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

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

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).

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.

Download or read book Frontiers in Drug Design Discovery Volume 10 written by Atta-ur-Rahman and published by Bentham Science Publishers. This book was released on 2021-02-03 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: Frontiers in Drug Design and Discovery is a book series devoted to publishing the latest and the most important advances in drug design and discovery. Eminent scientists have contributed chapters focused on all areas of rational drug design and drug discovery including medicinal chemistry, in-silico drug design, combinatorial chemistry, high-throughput screening, drug targets, and structure-activity relationships. This book series should prove to be of interest to all pharmaceutical scientists who are involved in research in drug design and discovery and who wish to keep abreast of rapid and important developments in the field. The tenth volume of this series brings together reviews covering topics related to the treatment of neoplasms, systems biology, respiratory diseases among others. Topics included in this volume are: - Recombinant Protein Production: from Bench to Biopharming - Plant Virus Nanoparticles and Virus like Particles (VLPs): Applications in Medicine - MAO Inhibitory Activity Of 4, 5-Dihydro-1 HPyrazole Derivatives: A Platform To Design Novel Antidepressants - Flavonoids Antagonize Effects of Alcohol in Cultured Hippocampal Neurons: A Drug Discovery Study - Hybrid Smart Materials for Topical Drug Delivery: Application of Scaffolds.

Download or read book Biotechnology written by Ronald P. Evens and published by CRC Press. This book was released on 2020-06-04 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

Download or read book GMP Audits in Pharmaceutical and Biotechnology Industries written by Mustafa Edik and published by CRC Press. This book was released on 2024-06-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.

Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2021-05-11 with total page 905 pages. Available in PDF, EPUB and Kindle. Book excerpt: Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

Download or read book Gene Delivery Systems written by Yashwant Pathak and published by CRC Press. This book was released on 2022-07-01 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique volume in our Drugs and Pharmaceutical Sciences series covers the development of gene therapy today, the technology involved, clinical applications of siRNA, non-viral vector-based mRNA delivery using nanotechnology, and RNA based vaccines for treating the infectious diseases. It also presents the current application of the CRISPR/Cas9 gene-editing technique which has revolutionized genome editing and which was awarded the 2020 Nobel Prize in Chemistry. Several new drug delivery systems are explored for the applications of gene therapy. These are found to be useful in treating chronic illnesses, including cancer and infectious diseases. Key Features: Overview of the development of gene therapy Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing Presents CRISPR gene therapy recent trends and applications Discusses siRNA, mRNA, and DNA plasmids

Download or read book Handbook of Drug Metabolism Third Edition written by Paul G. Pearson and published by CRC Press. This book was released on 2019-05-20 with total page 755 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition.

Download or read book Filtration and Purification in the Biopharmaceutical Industry Third Edition written by Maik W. Jornitz and published by CRC Press. This book was released on 2019-06-26 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Download or read book Percutaneous Absorption written by Nina Dragićević and published by CRC Press. This book was released on 2021-07-30 with total page 1008 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption: Drugs, Cosmetics, Mechanisms, Methods, Fifth Edition supplies new chapters on topics currently impacting the field including cutaneous metabolism, skin contamination, exposure to protein allergens, in vitro absorption methodology and the percutaneous absorption of chemical mixtures. Complete with studies on the role of the skin as a key portal of entry for chemicals into the body, this book serves as a detailed reference source for recent advances in the field, as well as an experimental guide for laboratory personnel. Key Features: Details in vivo and in vitro methods for measuring absorption, dermal decontamination, mechanisms of transdermal delivery, and the relationship of transepidermal water loss to percutaneous absorption Considers a range of mathematical models, the safety evaluation of cosmetic ingredients, the absorption of hair dyes, nanoparticles for drug delivery, and other novel methods of drug delivery Discusses topics including skin metabolism, the skin reservoir, and the effects of desquamation on absorption

Download or read book Gene Delivery written by Yashwant Pathak and published by CRC Press. This book was released on 2022-06-29 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gene delivery is a transport of genes of therapeutic values into the chromosomes of the cells or tissues which can be targeted to replace the faulty genes. In last two decades lot of research efforts are dedicated to gene delivery for therapeutic applications. Today gene therapy is promising approach in treatment of genetic diseases including mitochondrial related diseases like blindness, muscular dystrophy, cystic fibrosis, and some cancers. Gene Delivery Systems: Nano Delivery Technologies observes the exploration of nanotechnology for gene therapy and gene delivery. Written by prominent authors in the field, this book covers various aspects of gene delivery including challenges in delivering gene therapy, advances in genome editing, RNA-based gene therapy, Green nanoparticles for oligonucleotide delivery. Additional features include" Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Includes knowledge of the current application of CRISPR/Cas9 gene-editing technique; an approach that has recently been given the Noble Prize. Examines the development of mRNA vaccines for Covid -19 in challenging pandemic scenario Discusses siRNA, mRNA, and DNA plasmids.

