Formulation, Optimization, and Characterization of Transdermal Patches Leflunomide by Quality by Design Approach

Abstract

Dyspepsia, nausea, abdominal pain, and oral ulceration are the most common side effects of Leflunomide. Transdermal patches reduce the risk of first-pass metabolism and improve drug penetration through the skin. Leflunomide can be delivered more efficiently, resulting in a higher drug concentration at the site of action. The formulation's goal is to make sure that the drug stays on the inflamed tissue for a long time so that it can work better. Transdermal patches were formulated using Design expert software following Box Behnken design. HPMC and EC were selected as hydrophilic and hydrophobic polymers. DBP was used as permeation enhancer. Swelling index and in-vitro drug release were selected as evaluation response.