Mucosal Delivery Of Biopharmaceuticals

Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals.​ Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities.

Advances in biotechnology have provided scientists with an increasing number of biopharmaceuticals such as novel peptide and protein drugs as well as nucleic acid based drugs for gene therapy. However, successful delivery of these biopharmaceuticals is a major challenge because their molecular properties lead to poor physical and chemical stability in the body and limited membrane permeability. Therefore researchers are developing a range of new delivery technologies and materials to enable these new drugs to be delivered intact to their target sites. Delivery Technologies for Biopharmaceuticals describes strategies to overcome the main barriers for successful delivery of therapeutic peptides, proteins, and nucleic acid-based drugs or vaccines related to the site of administration and the target site. Many of the approaches described are reported in formulations in current clinical trials as well as in marketed products. Contents include: challenges in delivery of biopharmaceuticals novel formulation approaches for peptide and protein injectables non-viral chemical vectors and viral technology for delivery of nucleic acid based drugs immune response, adjuvants and delivery systems for vaccines several examples of delivery systems for different biopharmaceuticals a critical assessment of delivery technologies for biopharmaceuticals Delivery Technologies for Biopharmaceuticals is an essential single-volume introduction to the technologies used by researchers to ensure efficient delivery of this exciting new class of drugs. It will be of value to researchers and students working in drug delivery, formulation, biopharmaceuticals, medicinal chemistry, and new materials development.

This volume provides a comprehensive overview of the current issues facing scientists working on delivering drugs locally and systemically via the membranes that line the mouth. The book describes the anatomical and physiological challenges of this route for drug delivery and how they impact the design of oral mucosal drug delivery systems. It also provides a detailed description of current oral mucosal drug delivery technologies that overcome these challenges alongside research, development and assessment methods. In 11 authoritative chapters, the book affords an in-depth evaluation of the major issues associated with this route of administration, namely the retention of the drug/product at the site of administration and increasing drug permeability through the oral mucosa. The book provides insights into the in vitro and in vivo methods available to assess drug permeability and retention, offers solutions on how to improve the permeation of the drugs through the oral mucosa, and explores approaches to prolong drug/product retention at the site of administration. It also indicates future directions in research and product development. Oral Mucosal Drug Delivery and Therapy is a key resource for those wishing to extend their knowledge of this field.

This book focuses on the application of nanotechnology to deliver drugs and biological agents by the mucosal routes of administration i.e. nasal, pulmonary, buccal, and oral routes.It provides an overview of nanotechnology in drug delivery with a description of different types of nanoparticles, methods of preparation and characterization, and functionalization for site-specific drug delivery. Mucosal Delivery of Drugs and Biologics in Nanoparticles emphasize the use of nanoparticles in treating various cancers and infectious diseases. It broadens the use of nanoparticles by including biologics, including vaccines and immunotherapies, apart from drugs. It acknowledges the concerns around the potential toxicity of nanoparticles to the host; few chapters will discuss the biodistribution of these nanoparticles when mucosal routes of administration are employed. Further, the interaction of nanoparticles with the host's immune cells is discussed. Moreover,it reviews the regulatory aspects of nanotechnology in product development, especially when delivered by the mucosal route of administration. Lastly, discusses the challenges and opportunities to manufacture nanoparticles on an industrial scale. This book will be the first of its kind to focus on the design, development and delivery of nanoparticles when administered by different mucosal routes.

Nanotechnology has revolutionized the approach to designing and developing novel drug delivery systems. The last two decades have seen a great interest in the use of nanotechnology to offer efficient ways of delivering new and existing drugs and macromolecules. The focus of this book is the application of nanotechnology to deliver drugs and biological agents by the mucosal routes of administration i.e. nasal, pulmonary, buccal, and oral routes. It provides an overview of nanotechnology in drug delivery with a description of different types of nanoparticles, methods of preparation and characterization, and functionalization for site-specific drug delivery. The emphasis is on the use of nanoparticles in treating various cancers and infectious diseases. It broadens the use of nanoparticles by including biologics, including vaccines and immunotherapies, apart from drugs and acknowledges the concerns around the potential toxicity of nanoparticles to the host; several chapters will discuss the biodistribution of these nanoparticles when mucosal routes of administration are employed. Further, the interaction of nanoparticles with the host’s immune cells is discussed. Moreover, it reviews the regulatory aspects of nanotechnology in product development, especially when delivered by the mucosal route of administration. Lastly, discusses the challenges and opportunities to manufacture nanoparticles on an industrial scale. This book is the first of its kind to focus on the design, development and delivery of nanoparticles when administered by different mucosal routes.

