Process analytical technology

Abstract

Pharmaceutical granulation is a critical unit operation that is frequently utilized to modulate attributes of powder mixtures to aid in further processing (e.g., compaction or encapsulation), as today few pharmaceutical products are granules. The granulation processes must be designed to impart a high degree of control on many important physical attributes, such as granule size distribution, shape, content uniformity, moisture content and distribution, porosity, density, tensile strength, and surface morphology. These physical attributes are often critical to process-ability of granulations and for final product quality and performance (e.g., content uniformity, dissolution, stability, and bioavailability). An optimally designed granulation unit operation can be an excellent tool for minimizing variability and thereby reducing the risk of poor quality. Traditionally, granulation has been utilized to manage lot-lot and supplier-supplier variability in the physical attributes of pharmacopieal materials-excipients and drug substances.