Advances in Pharmaceutical Technology

Drug therapy via inhalation route is at the cutting edge of modern drug delivery research. There has been significant progress on the understanding of drug therapy via inhalation products. However, there are still problems associated with their formulation design, including the interaction between the active pharmaceutical ingredient(s) (APIs), excipients and devices. This book seeks to cover some of the most pertinent issues and challenges of such formulation design associated with industrial production and desirable clinical outcome. The chapter topics have been selected with a view to integrating the factors that require consideration in the selection and design of device and formulation components which impact upon patient usability and clinical effectiveness. The challenges involved with the delivery of macromolecules by inhalation to both adult and pediatric patients are also covered. Written by leading international experts from both academia and industry, the book will help readers (formulation design scientists, researchers and post-graduate and specialized undergraduate students) develop a deep understanding of key aspects of inhalation formulations as well as detail ongoing challenges and advances associated with their development.

Provides an extensive and up-to-date overview of the theory and application of computational pharmaceutics in the drug development process Exploring Computational Pharmaceutics - AI and Modeling in Pharma 4.0 introduces a variety of current and emerging computational techniques for pharmaceutical research. Bringing together experts from academia, industry, and regulatory agencies, this edited volume also explores the current state, key challenges, and future outlook of computational pharmaceutics while encouraging development across all sectors of the field. Throughout the text, the authors discuss a wide range of essential topics, from molecular modeling and process simulation to intelligent manufacturing and quantitative pharmacology. Building upon Exploring Computational Pharmaceutics - AI and Modeling in Pharma 4.0, this new edition provides a multi-scale perspective that reveals the physical, chemical, mathematical, and data-driven details of pre-formulation, formulation, process, and clinical studies, in addition to in vivo prediction in the human body and precision medicine in clinical settings. Detailed chapters address both conventional dosage forms and the application of computational technologies in advanced pharmaceutical research, such as dendrimer-based delivery systems, liposome and lipid membrane research, and inorganic nanoparticles. A major contribution to the development and promotion of computational pharmaceutics, this important resource: • Discusses the development track, achievements, and prospects of computational pharmaceutics • Presents multidisciplinary research to help physicists, chemists, mathematicians, and computer scientists locate problems in the field of drug delivery • Covers a wide range of technologies, including complex formulations for water-insoluble drugs, protein/peptide formulations, nanomedicine, and gene delivery systems • Focuses on the application of cutting-edge computational technologies and intelligent manufacturing of emerging pharmaceutical technologies • Includes a systematic overview of computational pharmaceutics and Pharma 4.0 to assist non-specialist readers Covering introductory, advanced, and specialist topics, Exploring Computational Pharmaceutics - AI and Modeling in Pharma 4.0 is an invaluable resource for computational chemists, computational analysts, pharmaceutical chemists, process engineers, process managers, and pharmacologists, as well as computer scientists, medicinal chemists, clinical pharmacists, material scientists, and nanotechnology specialists working in the field.

Hot-melt extrusion (HME)-melting a substance and forcing it through an orifice under controlled conditions to form a new material-is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. “Hot-Melt Extrusion: Pharmaceutical Applications” covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale-up considerations and regulatory issues. Topics covered include: • principles and die design of single screw extrusion • twin screw extrusion techniques and practices in the laboratory and on production scale • HME developments for the pharmaceutical industry • solubility parameters for prediction of drug/polymer miscibility in HME formulations • the influence of plasticizers in HME • applications of polymethacrylate polymers in HME • HME of ethylcellulose, hypromellose, and polyethylene oxide • bioadhesion properties of polymeric films produced by HME • taste masking using HME • clinical studies, bioavailability and pharmacokinetics of HME products • injection moulding and HME processing for pharmaceutical materials • laminar dispersive & distributive mixing with dissolution and applications to HME • technological considerations related to scale-up of HME processes • devices and implant systems by HME • an FDA perspective on HME product and process understanding • improved process understanding and control of an HME process with near-infrared spectroscopy “Hot-Melt Extrusion: Pharmaceutical Applications” is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science.

Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow. Readers will find insightful discussions of physiologically based modeling as a valuable asset in the biopharmaceutics toolkit and how to apply the principles of the field to special populations. The book goes on to discuss: • Thorough introductions to biopharmaceutics, basic pharmacokinetics, and biopharmaceutics measures • Comprehensive explorations of solubility, permeability, and dissolution • Practical discussions of the use of biopharmaceutics to inform candidate drug selection and optimization, as well as biopharmaceutics tools for rational formulation design • In-depth examinations of biopharmaceutics classification systems and regulatory biopharmaceutics, as well as regulatory biopharmaceutics and the impact of anatomy and physiology Perfect for professionals working in the pharmaceutical and biopharmaceutical industries, Biopharmaceutics - From Fundamentals to Industrial Practice is an incisive and up-to-date resource on the practical, pharmaceutical applications of the field.

