Description
Book SynopsisThe objective of this third edition is to consolidate within a single text the most current knowledge, practical methods, and regulatory considerations pertaining to formulations development with poorly water-soluble molecules. A pharmaceutical scientist’s approach toward solubility enhancement of a poorly water-soluble molecule typically includes detailed characterization of the compound’s physiochemical properties, solid-state modifications, advanced formulation design, non-conventional process technologies, advanced analytical characterization, and specialized product performance analysis techniques. The scientist must also be aware of the unique regulatory considerations pertaining to the non-conventional approaches often utilized for poorly water-soluble drugs. One faced with the challenge of developing a drug product from a poorly soluble compound must possess at a minimum a working knowledge of each of the above mentioned facets and detailed knowledge of most. In light of the magnitude of the growing solubility problem to drug development, this is a significant burden especially when considering that knowledge in most of these areas is relatively new and continues to develop.
Table of ContentsContents
1. Route-Specific Challenges in the Delivery of Poorly Water-Soluble Drugs ……………….. Zachary Warnken, Hugh D.C. Smyth, and Robert O. Williams III
2. Optimizing the Formulation of Poorly Water-Soluble Drugs………………………….. Xiangyu Ma, Daniel Ellenberger, Kevin P. O’Donnell, and Robert O. Williams III
3. Solid-State Techniques for Improving Solubility ……………………………………….. Miguel O. Jara, Justin R. Hughey, Siyuan Huang, and Robert O. Williams III
4. Mechanical Particle-Size Reduction Techniques…………………………..……….…… Javier O. Morales, Alan B. Watts, and Jason T. McConville
5. Co-solvent and Complexation Systems …………………………………………….... Junhuang Jiang and Robert O. Williams III
6. Injectable Formulations of Poorly Water-Soluble Drugs ………………………….…... Hannah L. O’Mary and Zhengrong Cui,
7. Lipid-Based Formulations…………………………………………………................... Daniel A. Davis Jr., Han-Hsuan Peng, and Robert O. Williams III
8. Structured Development Approach for Amorphous Systems ……………………….... Susanne Page, Reto Maurer, Nicole Wyttenbach, and Felix Ditzinger
9.
Melt Extrusion………………………………………………………………………. Stephen A. Thompson, Daniel A. Davis Jr., James C. DiNunzio, Charlie Martin,
Robert O. Williams III, and Feng Zhang
10. Spray-Drying Technology…………..………..………..………..……………………….. Dave A. Miller, Daniel Ellenberger, Tiago Porfirio, and Marco Gil
11. Pharmaceutical Cryogenic Technologies ………………………………………….... Sawittree Sahakijpijarn, Chaeho Moon, and Robert O. Williams III
12. Precipitation Technologies for Nanoparticle Production ……………………………. Tuangrat Praphawatvet and Robert O. Williams III
13. Emerging Technologies to Increase the Bioavailability of Poorly Water-Soluble Drugs …
Daniel A. Davis Jr., Rishi Thakkar, Mohammed Maniruzzaman, Dave A. Miller, Robert O. Williams III
14.
Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs…………………………………………………………………. .Zedong Dong and Hasmukh Patel
