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O granulation Elusive endpoint? Physical standardization offers an alternative Fred A. Rowley Solid Dosage Training High-shear granulation, also known as wet granulation, is a traditional means of preparing powders for tabletting and cap- sule filling. The process, however, is not well understood, and it's difficult to predict when the process is finished. This article describes a method of performing high-shear granulation that overcomes the drawbacks of relying only on probes and fixed liquid additions to reach the endpoint. ver the last two decades, many researchers have sought a better understanding of high-shear granulation. Some have even worked toward finding ways to predict the results of the process, which can involve a cornucopia of active pharmaceutical ingredients (APIs) and different combinations of excipients. At the same time, suppliers of granulation equipment have updated their machines to give more consistent results. Yet despite hundreds of stud- ies and countless symposia and improvements, high-shear granulation remains unpredictable. Tablets & Capsules January 2017 33

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