A Feasibility study for the Development of a Prospective Compaction Functionality test and the Establishment of a Compaction data BANK

Abstract

The feasibility for the development of a standard compaction functionality testing method, which is capable of comparing the relative tabletability features of different materials and different lots of the same material with high sensitivity, was tested using an Integrated Compaction Research System. The following factors were optimized: tablet weight, lubrication, tooling, punch displacement profile, pressure range, as well as other pre-, during and post-compaction parameters. The optimized test conditions were found to be as follows: the amount of material to be compacted was calculated to produce a compact with a true volume of 0.25ml; internal lubricant with magnesium stearate at a concentration of 0.5%; standard 10.3mm, flat-faced, round BB tooling; constant punch velocities of 100mm/s and 300mm/s; and a pressure range of 25 to 550MPa. Several model powders which included microcrystalline cellulose, dicalcium phosphate dihydrate, calcium sulfate, dextrates, lactose anhydrous, and spray dried lactose were tested. Using the data generated in this work, the establishment of a compaction data bank that can be utilized as a reference source for tablet formulation studies was also found to be feasible.