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.

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.

Selected papers from the 2011 International Conference on Advanced Design and Manufacturing Engineering (ADME 2011), 16-18 September 2011, Guangzhou, China

The authoritative textbook on the principles and practical applications of biopharmaceutics and pharmacokinetics Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics has been the standard textbook in its field for over 40 years. This eighth edition includes recent scientific developments in the field and embodies the collective contribution of experts with deep knowledge and experience in the selected subject areas. Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics, Eighth Edition provides the reader with a fundamental understanding of biopharmaceutics and pharmacokinetics principles that can be applied to patient drug therapy and rational drug product development. Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics, Eighth Edition has been expanded and revised to include advancements in biopharmaceutics and pharmacokinetics. The chapter sequence has been reorganized into four main sections, providing a more logical sequence for students. The textbook starts with fundamental concepts, followed by application of these principles to optimize drug therapy and to the rational development of drug products. Each chapter includes theoretical concepts with practical examples and clinical applications. Frequently asked questions provide a discussion of overall concepts. Features: Expanded and revised chapters to include scientific advances in biopharmaceutics and pharmacokinetics Four main sections providing a natural buildup of knowledge: introduction to biopharmaceutics and pharmacokinetics, fundamentals of biopharmaceutics, pharmacokinetic calculations, clinical pharmacokinetics and pharmacodynamics, and biopharmaceutics and pharmacokinetics in drug product development Additional chapters for this edition include: o Physiological factors related to drug absorption o Approaches to pharmacokinetics and pharmacodynamics calculations o Novel and complex dosage Forms o Clinical Development and Therapeutic Equivalence of Generic Drug and Biosimilar Products o Pharmacokinetics and Pharmacodynamics in Clinical Drug Product Development Additional information on drug therapy, drug product performance, and other related topics Frequently asked questions, practice problems, clinical examples and learning questions