The use of the SeDeM diagram expert system for the formulation of Captopril SR matrix tablets by direct compression

Abstract

The SeDeM diagram expert system has been used to study excipients, Captopril and designed formulations for their galenic characterization and to ascertain the critical points of the formula affecting product quality to obtain suitable formulations of Captopril direct compression SR matrix tablets. The application of the SeDeM diagram expert system enables selecting excipients with in order to optimize the formula in the preformulation and formulation studies. The methodology is based on the implementation of ICH Q8, establishing the design space of the formula with the use of experiment design, using the parameters of the SeDeM diagram expert system as system responses.

Keywords: Captopril; Diagram expert system; Direct compression; Index good compression (IGC); Preformulation; Quality by Design (ICH Q8); SeDeM; Slow release.