Formulating Poorly Water Soluble Drugs

The third edition of this book aims to consolidate the most current knowledge, practical methods, and regulatory considerations for formulating poorly water-soluble molecules into a single text. It covers compound characterization, solid-state modifications, formulation design, non-conventional process technologies, advanced analytical characterization, and product performance analysis techniques. Understanding these aspects is crucial for developing drug products from poorly soluble compounds, as knowledge in these areas is rapidly evolving.

Format: Hardback
Length: 693 pages
Publication date: 20 May 2022
Publisher: Springer Nature Switzerland AG

The third edition of this comprehensive text aims to consolidate the most current knowledge, practical methods, and regulatory considerations related to the development of formulations with poorly water-soluble molecules. A pharmaceutical scientist's approach to enhancing solubility typically involves a 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. Additionally, the scientist must be well-versed in the unique regulatory considerations associated with non-conventional approaches often employed for poorly water-soluble drugs.

Developing a drug product from a poorly soluble compound requires a thorough understanding of each of the aforementioned aspects and in-depth knowledge of most. Given the growing significance of the solubility problem in drug development, especially considering the rapid evolution of knowledge in these areas, this represents a significant challenge.

To address this challenge, the third edition of this text provides a comprehensive overview of the latest developments in solubility enhancement strategies. It covers a wide range of topics, including physicochemical property characterization, solid-state modifications, advanced formulation design, non-conventional process technologies, advanced analytical characterization, and specialized product performance analysis techniques.

Furthermore, the text emphasizes the importance of considering regulatory considerations throughout the development process, particularly for non-conventional approaches. It provides guidance on complying approaches to obtaining regulatory approval for these products, including strategies for conducting clinical trials and ensuring safety and efficacy.

By consolidating the most current knowledge and practical approaches in a single text, this third edition serves as a valuable resource for pharmaceutical scientists, researchers, and regulatory professionals involved in the development of formulations with poorly water-soluble molecules. It provides a comprehensive foundation for advancing the field and overcoming the challenges posed by these complex compounds.

Weight: 1511g
Dimension: 254 x 178 (mm)
ISBN-13: 9783030887186
Edition number: 3rd ed. 2022