Developing Solid Oral Dosage Forms

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 the development process of oral dosage forms. This new edition reflects the significant impact of AI and ML on pharmaceutical science in recent years, with six new chapters and extensive updates to existing content. The book covers essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, as well as their application to the research and development process of oral dosage forms. The Third Edition features new chapters on Evaluation of Drug Absorption from Oral Dosage Forms, Dissolution Evaluation of Enabling Formulations Based on Supersaturation, Patient-Centric Drug Product Design, and Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway. Additionally, existing chapters have been updated, combined, or completely rewritten to provide a well-organized and valuable reference. Topics such as spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-release dosage forms, biowaivers, and more are covered in this edition. Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is an indispensable resource for industry professionals and academics looking to stay current with the latest advancements in solid formulation development. This book not only provides a thorough understanding of the principles and techniques involved in the development process but also offers practical guidance on how to apply these concepts to real-world situations. With its extensive coverage of new topics and updates to existing chapters, this edition is an essential tool for those working in the field of pharmaceutical science.

• Updated with six new chapters, through coverage of the AI and ML impact in oral formulation, and the latest developments in 3D printing, continuous manufacturing and Industry 4.0 in pharma
• Includes practical application, showing how essential principles are applied to real-world situations
• Covers both Industry and Academic content needs, for professionals, researchers, and students alike
• Addresses preformulation, formulation, process design, characterization, scale-up, and production operations
• Introduces the patient-centric drug product design process