic product formulators, cosmetic scientists, quality control managers, cosmetic testing specialists, and technicians.
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)
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.
Book Synopsis Investigation of Microemulsions and Their Microstructures for Transdermal and Dermal Drug Delivery by : Ji Zhang
Download or read book Investigation of Microemulsions and Their Microstructures for Transdermal and Dermal Drug Delivery written by Ji Zhang and published by . This book was released on 2017 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug delivery through the skin, transdermally and topically, offers many advantages including reduced systemic toxicity and side-effects, avoidance of the hepatic first pass metabolism, improved patient compliance, enabling sustained or controlled drug release, and enhanced delivery to local target tissues. However, there are many challenges for this route of administration, the major one is the skin barrier function to drug permeation. Many different approaches have been studied and used for enhancing the drug skin permeation. Among them, chemical permeation enhancers and microemulsion formulations are some of widely studied approaches. The thesis work focused on microemulsion (ME) formulations for enhancing transdermal or dermal drug delivery. Specifically, the ME microstructures were investigated and correlated with enhancement effects of drug skin permeation or skin deposition. The results showed that a critical factor influencing ME formulation behavior was the water content that also correlated to the formulation microstructure, and the drug skin permeation increased significantly corresponding to the microstructure change from W/O, to Bi-continuous, and to O/W. This was the first time that this phenomenon had been systematically studied and reported, the microstructure of a microemulsion affected both hydrophobic and hydrophilic model drugs' transdermal permeation. The extent of trandermal permeation enhancement effect was more significant for hydrophobic drugs than hydrophilic drugs as water content increased and the corresponding microstructure changed in the ME formulation. Furthermore, at fixed water content, increasing oil content would result in higher transdermal permeation enhancement. The model drugs used in the study were lidocaine, ketoprofen, and caffeine, which represented compounds of varied physical and chemical properties. The findings were of practical significance for microemulsion formulation design and development in transdermal drug delivery. Secondly, in the present study, a combination of analytical methodologies was utilized to examine microemulsion microstructures. It was found that the cooling thermogram generated by Differential Scanning Calorimetry (DSC) provided a simple approach for microstructure determination, which to the author's knowledge, had not been reported before. Extensive DSC cooling experiments had been conducted to analyze three ME systems that had their microstructure characterized and known in the literature. It was showed that DSC derived microstructure results were in complete concordance with literature reports, and thus demonstrated that the cooling DSC method was an effective analytical technique for ME microstructure assessment. The results also showed that the DSC method provided additional advantages over conventional methods for being sensitive, accurate, and versatile. The developed cooling DSC methodology for ME microstructure analysis would greatly facilitate ME formulation characterization and development in the future. Finally, dermal delivery of hydrophobic drugs by microemulsion (ME) formulations and effect from ME microstructures were studied. The antifungal drug, clotrimazole (CLOT), was used as the model compound. ME formulations of different microstructures were prepared along water dilution line at fixed oil/(surfactant and co-surfactant) ratio of 1/9 (w/w) using isopropyl myristate as oil, Labrasol and Cremophor EL as surfactant and co-surfactant, and water. Permeation experiments on human cadaver skin were conducted for ME and the control formulations of different CLOT loads. Dermal delivery of CLOT assessed by the dermal drug concentrations was found to be significantly higher for MEs when compared with the control formulation, and the highest concentration was observed with O/W ME, suggesting ME microstructure was an important formulation variable for enhancing dermal delivery. ME gel formulations prepared by incorporating 1.0% (w/w) of Carbopol 980 showed comparable dermal CLOT concentration to MEs but up to 2.4 fold higher than the commercial CLOT cream product, Lotrimin®. Furthermore, FITC used as a model compound for highly hydrophobic drugs, was also studied for its dermal delivery by MEs in porcine skin penetration experiments. Results showed a consistent ME microstructure effect, suggested by significantly higher FITC concentrations in all skin layers, stratum corneum, viable epidermis, and dermis, from O/W ME over Bi-continuous and W/O MEs. Results from the present study highlighted ME microstructure effect on ME dermal delivery of hydrophobic drugs, and provided insight to drug dermal retention and transdermal permeation enhancements and their interplay.
Book Synopsis Dermatological Drug Development by : Tomoko Maeda-Chubachi
Download or read book Dermatological Drug Development written by Tomoko Maeda-Chubachi and published by Cambridge Scholars Publishing. This book was released on 2020-09-18 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).
