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The 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 facetsand 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.

Route-Specific Challenges in the Delivery of Poorly Water-Soluble Drugs.- Optimizing the Formulation of Poorly Water-Soluble Drugs.- Solid-State Techniques for Improving Solubility.- Mechanical Particle-Size Reduction Techniques.- Co-solvent and Complexation Systems.- Injectable Formulations of Poorly Water-Soluble Drugs.- Lipid-Based Formulations.- Structured Development Approach for Amorphous Systems.- Melt Extrusion.- Spray-Drying Technology.- Pharmaceutical Cryogenic Technologies.- Precipitation Technologies for Nanoparticle Production.- Emerging Technologies to Increase the Bioavailability of Poorly Water-Soluble Drugs.- Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs.
ISBN 978-3-030-88721-6
Article number 9783030887216
Media type Book
Edition number 3. Aufl.
Copyright year 2023
Publisher Springer, Berlin
Length XII, 693 pages
Illustrations XII, 693 p. 280 illus., 138 illus. in color.
Language English