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Recent and rapid progress in the field of biotechnology has resulted in an increasing number of novel macromolecular drugs with great promise for further advanced research and clinical application. However, the delivery of these macromolecular drugs by routes other than the parenteral route is difficult. The pipeline of macromolecular drugs derived from biotechnology presents a challenging opportunity to develop practical dosage forms that could be dosed via the oral route. Given this, the successful oral delivery of macromolecular drugs presents an enormous opportunity. Oral Delivery of Macromolecular Drugs will provide an overview of the innovative oral delivery technologies that have demonstrated success in human testing and will go on to cite the challenges, strategies, and future trends that are to be expected.
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The pace of new research and level of innovation repeatedly introduced into the field of drug delivery to the lung is surprising given its state of maturity since the introduction of the pressurized metered dose inhaler over a half a century ago. It is clear that our understanding of pulmonary drug delivery has now evolved to the point that inhalation aerosols can be controlled both spatially and temporally to optimize their biological effects. These abilities include controlling lung deposition, by adopting formulation strategies or device technologies, and controlling drug uptake and release through sophisticated particle technologies. The large number of contributions to the scientific literature and variety of excellent texts published in recent years is evidence for the continued interest in pulmonary drug delivery research. This reference text endeavors to bring together the fundamental theory and practice of controlled drug delivery to the airways that is unavailable elsewhere. Collating and synthesizing the material in this rapidly evolving field presented a challenge and ultimately a sense of achievement that is hopefully reflected in the content of the volume.
Over the past ten years several sophisticated in vitro test systems based on epithelial cell cultures have been introduced in the field of drug delivery. These models have been found to be very useful in characterizing the permeability of drugs across epithelial tissues, and in studying formulations or carrier systems for improved drug delivery and
Innovations in Nanoscience and Nanotechnology summarizes the state of the art in nano-sized materials. The authors focus on innovation aspects and highlight potentials for future developments and applications in health care, including pharmaceutics, dentistry, and cosmetics; information and communications; energy; and chemical engineering. The chapters are written by leading researchers in nanoscience, chemistry, pharmacy, biology, chemistry, physics, engineering, medicine, and social science. The authors come from a range of backgrounds including academia, industry, and national and international laboratories around the world. This book is ideally suited for researchers and students in chemistry, physics, biology, engineering, materials science, and medicine and is a useful guide for industrialists. It aims to provide inspiration for scientists, new ideas for developers and innovators in industry, and guidelines for toxicologists. It also provides guidelines for agencies and government authorities to establish safe working conditions.
The enormous advances in the immunologic aspects of biotherapeutics and nanomedicines in the past two decades has necessitated an authoritative and comprehensive reference source that can be relied upon by immunologists, biomedical researchers, clinicians, pharmaceutical companies, regulators, venture capitalists, and policy makers alike. This text provides a thorough understanding of immunology, therapeutic potential, clinical applications, adverse reactions, and approaches to overcoming immunotoxicity of biotherapeutics and nanomedicines. It also tackles critical, yet often overlooked topics such as immune aspects of nano-bio interactions, current FDA regulatory guidances, complement activation-related pseudoallergy (CARPA), advances in nanovaccines, and immunogenicity testing of protein therapeutics.
Aerosol therapy has significantly improved the treatment of a variety of respiratory diseases. Besides the treatment of respiratory diseases there is currently also a great interest to use the lungs as a portal to introduce drugs for systemic therapy. The success of therapy with the application of aerosolized medicaments depends on the possibility to deliver the proper amount of drug to the appropriate sites in the respiratory system, thus limiting the side effects to a minimum. Aerosolized delivery of drugs to the lung is optimized if, for a given chemical composition of a medicine, the target of deposition and the required mass of drug to be deposited are precisely defined. The next step is the specification of the number of respirable particles or droplets, to be generated by appropriate devices. Another very important factor for successful aerosol therapy is the condition of the patient coupled with his or her inhalation technique.
These volumes represent a comprehensive guide to prodrugs. They guide the reader through the current status of the prodrug concept and its many applications and highlight its many successes in overcoming formulation and delivery of problematic drugs. Replete with examples of approved and marketed prodrugs, these volumes introduce the topic to the novice as well as professional in the design of prodrugs.
The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.
This book discusses basics of brain diseases and the role of nanobiotechnology in existing treatment options for neurodegenerative disorders. It begins with an overview of brain diseases and the need for novel drug-delivery approaches. It highlights the current route for the intranasal advanced drug-delivery systems for brain diseases. It also discusses innovative categories of drug-delivery systems, including mesoporous silica nanoparticles, polymeric nanocarriers, and lipid-based nanocarriers through multi-responsive DDSs and their implications in brain disorders. Features: Includes an overview of brain diseases and highlights the need for novel drug-delivery approaches Focuses on theoreti...