Analytics Of Dissolution Testing Of Products Containing Nanosized Drugs With A View To Predicting Plasma Profiles

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Poorly Soluble Drugs

Author : Gregory K. Webster
Publisher : CRC Press
ISBN 13 : 1315340860
Total Pages : 578 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Poorly Soluble Drugs by : Gregory K. Webster

Download or read book Poorly Soluble Drugs written by Gregory K. Webster and published by CRC Press. This book was released on 2017-01-06 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.

Non-Biological Complex Drugs

Author : Daan J.A. Crommelin
Publisher : Springer
ISBN 13 : 3319162411
Total Pages : 390 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Non-Biological Complex Drugs by : Daan J.A. Crommelin

Download or read book Non-Biological Complex Drugs written by Daan J.A. Crommelin and published by Springer. This book was released on 2015-06-24 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.

In-Vitro and In-Vivo Tools in Drug Delivery Research for Optimum Clinical Outcomes

Author : Ambikanandan Misra
Publisher : CRC Press
ISBN 13 : 1351368710
Total Pages : 341 pages
Book Rating : 4.3/5 (513 download)

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Book Synopsis In-Vitro and In-Vivo Tools in Drug Delivery Research for Optimum Clinical Outcomes by : Ambikanandan Misra

Download or read book In-Vitro and In-Vivo Tools in Drug Delivery Research for Optimum Clinical Outcomes written by Ambikanandan Misra and published by CRC Press. This book was released on 2018-06-22 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the essentials of drug delivery research and provides a unique forum for scientific experimental methods that are exclusively focused by the in-vitro, ex-vivo, and in-vivo methodologies of drug delivery research and felicitates translational research. The book includes recent and novel approaches in evaluation methods of transdermal, nasal, ocular, oral and intraoral, gastro-retentive, colon-targeted, and brain-targeted drug delivery systems. Providing up to date and comprehensive information, this text is invaluable to students, teachers, scientists, and others employed in the field of drug delivery.

Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2012 Edition

Author :
Publisher : ScholarlyEditions
ISBN 13 : 1481645633
Total Pages : 953 pages
Book Rating : 4.4/5 (816 download)

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Book Synopsis Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2012 Edition by :

Download or read book Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2012 Edition written by and published by ScholarlyEditions. This book was released on 2013-01-10 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2012 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Molecular Pharmacology. The editors have built Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2012 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Molecular Pharmacology in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2012 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Formulating Poorly Water Soluble Drugs

Author : Robert O. Williams III
Publisher : Springer
ISBN 13 : 3319426095
Total Pages : 781 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Formulating Poorly Water Soluble Drugs by : Robert O. Williams III

Download or read book Formulating Poorly Water Soluble Drugs written by Robert O. Williams III and published by Springer. This book was released on 2016-12-16 with total page 781 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of this volume is to consolidate within a single text the most current knowledge, practical methods, and regulatory considerations pertaining to formulations development with poorly water-soluble molecules. A pharmaceutical scientist’s approach toward solubility enhancement of a poorly water-soluble molecule typically includes detailed characterization of the compound’s physiochemical properties, solid-state modifications, advanced formulation design, non-conventional process technologies, advanced analytical characterization, and specialized product performance analysis techniques. The scientist must also be aware of the unique regulatory considerations pertaining to the non-conventional approaches often utilized for poorly water-soluble drugs. One faced with the challenge of developing a drug product from a poorly soluble compound must possess at minimum a working knowledge of each of the abovementioned facets and detailed knowledge of most. In light of the magnitude of the growing solubility problem to drug development, this is a significant burden especially when considering that knowledge in most of these areas is relatively new and continues to develop

Oral Drug Absorption

Author : Jennifer B. Dressman
Publisher : CRC Press
ISBN 13 : 1420077341
Total Pages : 432 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Oral Drug Absorption by : Jennifer B. Dressman

Download or read book Oral Drug Absorption written by Jennifer B. Dressman and published by CRC Press. This book was released on 2016-04-19 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an

In Vitro-In Vivo Correlations

Author : David B. Young
Publisher : Springer Science & Business Media
ISBN 13 : 1468460366
Total Pages : 299 pages
Book Rating : 4.4/5 (684 download)

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Book Synopsis In Vitro-In Vivo Correlations by : David B. Young

Download or read book In Vitro-In Vivo Correlations written by David B. Young and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.

