Surfactants In Biopharmaceutical Development

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

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/.

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.

It is now twelve years since Solubilization by Surface-Active Agents appeared. Since the publication of that monograph the subject has expanded rapidly as the unique potential of surfactants has become known to a wider circle of scientists. In a recent review Menger (Accounts of Chemical Research, 12 (1979) 111) estimated that since 1970 there have been over 2800 publications on micelles and micellization alone. The topic of catalysis in micellar media was in an early stage of development in 1968 but the growth in this subject has given rise to an excellent textbook by Fendler and Fendler. We have felt for some time that a revision of Solubilization by Surface-Active Agents was overdue. The book has been out of print for some time. Owing to pressure of other work, Professor P. H. Elworthy and Dr C. B. Macfarlane were unable to undertake the work of revision but while working together on an undergraduate textbook the present authors decided to set to work, realizing both the impossibility of producing a comprehensive textbook and the need to alter the scope of the book. Micellar solubilization occurs over a relatively small surfactant concentration range; because of this and because the phenomenon is never observed in isolation, we have extended the text to include surface activity, emulsions and suspensions and, as our emphasis is on formulation of medicinal products, to the of the toxicology of surface-active agents.

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

This text book is a guide for pharmaceutical academics (students and teachers) as well as industry professionals learning about drug delivery and formulation. Chapters presents comprehensive information about self-emulsifying formulations by providing an in-depth understanding of the basic concepts and formulation mechanisms. This information is supplemented by details about current research and development in this field. Readers will learn about the types of self-emulsifying drug delivery systems, evaluation parameters and digestion models, among other topics. Key Features: - 9 chapters organized in a reader-friendly layout - complete guide on self-emulsifying drug delivery formulations, including lipid based systems, SMEDOs, surfactants, and oral dosage forms - includes basic concepts and current developments in research and industrial applications - presents information on conventional and herbal formulations - references for further reading

Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this Second Edition of a well-received reference test highlights typical formulations, the avoidance of formulation pitfalls, and compliance with established regulatory principles.