Developing solid oral dosage forms: pharmaceutical theory & practice

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers 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, 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, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more.--Provided by publisher.

I.THEORIES AND TECHNIQUES IN THE CHARACTERIZATION OF DRUG SUBSTANCES AND EXCIPIENTS -- 1.Solubility of Pharmaceutical Solids / H.(J.) Zhu -- 1.1.Introduction -- 1.2.Thermodynamics of Solutions -- 1.3.Theoretical Estimation of Solubility -- 1.4.Solubilization of Drug Candidates -- 1.5.Experimental Determination of Solubility -- References -- 2.Crystalline and Amorphous Solids / D. Zhou -- 2.1.Introduction -- 2.2.Definitions and Categorization of Solids -- 2.3.Thermodynamics and Phase Diagrams -- 2.4.Pharmaceutical Relevance and Implications -- 2.5.Transformations Among Solids -- 2.6.Methods of Generating Solids -- 2.7.Amorphous Drugs and Solid Dispersions -- 2.8.Special Topics -- References -- 3.Solid-State Characterization and Techniques / D. Zhou -- 3.1.Introduction -- 3.2.Microscopy -- 3.3.Powder X-ray Diffraction -- 3.4.Thermal Analysis -- 3.5.Vibrational Spectroscopy -- 3.6.Moisture Sorption -- 3.7.Hyphenated Techniques -- 3.8.Conclusion -- References -- 4.API Solid-Form Screening and Selection / R.V. Mantri -- 4.1.Introduction -- 4.2.Solid-Form Selection Considerations -- 4.3.Screening Solid-Forms of API -- 4.4.Identification and Analysis of Forms -- 4.5.Conclusions -- 4.6.Ca…