Current Advances in Drug Delivery Through Fast Dissolving/Disintegrating Dosage Forms


Book Description

Fast Dissolving/Disintegrating Dosage Forms (FDDFs) have been commercially available since the late 1990s. FDDFs were initially available as orodispersible tablets, and later, as orodipsersible films for treating specific populations (pediatrics, geriatrics, and psychiatric patients). Granules, pellets and mini tablets are among latest additions to these dosage forms, which are still in the development pipeline. As drug delivery systems, FDDFs enable quicker onset of action, immediate drug delivery, and sometimes offer bioavailability benefits due to buccal/sublingual absorption. With time, FDDF have evolved to deliver drugs in a sustained and controlled manner. Their current market and application is increasing in demands with advances in age adapted dosage forms for different patients and changing regulatory requirements that warrant mandatory assessments of new drugs and drug products before commercial availability. This book presents detailed information about FDDFs from their inception to recent developments. Readers will learn about the technical details of various FDDF manufacturing methods, formulation aspects, evaluation and methods to conduct clinical studies. The authors also give examples of marketed fast disintegrating/dissolving drug products in US, Europe, Japan, and India. This reference is ideal for pharmacology students at all levels seeking information about this specific form of drug delivery and formulation.




Drug Delivery to the Oral Cavity


Book Description

With contributions from recognized authorities in industry, academia, and government, this reference presents the state-of-the-art in the testing, formulation, and clinical evaluation of intraoral drug delivery products-summarizing intraoral dosage forms in various stages of research, as well as products currently on the market.




3D Printing of Pharmaceuticals


Book Description

3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.




Polymeric Drug Delivery Systems


Book Description

Emphasizing four major classes of polymers for drug delivery-water-soluble polymers, hydrogels, biodegradable polymers, and polymer assemblies-this reference surveys efforts to adapt, modify, and tailor polymers for challenging molecules such as poorly water-soluble compounds, peptides/proteins, and plasmid DNA.




Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems


Book Description

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.




Excipient Applications in Formulation Design and Drug Delivery


Book Description

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.




Oral Controlled Release Formulation Design and Drug Delivery


Book Description

This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.




Hot-Melt Extrusion


Book Description

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. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.




Polymer Gels


Book Description

This book addresses a range of synthesis and characterization techniques that are critical for tailoring and broadening the various aspects of polymer gels, as well as the numerous advantages that polymer gel-based materials offer. It presents a comprehensive collection of chapters on the recent advances and developments in the science and fundamentals of both synthetic and natural polymer-based gels. Topics covered include: synthesis and structure of physically/chemically cross-linked polymer-gels/polymeric nanogels; gel formation through non-covalent cross-linking; molecular design and characterization; polysaccharide-based polymer gels: synthesis, characterization, and properties; modified polysaccharide gels: silica-based polymeric gels as platforms for the delivery of pharmaceuticals; gel-based approaches in genomic and proteomic sciences; emulgels in drug delivery; and organogels. The book provides a cutting-edge resource for researchers and scientists working in various fields involving polymers, biomaterials, bio-nanotechnology and functional materials.




Recent Development of Electrospinning for Drug Delivery


Book Description

Several promising techniques have been developed to overcome the poor solubility and/or membrane permeability properties of new drug candidates, including different fiber formation methods. Electrospinning is one of the most commonly used spinning techniques for fiber formation, induced by the high voltage applied to the drug-loaded solution. With modifying the characteristics of the solution and the spinning parameters, the functionality-related properties of the formulated fibers can be finely tuned. The fiber properties (i.e., high specific surface area, porosity, and the possibility of controlling the crystalline–amorphous phase transitions of the loaded drugs) enable the improved rate and extent of solubility, causing a rapid onset of absorption. However, the enhanced molecular mobility of the amorphous drugs embedded into the fibers is also responsible for their physical–chemical instability. This Special Issue will address new developments in the area of electrospun nanofibers for drug delivery and wound healing applications, covering recent advantages and future directions in electrospun fiber formulations and scalability. Moreover, it serves to highlight and capture the contemporary progress in electrospinning techniques, with particular attention to the industrial feasibility of developing pharmaceutical dosage forms. All aspects of small molecule or biologics-loaded fibrous dosage forms, focusing on the processability, structures and functions, and stability issues, are included.