Contents

Preface ix

1. Principles of Solubility 1

Yuchuan Gong, David J.W. Grant, and Harry G. Brittain

2. Ionic Equilibria and the pH Dependence of Solubility 29

Harry G. Brittain

3. Solvent Systems for Crystallization and Polymorph Selection 53

Jonathan M. Miller, Anthony C. Blackburn, Dainius Macikenas, Benjamin M. Collman, and Nair Rodriguez-Hornedo

4. Solubility Issues in Early Discovery and HTS 111

Li Di and Edward H. Kerns

5. Practical Aspects of Solubility Determination in Pharmaceutical Preformulation 137

Wei-Qin (Tony) Tong

6. Biorelevant Dissolution Media 151

Anette Mullertz

7. Selection of Solvent Systems for Membrane-, Cell-, and

Tissue-Based Permeability Assessment 179

Françoise Ingels, Anna-Lena Ungell, and Patrick Augustijns

8. The Use of Solubilizing Excipients and Approaches to Generate Toxicology Vehicles for Contemporary Drug Pipelines 221

Marcus E. Brewster, Claire Mackie, Ann Lampo, Marc Noppe, and Thorsteinn Loftsson

9. Solubilizing Vehicles for Oral Formulation Development 257

Robert G. Strickley and Reza Oliyai

10. Solubilizing Systems for Parenteral Formulation

Development—Small Molecules 309

James E. Kipp

11. Aqueous Solubilizing Systems for Parenteral Formulation

Development—Proteins 341

Zahra Shahrokh

12. Non-Aqueous Systems for Formulation Development—Proteins 359

Cynthia L. Stevenson

13. Pharmaceutical Solvents as Vehicles for Topical Dosage Forms 403

Adrian Williams

14. Pharmaceutical Solvents for Pulmonary Drug Delivery 427

Erik Mogalian and Paul Brian Myrdal

Index 443

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