Amorphous Solid Dispersions

Author : Navnit Shah,Harpreet Sandhu,Duk Soon Choi,Hitesh Chokshi,A. Waseem Malick
Publisher : Springer
Page : 699 pages
File Size : 47,8 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.

Author : Ann Newman
Publisher : John Wiley & Sons
Page : 502 pages
File Size : 54,9 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

Author : Ann Newman
Publisher : John Wiley & Sons
Page : 504 pages
File Size : 47,7 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

Author : Vitaliy Khutoryanskiy,Hisham Al-Obaidi
Publisher : Mdpi AG
Page : 244 pages
File Size : 51,5 Mb
Release : 2022-01-11
Category : Science
ISBN : 3036526390

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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.

Author : Dennis Douroumis
Publisher : John Wiley & Sons
Page : 404 pages
File Size : 43,5 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.

Author : Michael A. Repka,Nigel Langley,James DiNunzio
Publisher : Springer Science & Business Media
Page : 474 pages
File Size : 43,6 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.

Author : Kohsaku Kawakami
Publisher : MDPI
Page : 202 pages
File Size : 46,7 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.

Author : Marzena Rams-Baron,Renata Jachowicz,Elena Boldyreva,Deliang Zhou,Witold Jamroz,Marian Paluch
Publisher : Springer
Page : 230 pages
File Size : 50,5 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.

Author : Stephen R. Byrn,George Zografi,Xiaoming (Sean) Chen
Publisher : John Wiley & Sons
Page : 432 pages
File Size : 45,5 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

Author : Pablo G. Debenedetti
Publisher : Princeton University Press
Page : 432 pages
File Size : 53,5 Mb
Release : 1996
Category : Science
ISBN : 0691085951

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Metastable Liquids by Pablo G. Debenedetti Pdf

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.

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Page : 470 pages
File Size : 45,8 Mb
Release : 2019-12-04
Category : Science
ISBN : 9783527343966

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Innovative Dosage Forms by Yogeshwar Bachhav Pdf

Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Author : Kristin Lehmkemper
Publisher : Unknown
Page : 145 pages
File Size : 40,5 Mb
Release : 2018
Category : Electronic
ISBN : 3843937060

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Physical Stability of Amorphous Solid Dispersions by Kristin Lehmkemper Pdf

Author : Rolf Hilfiker,Markus von Raumer
Publisher : John Wiley & Sons
Page : 618 pages
File Size : 40,5 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.

Author : Robert O. Williams III,Alan B. Watts,Dave A. Miller
Publisher : Springer Science & Business Media
Page : 648 pages
File Size : 48,8 Mb
Release : 2011-12-04
Category : Medical
ISBN : 1461411440

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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.

Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Publisher : John Wiley & Sons
Page : 394 pages
File Size : 55,6 Mb
Release : 2020-06-02
Category : Medical
ISBN : 9783527341122

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Drying Technologies for Biotechnology and Pharmaceutical Applications by Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros Pdf

A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.