Surfactants In Biopharmaceutical Development

Author : Atanas V. Koulov,Satish K Singh
Publisher : Academic Press
Page : 236 pages
File Size : 54,8 Mb
Release : 2023-08-25
Category : Medical
ISBN : 9780128125694

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Surfactants in Biopharmaceutical Development by Atanas V. Koulov,Satish K Singh Pdf

Surfactants in Biopharmaceutical Development addresses the progress, challenges and opportunities for surfactant research specific to pharmaceutical development, providing a broad range of important surfactant-related topics as they relate directly to the biopharmaceutical process. Chapters address fundamental topics, like mechanisms of protein stabilization by surfactants, the latest, state-of-the-art technology and methods to illustrate the practical application to biopharmaceutical development, forward-looking chapters on control strategies and novel surfactants, with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators. It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients by the industry and by regulators. Describes the current state of research on surfactants in the context of biopharmaceutical development, drawing upon contributions from international experts across industry, academia, and regulators Addresses the opportunities and challenges associated with surfactants in biologic drug development Provides a defining resource for practitioners in the biopharmaceutical industry, regulators and academics by summarizing the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume

Author : Lars Schiefelbein
Publisher : Cuvillier Verlag
Page : 178 pages
File Size : 43,6 Mb
Release : 2011-07-25
Category : Medical
ISBN : 9783736938328

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Sugar-Based Surfactants for Pharmaceutical Protein Formulations by Lars Schiefelbein Pdf

Nonionic Surfactants, Sugar-Based Surfactants, Alkylpolyglucosides, Protein Formulations

Author : Lars Kurt Johann Schiefelbein
Publisher : Unknown
Page : 157 pages
File Size : 46,7 Mb
Release : 2011
Category : Electronic
ISBN : 3869558326

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Sugar-based Surfactants for Pharmaceutical Protein Formulations by Lars Kurt Johann Schiefelbein Pdf

Author : Rajesh Krishna,Lawrence Yu
Publisher : Springer Science & Business Media
Page : 416 pages
File Size : 50,5 Mb
Release : 2007-09-20
Category : Medical
ISBN : 9780387723792

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Biopharmaceutics Applications in Drug Development by Rajesh Krishna,Lawrence Yu Pdf

The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

Author : M.R. Porter
Publisher : Unknown
Page : 224 pages
File Size : 44,6 Mb
Release : 1990-10-31
Category : Science
ISBN : UOM:39015019564254

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Recent Developments in the Technology of Surfactants by M.R. Porter Pdf

Author : Ferdinand Devinsky,Martin Pisarcik,Milos Lukác
Publisher : Unknown
Page : 0 pages
File Size : 45,5 Mb
Release : 2017-06
Category : Amphiphiles
ISBN : 1536119792

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Cationic Amphiphiles by Ferdinand Devinsky,Martin Pisarcik,Milos Lukác Pdf

Surfactants play an essential role in our daily lives. Their form of usage varies from detergents and cleaning agents through disinfectants and solubilisers up to industrial applications such as paints, oil recovery, anti-corrosion protective coatings, etc. A special distinct class of surfactants is represented by a double-chain, double-head form of surfactant molecules, which are called gemini surfactants. Gemini surfactants show physicochemical and aggregation properties which are superior to those of conventional, single-chain surfactants. From the perspective of applications, an important group of gemini surfactants is represented by cationic gemini surfactants. They have found numerous applications in the various fields such as solubilisation, textile coating, organic and polymer synthesis, electrochemistry, paper industry, etc. One of the most developing areas of cationic gemini surfactants application is the field of pharmaceutical applications. Interaction of cationic surfactants with the oppositely charged cell membrane has been known for a long time. Cationic gemini surfactants turned out to be very efficient bactericidal and antimicrobial agents. Moreover, recent development in this field indicates a cancerostatic effect of cationic geminis through a selective interaction of cationic gemini molecules with cancer cells. Another revolutionary field of cationic gemini surfactants application is their interaction with an oppositely charged electrolyte such as DNA. The interaction of DNA with various positively charged systems such as cationic surfactants, polymers and lipids is of great importance with respect to gene transmission through a biological cell membrane to achieve a therapeutic effect in a cell nucleus. The ambition of this monograph is to provide a complex view of synthesis, structure-aggregation, properties-biological activity relationship and recent applications of cationic gemini surfactants in the pharmaceutical field. Individual chapters in the monograph discuss the synthetic preparation of cationic surfactants, the effect of the structure of these compounds on their physical and physicochemical properties, particularly their aggregation properties and associated phenomena. A significant part of this publication is devoted to gemini surfactants, a relatively new class of surfactants whose special and surprising properties increasingly continue to draw the attention of the research community. The final part of the monograph is oriented on the use of cationic surfactants in biomedicine and pharmaceutical applications, where a special emphasis is put on their antimicrobial and antineoplastic activities. Finally, cationic surfactants as potent non-viral gene delivery vehicles are analysed and evaluated. The monograph is intended to serve as a guide for scientists and students in the field of pharmaceutical research and chemistry of colloids and surfactants.

