30MULTISCALE ASSESSMENT OF API PHYSICAL PROPERTIES IN THE CONTEXT OF MATERIALS SCIENCE TETRAHEDRON CONCEPT

Raimundo Ho, Yujin Shin, Yinshan Chen, Laura Poloni*, Shuang Chen, and Ahmad Y. Sheikh

Solid State Chemistry, AbbVie Inc., North Chicago, IL, USA

30.1 INTRODUCTION

Materials science and engineering is an interdisciplinary field focusing on the relationships between material's structure, properties, processing, and performance. The interplay between these elements of materials science is best represented as the materials science tetrahedron (MST) (Figure 30.1) [1, 2]. The ultimate goal of materials science and engineering is to enable the design and manufacture of product for a targeted performance criterion via application of engineering principles to control material properties from fundamental understanding of the structure–property relationships. Characterization, the core of MST, provides the bridge between the four interdependent elements of the MST that form the fundamental basis for engineering materials to meet target performance needs. A thorough understanding of material properties, process, and performance is an essential part of the pharmaceutical development process. Such insights are crucial to understand (i) material structure–property relationships, (ii) sensitivity of processing on material attributes, and (iii) the influence of material attributes on product performance such as safety, bioavailability, efficacy, manufacturability, stability, etc.

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