Water-Insoluble Drug Formulation, Second Edition

Description

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.

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

Related Subjects

1. Drug Development
2. Pharmaceutical Science
3. Pharmacy
4. Drug Design & Development
5. Pharmaceutical Science
6. Pharmacy