The Potential use of Compression Coating in the Blinding of Clinical Trial Supplies

Abstract

The use of compression coating to blind tablets for use in clinical trials has been found to be acceptable for a number of products when comparing the ‘in vitro’ dissolution rate of the manipulated and the parent tablet. The apparent dissolution rate for some products was found to be dependent upon the quantity of compression coat surrounding the parent tablet and the compaction pressure utilised. This was in some instances found to be an artifact of the paddle dissolution method resulting from coning of the compression coat excipients over the parent tablet during dissolution.