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.
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 Drugs and the Pharmaceutical Sciences. This book was released on 2022-06 with total page 0 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 death of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such as application is very different to that used for oral, IV, and other administration routes. Features Presents a practical guide for both industry and academia, Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery - skin structure, diffusion theory, laboratory methods - and the practicalities of formulation design, development and testing within the regulatory context, 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 Book jacket.
Book Synopsis Food and Drug Administration’s Role in Dermatology, An Issue of Dermatologic Clinics,E-Book by : Markham C. Luke
Download or read book Food and Drug Administration’s Role in Dermatology, An Issue of Dermatologic Clinics,E-Book written by Markham C. Luke and published by Elsevier Health Sciences. This book was released on 2022-06-24 with total page 121 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this issue, guest editors bring their considerable expertise to this important topic. Provides in-depth reviews on the latest updates in the field, providing actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create these timely topic-based reviews.
Book Synopsis Aulton's Pharmaceutics E-Book by : Kevin M.G. Taylor
Download or read book Aulton's Pharmaceutics E-Book written by Kevin M.G. Taylor and published by Elsevier Health Sciences. This book was released on 2021-04-23 with total page 1052 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essential pharmaceutics textbook One of the world’s best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees. Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor and Michael Aulton, this new edition includes the science of formulation, pharmaceutical manufacturing and drug delivery. All aspects of pharmaceutics are covered in a clear and readily accessible way and extensively illustrated throughout, providing an essential companion to the entire pharmaceutics curriculum from day one until the end of the course. Fully updated throughout, with the addition of new chapters, to reflect advances in formulation and drug delivery science, pharmaceutical manufacturing and medicines regulation Designed and written for newcomers to the design and manufacture of dosage forms Relevant pharmaceutical science covered throughout Includes the science of formulation and drug delivery Reflects current practices and future applications of formulation and drug delivery science to small drug molecules, biotechnology products and nanomedicines Key points boxes throughout Over 400 online multiple choice questions
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
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 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
Book Synopsis Pharmaceutical Drug Product Development and Process Optimization by : Sarwar Beg
Download or read book Pharmaceutical Drug Product Development and Process Optimization written by Sarwar Beg and published by CRC Press. This book was released on 2020-05-01 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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
Book Synopsis Pharmaceutical Microscopy by : Robert Allen Carlton
Download or read book Pharmaceutical Microscopy written by Robert Allen Carlton and published by Springer Science & Business Media. This book was released on 2011-05-04 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microscopy plays an integral role in the research and development of new medicines. Pharmaceutical Microscopy describes a wide variety of techniques together with numerous practical applications of importance in drug development. The first section presents general methods and applications with an emphasis on the physical science aspects. Techniques covered include optical crystallography, thermal microscopy, scanning electron microscopy, energy dispersive x-ray spectrometry, microspectroscopy (infrared and Raman), and particle size and shape by image analysis. The second section presents applications of these techniques to specific topics of pharmaceutical interest, including studies of polymorphism, particle size and shape analysis, and contaminant identification. Pharmaceutical Microscopy is designed for those scientists who must use these techniques to solve pharmaceutical problems but do not need to become expert microscopists. Consequently, each section has exercises designed to teach the reader how to use and apply the techniques in the book. Although the focus is on pharmaceutical development, workers in other fields such as food science and organic chemistry will also benefit from the discussion of techniques and the exercises. Provides comprehensive coverage of key microscopy techniques used in pharmaceutical development Helps the reader to solve specific problems in pharmaceutical quality assurance Oriented and designed for pharmaceutical scientists who need to use microscopy but are not expert microscopists Includes a large number of practical exercises to give the reader hands-on experience with the techniques Written by an author with 21 years of experience in the pharmaceutical industry
Book Synopsis Specification of Drug Substances and Products by : Christopher M. Riley
Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Elsevier. This book was released on 2024-09-27 with total page 910 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines. This edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the 2nd edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions. Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug–device combination products such as digital drug delivery systems, transdermal systems, and inhalation products. Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).
Book Synopsis Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems by : Ashok Katdare
Download or read book Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems written by Ashok Katdare and published by CRC Press. This book was released on 2006-07-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.
Book Synopsis Dermal Drug Delivery by : Tapash K. Ghosh
Download or read book Dermal Drug Delivery written by Tapash K. Ghosh and published by CRC Press. This book was released on 2020-01-21 with total page 409 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
