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Full Description
During the onset of any clinical trial there are many factors and variables to consider. Funding, time restraints, and regulatory agency guidelines are factors that often influence which variables will be studied, leaving other important information out of the study. Preformulation in Solid Dosage Form Development covers every topic of critical importance to the preformulation stages of drug development. Serving as a handbook or stand-alone reference, this text equips those in academia and the pharmaceutical industry with both basic and applied principles for the characterization of drugs, excipients, and products, and deals with the issues relating to predictability, identification, and product development during preformulation stages through Phase I of clinical trials.
With contributions from an international panel of experts in the field, this guide:
outlines an updated preformulation program for modern drug development issues that includes particle morphology, characterization, thermal analysis, and solubility methods
contains rational designs for the structure of formulation studies
covers the importance of preformulation design using artificial neural networks and computational prediction techniques, and examines the concepts of preliminary-preformulation
discusses the typical drug-excipient interactions that could occur during the course of development and methods of characterization
includes novel methods to determine the physical and chemical stability of new formulations
reviews the structure, content, and format of the preformulation report
examines the significance of drug substance physiochemical properties, in regulatory quality by design
Contents
1. Introduction and Overview. 2. Preliminary Preformulation. 2.1. Accelerating the Course of Preliminary-Preformulation through Prediction of Molecular Physical Properties and Integrated Analytical Data Management. 2.2. Prediction of Crystallographic Characteristics. 2.3. Salt Selection for Pharmaceutical Compounds. 2.4. Intelligent Preformulation Design and Predictions using Artificial Neural Networks. 3. Profiling the Drug Substance. 3.1. Developing a Profile of the Active Pharmaceutical Ingredient. 3.2. Particle Morphology and Characterization in Preformulation. 3.3. Preparation and Identification of Polymorphs and Solvatomorphs. 3.4. X-Ray Diffraction Methods for the Characterization of Solid Pharmaceutical Materials. 3.5. Spectroscopic Methods for the Characterization of Drug Substances. 3.6. Thermal Analysis and Calorimetric Methods for the Characterization of New Crystal Forms. 3.7. Solubility Methods for the Characterization of New Crystal Forms. 4. Development of the Ideal Formulation. 4.1. Overview of the Solid Dosage Form Preformulation Program . 4.2. Drug-Excipient Interactions Appropriate to Solid Dosage Forms. 4.3. Methods for the Determination of the Physical and Chemical Stability of a New Solid Dosage Form. 4.4. Dissolution Testing. 5. Beyond Preformulation. 5.1. Structure, Content, and Format of the Preformulation Report. 5.1. Significance of Drug Substance Physicochemical Properties in Regulatory Quality by Design.
