Application of modified SeDeM expert diagram system for selection of direct compression excipient for liquisolid formulation of Neusilin® US2

Abstract

In the present investigations, the SeDeM expert diagram system, modified to include two important compression properties, i.e. mean yield pressure, Py, and compactibility parameter, σtmax, was used to identify a diluent most suitable for the direct compression of a liquisolid formulation of Neusilin® US2 (50NEU). The mean incidence values of 50NEU demonstrated that it had poor flowability and compactibility, and was highly hygroscopic. Three commonly used directly compressible tablet diluents, viz. lactose monohydrate, microcrystalline cellulose, and dibasic calcium phosphate, selected based on their index of good compressibility (IGC) values were evaluated for their usefulness for direct compression of 50NEU. Mathematical equations based on the linear and power mixing rules were used to calculate the percentage of diluent required for direct compression. The powder blends prepared using lactose monohydrate resulted in fragile tablets, dibasic calcium phosphate exhibited poor compactibility, however, powder blends containing microcrystalline cellulose resulted in tablets with acceptable compactibility. This demonstrated the significance of a rational selection of excipients based on their SeDeM parameters rather than the IGC values. Additionally, the study results showed that the modified SeDeM expert system was superior to the conventional SeDeM system for the selection of diluent for direct compression.