基本説明
錠剤の設計、製剤、生産と評価、投薬形態の最適化をまとめたレファレンス。
Contents: Volume 1. Fundamentals and Unit Operations/ Volume 2. Rational Design and Formulation with Excipients/ Voume 3. Modern Manufacture and Control.
Full Description
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. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, and with over 700 illustrations it guides pharmaceutical scientists and engineers through difficult and technical procedures in a simple easy-to-follow format.
New to the third edition:
Contents
Volume I: Fundamentals and Unit Operations
Principles of Sampling for Particulate Solids. Particle Size and Shape. Flow: General Principles of Bulk Solids Handling. Blending and Blend Uniformity. Milling. Drying. Spray Drying: Theory and Pharmaceutical Applications. Wet Granulation. Dry Granulation. The Preparation of Pellets by Extrusion/Spheronization. Coating Processes and Equipment. Aqueous Polymeric Film Coating. The Application of Thermal Analysis to Pharmaceutical Dosage Forms. Preformulation Studies for Tablet Formulation Development. Stability Kinetics. Compaction Simulation. Compression and Compaction.
Volume II: Rational Design and Formulation with Excipients
Preface. Mass Transfer (from solid oral dosage forms). Approaches for Improving Bioavailability of Poorly Soluble Drugs. Experimental Design and Multivariate Optimization Tools in Formulation and Process Development. Knowledge-Based Systems and Other AI Applications for Tableting. Direct Compression and the Role of Filler-Binders. Disintegrants in Tableting. Orally Disintegrating Tablets and Related Tablet Formulations. Formulation Challenges: Multiple Vitamin and Mineral Dosage Forms. Botanicals and Their Formulation into Oral Solid Dosage Forms. Formulation of Specialty Tablets for Slow Oral Dissolution. Formulation of Specialty Tablets for Slow Oral Dissolution. Swellable and Rigid Matrices Controlled Release Matrices with Cellulose Ethers. Carragenenans in Solid Dosage Form Design. Osmotic Systems. Tableting of Multiparticulate Modified Release Systems.
Volume III: Modern Manufacture and Control
Preface. Tooling for Pharmaceutical Processing. Tablet Press Instrumentation in the Research and Development Environment. Pharmaceutical Manufacturing: Changes in Paradigms. A Forward-Looking Approach to Process Scale-Up for Solid Dose Manufacturing. Dissolution and Drug Release. Setting Dissolution Specifications. Mechanical Strength of Tablets. CGMPs for the 21st Century and ICH Quality Initiatives. Intellectual Property, Patent and Patenting Process in Pharmaceutical Industry. Near-Infrared Chemical Imaging of Pharmaceutical Oral Solid Dosage Forms. Surface Area, Porosity and Related Physical Characteristics.
