Optimal process design for the manufacture of transdermal drug delivery systems

Abstract

In a pharmaceutical market characterized by increasing competition, assessment criteria related to system design are assuming greater importance. This is true for both conventional dosage forms and drug delivery systems (DDS), as manufacturers strive to achieve adequate patient convenience and compliance. At the same time, the process design for the manufacture of DDS must comply with current good manufacturing practices, and give sufficient consideration to associated environmental issues. Related problems must be solved under social and safety pressures, which, in turn, become economic pressures, such as the consideration of control methods. In addition, both the system design and the process design have a major impact on the cost of goods, as well as on the levels of complexity or risk associated with development.