Pharmaceutical Excipients

Author: Otilia M. Y. Koo
Publisher: John Wiley & Sons
ISBN: 9781118992425
Release Date: 2016-10-03
Genre: Medical

This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients

Multivariate Analysis in the Pharmaceutical Industry

Author: Ana Patricia Ferreira
Publisher: Academic Press
ISBN: 9780128110669
Release Date: 2018-04-24
Genre: Medical

Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

Developing Solid Oral Dosage Forms

Author: Yihong Qiu
Publisher: Academic Press
ISBN: 9780128026373
Release Date: 2016-11-08
Genre: Medical

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Biodegradable and Biobased Polymers for Environmental and Biomedical Applications

Author: Susheel Kalia
Publisher: John Wiley & Sons
ISBN: 9781119117353
Release Date: 2016-01-29
Genre: Technology & Engineering

This volume incorporates 13 contributions from renowned experts from the relevant research fields that are related biodegradable and biobased polymers and their environmental and biomedical applications. Specifically, the book highlights: Developments in polyhydroxyalkanoates applications in agriculture, biodegradable packaging material and biomedical field like drug delivery systems, implants, tissue engineering and scaffolds The synthesis and elaboration of cellulose microfibrils from sisal fibres for high performance engineering applications in various sectors such as the automotive and aerospace industries, or for building and construction The different classes and chemical modifications of tannins Electro-activity and applications of Jatropha latex and seed The synthesis, properties and applications of poly(lactic acid) The synthesis, processing and properties of poly(butylene succinate), its copolymers, composites and nanocomposites The different routes for preparation polymers from vegetable oil and the effects of reinforcement and nano-reinforcement on the physical properties of such biobased polymers The different types of modified drug delivery systems together with the concept of the drug delivery matrix for controlled release of drugs and for antitumor drugs The use of nanocellulose as sustainable adsorbents for the removal of water pollutants mainly heavy metal ions, organic molecules, dyes, oil and CO2 The main extraction techniques, structure, properties and different chemical modifications of lignins Proteins and nucleic acids based biopolymers The role of tamarind seed polysaccharide-based multiple-unit systems in sustained drug release

Handbook of Pharmaceutical Excipients

Author: Raymond C. Rowe
Publisher: Amer Pharmacists Assn
ISBN: 1582121354
Release Date: 2009-01-01
Genre: Medical

An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs. Incorporates information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data; extensive data provided on the applications, licensing, and safety of excipients; comprehensively cross-referenced and indexed, with many additional excipients described as related substances and an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available.

Handbook of Pharmaceutical Wet Granulation

Author: Ajit S. Narang
Publisher: Academic Press
ISBN: 9780323481038
Release Date: 2018-08-31
Genre: Medical

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Excipient Development for Pharmaceutical Biotechnology and Drug Delivery Systems

Author: Ashok Katdare
Publisher: CRC Press
ISBN: 1420004131
Release Date: 2006-07-28
Genre: Medical

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenues for regulatory review and allowance to use. 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.

Polyvinylpyrrolidone Excipients for Pharmaceuticals

Author: Volker Bühler
Publisher: Springer Science & Business Media
ISBN: 3540234128
Release Date: 2005
Genre: Medical

The book describes the properties, analytical methods and the applications of different polyvinylpyrrolidone excipients (povidone, crospovidone, copovidone etc.) for use in pharmaceutical preparations. This group of excipients is one of the most important excipients used in modern technology to produce drugs. The book is intended for all persons working in the research, development and quality control of drugs. It gives a survey of all applications in solid, liquid and semisolid dosage forms including many drug formulation examples and more than 600 references to the literature.

Dosage Form Design Parameters

Author:
Publisher: Academic Press
ISBN: 9780128144220
Release Date: 2018-07-25
Genre: Medical

Dosage Form Design Parameters, Volume II, 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

Essential Chemistry for Formulators of Semisolid and Liquid Dosages

Author: Vitthal S. Kulkarni
Publisher: Academic Press
ISBN: 9780128010723
Release Date: 2015-10-15
Genre: Science

A needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemistry of mixing different phases and test methods for the stability study of nonsolid formulations. The book covers foundational surface/colloid chemistry, which forms the necessary background for making emulsions, suspensions, solutions, and nano drug delivery systems, and the chemistry of mixing, which is critical for further formulation of drug delivery systems into semisolid (gels, creams, lotions, and ointments) or liquid final dosages. Expanding on these foundational principles, this useful guide explores stability testing methods, such as particle size, rheological/viscosity, microscopy, and chemical, and closes with a valuable discussion of regulatory issues. Essential Chemistry for Formulators of Semisolid and Liquid Dosages offers scientists and students the foundation and practical guidance to make and analyze semisolid and liquid formulations. Unique coverage of the underlying chemistry that makes possible stable dosages Quality content written by experienced experts from the drug development industry Valuable information for academic and industrial scientists developing topical and liquid dosage formulations for pharmaceutical as well as skin care and cosmetic products

Excipient Applications in Formulation Design and Drug Delivery

Author: Ajit S Narang
Publisher: Springer
ISBN: 9783319202068
Release Date: 2015-10-07
Genre: Medical

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.

