Experimental Design in Dissolution Testing

Abstract

Comparison of dissolution profiles may be facilitated by blocking the individual units of a given batch, thus greatly reducing the possibility of error from variation between experimental runs. Experimental designs are described which allow valid comparisons to be made between batches, as well as allowing the between run variation to he assessed and identifying any systematic errors resulting from differences between vessels. The number of tests reguired may freguently be reduced, and the need for replicate testing eliminated. The limitation of 6 vessels per run imposes certain restrictions in the experimental designs possible. Applications of these experimental designs in characterisation of dosage forms by their pH-dissolution topography and their use in factorial formulation experiments are described.