Chitosan is a linear polysaccharide commercially produced by the deacetylation of chitin. It is non-toxic, biodegradable, biocompatible, and acts as a bioadhesive with otherwise unstable biomolecules - making it a valuable component in the formulation of biopharmaceutical drugs. Chitosan-Based Systems for Biopharmaceuticals provides an extensive overview of the application of chitosan and its derivatives in the development and optimisation of biopharmaceuticals. The book is divided in four different parts. Part I discusses general aspects of chitosan and its derivatives, with particular emphasis on issues related to the development of biopharmaceutical chitosan-based systems. Part II deals with the use of chitosan and derivatives in the formulation and delivery of biopharmaceuticals, and focuses on the synergistic effects between chitosan and this particular subset of pharmaceuticals. Part III discusses specific applications of chitosan and its derivatives for biopharmaceutical use. Finally, Part IV presents diverse viewpoints on different issues such as regulatory, manufacturing and toxicological requirements of chitosan and its derivatives related to the development of biopharmaceutical products, as well as their patent status, and clinical application and potential. Topics covered include: chemical and technological advances in chitins and chitosans useful for the formulation of biopharmaceuticals physical properties of chitosan and derivatives in sol and gel states absorption promotion properties of chitosan and derivatives biocompatibility and biodegradation of chitosan and derivatives biological and pharmacological activity of chitosan and derivatives biological, chemical and physical compatibility of chitosan and biopharmaceuticals approaches for functional modification or crosslinking of chitosan use of chitosan and derivatives in conventional biopharmaceutical dosage forms manufacture techniques of chitosan-based microparticles and nanoparticles for biopharmaceuticals chitosan and derivatives for biopharmaceutical use: mucoadhesive properties chitosan-based systems for mucosal delivery of biopharmaceuticals chitosan-based delivery systems for mucosal vaccination chitosan-based nanoparticulates for oral delivery of biopharmaceuticals chitosan-based systems for ocular delivery of biopharmaceuticals chemical modification of chitosan for delivery of DNA and siRNA target-specific chitosan-based nanoparticle systems for nucleic acid delivery functional PEGylated chitosan systems for biopharmaceuticals stimuli-sensitive chitosan-based systems for biopharmaceuticals chitosan copolymers for biopharmaceuticals application of chitosan for anti-cancer biopharmaceutical delivery chitosan-based biopharmaceuticals scaffolds in tissue engineering and regenerative medicine wound healing properties of chitosan and its use in wound dressing biopharmaceuticals toxicological properties of chitosan and derivatives for biopharmaceutical applications regulatory status of chitosan and derivatives patentability and intellectual property issues quality control and good manufacturing practice preclinical and clinical use of chitosan and derivatives for biopharmaceuticals Chitosan-Based Systems for Biopharmaceuticals is an important compendium of fundamental concepts, practical tools and applications of chitosan-based biopharmaceuticals for researchers in academia and industry working in drug formulation and delivery, biopharmaceuticals, medicinal chemistry, pharmacy, bioengineering and new materials development.

A natural long-chain polymer, chitin is the main component of the cell walls of fungi, the exoskeletons of arthropods (including crustaceans and insects), the radulas of mollusks, and the beaks and internal shells of cephalopods. However, marine crustacean shells are the primary sources of the chitin derivative chitosan. Chitin and chitosan are use

Mucoadhesive polymers are widely used in the design of dosage forms for transmucosal drug delivery to the eye, respiratory, gastrointestinal and reproductive tracts. These routes of drug administration offer a number of advantages including improved drug bioavailability, reduced frequency of administration, and the avoidance for the use of injections. This book represents a collection of reviews and original research articles in the area of mucoadhesive polymers and dosage forms. It covers the design of mucoadhesive forms from commercially-available water-soluble polymers, their mixture and complexes as well as some materials, whose mucoadhesive properties were enhanced through chemical modification. With contributions from leading experts in mucoadhesive polymers and formulations, this book will be a very useful source of information for researchers in polymer, pharmaceutical and formulation sciences.