Optimization of diluents on the basis of SeDeM-ODT expert system for formulation development of ODTs of glimepiride

Abstract

The present study aimed to optimize diluents characteristics (rheological characteristics, compressibility and disintegration behavior) using SeDeM-ODT expert system, to mask poor characteristics of APIs and will help in development of a formulation which is to be processed by direct compression technique. On the basis of SeDeM-ODT experts system, various parameters were determined for glimepiride, diluents and other excipients, and evaluated their suitability for direct compression and bucco-dispersibility. Diluents were selected and powder blend of all the developed formulations were tested as per SeDeM-ODT expert system. Powder blends were compressed to ODTs and cross carmellose sodium was used as super dissintegrant. Different parameters of the powder blend related to flow were evaluated while compressed tablets were subjected to various official and un-official quality control tests. SeDeM-ODT Experts system was successfully applied for optimization of diluents and all the formulations exhibited better flow, disintegration behavior and sufficient mechanical strength, irrespective of the addition of other excipients having poor characteristics. Results of the developed formulations was same as predicted in terms of rapid disintegration (disintegration < 60sec) and high mechanical strength (crushing strength greater than 40 N) of the tablets. SeDeM-ODT expert system can help in selection of diluents with optimum characteristics, required for tablet preparation by direct compression, facilitating the process of formulation development and avoided extensive experimentation, as carried out in conventional statistical optimization.