Covering every topic of critical importance to the preformulation stages of development, this guide equips those in the pharmaceutical industry with basic and applied principles for the characterization of new drug compounds and substances-considering the identification, stability, structure, and mechanisms of drug candidates during preformulation through Phase I of clinical trials.
The Handbook of Food Products Manufacturing is a definitive master reference, providing an overview of food manufacturing in general, and then covering the processing and manufacturing of more than 100 of the most common food products. With editors and contributors from 24 countries in North America, Europe, and Asia, this guide provides international expertise and a truly global perspective on food manufacturing.
Granulation provides a complete and comprehensive introduction on the state-of-the-art of granulation and how it can be applied both in an academic context and from an industrial perspective. Coupling science and engineering practices it covers differing length scales from the sub-granule level through behaviour through single granules, to bulk granule behaviour and equipment design. With special focus on a wide range of industrially relevant areas from fertilizer production, through to pharmaceuticals. Experimental data is complemented by mathematical modelling in this emerging field, allowing for a greater understanding of the basis of particle products and this important industry sector.Four themes run through the book:
1. The Macro Scale processing for Granulation including up to date descriptions of the methods used for granulation and how they come about and how to monitor on-line these changes.
2. The Applications of granulation from an industrial perspective, with current descriptive roles and how they are undertaken with relevance to industry, and effective properties.
3. Mechanistic descriptions of granulation and the different rate processes occurring within the granulator. This includes methods of modelling the process using Population Balance Equations, and Multi-level Computational Fluid Dynamics Models.
4. The Micro Scale: Granules and Smaller, looking at single granules and there interactions and modelling, while also considering the structure of granules and their constituent liquid bridges.
* Covers a wide range of subjects and industrial applications
* Provides an understanding of current issues for industrial and academic environments
* Allows the reader an understanding of the science behind engineered granulation processes
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 much-needed reformulation of currently marketed products can be significantly affected by these challenges. Water Insolubility is the Primary Culprit in over 40% of New Drug Development Failures
The most comprehensive resource on the topic, this second 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 solubility properties and their impact on formulation, from theory to industrial practice. With detailed discussion on how these properties contribute to solubilization and dissolution, the text also features six brand new chapters on water-insoluble drugs, exploring regulatory aspects, pharmacokinetic behavior, early phase formulation strategies, lipid based systems for oral delivery, modified release of insoluble drugs, and scalable manufacturing aspects. The book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies 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.
Plastics are the most important class of packaging materials. This successful handbook, now in its second edition, covers all important aspects of plastic packaging and the interdisciplinary knowledge needed by food chemists, pharmaceutical chemists, food technologists, materials scientists, process engineers, and product developers alike.This is an indispensable resource in the search for the optimal plastic packaging. Materials characteristics, additives and their effects, mass transport phenomena, quality assurance, and recent regulatory requirements from FDA and European Commission are covered in detail with ample data.
Covering the recently passed 45 CFR, and the parallel CFR 21 Part 11 and HIPAA regulations 160, 162, and 164, this book provides guidance for purchasing, installing, validating, and managing commercial off-the-shelf software data for collection and retention. Addressing the interface between these regulations and how to be in compliance with them, the authors cover audit trails, validation, documentation, training, and how to establish and maintain security and accountability. They discuss what the regulations mean in terms of industry standard, explain the audit function for facilities that are subject to the newer HIPAA regulations, and present the standards for documentation.
Expanded to include extensive new material on the critical role of purification and detailing the significant advances in filtration science and technology, this Second Edition of a classic reference provides state-of-the-science information on all aspects of filtration and purification, including current methods, processes, technologies, equipment, and the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries.
