Idealized Approach to the Optimal Design, Development and Evaluation of Drug Delivery Systems I: Drug Bioavailability Input-Pharmacological Response Output Relationships

Abstract

The marketing of drug delivery systems possessing an optimal therapeutic utility is the principal concern of the drug industry. It is necessary and useful in systematically pursuing the rational design and development of optimal drug delivery systems, to establish performance criteria upon which to base their evaluation and gauge the success of these efforts at any stage of the development. This first communication discusses the drug bioavailability input-pharmacological response output relationships which provide the means for establishing such guidelines. Part II discusses the application of these relationships and presents a rational, although idealized, approach to the development of drug products designed to elicit optimally sought pharmacological response behavior. The role of a new method of in-vitro drug product testing which is optimally predictive of in-vivo bioavailability, is presented. Examples are drawn from ongoing research in the authors' laboratories. The limitations within which the general ideals of ultimately optimal behavior of drug delivery systems are applicable and practical to achieve are discussed.