Zeitschrift für Bioanalyse und Biomedizin

Transdermal Drug Delivery System-Quality by Design Approach

Abstract

Alok Bandyopadhyay

Transdermal Drug Delivery System (TDDS) is a delivery system of continuous drug penetration through the skin at a reproducible rate over the intended application time period. This process is accomplished by two technologies: (a) Passive, and (b) Active. The former uses particulate system or chemical penetration system enhancers, whereas active technology uses electrical device to overcome skin barriers. Some of the major reported products have quality issues. Several guidance’s are published on this aspect. For better understanding, FDA suggested to perform the development of delivery system through Quality by Design (QbD) approach.

Although there are some limitations e.g. skin tolerability, skin barrier properties and variability of application site conditions, but also there are several advantages. Convenience, visibility of drug administration, consistent serum levels through steady permeation of drug across the skin, suited for delivery of drugs unstable for GI tract, removal of patch due to adverse event are all in the advantage category. So it is suggested that all critical parameters should be finalized in the pharmaceutical manufacturing development phases. The Quality Target Product Profile (QTTP) is required to establish a consistent quality product devoid of any quality issues. Overall, essential parameters are to be finalized in pharmaceutical development in order to devoid of any quality issues.