Pharmaceutical Amorphous Solid Dispersions

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Pharmaceutical Amorphous Solid Dispersions

Ann Newman

Author : Ann Newman
Publisher : John Wiley & Sons
Page : 502 pages
File Size : 45,7 Mb
Release : 2015-03-09
Category : Science
ISBN : 9781118455203

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Pharmaceutical Amorphous Solid Dispersions by Ann Newman Pdf

Providing a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology – a leading platform to deliver poorly water soluble drugs, a major hurdle in today’s pharmaceutical industry. • Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems • Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations • Has an appendix with structure and property information for polymers commonly used in drug development and with marketed drugs developed using the amorphous sold dispersion approach • Addresses global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world

Pharmaceutical Amorphous Solid Dispersions

Ann Newman

Author : Ann Newman
Publisher : John Wiley & Sons
Page : 504 pages
File Size : 54,5 Mb
Release : 2015-02-27
Category : Science
ISBN : 9781118901380

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Pharmaceutical Amorphous Solid Dispersions by Ann Newman Pdf

Providing a roadmap from early to late stages of drug development,this book overviews amorphous solid dispersion technology – aleading platform to deliver poorly water soluble drugs, a majorhurdle in today’s pharmaceutical industry. • Helps readers understand amorphous solid dispersionsand apply techniques to particular pharmaceutical systems • Covers physical and chemical properties, screening,scale-up, formulation, drug product manufacture, intellectualproperty, and regulatory considerations • Has an appendix with structure and propertyinformation for polymers commonly used in drug development and withmarketed drugs developed using the amorphous sold dispersionapproach • Addresses global regulatory issues including USAregulations, ICH guidelines, and patent concerns around theworld

Amorphous Solid Dispersions

Navnit Shah,Harpreet Sandhu,Duk Soon Choi,Hitesh Chokshi,A. Waseem Malick

Author : Navnit Shah,Harpreet Sandhu,Duk Soon Choi,Hitesh Chokshi,A. Waseem Malick
Publisher : Springer
Page : 702 pages
File Size : 55,5 Mb
Release : 2014-11-21
Category : Medical
ISBN : 9781493915989

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Amorphous Solid Dispersions by Navnit Shah,Harpreet Sandhu,Duk Soon Choi,Hitesh Chokshi,A. Waseem Malick Pdf

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.

Solid Dispersions for Drug Delivery

Vitaliy Khutoryanskiy,Hisham Al-Obaidi

Author : Vitaliy Khutoryanskiy,Hisham Al-Obaidi
Publisher : Unknown
Page : 243 pages
File Size : 52,5 Mb
Release : 2022
Category : Electronic
ISBN : 3036526382

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Solid Dispersions for Drug Delivery by Vitaliy Khutoryanskiy,Hisham Al-Obaidi Pdf

Since their first application in the improvement of solubility of orally delivered drugs, applications of solid dispersions have considerably expanded to include cancer, infections, and inflammatory conditions. This book presents recent advancements in the development and use of solid dispersions for different therapeutic applications. This book can be particularly useful for researchers as well as postgraduate students in formulation sciences and drug delivery. Undergraduate students will also find elements of this book very relevant to scientific fundamentals such as solubility and crystallization of amorphous materials as well as drug delivery challenges.

Amorphous Drugs

Marzena Rams-Baron,Renata Jachowicz,Elena Boldyreva,Deliang Zhou,Witold Jamroz,Marian Paluch

Author : Marzena Rams-Baron,Renata Jachowicz,Elena Boldyreva,Deliang Zhou,Witold Jamroz,Marian Paluch
Publisher : Springer
Page : 230 pages
File Size : 43,8 Mb
Release : 2018-02-09
Category : Science
ISBN : 9783319720029

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Amorphous Drugs by Marzena Rams-Baron,Renata Jachowicz,Elena Boldyreva,Deliang Zhou,Witold Jamroz,Marian Paluch Pdf

This book explains theoretical and technological aspects of amorphous drug formulations. It is intended for all those wishing to increase their knowledge in the field of amorphous pharmaceuticals. Conversion of crystalline material into the amorphous state, as described in this book, is a way to overcome limited water solubility of drug formulations, in this way enhancing the chemical activity and bioavailability inside the body. Written by experts from various fields and backgrounds, the book introduces to fundamental physical aspects (explaining differences between the ordered and the disordered solid states, the enhancement of solubility resulting from drugs amorphization, physical instability and how it can be overcome) as well as preparation and formulation procedures to produce and stabilize amorphous pharmaceuticals. Readers will thus gain a well-funded understanding and find a multi-faceted discussion of the properties and advantages of amorphous drugs and of the challenges in producing and stabilizing them. The book is an ideal source of information for researchers and students as well as professionals engaged in research and development of amorphous pharmaceutical products.