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.

Download or read book Cosmetic Creams written by Wilfried Rähse and published by John Wiley & Sons. This book was released on 2020-01-13 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to cosmetic creams that focuses on formulation, production, and safety concerns Cosmetic Creams: Development, Manufacture and Marketing of Effective Skin Care Products puts the focus on the structure and formulation of a cosmetic cream, the production process, the effect of each ingredient, as well as safety considerations. Comprehensive in scope, the book contains a basic definition of cosmetics and describes the types of skin creams currently on the market, the major ingredients used, and example compositions. The author, Wilfried Rähse?a noted expert on the topic?offers guidelines for estimating manufacturing costs and includes procedures for an effective safety assessment. The book contains information on various aspects of skin penetration and production and covers issues like materials used and hygienic packaging. In addition, Rähse reviews legal regulations with an emphasis on the European market. He discusses GMP and EHEDG directives. This important book: -Offers a comprehensive resource that explores all aspects of cosmetic cream manufacturing and marketing -Provides valuable guidelines for practitioners in the field -Covers the underlying technologies of cosmetic creams -Includes a review of raw material and manufacturing costs, hygiene and safety, and legal regulations -Written by an author with more than 30 years? experience in the industry Written for cosmetic chemists, chemists in industry, chemical engineers, dermatologists, Cosmetic Creams: Development, Manufacture and Marketing of Effective Skin Care Products, offers a unique industrial perspective of the topic that is comprehensive in scope.

Download or read book pH of the Skin Issues and Challenges written by C. Surber and published by Karger Medical and Scientific Publishers. This book was released on 2018-08-21 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concept of expressing acidity as the negative logarithm of the hydrogen ion concentration was defined and termed pH in the beginning of the 20th century. The general usefulness of the pH concept for life science was recognized and later gained importance to analytical research. Reports on results of pH measurements from living skin established the term acid mantle - the skin's own protective shield that maintains a naturally acid pH. It is invisible to the eye but crucial to the overall wellbeing of skin. Chronic alkalization can throw this acid mantle out of balance, leading to inflammation, dermatitis, and atopic skin diseases. It is therefore no surprise, that skin pH shifts have been observed in various skin pathologies. It is also obvious that the pH in topically applied preparations may play an important role. Optimal pH and buffer capacity within topical preparations not only support stability of active ingredients and auxiliary materials, but may also increase absorption of the non-ionized species of an acidic or a basic active ingredient. They may even open up opportunities to modify and "correct" skin pH and hence accelerate barrier recovery and maintain or enhance barrier integrity. Further efforts are needed to standardize and improve pH measurements in biological media or pharmaceutical/cosmetic vehicles to increase and ensure quality, comparability, and relevance of research data. In this volume, we present a unique collection of papers that address past, present and future issues of the pH of healthy and diseased skin. It is hoped that this collection will foster future efforts in clinical and experimental skin research.

Download or read book Handbook of Formulating Dermal Applications written by Nava Dayan and published by John Wiley & Sons. This book was released on 2016-12-07 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt: The conceptualization and formulation of skin care products intended for topical use is a multifaceted and evolving area of science. Formulators must account for myriad skin types, emerging opportunities for product development as well as a very temperamental retail market. Originally published as "Apply Topically" in 2013 (now out of print), this reissued detailed and comprehensive handbook offers a practical approach to the formulation chemist's day-to-day endeavors by: Addressing the innumerable challenges facing the chemist both in design and at the bench, such as formulating with/for specific properties; formulation, processing and production techniques; sensory and elegancy; stability and preservation; color cosmetics; sunscreens; Offering valuable guidance to troubleshooting issues regarding ingredient selection and interaction, regulatory concerns that must be addressed early in development, and the extrapolation of preservative systems, fragrances, stability and texture aids; Exploring the advantages and limitations of raw materials; Addressing scale-up and pilot production process and concerns; Testing and Measurements Methods. The 22 chapters written by industry experts such as Roger L. McMullen, Paul Thau, Hemi Nae, Ada Polla, Howard Epstein, Joseph Albanese, Mark Chandler, Steve Herman, Gary Kelm, Patricia Aikens, and Sam Shefer, along with many others, give the reader and user the ultimate handbook on topical product development.