Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is a comprehensive and up-to-date guide for professionals and academics engaged in all aspects of oral dosage form development, from discovery support through commercial manufacturing. This new edition features 13 new or rewritten chapters, along with significant updates to existing content, reflecting the latest advancements in the field, including new theories, scientific findings, approaches, techniques, modeling, and the emerging opportunities offered by AI.
This book consists of 44 chapters covering in-depth principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their applications throughout the R&D process and commercial production of oral dosage forms. New chapters address topics such as absorption evaluation of oral dosage forms, formulation principles, and applications based on supersaturation, patient-centric product design, product design through the 505(b)(2) NDA pathway, design of experiments (DoE), process modeling, 3D printing, and machine learning applications in commercial manufacturing. Existing chapters have been updated or completely rewritten to provide advanced information and include practical case studies. Important topics such as amorphous solid dispersions, modified-release delivery, manufacturing technologies, modeling and simulation, fundamentals of dissolution and bioequivalence, IVIVC, biowaivers, regulatory frameworks, and many others are covered.
The new edition of this book is an indispensable resource for industry professionals, academic institutions, and regulatory bodies seeking to stay current with advances in solid dosage form development and manufacturing. It offers a thorough understanding of fundamental principles and techniques, along with practical guidance on applying these concepts to real-world challenges. Expanded and updated content: Includes 13 new or extensively rewritten chapters covering topics such as supersaturation, oral absorption, DoE, and its applications in product development, and the latest advancements in 3D printing, continuous manufacturing, modeling, machine learning, and Industry 4.0 Practical focus: Demonstrates the importance and application of essential pharmaceutical principles to real- world product development challenges Comprehensive audience coverage: Serves as a valuable reference for industry product development scientists and engineers, academic researchers, regulatory reviewers, and graduate students End-to-end development coverage: Addresses preformulation and biopharmaceutics studies, formulation and process design, characterization, development, scale-up, and commercial manufacturing operations Patient-centered design: Introduces patient-centric drug product design processes to support improved therapeutic outcomes