Biblioteca Virtual en Salud

A pharmaceutical scientist's approach towardsolubility enhancement of a poorly water-soluble molecule typicallyincludes detailed characterization of the compound's physiochemicalproperties, solid-state modifications, advanced formulation design,non-conventional process technologies, advanced analyticalcharacterization, and specialized product performance analysistechniques. The scientist must also be aware of the uniqueregulatory considerations pertaining to the non-conventionalapproaches often utilized for poorly water-soluble drugs. One facedwith the challenge of developing a drug product from a poorlysoluble compound must possess at minimum a working knowledge ofeach of the abovementioned facets and detailed knowledge of most.In light of the magnitude of the growing solubility problem to drugdevelopment, this is a significant burden especially whenconsidering that knowledge in most of these areas is relatively newand continues to develop. There are numerous literature resourcesavailable to pharmaceutical scientists to educate and provideguidance toward formulations development with poorly water-solubledrugs; however, a single, comprehensive reference is lacking.Furthermore, without access to a vast journal library, the detailedmethods used to implement these approaches are not available. Theobjective of this volume is therefore to consolidate within asingle text the most current knowledge, practical methods, andregulatory considerations pertaining to formulations developmentwith poorly water-soluble molecules.