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Optimization of the Cohesion Index in the SeDeM Diagram Expert System and application of SeDeM Diagram: An improved methodology to determine the Cohesion Index

2018; Public Library of Science; Volume: 13; Issue: 9 Linguagem: Inglês

10.1371/journal.pone.0203846

1932-6203

Isaac Nofrerias, Anna Nardi, Marc Suñé-Pou, Joost Boeckmans, Josep M. Suñé‐Negre, Encarna García‐Montoya, Pilar Pérez‐Lozano, Josep R. Ticó Grau, Montserrat Miñarro Carmona,

Chemical Thermodynamics and Molecular Structure

In this study, we suggest optimizing the methodology to determine the Cohesion Index (Icd) in order to avoid mistaken characterizations due to powder bulk density. For this purpose, five different excipients, with different bulk densities and of different chemical nature, were compressed at different heights. Their compression and their tablet characterization enable establishing a powder weight for compression in accordance with its bulk density. Therefore, the resulting tablet will have a height within a defined range of heights where it has no critical effects on its hardness. Then, the impact of this optimization is shown in a formula development, one of the main SeDeM’s applications. A mathematical equation was used to calculate the theoretical amount of excipient to formulate the API according to both methodologies. The compression results demonstrate that the characterization with the NM-Icd is more accurate than the previous one while preserving its simplicity.