Analytical Techniques in the Pharmaceutical Sciences

Author : Anette Müllertz
Publisher : Springer
ISBN 13 : 1493940295
Total Pages : 829 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Analytical Techniques in the Pharmaceutical Sciences by : Anette Müllertz

Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Amorphous Solid Dispersions

Author : Navnit Shah
Publisher : Springer
ISBN 13 : 1493915983
Total Pages : 702 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Amorphous Solid Dispersions by : Navnit Shah

Download or read book Amorphous Solid Dispersions written by Navnit Shah and published by Springer. This book was released on 2014-11-21 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

3D Printed Microfluidic Devices

Author : Savas Tasoglu
Publisher : MDPI
ISBN 13 : 3038974676
Total Pages : 213 pages
Book Rating : 4.0/5 (389 download)

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Book Synopsis 3D Printed Microfluidic Devices by : Savas Tasoglu

Download or read book 3D Printed Microfluidic Devices written by Savas Tasoglu and published by MDPI. This book was released on 2019-01-10 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a printed edition of the Special Issue "3D Printed Microfluidic Devices" that was published in Micromachines

Dosage Form Design Considerations

Author :
Publisher : Academic Press
ISBN 13 : 0128144246
Total Pages : 881 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Dosage Form Design Considerations by :

Download or read book Dosage Form Design Considerations written by and published by Academic Press. This book was released on 2018-07-28 with total page 881 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Oral Lipid-Based Formulations

Author : David J. Hauss
Publisher : CRC Press
ISBN 13 : 1420017268
Total Pages : 370 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Oral Lipid-Based Formulations by : David J. Hauss

Download or read book Oral Lipid-Based Formulations written by David J. Hauss and published by CRC Press. This book was released on 2007-06-08 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem

Excipient Applications in Formulation Design and Drug Delivery

Author : Ajit S Narang
Publisher : Springer
ISBN 13 : 3319202065
Total Pages : 700 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Excipient Applications in Formulation Design and Drug Delivery by : Ajit S Narang

Download or read book Excipient Applications in Formulation Design and Drug Delivery written by Ajit S Narang and published by Springer. This book was released on 2015-10-07 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Melt Extrusion

Author : Michael A. Repka
Publisher : Springer Science & Business Media
ISBN 13 : 1461484324
Total Pages : 472 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Melt Extrusion by : Michael A. Repka

Download or read book Melt Extrusion written by Michael A. Repka and published by Springer Science & Business Media. This book was released on 2013-10-11 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Drug Delivery Systems: Advanced Technologies Potentially Applicable in Personalised Treatment

Author : Jorge Coelho
Publisher : Springer Science & Business Media
ISBN 13 : 9400760108
Total Pages : 433 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Drug Delivery Systems: Advanced Technologies Potentially Applicable in Personalised Treatment by : Jorge Coelho

Download or read book Drug Delivery Systems: Advanced Technologies Potentially Applicable in Personalised Treatment written by Jorge Coelho and published by Springer Science & Business Media. This book was released on 2013-03-15 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is part of a series dedicated to recent advances on preventive, predictive and personalised medicine (PPPM). It focuses on the theme of “Drug delivery systems: advanced technologies potentially applicable in personalised treatments”. The critical topics involving the development and preparation of effective drug delivery systems, such as: polymers available, self-assembly, nanotechnology, pharmaceutical formulations, three dimensional structures, molecular modeling, tailor-made solutions and technological tendencies, are carefully discussed. The understanding of these areas constitutes a paramount route to establish personalised and effective solutions for specific diseases and individuals.

Biomedical Applications of Nanoparticles

Author : Alexandru Mihai Grumezescu
Publisher : William Andrew
ISBN 13 : 0128166304
Total Pages : 532 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biomedical Applications of Nanoparticles by : Alexandru Mihai Grumezescu

Download or read book Biomedical Applications of Nanoparticles written by Alexandru Mihai Grumezescu and published by William Andrew. This book was released on 2019-02-28 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Applications of Nanoparticles describes the most interesting and investigated biomedical applications of nanoparticles, emphasizing their therapeutic impact. Progress made in the therapy of severe diseases, such as cancer and difficult infections is strictly correlated to the scientific progress and technological development in the field of materials science. Nanoparticles have numerous therapeutic applications, starting with the design of new drugs, delivery systems, therapeutic materials, and their contribution to the development of preventive strategies. The book highlights the impact of nanoparticles on the therapy of infections, antimicrobial effect and also anti-cancer strategies. Successful examples are given throughout the book, along with analysis in order to improve future outcomes of novel therapies. - Highlights the term nanotherapeutics and presents several classifications of nanotherapeutics from different points-of-view - Presents the recent progress related to nanotherapeutics in the oral cavity - Provides the recent progress in the field of biomedical nanoparticles

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Author : Ashok Katdare
Publisher : CRC Press
ISBN 13 : 1420004131
Total Pages : 474 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems by : Ashok Katdare

Download or read book Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems written by Ashok Katdare and published by CRC Press. This book was released on 2006-07-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.