Development of a Modified-Release Fast-Disintegrating Tablet (Harnal D) Containing Fine, Modified-Release Particles

Harnal D is a fast-disintegrating tablet containing fine, modified-release (MR) particles. The dissolution-controlled film on the MR particles consisted of a mixture of water-soluble and -insoluble polymers, with a very smooth particle surface (as determined by SEM observation). During dissolution testing, very fine pores on the surface of the MR particles were formed, and the drug release rate was controlled through these pores. The dissolution-controlled film was usually damaged during the compression process, and thus the dissolution rate increased. However WOWTAB technology, which was applied to Harnal D, can be manufactured at a low compression pressure, thereby avoiding damage to the dissolution-controlled film. In fact, there was no difference in the dissolution rate between the MR particles and tablet.