Pharmaceutical Solid Dispersion Technology

Muhammad J. Habib

Author : Muhammad J. Habib
Publisher : CRC Press
Page : 114 pages
File Size : 48,6 Mb
Release : 2000-10-05
Category : Medical
ISBN : 1566768136

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Pharmaceutical Solid Dispersion Technology by Muhammad J. Habib Pdf

There has not, until now, been a single up-to-date volume to provide those in drug R&D with practical information on all aspects of solid dispersion technology for drugs. This forthcoming volume finally provides such a guide and reference. The unified presentation by a team of specialists in this field is designed for practical application. Theoretical concepts are covered for a fuller understanding of current techniques. All significant recent developments are included.

Recent Progress in Solid Dispersion Technology

Kohsaku Kawakami

Author : Kohsaku Kawakami
Publisher : MDPI
Page : 202 pages
File Size : 42,9 Mb
Release : 2019-10-01
Category : Science
ISBN : 9783039215010

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Recent Progress in Solid Dispersion Technology by Kohsaku Kawakami Pdf

Amorphous solid dispersion (ASD) is a powerful formulation technology to improve oral absorption of poorly soluble drugs. Despite their being in existence for more than half a century, controlling ASD performance is still regarded as difficult because of ASD’s natural non-equilibrium. However, recent significant advances in ASD knowledge and technology may enable a much broader use of ASD technology. This Special Issue, which includes 3 reviews and 6 original articles, focuses on recent progresses in ASD technology in hopes of helping to accelerate developmental studies in the pharmaceutical industry. In striving for a deep understanding of ASD non-equilibrium behavior, the Special issue also delves into and makes progress in the theory of soft-matter dynamics.

Solid-State Properties of Pharmaceutical Materials

Stephen R. Byrn,George Zografi,Xiaoming (Sean) Chen

Author : Stephen R. Byrn,George Zografi,Xiaoming (Sean) Chen
Publisher : John Wiley & Sons
Page : 432 pages
File Size : 54,8 Mb
Release : 2017-07-12
Category : Science
ISBN : 9781119264446

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Solid-State Properties of Pharmaceutical Materials by Stephen R. Byrn,George Zografi,Xiaoming (Sean) Chen Pdf

Presents a detailed discussion of important solid-state properties, methods, and applications of solid-state analysis Illustrates the various phases or forms that solids can assume and discussesvarious issues related to the relative stability of solid forms and tendencies to undergo transformation Covers key methods of solid state analysis including X-ray powder diffraction, thermal analysis, microscopy, spectroscopy, and solid state NMR Reviews critical physical attributes of pharmaceutical materials, mainly related to drug substances, including particle size/surface area, hygroscopicity, mechanical properties, solubility, and physical and chemical stability Showcases the application of solid state material science in rational selection of drug solid forms, analysis of various solid forms within drug substance and the drug product, and pharmaceutical product development Introduces appropriate manufacturing and control procedures using Quality by Design, and other strategies that lead to safe and effective products with a minimum of resources and time

Hot-Melt Extrusion

Dennis Douroumis

Author : Dennis Douroumis
Publisher : John Wiley & Sons
Page : 404 pages
File Size : 45,6 Mb
Release : 2012-04-24
Category : Science
ISBN : 9781118307878

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Hot-Melt Extrusion by Dennis Douroumis Pdf

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.

Formulating Poorly Water Soluble Drugs

Robert O. Williams III,Alan B. Watts,Dave A. Miller

Author : Robert O. Williams III,Alan B. Watts,Dave A. Miller
Publisher : Springer Science & Business Media
Page : 656 pages
File Size : 50,5 Mb
Release : 2011-12-04
Category : Medical
ISBN : 9781461411444

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Formulating Poorly Water Soluble Drugs by Robert O. Williams III,Alan B. Watts,Dave A. Miller Pdf

This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds. Further, this book is designed to provide practical guidance for overcoming formulation challenges toward the end goal of improving drug therapies with poorly water-soluble drugs. Enhancing solubility via formulation intervention is a unique opportunity in which formulation scientists can enable drug therapies by creating viable medicines from seemingly undeliverable molecules. With the ever increasing number of poorly water-soluble compounds entering development, the role of the formulation scientist is growing in importance. Also, knowledge of the advanced analytical, formulation, and process technologies as well as specific regulatory considerations related to the formulation of these compounds is increasing in value. Ideally, this book will serve as a useful tool in the education of current and future generations of scientists, and in this context contribute toward providing patients with new and better medicines.

Melt Extrusion

Michael A. Repka,Nigel Langley,James DiNunzio

Author : Michael A. Repka,Nigel Langley,James DiNunzio
Publisher : Springer Science & Business Media
Page : 472 pages
File Size : 49,6 Mb
Release : 2013-10-11
Category : Medical
ISBN : 9781461484325

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Melt Extrusion by Michael A. Repka,Nigel Langley,James DiNunzio Pdf

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.

