The Role Of Microstructure In Topical Drug Product Development

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The Role of Microstructure in Topical Drug Product Development

Nigel Langley,Bozena Michniak-Kohn,David W. Osborne
The Role of Microstructure in Topical Drug Product Development Book PDF

Author : Nigel Langley,Bozena Michniak-Kohn,David W. Osborne
Publisher : Springer
Page : 199 pages
File Size : 45,9 Mb
Release : 2019-08-07
Category : Medical
ISBN : 9783030173555

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The Role of Microstructure in Topical Drug Product Development by Nigel Langley,Bozena Michniak-Kohn,David W. Osborne Pdf

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.

Introduction to Cosmetic Formulation and Technology

Gabriella Baki
Introduction to Cosmetic Formulation and Technology Book PDF

Author : Gabriella Baki
Publisher : John Wiley & Sons
Page : 836 pages
File Size : 50,5 Mb
Release : 2022-12-12
Category : Science
ISBN : 9781119709831

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Introduction to Cosmetic Formulation and Technology by Gabriella Baki Pdf

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.

Compounded Topical Pain Creams

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams
Compounded Topical Pain Creams Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams
Publisher : National Academies Press
Page : 353 pages
File Size : 51,7 Mb
Release : 2020-07-21
Category : Medical
ISBN : 9780309672184

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Compounded Topical Pain Creams by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams Pdf

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.

Dermatological Drug Development

Tomoko Maeda-Chubachi,Elizabeth Kernodle Hussey,Sylvia Furst
Dermatological Drug Development Book PDF

Author : Tomoko Maeda-Chubachi,Elizabeth Kernodle Hussey,Sylvia Furst
Publisher : Cambridge Scholars Publishing
Page : 146 pages
File Size : 42,8 Mb
Release : 2020-09-18
Category : Medical
ISBN : 9781527559677

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Dermatological Drug Development by Tomoko Maeda-Chubachi,Elizabeth Kernodle Hussey,Sylvia Furst Pdf

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).

Biological Drug Products

Wei Wang,Manmohan Singh
Biological Drug Products Book PDF

Author : Wei Wang,Manmohan Singh
Publisher : Wiley
Page : 0 pages
File Size : 43,8 Mb
Release : 2013-10-07
Category : Medical
ISBN : 1118148894

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Biological Drug Products by Wei Wang,Manmohan Singh Pdf

Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.

Food and Drug Administration’s Role in Dermatology, An Issue of Dermatologic Clinics,E-Book

Markham C. Luke
Food and Drug Administration s Role in Dermatology An Issue of Dermatologic Clinics E Book Book PDF

Author : Markham C. Luke
Publisher : Elsevier Health Sciences
Page : 121 pages
File Size : 46,5 Mb
Release : 2022-06-24
Category : Medical
ISBN : 9780323849708

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Food and Drug Administration’s Role in Dermatology, An Issue of Dermatologic Clinics,E-Book by Markham C. Luke Pdf

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.

The Art and Science of Dermal Formulation Development

Marc B. Brown,Adrian C. Williams
The Art and Science of Dermal Formulation Development Book PDF

Author : Marc B. Brown,Adrian C. Williams
Publisher : CRC Press
Page : 248 pages
File Size : 47,6 Mb
Release : 2019-03-01
Category : Medical
ISBN : 9780429596063

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The Art and Science of Dermal Formulation Development by Marc B. Brown,Adrian C. Williams Pdf

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

Aulton's Pharmaceutics E-Book

Kevin M.G. Taylor,Michael E. Aulton
Aulton s Pharmaceutics E Book Book PDF

Author : Kevin M.G. Taylor,Michael E. Aulton
Publisher : Elsevier Health Sciences
Page : 1052 pages
File Size : 42,7 Mb
Release : 2021-04-23
Category : Medical
ISBN : 9780702081569

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Aulton's Pharmaceutics E-Book by Kevin M.G. Taylor,Michael E. Aulton Pdf

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

Pharmaceutical Drug Product Development and Process Optimization

Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda
Pharmaceutical Drug Product Development and Process Optimization Book PDF

Author : Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda
Publisher : CRC Press
Page : 382 pages
File Size : 42,5 Mb
Release : 2020-05-01
Category : Business & Economics
ISBN : 9781000731323

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Pharmaceutical Drug Product Development and Process Optimization by Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda Pdf

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.

