SynopsisPharmaceutical Dosage Forms: Tablets, Third Editionis a comprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form. The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients Volume 1 focuses unit operations and mechanical properties. This reference examines the fundamental physical and chemical processes that the different unit operations use, and then apply this knowledge to the discussion of the varying unit operations and processes.
Table of ContentsVolume 1: Unit Operations and Mechanical Properties Dedication Foreword Preface Contributors 1. Principles of Sampling for Particulate Solids 2. Particle and Powder Bed Properties 3. Flow: General Principles of Bulk Solids Handiing 4. Blending and Blend Uniformity 5. Milling 6. Drying 7. Spray Drying: Theory and Pharmaceutical Applications 8. Pharmaceutical Granulation Processes, Mechanism, and the Use of Binders 9. Dry Granulation 10. The Preparation of Pellets by Extrusion/Spheronization 11. Coating Processes and Equipment 12. Aqueous Polymeric Film Coating 13. The Application of Thermal Analysis to Pharmaceutical Dosage Forms 14. Preformulation Studies for Tablet Formulation Development 15. Stability Kinetics 16. Compaction Simulation 17. Compression and Compaction IndexVolume 2: Rational Design and Formulation Dedication Foreword Preface Contributors 1. Mass Transfer from Solid Oral Dosage Form 2. Approaches for Improving Bioavailability of Poorly Soluble Drugs 3. Aims and Objectives and of Experimental Design and Optimization in Formulation and Process Development 4. Knowledge-based Systems and Other AI Applications for Tableting 5. Direct Compression and the Role of Filler-binders 6. Disintegrants in Tableting 7. Lubricants, Glidants and Antiadherents 8. Surfactants and Colors in Tablets 9. Orally Disintegrating Tablets and Related Tablet Formulations 10. Formulation Challenges: Multiple Vitamin and Mineral Dosage Forms 11. Botanicals and Their Formulation into Oral Solid Dosage Forms 12. Formulation of Specialty Tablest for Slow Oral Dissolution 13. Formulation and Design of Veterinary Tablets 14. Swellable and Rigid Matrices: Controlled Release Matrices with Cellulose 15. Carrageenans in Solid Dosage Form Design 16. Osmotic Systems 17. Tableting of Multiparticulate Modified Release Systems IndexVolume 3: Manufacture and Process Control Dedication Foreword Preface Contributors 1. Tooling for Pharmaceutical Processing 2. Tablet Press Instrumentation in the Research and Development Environment 3. Pharmaceutical Manufacturing: Changes in Paradigms 4. A Forword-Looking Approach to process Scale-Up for Solid Dose 5. Dissolution and Drug Release Testing 6. Setting Dissolution Specifications 7. Mechanical Strength of Tablets 8. cGmps for the 21st Century and ICH Quality Initiatives 9. Intellectual Property, Patent, and Patenting Process in the Pharmaceutical 10. Near-infrared Chemical Imaging for Characterizing Pharmaceutical dosage Forms 11. Surface Area, Porosity, and Related Physical Characteristics