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The objective of this volume 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 minimum a working knowledge of each of the abovementioned 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
Sommario
Route-Specific Challenges in 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.- Solubilized Formulations.- Injectable Formulations of Poorly Water Soluble Drugs.- Design and Development of Self-Emulsifying Lipid Formulations for Improving Oral Bioavailability of Poorly Water-Soluble and Lipophilic Drugs.- 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.- Regulatory Considerations for Development and Commercialization of Poorly Water Soluble Drugs.
