Water-insoluble drug formulation

著者

    • Liu, Rong

書誌事項

Water-insoluble drug formulation

edited by Rong Liu

CRC Press, c2008

2nd ed

  • : hardcover

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

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.

目次

Introduction, R. Liu Solubility Theories, S.H. Neau Prediction of Solubility, Y. Chen, X. Oi, and R. Liu Preformulation Aspects of Insoluble Compounds, W.Q. Tong and H. Zhou Water-Insoluble Drugs and their Pharmacokinetic Behaviors, H. Zhou Regulatory Aspects of Dissolution for Low Solubility Drug Products, P. Sathe, R.A. Lionberger, and LX.. Yu Formulation Strategies and Practice Used for Drug Candidates with Water-Insoluble Properties for Toxicology, Biology, and Pharmacology Studies in Discovery Support, L.-F. Huang and J. Dong Applications of Complexation in the Formulation of Insoluble Compounds, W.-Q. Tong and H. Wen Solubilization Using CoSolvent Approach, J.S. Trivedi Emulsions, Microemulsions, and Lipid-based Drug Delivery Systems for Drug Solubilization and Delivery, Part I: Parenteral Applications, J.B. Cannon, Y. Shi, and P. Gupta Emulsions, Microemulsions, and Lipid-based Drug Delivery Systems for Drug Solubilization and Delivery, Part II: Oral Applications, J.B. Cannon and M.A. Long Micellization and Drug Solubility Enhancement, R. Liu and R.-M. Dannenfelser, and S. Li Micellization and Drug Solubility Enhancement Part II: Polymeric Micelles, R. Liu, M.L. Forrest, and G.S. Kwon Liposomes in Solubilization, R. Liu, J.B. Cannon, and Y.S. Paspal Pharmaceutical Salts, S.H. Neau Prodrugs for Improved Aqueous Solubility, S.H. Neau Particle Size Reduction, R.W. Lee, J.M. Shaw, J. McShane, R.W. Wood, and D.B. Shenoy Development of Solid Dispersions for Poorly Water-Soluble Drugs, M. Vasanthavada, W.-Q. Tong, and A. Serajuddin Alternation of the Solid State of the Drug Substances: Polymorphs, Solvates, and Amorphous Forms, P. Myrdal and M.J. Jozwiakowski Pharmaceutical Powder Technology - Building the Pyramid of Knowledge and the Challenge of FDA's PAT Initiative, H. Leuenberger and G. Betz Soft Gelatin Capsules Development, E. Tabibi and S.L. Gupta Oral Modified-Release Drug Delivery for Water-Insoluble Drugs, S. Li, N. Wang, and R. Liu Scalable Manufacturing of Water-Insoluble Drug Products, N. Pathak and R. Huang Drug Products, N. Pathak and R. Huang

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