Preformulation in Solid Dosage Form Development volume 159

Covering every topic of critical importance to the preformulation stages of development, this guide equips those in the pharmaceutical industry with basic and applied principles for the characterization of new drug compounds and substances-considering the identification, stability, structure, and mechanisms of drug candidates during preformulation through Phase I of clinical trials.

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

Accelerating the course of preliminary-preformulation through prediction of molecular physical properties and integrated analytical data management / Robert S. DeWitte, Michel Hachey, and Harry G. Brittain Prediction of crystallographic characteristics / Steve Spanton Salt selection for pharmaceutical compounds / Sherif I. Badawy, Miriam K. Franchini, and Munir A. Hussain Intelligent preformulation design and predictions using artificial neural networks / Nkere K. Ebube Developing a profile of the active pharmaceutical ingredient / Harry G. Brittain Particle morphology and characterization in preformulation / Alan Rawle Preparation and identification of polymorphs and solvatomorphs / Harry G. Brittain X-ray diffraction methods for the characterization of solid pharmaceutical materials / Jean Blachere and Harry G. Brittain Spectroscopic methods for the characterization of drug substances / Harry G. Brittain Thermal analysis and calorimetric methods for the characterization of new crystal forms / Dennette Murphy Shelley Rabel Solubility methods for the characterization of new crystal forms / Harry G. Brittain Overview of the solid dosage form preformulation program / Harry G. Brittain Drug-excipient interactions appropriate to solid dosage forms / Moji Christianah Adeyeye Methods for the determination of the physical and chemical stability of a new solid dosage form / Harry G. Brittain Dissolution testing / Chuck Collins and George Wong Structure, content, and format of the preformulation report / Ram N. Gidwani Significance of drug substance physicochemical properties in regulatory quality by design / Sau Lawrence Lee, Andre S. Raw, and Lawrence Yu. "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 will equip those in academia and the pharmaceutical industry with both basic and applied principles for the characterization of drugs, excipients, and products, and will also deal with the issues relating to predictability, identification, and product development during preformulation stages through Phase I of clinical trials."--BOOK JACKET Intends to equip those in the pharmaceutical industry with basic and applied principles for the characterization of drug compounds and substances-considering the identification, stability, structure, and mechanisms of drug candidates during preformulation through Phase I of clinical trials