Experimental Design for Pharmaceutical Process Characterisation and Optimisation Using an Exchange Algorithm

Abstract

Efficient experimental design may be used to maximise the information available from a given number of experiments (1, 2, 3, 4). In the development of new molecules the amount of drug available for formulation studies is often restricted. Thus in studying a given process the experiment is designed so that the necessary information is obtained given there is only enough material for a limited number of operations.

We have studied the effects of process variables on the characteristics of a conventional tablet formulation of a soluble drug; the factorial design was optimised by an exchange algorithm.