Pharmaceutical Amorphous Solid Dispersions

by Ann Newman

Author	: Ann Newman
Publisher	: John Wiley & Sons
Total Pages	: 502
Release	: 2015-03-09
Genre	: Science
ISBN	: 1118455207

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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

Amorphous Solid Dispersions

by Navnit Shah

Author	: Navnit Shah
Publisher	: Springer
Total Pages	: 702
Release	: 2014-11-21
Genre	: Medical
ISBN	: 1493915983

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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.

Hot-Melt Extrusion

by Dennis Douroumis

Author	: Dennis Douroumis
Publisher	: John Wiley & Sons
Total Pages	: 404
Release	: 2012-04-24
Genre	: Science
ISBN	: 1118307879

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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.

Recent Progress in Solid Dispersion Technology

by Kohsaku Kawakami

Author	: Kohsaku Kawakami
Publisher	:
Total Pages	: 1
Release	: 2019
Genre	: Electronic books
ISBN	: 9783039215027

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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.

Melt Extrusion

by Michael A. Repka

Author	: Michael A. Repka
Publisher	: Springer Science & Business Media
Total Pages	: 472
Release	: 2013-10-11
Genre	: Medical
ISBN	: 1461484324

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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.

Pharmaceutical Solid Dispersion Technology

by Muhammad J. Habib

Author	: Muhammad J. Habib
Publisher	: CRC Press
Total Pages	: 114
Release	: 2000-10-05
Genre	: Medical
ISBN	: 9781566768139

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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.

Formulating Poorly Water Soluble Drugs

by Robert O. Williams III

Author	: Robert O. Williams III
Publisher	: Springer Science & Business Media
Total Pages	: 656
Release	: 2011-12-04
Genre	: Medical
ISBN	: 1461411440

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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.

Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics

by Patrick Augustijns

Author	: Patrick Augustijns
Publisher	: Springer Science & Business Media
Total Pages	: 466
Release	: 2007-08-06
Genre	: Medical
ISBN	: 0387691545

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Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the gamut from recrystallization solvents to biorelevant media. The goal of this contribution to the AAPS Biotechnology: Pharmaceutical Aspects series is to generate both a practical handbook as well as a reference allowing the reader to make effective decisions concerning the use of solvents and solvent systems. To this end, the monograph was created by inviting recognized experts from a number of fields to author relevant sections. Specifically, 15 chapters have been designed covering the theoretical background of solubility, the effect of ionic equilibria and pH on solubilization, the use of solvents to effect drug substance crystallization and polymorph selection, the use of solvent systems in high throughput screening and early discovery, solvent use in preformulation, the use of solvents in bio-relevant dissolution and permeation experiments, solvents and their use as toxicology vehicles, solubilizing media and excipients in oral and parenteral formulation development, specialized vehicles for protein formulation and solvent systems for topical and pulmonary drug administration. The chapters are organized such that useful decision trees are included together with the scientific underpinning for their application. In addition, trends in the use of solvent systems and a balance of current views make this monograph useful to both the novice and experienced researcher and to scientists at all developmental stages from early discovery to late pharmaceutical operations.

Water-Insoluble Drug Formulation

by Ron Liu

Author	: Ron Liu
Publisher	: CRC Press
Total Pages	: 781
Release	: 2018-03-12
Genre	: Medical
ISBN	: 1351646826

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Properties and Formulation: From Theory to Real-World Application Scientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. Issues surrounding water insolubility can postpone or completely derail important new drug development. Even the much-needed reformulation of currently marketed products can be significantly affected by these challenges. More recently it was reported that the percentage increased to 90% for the candidates of new chemical entities in the discovery stage and 75% for compounds under development. In the most comprehensive resource on the topic, this third edition of Water-Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe the detailed discussion on solubility theories, solubility prediction models, the aspects of preformulation, biopharmaceutics, pharmacokinetics, regulatory, and discovery support of water-insoluble drugs to various techniques used in developing delivery systems for water-insoluble drugs. This book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies and featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field. The aim of this book is to provide a handy reference for pharmaceutical scientists in the handling of formulation issues related to water-insoluble drugs. In addition, this book may be useful to pharmacy and chemistry undergraduate students and pharmaceutical and biopharmaceutical graduate students to enhance their knowledge in the techniques of drug solubilization and dissolution enhancement.