Developing Solid Oral Dosage Forms ─ Pharmaceutical Theory & Practice

The second edition of Developing Solid Oral Dosage Forms illustrates how to develop high-quality, safe and effective pharmaceutical products by discussing the latest techniques, tools and scientific advances in preformulation investigation, formulation and process design, characterization and scale-up and production operations. This book continues to cover the essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized and valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modelling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers and much more.

• Written and edited by a team of international leading experts with experience and knowledge across industry, academia and regulatory settings
• Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support and much more
• Presents new case studies throughout the book and a section completely devoted to regulatory aspects, including global product regulation and international perspectives