Author : Nicholas W. Warne,Hanns-Christian Mahler
Publisher : Springer
Page : 599 pages
File Size : 55,9 Mb
Release : 2018-06-20
Category : Medical
ISBN : 9783319906034

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Challenges in Protein Product Development by Nicholas W. Warne,Hanns-Christian Mahler Pdf

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Author : Anonim
Publisher : ScholarlyEditions
Page : 4229 pages
File Size : 49,9 Mb
Release : 2012-01-09
Category : Medical
ISBN : 9781464963421

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Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition by Anonim Pdf

Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation. The editors have built Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation 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: 2011 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/.

Author : Alexandre Gomes Rodrigues
Publisher : Elsevier
Page : 376 pages
File Size : 53,6 Mb
Release : 2020-06-10
Category : Technology & Engineering
ISBN : 9780444643025

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New and Future Developments in Microbial Biotechnology and Bioengineering by Alexandre Gomes Rodrigues Pdf

New and Future Developments in Microbial Biotechnology and Bioengineering: Microbial Biomolecules: Properties, Relevance and Their Translational Applications presents a concise review on microbial biotechnology, along with impacts and recent results from research centers, small companies and large enterprises. The book brings the most relevant information on how we can use resources - in this case from microorganisms - and technology to develop solutions in fields like biofuels, food, cosmetics and medicine. It covers case studies of start-ups in the field and explains how scientists have moved their ideas into profitable bio-based products that are necessary for our current living standards. In addition, the book describes strategic governmental programs designed to exploit biomass in a sustainable way, along with detailed information on research in several high-impact, worldwide laboratories. It gives concrete examples of ongoing research from molecules to methods, such as L-asparaginase, extremophiles, new diagnostics tools and the analytical methods that have raised the quality of the data obtained, thereby boosting the so-called bioeconomy. Comprises a unique source of information on the various applications of microbial biomolecules Provides resourceful material for new ideas and strong rational/application-oriented stories Discusses biotech companies in various areas (biofuel, food, medicine, etc.) who are actively using microbial biomolecules Outlines scientific discoveries and their translation into profitable products Gives an insight perspective of institutional and governmental strategic research programs aiming to preserve, explore and generate benefits from microbial biomolecules

Author : Gregory K. Webster,Robert G. Bell,J. Derek Jackson
Publisher : CRC Press
Page : 728 pages
File Size : 42,5 Mb
Release : 2017-01-06
Category : Medical
ISBN : 9781315340869

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Poorly Soluble Drugs by Gregory K. Webster,Robert G. Bell,J. Derek Jackson Pdf

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.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1352 pages
File Size : 52,8 Mb
Release : 2008-03-21
Category : Medical
ISBN : 9780470249024

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Preclinical Development Handbook by Shayne Cox Gad Pdf

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Author : Ajit S Narang,Sai H S. Boddu
Publisher : Springer
Page : 681 pages
File Size : 43,9 Mb
Release : 2015-10-07
Category : Medical
ISBN : 9783319202068

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Excipient Applications in Formulation Design and Drug Delivery by Ajit S Narang,Sai H S. Boddu Pdf

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 : Ashok Katdare,Mahesh Chaubal
Publisher : CRC Press
Page : 474 pages
File Size : 43,6 Mb
Release : 2006-07-28
Category : Medical
ISBN : 9781420004137

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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems by Ashok Katdare,Mahesh Chaubal Pdf

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.

Author : Damian J. Houde,Steven A. Berkowitz
Publisher : Elsevier
Page : 586 pages
File Size : 43,8 Mb
Release : 2019-11-13
Category : Medical
ISBN : 9780444641748

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Biophysical Characterization of Proteins in Developing Biopharmaceuticals by Damian J. Houde,Steven A. Berkowitz Pdf

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data. Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Author : J E Aguilar
Publisher : Elsevier
Page : 304 pages
File Size : 54,8 Mb
Release : 2013-09-30
Category : Medical
ISBN : 9781908818508

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Formulation Tools for Pharmaceutical Development by J E Aguilar Pdf

A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools. Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software. Coverage of artificial intelligence tools, new expert systems, understanding of pharmaceutical processes, robust development of medicines, and new ways to develop medicines Development of drugs and medicines using mathematical tools Compilation of expert system developed around the world