Comparative Evaluation of A New Direct Compression Excipient, Soludex™ 15

Abstract

Soludex™15, a new corn-based maltodextrin, has been evaluated and compared to nine frequently used commercial excipients for direct compression. The properties of the excipients reported are median size, particle size distribution, bulk density, flow rate, repose angle, moisture content, and hardness and compressibility at several compaction pressures. The influence of concentration of lubricant and mixing time with a lubricant on hardness of Soludex 15 compacts were determined. The effect of 1% magnesium stearate on the hardness of compacts was determined for the ten excipients. Model formulations for direct compression tablets using Soludex 15 are presented, and for a batch of these tablets the weight variation, friability, hardness, disintegration and dissolution are reported. Soludex 15 exhibited excellent flow and compressibility, and model tablets using Soludex 15 as the direct compression diluent met USP specifications and provided a rapid dissolution of the active ingredient.