Dermal Drug Delivery

Tapash K. Ghosh
Dermal Drug Delivery Book PDF

Author : Tapash K. Ghosh
Publisher : CRC Press
Page : 409 pages
File Size : 40,8 Mb
Release : 2020-01-21
Category : Medical
ISBN : 9781315356648

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Dermal Drug Delivery by Tapash K. Ghosh Pdf

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.

Percutaneous Absorption

Robert L. Bronaugh,Howard I. Maibach
Percutaneous Absorption Book PDF

Author : Robert L. Bronaugh,Howard I. Maibach
Publisher : CRC Press
Page : 992 pages
File Size : 50,8 Mb
Release : 1999-05-28
Category : Science
ISBN : 1420000942

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Percutaneous Absorption by Robert L. Bronaugh,Howard I. Maibach Pdf

Since publication of the Second Edition in 1989, numerous innovations have occurred that affect the way scientists look at issues in the field of percutaneous absorption. Focusing on recent advances as well as updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption, Third Edition provides thorough coverage of the skin's role as an important portal of entry for chemicals into the body. Assembles the work of nearly 80 experts-30 more than the Second Edition-into a unified, comprehensive volume that contains the latest ideas and research! Complete with nearly 600 drawings, photographs, equations, and tables and more than 1600 bibliographic citations of pertinent literature, Percutaneous Absorption, Third Edition details the applied biology of percutaneous penetration factors that affect skin permeation, such as age, vehicles, metabolism, hydration of skin, and chemical structure in vivo and in vitro techniques for measuring absorption, examining factors influencing methodology such as animal models, volatility of test compound, multiple dosage, and artificial membranes procedures for use in transdermal delivery, exploring topics such as effects of penetration enhancers on absorption, optimizing absorption, and the topical delivery of drugs to muscle tissue And presents new chapters on mathematical models cutaneous metabolism prediction of percutaneous absorption in vitro absorption methodology dermal decontamination concentration of chemicals in skin transdermal drug delivery mechanisms of absorption safety evaluation of cosmetics absorption of drugs and cosmetic ingredients nail penetration Emphasizes human applications-particularly useful for pharmacists, pharmacologists, dermatologists, cosmetic scientists, biochemists, toxicologists, public health officials, manufacturers of cosmetic and toiletry products, and graduate students in these disciplines! An invaluable reference source for readers who need to keep up with the latest developments in the field, Percutaneous Absorption, Third Edition is also an excellent experimental guide for laboratory personnel.

Topical Drug Bioavailability, Bioequivalence, and Penetration

Vinod P. Shah,Howard I. Maibach,John Jenner
Topical Drug Bioavailability Bioequivalence and Penetration Book PDF

Author : Vinod P. Shah,Howard I. Maibach,John Jenner
Publisher : Springer
Page : 393 pages
File Size : 50,6 Mb
Release : 2015-01-30
Category : Medical
ISBN : 9781493912896

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Topical Drug Bioavailability, Bioequivalence, and Penetration by Vinod P. Shah,Howard I. Maibach,John Jenner Pdf

This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.

Theory and Applications of Nonparenteral Nanomedicines

Prashant Kesharwani,Sebastien Taurin,Khaled Greish
Theory and Applications of Nonparenteral Nanomedicines Book PDF

Author : Prashant Kesharwani,Sebastien Taurin,Khaled Greish
Publisher : Academic Press
Page : 542 pages
File Size : 50,9 Mb
Release : 2020-09-12
Category : Medical
ISBN : 9780128204672

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Theory and Applications of Nonparenteral Nanomedicines by Prashant Kesharwani,Sebastien Taurin,Khaled Greish Pdf

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

Specification of Drug Substances and Products

Christopher M. Riley,Thomas W. Rosanske,George L. Reid
Specification of Drug Substances and Products Book PDF

Author : Christopher M. Riley,Thomas W. Rosanske,George L. Reid
Publisher : Elsevier
Page : 696 pages
File Size : 46,6 Mb
Release : 2020-07-23
Category : Science
ISBN : 9780081028254

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Specification of Drug Substances and Products by Christopher M. Riley,Thomas W. Rosanske,George L. Reid Pdf

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Excipient Applications in Formulation Design and Drug Delivery

Ajit S Narang,Sai H S. Boddu
Excipient Applications in Formulation Design and Drug Delivery Book PDF

Author : Ajit S Narang,Sai H S. Boddu
Publisher : Springer
Page : 681 pages
File Size : 41,6 Mb
Release : 2015-10-07
Category : Medical
ISBN : 9783319202068

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Excipient Applications in Formulation Design and Drug Delivery by Ajit S Narang,Sai H S. Boddu Pdf

In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.