Study of Ex Vivo and In Vivo Effect of Topical Ionic Solution of Diclofenac Sodium in Male Albino Rats Using Iontophoretic Technique.

Abstract

Background: This study is designed to overcome the limitations of transdermal drug delivery by developing a customized iontophoretic device to rapidly increase the delivery of NSAIDs (diclofenac sodium [DS]).

Methods: Three concentrations of DS topical solution were prepared. A customized iontophoretic device has been designed to study the effect of the device in vitro, ex vivo, and in vivo on the release of DS topical solution.

Results: Release of DS using an iontophoretic device was found proportional to the drug concentration with respect to time and current applied, i.e., 2.0% solution showed more promising drug release than 1.5% and 1.0%. Likewise, the release rate of DS is much higher at 5 mA than at 1 mA current. The most prominent in vitro concentration of DS (2%) showed a significant reduction in the rat's paw size compared with the in vivo control and passive control groups.

Conclusion: The consistency of these results across both ex vivo and in vivo studies underscores the efficacy and preclinical proof-of-concept for this iontophoretic technique. While these results are promising, further studies on long-term skin tolerability and irritation are required to establish its safety profile for human use in enhancing drug delivery. This work provides a solid foundation for further development of noninvasive drug delivery systems for topical applications, offering a promising approach for improving therapeutic outcomes.