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.

Learn about the analytical tools used to characterize particulate drug delivery systems with this comprehensive overview. Edited by a leading expert in the field, “Characterization of Pharmaceutical Nano-and Microsystems” provides a complete description of the analytical techniques used to characterize particulate drug systems on the micro-and nanoscale. The book offers readers a full understanding of the basic physicochemical characteristics, material properties and differences between micro-and nanosystems. It explains how and why greater experience and more reliable measurement techniques are required as particle size shrinks, and the measured phenomena grow weaker. “Characterization of Pharmaceutical Nano-and Microsystems” deals with a wide variety of topics relevant to chemical and solid-state analysis of drug delivery systems, including drug release, permeation, cell interaction, and safety. It is a complete resource for those interested in the development and manufacture of new medicines, the drug development process, and the translation of those drugs into life-enriching and lifesaving medicines. “Characterization of Pharmaceutical Nano-and Microsystems” covers all of the following topics: An introduction to the analytical tools applied to determine particle size, morphology, and shape Common chemical approaches to drug system characterization A description of solid-state characterization of drug systems Drug release and permeation studies Toxicity and safety issues The interaction of drug particles with cells Perfect for pharmaceutical chemists and engineers, as well as all other industry professionals and researchers who deal with drug delivery systems on a regular basis, “Characterization of Pharmaceutical Nano-and Microsystems” also belongs on bookshelves of interested students and faculty who interact with this topic.

The latest research on techniques for effective healing of chronic and difficult to heal wounds The healing of chronic wounds is a global medical concern, specifically for patients suffering from obesity and type II diabetes. Therapeutic Dressing and Wound Healing Applications is an essential text for research labs, industry professionals, and general clinical practitioners that want to make the shift towards advanced therapeutic dressing and groundbreaking wound application for better healing. This book takes a clinical and scientific approach to wound healing, and includes recent case studies to highlight key points and areas of improvement. It is divided into two key sections that include insight into the biochemical basis of wounds, as well as techniques and recent advancements. Chapters include information on: ● Debridement and disinfection properties of wound dressing ● Biofilms, silver nanoparticles, and honey dressings ● Clinical perspectives for treating diabetic wounds ● Treating mixed infections ● Wound healing and tissue regeneration treatments ● Gene based therapy, 3D bioprinting and freeze-dried wafers Anyone looking to update and improve the treatment of chronic wounds for patients will find the latest pertinent information in Therapeutic Dressing and Wound Healing Applications.

Molecular modeling techniques have been widely used in drug discovery fields for rational drug design and compound screening. Now these techniques are used to model or mimic the behavior of molecules and help us study formulation at the molecular level. Computational pharmaceutics enables us to understand the mechanism of drug delivery, and to develop new drug delivery systems. The book discusses the modeling of different drug delivery systems, including cyclodextrins, solid dispersions, polymorphism prediction, dendrimer-based delivery systems, surfactant-based micelle, polymeric drug delivery systems, liposome, protein/peptide formulations, non-viral gene delivery systems, drug-protein binding, silica nanoparticles, carbon nanotube-based drug delivery systems, diamond nanoparticles and layered double hydroxides (LDHs) drug delivery systems. Although there are a number of existing books about rational drug design with molecular modeling techniques, these techniques still look mysterious and daunting for pharmaceutical scientists. This book fills the gap between pharmaceutics and molecular modeling and presents a systematic and overall introduction to computational pharmaceutics. It covers all introductory, advanced and specialist levels. It provides a totally different perspective to pharmaceutical scientists and will greatly facilitate the development of pharmaceutics. It also helps computational chemists to look for the important questions in the drug delivery field.

Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms' performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. • Covers both oral and non-oral dosage forms • Describes current regulatory conditions for in vitro drug release testing • Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.

