Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition

Preformulation studies are physical, chemical, and biological studies to characterize a drug substance for proper design, while effectiveness is determined during formulation studies. This Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition, provides detailed descriptions of preformulation methodologies, techniques, and tools for a comprehensive characterization of new drug entities. It covers chemical, biological, and botanical new active entities and includes flow charts and theoretical treatment for dissolution, solubility, stability, and solid-state characterization.

Format: Paperback / softback
Length: 576 pages
Publication date: 14 June 2022
Publisher: Taylor & Francis Ltd

Preformulation studies encompass a comprehensive range of physical, chemical, and biological investigations that are essential in characterizing a drug substance to facilitate the appropriate design of a drug product. These studies play a crucial role in determining the effectiveness of a drug product during its formulation phase. While there may be some overlap in practice between preformulation and formulation, each discipline represents a distinct stage in the development of a new drug.

In this extensively revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition, the focus is entirely on preformulation principles. It offers detailed descriptions of preformulation methodologies, provides a comprehensive state-of-the-art overview of each technique, and lists the available tools that aid in the comprehensive characterization of a new drug entity.

Key Features:

Addresses the preformulation studies of three distinct types of new active entities: chemical, biological, and botanical, which is the latest established class of active ingredients classified by the FDA.

Illustrates the activities involved in preformulation studies and establishes a methodology for tasking drug development projects.

Includes extensive flow charts for characterization decision-making.

Provides extensive theoretical treatment of principles essential for testing dissolution, solubility, stability, and solid-state characterization.

Includes over 50% new material, making it an invaluable resource for researchers, scientists, and pharmaceutical professionals involved in drug development.

Weight: 1070g
Dimension: 234 x 156 (mm)
ISBN-13: 9781032338477
Edition number: 2 ed