Controlled Drug Delivery

Author: M A Mateescu
Publisher: Elsevier
ISBN: 9781908818676
Release Date: 2014-12-09
Genre: Medical

In complex macromolecules, minor modifications can generate major changes, due to self-assembling capacities of macromolecular or supramolecular networks. Controlled Drug Delivery highlights how the multifunctionality of several materials can be achieved and valorized for pharmaceutical and biopharmaceutical applications. Topics covered in this comprehensive book include: the concept of self-assembling; starch and derivatives as pharmaceutical excipients; and chitosan and derivatives as biomaterials and as pharmaceutical excipients. Later chapters discuss polyelectrolyte complexes as excipients for oral administration; and natural semi-synthetic and synthetic materials. Closing chapters cover protein-protein associative interactions and their involvement in bioformulations; self-assembling materials, implants and xenografts; and provide conclusions and perspectives. Offers novel perspectives of a new concept: how minor alterations can induce major self-stabilization by cumulative forces exerted at short and long distances Gives guidance on how to approach modifications of biopolymers for drug delivery systems and materials for implants Describes structure-properties relationships in proposed excipients, drug delivery systems and biomedical materials

Colloid and Interface Science in Pharmaceutical Research and Development

Author: Hiroyuki Ohshima
Publisher: Elsevier
ISBN: 9780444626080
Release Date: 2014-07-23
Genre: Technology & Engineering

Colloid and Interface Science in Pharmaceutical Research and Development describes the role of colloid and surface chemistry in the pharmaceutical sciences. It gives a detailed account of colloid theory, and explains physicochemical properties of the colloidal-pharmaceutical systems, and the methods for their measurement. The book starts with fundamentals in Part I, covering fundamental aspects of colloid and interface sciences as applied to pharmaceutical sciences and thus should be suitable for teaching. Parts II and III treat applications and measurements, and they explains the application of these properties and their influence and use for the development of new drugs. Provides a clear description of the fundamentals of colloid and interface science relevant to drug research and development Explains the physicochemical/colloidal basis of pharmaceutical science Lists modern experimental characterization techniques, provides analytical equations and explanations on analyzing the experimental data Describes the most advanced techniques, AFM (Atomic Force Microscopy), SFA (Surface Force Apparatus) in detail

Microsized and Nanosized Carriers for Nonsteroidal Anti Inflammatory Drugs

Author: Bojan Čalija
Publisher: Academic Press
ISBN: 9780128040805
Release Date: 2017-01-03
Genre: Medical

Microsized and Nanosized Carriers for Nonsteroidal Anti-Inflammatory Drugs: Formulation Challenges and Potential Benefits provides a unique and complete overview of novel formulation strategies for improvement of the delivery of NSAIDs via encapsulation in microsized and nanosized carriers composed of different materials of natural and synthetic origin. This book presents the latest research on advances and limitations of both microsized and nanosized drug carriers and NSAIDs before discussing the formulation aspects of these drug carriers that are intended for oral, dermal, and transdermal administration of NSAIDs. In addition, functionality of these materials as potential excipients for microsized and nanosized carriers is discussed and debated. Practical solutions for improving effectiveness of these drugs are included throughout the book, making this an important resource for graduate students, professors, and researchers in the pharmaceutical sciences. Covers a wide range of microsized and nanosized carriers in one resource, including particulate carriers (microparticles, nanoparticles, and zeolites) and the soft colloidal carriers, such as micro-emulsions and nano-emulsions Presents the reader with various formulation approaches dependent on the characteristics of the material, model drug, and desired route of administration Approaches are based on the latest research in the area and formulation strategies may have broader applications to the encapsulation of other active pharmaceutical ingredients

Chemical Aspects of Drug Delivery Systems

Author: D. R. Karsa
Publisher: Royal Society of Chemistry
ISBN: 0854047069
Release Date: 1996-01-01
Genre: Medical

This book reflects the modern challenge to devise effective drug delivery and targeting systems, giving particular emphasis to recent innovations in the field.