Capitalizing on Aggregate Data for Gaining Process Understanding––Effect of Raw Material, Environmental and Process Conditions on the Dissolution Rate of a Sustained Release Product

Abstract

Continuous improvement of pharmaceutical manufacturing operations has not evolved at the same rate as it has in other industries. Although time-series data are routinely collected as part of equipment control systems, the data are usually not thoroughly evaluated. This article investigates batch data, in-process and release laboratory test data and time-series data from granulation, fluid-bed drying and coating operations in an effort to determine which parameters are most critical to the dissolution of a matrixrelease, solid oral dosage form of a poorly soluble drug.