Development And Optimization of Baricitinib -Nanoparticle Loaded Transdermal Patches for Treatment in Rheumatoid Arthritis

Abstract

Objectives: The study aimed to develop and optimize Baricitinib-loaded nanoparticles (BCT-NPs) for incorporation into a transdermal patch to improve drug bioavailability and ensure controlled drug release. Methods: Nanoparticles were prepared using the nanoprecipitation method with Eudragit RL100 and DMSO. A 3² factorial design was employed to optimize key formulation parameters such as polymer concentration and solvent volume. BCT-NPs were characterized for particle size, entrapment efficiency (EE), and zeta potential. The optimized batch was incorporated into a hydrogel-based transdermal patch and evaluated for physicomechanical and release properties. In vitro release kinetics and accelerated stability studies were also conducted. Results: The optimized batch (NF5) demonstrated a particle size of 116.6 ± 10.3 nm, entrapment efficiency of 79.67 ± 2.45%, and zeta potential of –39.32 mV. Among transdermal patches, TNF2 exhibited superior performance with optimal tensile strength (1.432 ± 0.07 kg/cm²), folding endurance (193 ± 1.21), and cumulative drug release of 83.29% at 12 h. Zero-order kinetics (R² = 0.9816) best described the release profile. Accelerated stability testing confirmed the formulation’s physical and chemical stability over three months. Conclusion: The factorial-optimized BCT-NPs loaded transdermal patch demonstrated effective drug encapsulation, sustained release, and robust mechanical properties. This formulation holds potential for enhancing the clinical management of Baricitinib therapy via non-invasive, patient-compliant delivery. Further in vivo studies are warranted to confirm its therapeutic applicability and bioavailability improvements.