Liu R. (ed.) Water-Insoluble Drug Formulation

Second Edition. – Boca Raton: CRC Press. – 2008. – 685 p. This book has its origin in a training course, “The Role of Drug Solubility in Formulation Development,” offered by the American Association of Pharmaceutical Scientists, 6 years ago in Chicago. The course was designed to help young pharmaceutical scientists and pharmacy graduate students solve problems often encountered in dealing with water-insoluble drugs in their research and drug development programs, which was chaired by Dr. Maureen Donovan from the University of Iowa College of Pharmacy, with lectures by Drs. Steven Neau from University of Missouri-Kansas City College of Pharmacy, Pramod Gupta from Abbott Laboratories, and myself, then working at American Cyanamid Company. Approximately 1 year after the course, I was approached It has been 7 years since the book “Water-Insoluble Drug Formulation” was published in the year of 2000. Both the publisher and I have received much positive feedback on the book from the readers since its publication. In the past decade, however, the field of water-insoluble drug delivery has seen much progress and advancement. In the second edition of the book, chapters in the first edition have been updated (the chapter that described solid dispersion has been completely revised), and six new chapters have been added. The new chapters are as follows: Water-Insoluble Drugs and Their Pharmacokinetic Behaviors; Regulatory Aspects of Dissolution for Low-Solubility Drug Products; Formulation Strategies and Practice Used for Drug Candidates with Water-Insoluble Properties for Toxicology, Biology, and Pharmacology Studies in Discovery Support; Emulsion, Microemulsion, and Lipid-Based Drug Delivery Systems for Drug Solubilization and Delivery in Oral Applications; Oral Modified-Release Drug Delivery for Water-Insoluble Drugs; and Scalable Manufacturing of Water-Insoluble Drug Products.Solubility Theories.
Prediction of Solubility.
Preformulation Aspects of Insoluble Compounds.
Water-Insoluble Drugs and Their Pharmacokinetic Behaviors.
Regulatory Aspects of Dissolution for Low Solubility Drug Products.
Formulation Strategies and Practice Used for Drug Candidates with Water-Insoluble Properties for y, Biology, and Pharmacology Studies in Discovery Support.
Applications of Complexation in the Formulation of Insoluble Compounds.
Solubilization Using Cosolvent Approach.
Emulsions, Microemulsions, and Lipid-Based Drug Delivery Systems for Drug Solubilization and Delivery — Part I: Parenteral Applications.
Emulsions, Microemulsions, and Lipid-Based Drug Delivery Systems for Drug Solubilization and Delivery — Part II: Oral Applications.
Micellization and Drug Solubility Enhancement.
Micellization and Drug Solubility Enhancement Part II: Polymeric Micelles.
Liposomes in Solubilization.
Pharmaceutical Salts.
Prodrugs for Improved Aqueous Solubility.
Particle Size Reduction.
Development of Solid Dispersion for Poorly Water-Soluble Drugs.
Alteration of the Solid State of the Drug Substances: Polymorphs, Solvates, and Amorphous Forms.
Pharmaceutical Powder Technology — Building the Pyramid of Knowledge and the Challenge of FDA’s PAT Initiative.
Soft Gelatin Capsules Development.
Oral Modified-Release Drug Delivery for Water-Insoluble Drugs.
Scalable Manufacturing of Water-Insoluble Drug Products.