Developing Solid Oral Dosage Forms
Pharmaceutical Theory and Practice
by Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Rao V. Mantri, Lawrence Yu
3rd Edition
Publisher: Academic Press
Book Details
| Print ISBN | 9780443341564 |
| eText ISBN | 9780443341571 |
| Publisher | Academic Press |
| Publishing Year | 2026 |
| Edition | 3rd Edition |
| Language | English |
Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 3rd Edition delivers a comprehensive reference focused on the theoretical principles and applied practices of solid oral drug formulation. Designed for industry product development scientists, formulation engineers, academic researchers, regulatory reviewers, and graduate students, this publication establishes a clear scientific framework for evaluating and developing solid oral dosage forms.
The content concentrates on critical aspects of drug delivery performance and dosage form design. Primary thematic arcs examine the systematic evaluation of oral drug absorption across physicochemical and biological pathways, advanced formulation techniques reliant on supersaturation to deliver challenging poorly soluble active pharmaceutical ingredients, and practical considerations involved in patient-centric drug product design.
A defining feature of this 3rd Edition is the inclusion of 13 new or rewritten chapters that present contemporary scientific methodologies across physical pharmacy and industrial practice. This reference work provides reliable technical guidance for academic research environments, industrial product development teams, and regulatory review units.
Table of Contents
Chapter 1: Solubility of Pharmaceutical Solids
Chapter 2: Crystalline and Amorphous Solids
Chapter 3: Solid-State Characterization and Techniques
Chapter 4: API Solid-Form Screening and Selection
Chapter 5: Drug Stability and Degradation Studies
Chapter 6: Excipient Compatibility and Functionality
Chapter 7: Polymer Properties and Characterization
Chapter 8: Interfacial Phenomena
Chapter 9: The Fundamentals of Diffusion and Dissolution
Chapter 10: Particle, Powder, and Compact Characterization
Chapter 11: Oral Drug Absorption: Pathways, Physicochemical and Biological Factors, and Methods of Study
Chapter 12: Evaluation of Drug Absorption from Oral Dosage Forms
Chapter 13: Dissolution Testing of Solid Products
Chapter 14: Bioavailability and Bioequivalence
Chapter 15: In Vitro-In Vivo Correlations: Fundamentals, Development Considerations, and Applications
Chapter 16: Oral Delivery of Challenging Poorly Soluble Drugs via Supersaturation: Principles and Applications
Chapter 17: Patient-centric Drug Product Design: Rational and Practical Considerations
Chapter 18: Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway
Chapter 19: Oral Formulations for Preclinical Studies: Principle, Design, and Development
Chapter 20: Product and Process Development of Solid Oral Dosage Forms
Chapter 21: Rational design of Amorphous Solid Dispersions
Chapter 22: Rational Design of Oral Modified-Release Drug Delivery Systems
Chapter 23: Basic Principles of The Design of Experiments
Chapter 24: Established unit operation models for solid oral dosage forms from an industrial perspective
Chapter 25: Analytical Method Development of Solid Dosage Forms
Chapter 26: Statistical Design and Analysis of Long-Term Stability Studies for Drug Products
Chapter 27: Packaging Selection for Solid Oral Dosage Forms
Chapter 28: Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation
Chapter 29: Specification Setting and Manufacturing Process Control for Solid Oral Drug Products
Chapter 30: Process Development and Scale-Up: Providing Reliable Powder Flow and Product Uniformity
Chapter 31: Capsules Dosage Form: Formulation and Manufacturing Considerations
Chapter 32: Process Development and Scale-Up: High Shear Wet Granulation process
Chapter 33: Process Development and Scale-Up: Fluid-bed Granulation
Chapter 34: Process Development and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs
Chapter 35: Process development and scale-up: Twin screw extrusion
Chapter 36: Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice
Chapter 37: Development, Scale-Up and Optimization of Process Parameters: Tablet Compression
Chapter 38: Development and Scale-Up of Process Parameters: Pan Coating
Chapter 39: Development, Scale-Up and Optimization of Process Parameters: Wurster Coating
Chapter 40: Ensuring Commercial Manufacturing and Product Quality Through Science- and AI-Driven Approaches
Chapter 41: Continuous Manufacturing: Modernizing Pharmaceutical Manufacturing with Advanced Technologies and 3D Printing
Chapter 42: Drug Product Approval in the United States and International Harmonization
Chapter 43: Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances
Chapter 44: Modern Pharmaceutical Regulations: Quality Assessment for Drug Products
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