Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development
Author: J E Aguilar
Publsiher: Elsevier
Total Pages: 304
Release: 2013-09-30
ISBN 10: 1908818506
ISBN 13: 9781908818508
Language: EN, FR, DE, ES & NL

Formulation tools for Pharmaceutical Development Book Review:

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

Essentials of Pharmaceutical Preformulation

Essentials of Pharmaceutical Preformulation
Author: Simon Gaisford,Mark Saunders
Publsiher: John Wiley & Sons
Total Pages: 272
Release: 2012-10-22
ISBN 10: 1118423240
ISBN 13: 9781118423240
Language: EN, FR, DE, ES & NL

Essentials of Pharmaceutical Preformulation Book Review:

Essentials of Pharmaceutical Preformulation is a study guide which describes the basic principles of pharmaceutical physicochemical characterisation. Successful preformulation requires knowledge of fundamental molecular concepts (solubility, ionisation, partitioning, hygroscopicity and stability) and macroscopic properties (physical form, such as the crystalline and amorphous states, hydrates, solvates and co-crystals and powder properties), familiarity with the techniques used to measure them and appreciation of their effect on product performance, recognising that often there is a position of compromise to be reached between product stability and bioavailability. This text introduces the basic concepts and discusses their wider implication for pharmaceutical development, with reference to many case examples of current drugs and drug products. Special attention is given to the principles and best-practice of the analytical techniques that underpin preformulation (UV spectrophotometry, TLC, DSC, XRPD and HPLC). The material is presented in the typical order that would be followed when developing a medicine and maps onto the indicative pharmacy syllabus of the Royal Pharmaceutical Society of Great Britain Undergraduate-level pharmacy students and R&D / analytical scientists working in the pharmaceutical sector (with or without a pharmaceutical background) will find this text easy to follow with relevant pharmaceutical examples. Essential study guide for pharmacy and pharmaceutical science students Covers the pharmaceutical preformulation components of the Royal Pharmaceutical Society of Great Britain’s indicative syllabus Easy to follow text highlighted with relevant pharmaceutical examples Self-assessment assignments in a variety of formats Written by authors with both academic and industrial experience Companion website with further information to maximise learning

Water Insoluble Drug Formulation

Water Insoluble Drug Formulation
Author: Ron Liu
Publsiher: CRC Press
Total Pages: 736
Release: 2018-03-12
ISBN 10: 1498729428
ISBN 13: 9781498729420
Language: EN, FR, DE, ES & NL

Water Insoluble Drug Formulation Book Review:

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.

3D Printing of Pharmaceuticals and Drug Delivery Devices

3D Printing of Pharmaceuticals and Drug Delivery Devices
Author: Dimitrios A. Lamprou
Publsiher: MDPI
Total Pages: 436
Release: 2020-07-01
ISBN 10: 3039364235
ISBN 13: 9783039364237
Language: EN, FR, DE, ES & NL

3D Printing of Pharmaceuticals and Drug Delivery Devices Book Review:

The 3D printing (3DP) process was patented in 1986; however, only in the last decade has it begun to be used for medical applications, as well as in the fields of prosthetics, bio-fabrication, and pharmaceutical printing. 3DP or additive manufacturing (AM) is a family of technologies that implement layer-by-layer processes in order to fabricate physical models based on a computer aided design (CAD) model. 3D printing permits the fabrication of high degrees of complexity with great reproducibility in a fast and cost-effective fashion. 3DP technology offers a new paradigm for the direct manufacture of individual dosage forms and has the potential to allow for variations in size and geometry as well as control dose and release behavior. Furthermore, the low cost and ease of use of 3DP systems means that the possibility of manufacturing medicines and medical devices at the point of dispensing or at the point of use could become a reality. 3DP thus offers the perfect innovative manufacturing route to address the critical capability gap that hinders the widespread exploitation of personalized medicines for molecules that are currently not easy to deliver. This Special Issue will address new developments in the area of 3D printing and bioprinting for drug delivery applications, covering the recent advantages and future directions of additive manufacturing for pharmaceutical products.

Computer aided applications in pharmaceutical technology

Computer aided applications in pharmaceutical technology
Author: Ljiljana Djekic,Dragana Vasiljevic,Marija Primorac
Publsiher: Elsevier Inc. Chapters
Total Pages: 300
Release: 2013-04-10
ISBN 10: 0128091886
ISBN 13: 9780128091883
Language: EN, FR, DE, ES & NL

Computer aided applications in pharmaceutical technology Book Review:

This chapter introduces the concept of formulation development assisted by computer applications. Development and optimization of various types of pharmaceutical emulsions microemulsions, self-microemulsifying systems, and double emulsions are presented. Illustrative examples are presented to demonstrate the ability of computer-aided tools to facilitate formulation development. Various techniques, such as design of experiments and artificial neural networks, are implemented for optimization of the formulation and/or processing parameters. Furthermore, some of the critical quality attributes and processing parameters are optimized simultaneously. The examples presented should serve as the foundation for the future quality-by-design development of pharmaceutical emulsion and (self) microemulsion formulations.

Multivariate Analysis in the Pharmaceutical Industry

Multivariate Analysis in the Pharmaceutical Industry
Author: Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn
Publsiher: Academic Press
Total Pages: 464
Release: 2018-04-24
ISBN 10: 012811066X
ISBN 13: 9780128110669
Language: EN, FR, DE, ES & NL

Multivariate Analysis in the Pharmaceutical Industry Book Review:

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

Pharmaceutical Suspensions

Pharmaceutical Suspensions
Author: Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall
Publsiher: Springer Science & Business Media
Total Pages: 327
Release: 2009-11-05
ISBN 10: 9781441910875
ISBN 13: 1441910875
Language: EN, FR, DE, ES & NL

Pharmaceutical Suspensions Book Review:

The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.

