Poorly Soluble Drugs Dissolution and Drug Release

1. The Modern Pharmaceutical Development Challenge: BCS Class II and IV Drugs

Gregory K. Webster, Robert G. Bell, and J. Derek Jackson

2. Solubility Determinations for Pharmaceutical API

Kofi Asare-Addo and Barbara R. Conway

3. Use of Surfactants in Dissolution Testing

Amit Gupta

4. Intrinsic Dissolution Evaluation of Poorly Soluble Drugs

Michele Georges Issa and Humberto Gomes Ferraz

5. Oral Delivery of Poorly Soluble Drugs

Dev Prasad, Akash Jain, and Sudhakar Garad

6. A Staged Approach to Pharmaceutical Dissolution Testing

Gregory K. Webster, Xi Shao, and Paul D. Curry, Jr.

7. Development and Application of in vitro Two-Phase Dissolution Method for Poorly Water-Soluble Drugs

Ping Gao, Yi Shi, and Jonathan M. Miller

8. The Use of Apparatus 3 in Dissolution Testing of Poorly Soluble Drug Formulations

1. Dissolution of Nanoparticle Drug Formulations

John Bullock

2. Dissolution of Lipid-Based Drug Formulations

Stephen M. Cafiero

3. Dissolution of Stabilized Amorphous Drug Formulations

Justin R. Hughey

4. Dissolution of Pharmaceutical Suspensions

Beverly Nickerson, Michele Xuemei Guo, Kenneth J. Norris, and Ling Zhang

5. Dissolution Testing of Poorly Soluble Drugs: "Biorelevant Dissolution"

Mark McAllister and Irena Tomaszewska

6. Clinically Relevant Dissolution for Low-Solubility Immediate-Release Products

Paul A. Dickinson, Talia Flanagan, David Holt, and Paul W. Stott

7. The QbD Approach to Method Development and Validation for Dissolution Testing

Alger D. Salt

8. Regulatory Considerations in Dissolution and Drug Release of BCS Class II and IV Compounds

Robert G. Bell and Laila Kott

9. Dissolution of Liquid-Filled Capsules Based Formulations

Rampurna Prasad Gullapalli

10. Current and Emerging Non-compendial Methods for Dissolution Testing

Biography

Gregory K. Webster is a senior principal research scientist with AbbVie Inc.’s Global Analytical Research and Development. He obtained his BS in chemistry from St. Xavier College, USA, MS in analytical chemistry from Governors State University, USA, and PhD in analytical chemistry from Northern Illinois University. Dr. Webster’s industrial career spans an employment history with several major pharmaceutical companies. His first book with Pan Stanford Publishing, Supercritical Fluid Chromatography: Advances and Applications in Pharmaceutical Analysis, was published in 2014.

Robert G. Bell is president of Drug and Biotechnology Development LLC, USA, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development. He received his education from the University of Florida and has worked with the pharmaceutical industry for over 30 years. Dr. Bell is adjunct faculty at Virginia Commonwealth University and the University of Florida College of Pharmacy and a member of the Council of Experts, General Chapters—Biological Analysis for United States Pharmacopeia.

J. Derek Jackson is director of Analytical Development at Flexion Therapeutics Inc, USA. He earned his BS and MA in chemistry from the College of William and Mary in Virginia. Derek has been engaged in all stages of pharmaceutical discovery, research, and development for 20 years, in both large pharma and small- to midcap biotech companies.

"Even those who have been developing dissolution methods for years will find valuable information, since this text goes well beyond the basics of dissolution development for poorly soluble drugs. . . . The book walks through the lifecycle of a dissolution method for a poorly soluble compound, starting with solubility and intrinsic dissolution, including use of surfactants, has chapters that address several of the strategies used for formulation development and the staged approach to development of dissolution methods, provides chapters on alternatives to the traditional USP dissolution Apparatus 1 and 2, including Apparatus 3 and 4 and noncompendial approaches, then moves to some of the most interesting information describing biorelevant dissolution, clinically relevant dissolution, QbD approaches, and regulatory considerations. . . . Overall, this is a book that I strongly recommend for everyone involved in dissolution method development. It goes into much greater detail than similar texts and provides practical information that will prove helpful in addressing the concepts presented, both from a scientific and a regulatory perspective."
--Dissolution Technologies, February 2017