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A Novel Method for Estimating Solid Fraction of Roller-Compacted Ribbons
Authors:Paul Nkansah  Sy-Juen Wu  Stephanie Sobotka  Ken Yamamoto  Zezhi J Shao
Affiliation:1. Pfizer Global Research &2. Development, Pharmaceutical Sciences, Ann Arbor, Michigan, USApaul.nkansah@pfizer.com;4. Development, Pharmaceutical Sciences, Ann Arbor, Michigan, USA
Abstract:A simple method has been developed to estimate solid fraction or relative density of compacts using the weight of ribbons produced during roller compaction. The method provides an alternative to the commonly used dimensional measurement, especially for formulations not amenable to forming quality ribbons. Surface texture of the compaction rolls has been taken into consideration in our mathematical treatment along with correction for ribbon relaxation. Ribbon relaxation occurring upon ribbon exiting the compaction zone is estimated using roll geometry, roll gap, and ribbon thickness. Detailed experimental runs have been carried out to confirm the validity of the proposed theory. The predicted solid fraction was found comparable to that from actual dimensional measurement by caliper. In the case of the microcrystalline cellulose/dicalcium phosphate one:one formulation, the predicted solid fraction had an error sum of squares (SSE) of 2.64E-03 when compared to the dimensional method. When relaxation was included, the SSE decreased by four folds. Similarly, for the microcrystalline cellulose/lactose monohydrate 2:1 formulation, the SSE decreased twelfth folds when relaxation was taken into consideration. These results further confirm the utility of the proposed throughput method for estimating the solid fraction of ribbons.
Keywords:roller compaction  dry granulation  solid fraction  Gerteis Mini-pactor®
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