Water-Insoluble Drug Formulation / Edition 2

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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.

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Editorial Reviews

Describes techniques used for water-soluble formulations, providing step-by-step instructions as well as scientific background on drug and water properties and how they contribute to solubilization and dissolution. Reviews theories on interactions between solutes and solvents, and gives information on designing drug candidates with improved aqueous solubility before they are synthesized. Explains the physiochemical and biopharmaceutical properties of a water-insoluble drug, and gives techniques for development of oral solid dosage forms. Also provides formulation techniques to enhance bioavailability for oral liquid dosage forms and to solubilize water-insoluble drugs for parenteral dosage forms. The editor directs product development at Bristol-Meyers Squibb Worldwide Consumer Medicines. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9780849396441
  • Publisher: Taylor & Francis
  • Publication date: 1/11/2008
  • Edition description: REV
  • Edition number: 2
  • Pages: 688
  • Product dimensions: 6.90 (w) x 10.10 (h) x 1.80 (d)

Table of Contents

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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