Author: Dennis Douroumis Publisher: John Wiley & Sons ISBN: 1118307879 Category : Science Languages : en Pages : 404
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.
Author: Michael A. Repka Publisher: Springer Science & Business Media ISBN: 1461484324 Category : Medical Languages : en Pages : 472
Book Description
This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.
Author: Navnit Shah Publisher: Springer ISBN: 1493915983 Category : Medical Languages : en Pages : 702
Book Description
This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol®, and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems. Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.
Author: Ajit S Narang Publisher: Springer ISBN: 3319202065 Category : Medical Languages : en Pages : 700
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.
Author: Clive G. Wilson Publisher: Springer Science & Business Media ISBN: 1461410045 Category : Medical Languages : en Pages : 415
Book Description
Controlled Release in Oral Drug Delivery provides focus on specific topics, complementing other books in the initial CRS series. Each chapter sets the context for the inventions described and describe the latitude that the inventions allow. In order to provide some similar look to each chapter, the coverage includes the historical overview, candidate drugs, factors influencing design and development, formulation and manufacturing and delivery system design. This volume was written along three main sections: the relevant anatomy and physiology, a discussion on candidates for oral drug delivery and the major three groups of controlled release systems: diffusion control (swelling and inert matrices); environmental control (pH sensitive coatings, time control, enzymatic control, pressure control) and finally lipidic systems.
Author: Harsha Kharkwal Publisher: CABI ISBN: 1780644477 Category : Medical Languages : en Pages : 218
Book Description
Natural polymers have been utilized extensively in food, pharmaceuticals, cosmetics, textiles, oil drilling and paint industries. Their non-toxic and inexpensive attributes readily enhance their commercial acceptability and make them potent agents in lieu of synthetic polymers. This book explores the opportunistic utility of natural polymers in developing effective drug delivery systems and provides a comprehensive and up-to-date analysis of their source, chemical structure and mechanism of action. Covering novel polymers for drug delivery - in particular extracts from plants, microorganisms and proteins, as well as water soluble and water insoluble biodegradable polymers - it presents an encyclopaedic overview of natural polymers'. Natural Polymers for Drug Delivery is an invaluable resource for researchers, students and industrial scientists in the fields of biochemistry, chemistry, pharmacology and food science.
Author: Mohammed Maniruzzaman Publisher: Smithers Rapra ISBN: 1910242128 Category : Science Languages : en Pages : 249
Book Description
Over the past few decades, hot-melt extrusion (HME) techniques have been shown to exhibit remarkable potential for the manufacture of various pharmaceutical products. HME is an emerging processing technology used primarily for the manufacture of pharmaceutical solid dispersions, combining the advantages of a solvent-free process with fewer production steps making it suitable for easy to scale-up and continuous manufacturing applications. A single unit HME based operation, employing heat and mechanical shear, has displayed a significant potential to retain the stability even of thermo-labile therapeutics e.g., proteins. HME has now explicitly been established from a quality-by-design viewpoint for in-line data monitoring as per the recent guidelines issued by the US Food and Drugs Administration (FDA).This book will focus primarily on the foregoing subject areas and will be of significant interest to a broad/interdisciplinary readership across the industries and academia for, (but not limited to) the following reasons:- Emerging HME processes and applications for multiple drug delivery.- Solid-state engineering, solubility enhancement, controlled release, taste masking and sustained release case studies from a continuous manufacturing view-point.- Means to explore the potential of continuous manufacture of co-crystals for promoting solvent free production methods.- Scale-up case study and issue considerations and studies on the regulatory guidelines (FDA) for continuous manufacturing involving emerging HME techniques.
Author: Harold F. Giles Jr Publisher: William Andrew ISBN: 1437734820 Category : Technology & Engineering Languages : en Pages : 638
Book Description
The second edition of Extrusion is designed to aid operators, engineers, and managers in extrusion processing in quickly answering practical day-to-day questions. The first part of the book provides the fundamental principles, for operators and engineers, of polymeric materials extrusion processing in single and twin screw extruders. The next section covers advanced topics including troubleshooting, auxiliary equipment, and coextrusion for operators, engineers, and managers. The final part provides applications case studies in key areas for engineers such as compounding, blown film, extrusion blow molding, coating, foam, and reprocessing. This practical guide to extrusion brings together both equipment and materials processing aspects. It covers basic and advanced topics, for reference and training, in thermoplastics processing in the extruder. Detailed reference data are provided on such important operating conditions as temperatures, start-up procedures, shear rates, pressure drops, and safety. - A practical guide to the selection, design and optimization of extrusion processes and equipment - Designed to improve production efficiency and product quality - Focuses on practical fault analysis and troubleshooting techniques
Author: Munmaya Mishra Publisher: CRC Press ISBN: 1482232340 Category : Medical Languages : en Pages : 1516
Book Description
The field of encapsulation, especially microencapsulation, is a rapidly growing area of research and product development. The Handbook of Encapsulation and Controlled Release covers the entire field, presenting the fundamental processes involved and exploring how to use those processes for different applications in industry. Written at a level comp
Author: Lisa C. du Toit Publisher: Elsevier ISBN: 0128184728 Category : Technology & Engineering Languages : en Pages : 318
Book Description
Advanced 3D-Printed Systems and Nanosystems for Drug Delivery and Tissue Engineering explores the intricacies of nanostructures and 3D printed systems in terms of their design as drug delivery or tissue engineering devices, their further evaluations and diverse applications. The book highlights the most recent advances in both nanosystems and 3D-printed systems for both drug delivery and tissue engineering applications. It discusses the convergence of biofabrication with nanotechnology, constructing a directional customizable biomaterial arrangement for promoting tissue regeneration, combined with the potential for controlled bioactive delivery. These discussions provide a new viewpoint for both biomaterials scientists and pharmaceutical scientists. - Shows how nanotechnology and 3D printing are being used to create systems which are intelligent, biomimetic and customizable to the patient - Explores the current generation of nanostructured 3D printed medical devices - Assesses the major challenges of using 3D printed nanosystems for the manufacture of new pharmaceuticals
Author: Dennis Douroumis
Author: Michael A. Repka
Author: Navnit Shah
Author: Ajit S Narang
Author: Clive G. Wilson
Author: Harsha Kharkwal
Author: Mohammed Maniruzzaman
Author: Harold F. Giles Jr
Author: Munmaya Mishra
Author: Lisa C. du Toit