ABSTRACT

Optimization of a formulation or process is finding the best possible composition or operating conditions. Determining such a composition or set of conditions is an enormous task, probably impossible, certainly unnecessary, and in practice, optimization may be considered as the search for a result that is satisfactory and at the same time the best possible within a limited field of search. Once the dosage form has been selected, the excipients must be identified, their choice often limited by practical considerations of time and resources determined by patents, company practice, or according to expert knowledge. Quite wide limits are generally chosen for screening quantitative factors. They are then often narrowed for more detailed quantitative study of the influence of factors where interactions between factors them are taken into account and for determining a predictive model for optimization. Once the important effects have been identified, a simplified model can be written.