Provides a review of novel pharmaceutical approaches for Tuberculosis drugs. • Presents a novel perspective on tuberculosis prevention and treatment • Considers the nature of disease, immunological responses, vaccine and drug delivery, disposition and response • Multidisciplinary appeal, with contributions from microbiology, immunology, molecular biology, pharmaceutics, pharmacokinetics, chemical and mechanical engineering

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. • Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing • Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design • Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions • Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, “Continuous Manufacturing of Pharmaceuticals” is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

A practical guide to Quality by Design for pharmaceutical product development “Pharmaceutical Quality by Design: A Practical Approach” outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with “Quality by Design” is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: • Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development • Puts the focus on the industrial aspects of the new QbD approach • Includes several illustrative examples of applications of QbD in practice • Offers advanced specialist topics that can be systematically applied to industry “Pharmaceutical Quality by Design” offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Many newly proposed drugs suffer from poor water solubility, thus presenting major hurdles in the design of suitable formulations for administration to patients. Consequently, the development of techniques and materials to overcome these hurdles is a major area of research in pharmaceutical companies. “Drug Delivery Strategies for Poorly Water-Soluble Drugs” provides a comprehensive overview of currently used formulation strategies for hydrophobic drugs, including liposome formulation, cyclodextrin drug carriers, solid lipid nanoparticles, polymeric drug encapsulation delivery systems, self—microemulsifying drug delivery systems, nanocrystals, hydrosol colloidal dispersions, microemulsions, solid dispersions, cosolvent use, dendrimers, polymer-drug conjugates, polymeric micelles, and mesoporous silica nanoparticles. For each approach the book discusses the main instrumentation, operation principles and theoretical background, with a focus on critical formulation features and clinical studies. Finally, the book includes some recent and novel applications, scale-up considerations and regulatory issues. Drug Delivery Strategies for Poorly Water-Soluble Drugs is an essential multidisciplinary guide to this important area of drug formulation for researchers in industry and academia working in drug delivery, polymers and biomaterials.

3D Printing of Pharmaceutical and Drug Delivery Devices 3D Printing of Pharmaceutical and Drug Delivery Devices Discover the latest, fast-developing technology to help move towards more cost-effective, small-batch, decentralized manufacturing of personalized systems 3D printing has revolutionized manufacturing. Its precision and flexibility have enabled the large-scale production of materials and devices too complex for conventional industrial manufacturing. This has been particularly revolutionary in the field of pharmaceutical production, where 3D printing is being integrated into the manufacture of both drugs and drug delivery devices. It has never been more important for industry professionals to understand this form of production. 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside offers a comprehensive overview of 3D printing technology and its pharmaceutical applications. It introduces readers to a world in which bespoke drug delivery systems developed for specific users or conditions is rapidly becoming a reality. Its detailed coverage of strategies and industrial processes incorporates the latest research and real-world experience of production. 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside readers will also find: • A multi-disciplinary authorial team of industry leaders • Discussion of common technical and regulatory barriers and their possible solutions • Far-ranging discussion of pharmaceutical applications across all sectors 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside is essential reading for pharmaceutical industry professionals and researchers looking to occupy the leading edge.

Nanotechnology in Therapeutics Comprehensive reference delivering a framework to develop and assess nanosystems that provide unique advantages in biomedical applications Nanotechnology in Therapeutics explores the idea that by studying in depth the behavior of living organisms, especially the functionality of their cell membranes, we can develop and evaluate innovative bio-inspired nanosystems that are able to deliver small molecules, biomolecules like proteins, peptides, and other genetic material in terms of the production of new therapies and vaccines. The main concept promoted in this book is an integrated approach for producing new medicines following the nanotoxicity, biotoxicity, regulatory, and ethical guidelines, which are also covered in the book. The book is divided into three parts. Part A provides an introduction and a historical overview of nanotechnology. Part B delves deeper into issues relating to lipid and polymeric nanostructures in medicine. Part C presents the regulatory landscape around nanotechnology and nanomedicine, while highlighting the need to keep an eye on emerging technologies such as artificial intelligence and machine learning. Overall, this book opens up biomedical applications for previously challenging drugs and drug targets. Written by a highly qualified professor with significant pertinent research experience, Nanotechnology in Therapeutics includes discussion on: • Eukaryotic cell membranes, their structural properties, and the thermodynamic payload of their lipid bilayers • The DLVO (Derjaguin, Landau, Verwey and Overbeek) theory as a scientific tool for studying the stability and the behavior of nanoparticles • Liposomes, lipid nanoparticles, and solid lipid nanoparticles, as well as polymeric nanoparticles, like micelles, polymersomes, and dendrimers • Issues in the approval process of nanomedicines by the regulatory agencies, such as complexity, chaos, and nonlinear dynamics With comprehensive coverage of novel concepts that have the potential to transform how new medicines are designed and developed, Nanotechnology in Therapeutics is an essential resource on the subject for chemists in industry, as well as biomedical and pharmaceutical engineers.