Polymorphism in the Pharmaceutical Industry

Rolf Hilfiker,Markus von Raumer

Author : Rolf Hilfiker,Markus von Raumer
Publisher : John Wiley & Sons
Page : 618 pages
File Size : 47,9 Mb
Release : 2019-01-04
Category : Science
ISBN : 9783527697854

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Polymorphism in the Pharmaceutical Industry by Rolf Hilfiker,Markus von Raumer Pdf

"Polymorphism in the Pharmaceutical Industry - Solid Form and Drug Development" highlights the relevance of polymorphism in modern pharmaceutical chemistry, with a focus on quality by design (QbD) concepts. It covers all important issues by way of case studies, ranging from properties and crystallization, via thermodynamics, analytics and theoretical modelling right up to patent issues. As such, the book underscores the importance of solid-state chemistry within chemical and pharmaceutical development. It emphasizes why solid-state issues are important, the approaches needed to avoid problems and the opportunities offered by solid-state properties. The authors include true polymorphs as well as solvates and hydrates, while providing information on physicochemical properties, crystallization thermodynamics, quantum-mechanical modelling, and up-scaling. Important analytical tools to characterize solid-state forms and to quantify mixtures are summarized, and case studies on solid-state development processes in industry are also provided. Written by acknowledged experts in the field, this is a high-quality reference for researchers, project managers and quality assurance managers in pharmaceutical, agrochemical and fine chemical companies as well as for academics and newcomers to organic solid-state chemistry.

Chemical Engineering in the Pharmaceutical Industry

Mary T. am Ende,David J. am Ende

Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Page : 1435 pages
File Size : 50,5 Mb
Release : 2019-04-08
Category : Technology & Engineering
ISBN : 9781119285502

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Chemical Engineering in the Pharmaceutical Industry by Mary T. am Ende,David J. am Ende Pdf

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Metastable Liquids

Pablo G. Debenedetti

Author : Pablo G. Debenedetti
Publisher : Princeton University Press
Page : 432 pages
File Size : 40,7 Mb
Release : 2020-06-16
Category : Science
ISBN : 9780691213941

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Metastable Liquids by Pablo G. Debenedetti Pdf

Metastable Liquids provides a comprehensive treatment of the properties of liquids under conditions where the stable state is a vapor, a solid, or a liquid mixture of different composition. It examines the fundamental principles that govern the equilibrium properties, stability, relaxation mechanisms, and relaxation rates of metastable liquids. Building on the interplay of kinetics and thermodynamics that determines the thermophysical properties and structural relaxation of metastable liquids, it offers an in-depth treatment of thermodynamic stability theory, the statistical mechanics of metastability, nucleation, spinodal decomposition, supercooled liquids, and the glass transition. Both traditional topics--such as stability theory--and modern developments--including modern theories of nucleation and the properties of supercooled and glassy water--are treated in detail. An introductory chapter illustrates, with numerous examples, the importance and ubiquity of metastable liquids. Examples include the ascent of sap in plants, the strategies adopted by many living organisms to survive prolonged exposure to sub-freezing conditions, the behavior of proteins at low temperatures, metastability in mineral inclusions, ozone depletion, the preservation and storage of labile biochemicals, and the prevention of natural gas clathrate hydrate formation. All mathematical symbols are defined in the text and key equations are clearly explained. More complex mathematical explanations are available in the appendixes.

Developing Solid Oral Dosage Forms

Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri

Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publisher : Academic Press
Page : 1178 pages
File Size : 48,5 Mb
Release : 2016-11-08
Category : Medical
ISBN : 9780128026373

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Developing Solid Oral Dosage Forms by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri Pdf

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Pharmaceutical Amorphous Solid Dispersions

Pharmaceutical Amorphous Solid Dispersions by Ann Newman Pdf

Pharmaceutical Amorphous Solid Dispersions by Ann Newman Pdf

Amorphous Solid Dispersions by Navnit Shah,Harpreet Sandhu,Duk Soon Choi,Hitesh Chokshi,A. Waseem Malick Pdf

Solid Dispersions for Drug Delivery by Vitaliy Khutoryanskiy,Hisham Al-Obaidi Pdf

Amorphous Drugs by Marzena Rams-Baron,Renata Jachowicz,Elena Boldyreva,Deliang Zhou,Witold Jamroz,Marian Paluch Pdf

Pharmaceutical Solid Dispersion Technology by Muhammad J. Habib Pdf

Recent Progress in Solid Dispersion Technology by Kohsaku Kawakami Pdf

Solid-State Properties of Pharmaceutical Materials by Stephen R. Byrn,George Zografi,Xiaoming (Sean) Chen Pdf

Hot-Melt Extrusion by Dennis Douroumis Pdf

Formulating Poorly Water Soluble Drugs by Robert O. Williams III,Alan B. Watts,Dave A. Miller Pdf

Melt Extrusion by Michael A. Repka,Nigel Langley,James DiNunzio Pdf

Polymorphism in the Pharmaceutical Industry by Rolf Hilfiker,Markus von Raumer Pdf

Chemical Engineering in the Pharmaceutical Industry by Mary T. am Ende,David J. am Ende Pdf

Metastable Liquids by Pablo G. Debenedetti Pdf

Developing Solid Oral Dosage Forms by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri Pdf

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