Publisher: CRC Press
Year of Publication: 2016
Author(s) : Gregory K. Webster, Robert G. Bell and J. Derek Jackson
This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and/or chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as to fulfill regulatory obligations with respect to biopharmaceutical assessment and product quality understanding.
This book includes a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds (BCS Class 2 and 4) and formulations, biorelevant phase-appropriate approaches to dissolution development, formulation and solubilization techniques to overcome solubility challenges associated with the development of BCS Class 2 and 4 products as well as dissolution instrumentation and media selection for dissolution development with various dosage forms.