Preformulation in Solid Dosage Form Development

Moji Christianah Adeyeye, Harry G. Brittain, Moji Christianah Adeyeye, Harry G. Brittain

• Publisher: CRC Press
• Year: 2008
• Print ISBN: 9780824758097
• eBook ISBN: 9780849360862
• Edition: 1
• Topic: Medicina
• Subtopic: Farmacologia

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 imp

Table of contents

• Front cover
• Prefaces
• Contents
• Contributors
• Part 1: Introduction
• Chapter 1.1 Introduction and Overview to the Preformulation Development of Solid Dosage Forms
• Part 2: Preliminary Preformulation
• Chapter 2.1 Accelerating the Course of Preliminary Preformulation Through Prediction of Molecular Physical Properties and Integrated Analytical Data Management
• Chapter 2.2. Prediction ofCrystallographic Characteristics
• Chapter 2.3 Salt Selection for Pharmaceutical Compounds
• Chapter 2.4 Intelligent Preformulation Design and Predictions Using Artificial Neural Networks
• Part 3: Profiling the Drug Substance
• Chapter 3.1. Developing a Profile of the Active Pharmaceutical Ingredient
• Chapter 3.2. Particle Morphology and Characterization in Preformulation
• Chapter 3.3. Preparation and Identification of Polymorphs and Solvatomorphs
• Chapter 3.4 X-Ray Diffraction Methods for the Characterization of Solid Pharmaceutical Materials
• Chapter 3.5 Spectroscopic Methods for the Characterization of Drug Substances
• Chapter 3.6 Thermal Analysis and Calorimetric Methods for the Characterization of New Crystal Forms
• Chapter 3.7 Solubility Methods for the Characterization of New Crystal Forms
• Part 4: Development of the Ideal Formulation
• Chapter 4.1 Overview of the Solid Dosage Form Preformulation Program
• Chapter 4.2 Drug-Excipient Interaction Occurances During Solid Dosage Form Development
• Chapter 4.3 Methodology for the Evaluation of Chemical and Physical Interactions Between Drug Substances and Excipients
• Chapter 4.4 Dissolution Testing
• Part 5: Beyond Preformulation
• Chapter 5.1 Structure, Content, and Format of the Preformulation Report
• Chapter 5.2 Significance of Drug Susbtance Physicochemical Properties in Regulatory Quality by Deisgn*
• Index
• Back cover