Development and Characterization of Diclofenac Sodium Transdermal Patches Using Chitosan Natural Polymer Matrix

Abstract

The present research investigates the development and evaluation of Diclofenac Sodium transdermal patches utilizing chitosan as a natural polymer matrix. Non-steroidal anti-inflammatory drugs like Diclofenac Sodium are widely used but often cause gastrointestinal complications when administered orally due to first-pass hepatic metabolism. To overcome these limitations, a transdermal drug delivery system was developed using chitosan, a biocompatible and biodegradable polymer with excellent film-forming and bioadhesive properties. Transdermal patches were fabricated using the solvent casting method, incorporating suitable plasticizers to improve mechanical strength and flexibility. The formulated patches were characterized for physical appearance, thickness, weight uniformity, moisture content, folding endurance, tensile strength, and drug content uniformity. In-vitro drug release studies demonstrated sustained release of Diclofenac Sodium over 24 hours, achieving more than 85% cumulative release. Kinetic modeling revealed that the release profile best fit the Higuchi model, indicating diffusion-controlled drug release, with Korsmeyer-Peppas analysis confirming non-Fickian transport. Statistical analysis confirmed significant differences in release profiles among batches, highlighting the influence of formulation parameters. The findings underscore the feasibility of using chitosan as a natural polymer matrix for developing effective transdermal systems, offering an alternative to oral non-steroidal anti-inflammatory drugs therapy with improved patient compliance and reduced side effects. Further studies are needed to validate the in-vivo performance and ensure clinical safety. Overall, this research contributes valuable insights into the potential of natural polymers in advancing patient-friendly drug delivery technologies.