Idealized Approach to the Optimal Design, Development, and Evaluation OP Drug Delivery Systems II: Optimization OP Drug Bioavailability Inputs and in-vitro Drug Release Testing

Abstract

This report is a continuation of a previous communication concerning the role of drug bioavailability input-pharmacological response output relationships in drug delivery system design, development, and evaluation. The degree of control of ophthalmic. drug action by dosage form design is exemplified with two antiglaucoma drugs. Computer simulations are presented to demonstrate the control of simultaneously occurring therapeutic and toxic drug actions which can be achieved through systemic drug input optimization. An optimally predictive in-vitro drug bioavailability testing apparatus and its mode of operation during product development studies, to function as a replacement for a panel of human subjects, is described. An overall, idealized scheme for rationally approaching the development of drug products is presented. Results of ongoing research in the authors' laboratories are provided as examples.