Water-Insoluble Drug Formulation
Second edition
edited by Rong Liu

The most comprehensive resource on the topic, this second edition of Water Insoluble Drug Formulation provides the scientific background and step-by-step guidance needed to deal with solubility issues in drug development.

Features:

• Reviews existing theories of interactions between solutes and solvents
• Details the drug discovery support area for designing new drug candidates with improved aqueous solubility and maximized exposure
• Describes the physiochemical and biopharmaceutical properties of water-insoluble drugs
• Includes dissolution rate enhancement and related techniques for the development of oral solid dosage forms
• Presents formulation techniques to enhance bioavailability for oral dosage forms
• Demonstrates solubilization examples in parenteral applications

The book 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
• 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.

Contents

1. Introduction
2. Solubility Theories
3. Prediction of Solubility
4. Preformulation Aspects of Insoluble Compounds
5. Water-Insoluble Drugs and their Pharmacokinetic Behaviors
6. Regulatory Aspects of Dissolution for Low Solubility Drug Products
7. Formulation Strategies and Practice Used for Drug Candidates with
8. Water-Insoluble Properties for Toxicology, Biology, and Pharmacology Studies in Discovery Support
9. Applications of Complexation in the Formulation of Insoluble Compounds
10. Solubilization Using CoSolvent Approach
11. Emulsions, Microemulsions, and Lipid-based Drug Delivery Systems for Drug Solubilization and Delivery, Part I: Parenteral Applications
12. Emulsions, Microemulsions, and Lipid-based Drug Delivery Systems for Drug Solubilization and Delivery, Part II: Oral Applications
13. Micellization and Drug Solubility Enhancement
14. Polymeric Micelles in Water-insoluble Drug Delivery
15. Liposomes in Solubilization
16. Pharmaceutical Salts
17. Prodrugs for Improved Aqueous Solubility
18. Particle Size Reduction
19. Development of Solid Dispersions for Poorly Water-Soluble Drugs
20. Alternation of the Solid State of the Drug Substances: Polymorphs, Solvates, and Amorphous Forms
21. Pharmaceutical Powder Technology – Building the Pyramid of Knowledge and the Challenge of FDA’s PAT Initiative
22. Soft Gelatin Capsules Development
23. Oral Modified-Release Drug Delivery for Water-Insoluble Drugs
24. Scalable Manufacturing of Water-Insoluble Drug Products

Index

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