ACCELERATED DISSOLUTION RATE ANALYSIS (ACDRA) FOR CONTROLLED-RELEASE DRUGS - APPLICATION TO ROXIAM(R)

Accelerated dissolution rate analysis by elevated temperature has been applied to the release of remoxipride from a controlled release drug, Roxiam(R), and compared to the standard USP method. A PLS model has b een used in evaluating the factors of importance of the release as wel l as for the comparison to the standard USP method. ACelerated Dissolu tion Rate Analysis (ACDRA) offers the possibility of substantial reduc tion of analysis time. The time needed for one analysis with ACDRA is less than 5% of the USP-method. The automated analytical procedure is well suited for use in process control as well as in the early stages of the formulation development.