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 chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development.
Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.
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.
"Even those who have been developing dissolution methods for years will find valuable information, since this text goes well beyond the basics of dissolution development for poorly soluble drugs. . . . The book walks through the lifecycle of a dissolution method for a poorly soluble compound, starting with solubility and intrinsic dissolution, including use of surfactants, has chapters that address several of the strategies used for formulation development and the staged approach to development of dissolution methods, provides chapters on alternatives to the traditional USP dissolution Apparatus 1 and 2, including Apparatus 3 and 4 and noncompendial approaches, then moves to some of the most interesting information describing biorelevant dissolution, clinically relevant dissolution, QbD approaches, and regulatory considerations. . . . Overall, this is a book that I strongly recommend for everyone involved in dissolution method development. It goes into much greater detail than similar texts and provides practical information that will prove helpful in addressing the concepts presented, both from a scientific and a regulatory perspective."
--Dissolution Technologies, February 2017
