Endpoint Determination and Its Relevance to Physicochemical Characteristics of Solid Dosage Forms

Abstract

The focus of this research paper is on various aspects of endpoint determination of a typical wet granulation process. The determination of endpoint is highly variable for a conventional wet granulation process. However, high-shear granulators provide for precision in granulation, via the control of a majority of variables that are critical in wet granulation. Therefore, the use of precision in determination of endpoint to beneficially affect the performance of compressed tablets is very desirable. The main objective of this study is to examine the relevance of endpoint determination in controlling performance characteristics of compressed tablets such as hardness, friability, disintegration time, and dissolution time. The effect of three variables—namely endpoint of wet granulation process, press speed (or dwell time), and compression force—on the performance of compressed tablets has been evaluated using a full-factorial experimental design and response surface methodology. Also, the hypothesis of counteracting inherent variability of a wet granulation process by rational selection of press speed and compression force has been investigated.