High Throughput Formulation Development of Biopharmaceuticals

High Throughput Formulation Development of Biopharmaceuticals
Author: Vladimir I. Razinkov,Gerd Kleemann
Publsiher: Woodhead Publishing
Total Pages: 132
Release: 2016-09-29
ISBN 10: 190881876X
ISBN 13: 9781908818768
Language: EN, FR, DE, ES & NL

High Throughput Formulation Development of Biopharmaceuticals Book Review:

High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research
Author: Anonim
Publsiher: Academic Press
Total Pages: 976
Release: 2020-09-02
ISBN 10: 0128144556
ISBN 13: 9780128144558
Language: EN, FR, DE, ES & NL

The Future of Pharmaceutical Product Development and Research Book Review:

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Pharmaceutical Product Development

Pharmaceutical Product Development
Author: Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee
Publsiher: CRC Press
Total Pages: 433
Release: 2016-05-25
ISBN 10: 1498730787
ISBN 13: 9781498730785
Language: EN, FR, DE, ES & NL

Pharmaceutical Product Development Book Review:

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.

Oral Formulation Roadmap from Early Drug Discovery to Development

Oral Formulation Roadmap from Early Drug Discovery to Development
Author: Elizabeth Kwong
Publsiher: John Wiley & Sons
Total Pages: 272
Release: 2017-02-06
ISBN 10: 1118907337
ISBN 13: 9781118907337
Language: EN, FR, DE, ES & NL

Oral Formulation Roadmap from Early Drug Discovery to Development Book Review:

Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing

Strategies for Formulations Development

Strategies for Formulations Development
Author: Ronald Snee,Roger Hoerl
Publsiher: SAS Institute
Total Pages: 294
Release: 2016-09-27
ISBN 10: 1629605301
ISBN 13: 9781629605302
Language: EN, FR, DE, ES & NL

Strategies for Formulations Development Book Review:

Strategies for Formulations Development: A Step-by-Step Guide Using JMP is based on the authors' significant practical experience partnering with scientists to develop strategies to accelerate the formulation (mixtures) development process. The authors not only explain the most important methods used to design and analyze formulation experiments, but they also present overall strategies to enhance both the efficiency and effectiveness of the development process. With this book you will be able to: Approach the development process from a strategic viewpoint with the overall end result in mind. Design screening experiments to identify components that are most important to the performance of the formulation. Design optimization experiments to identify the maximum response in the design space. Analyze both screening and optimization experiments using graphical and numerical methods. Optimize multiple criteria, such as the quality, cost, and performance of product formulations. Design and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%. Linking dynamic graphics with powerful statistics, JMP helps construct a visually compelling narrative to interactively share findings that are coherent and actionable by colleagues and decision makers. Using this book, you can take advantage of computer generated experiment designs when classical designs do not suffice, given the physical and economic constraints of the experiential environment. Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is unique because it provides formulation scientists with the essential information they need in order to successfully conduct formulation studies in the chemical, biotech, and pharmaceutical industries.

Formulation and Analytical Development for Low Dose Oral Drug Products

Formulation and Analytical Development for Low Dose Oral Drug Products
Author: Jack Zheng
Publsiher: John Wiley & Sons
Total Pages: 496
Release: 2009-02-09
ISBN 10: 0470056096
ISBN 13: 9780470056097
Language: EN, FR, DE, ES & NL

Formulation and Analytical Development for Low Dose Oral Drug Products Book Review:

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publsiher: Academic Press
Total Pages: 1176
Release: 2016-11-08
ISBN 10: 0128026375
ISBN 13: 9780128026373
Language: EN, FR, DE, ES & NL

Developing Solid Oral Dosage Forms Book Review:

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

Challenges in Protein Product Development

Challenges in Protein Product Development
Author: Nicholas W. Warne,Hanns-Christian Mahler
Publsiher: Springer
Total Pages: 599
Release: 2018-07-22
ISBN 10: 3319906038
ISBN 13: 9783319906034
Language: EN, FR, DE, ES & NL

Challenges in Protein Product Development Book Review:

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.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 1384
Release: 2008-03-21
ISBN 10: 0470259809
ISBN 13: 9780470259801
Language: EN, FR, DE, ES & NL

Pharmaceutical Manufacturing Handbook Book Review:

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Essential Chemistry for Formulators of Semisolid and Liquid Dosages

Essential Chemistry for Formulators of Semisolid and Liquid Dosages
Author: Vitthal S. Kulkarni,Charles Shaw
Publsiher: Academic Press
Total Pages: 256
Release: 2015-10-15
ISBN 10: 012801072X
ISBN 13: 9780128010723
Language: EN, FR, DE, ES & NL

Essential Chemistry for Formulators of Semisolid and Liquid Dosages Book Review:

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

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
Author: Preetanshu Pandey,Rahul Bharadwaj
Publsiher: Woodhead Publishing
Total Pages: 464
Release: 2016-09-26
ISBN 10: 0081001800
ISBN 13: 9780081001806
Language: EN, FR, DE, ES & NL

Predictive Modeling of Pharmaceutical Unit Operations Book Review:

The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Innovative Dosage Forms

Innovative Dosage Forms
Author: Yogeshwar Bachhav
Publsiher: John Wiley & Sons
Total Pages: 472
Release: 2019-10-28
ISBN 10: 3527343962
ISBN 13: 9783527343966
Language: EN, FR, DE, ES & NL

Innovative Dosage Forms Book Review:

Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publsiher: Academic Press
Total Pages: 978
Release: 2009-03-10
ISBN 10: 9780080932729
ISBN 13: 008093272X
Language: EN, FR, DE, ES & NL

Developing Solid Oral Dosage Forms Book Review:

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies