Formulation and Evaluation of Niosomal Loaded Transdermal Patches for the Treatment of Osteoarthritis

Abstract

Introduction: Osteoarthritis (OA) is a degenerative joint disease resulting from the breakdown of joint cartilage and underlying bone. The most common symptoms of osteoarthritis are joint pain and stiffness. The major hurdle in its treatment is that the oral administration of NSAIDs (Lornoxicam) causes side effects like GI side effects, cardiovascular problems, liver is-sues, or renal problems. Thus, there is a need to develop a Transdermal drug delivery system for the transport of drugs, which reduces side effects and has several benefits over oral delivery, and a Novel drug delivery system to enhance the permeation of drugs and give relief from symptoms of OA. Objectives: This work deals with the formulation and evaluation of niosomal-loaded Transdermal Patches for the treatment of Osteoarthritis. Method: The Niosomes were prepared using the thin film hydration method, and Niosomal-loaded Transdermal patches were prepared using the Solvent Casting method. The preliminary evaluation and characterization studies were conducted to find the optimized formulation. The in-vitro release and ex-vivo permeation studies were investigated. Stability studies were also assessed. Result: The prepared Niosomes suspension (F2) was found to have particle size 320.2 nm, Zeta potential 23.9 mV, and Drug entrapment 79 ± 0.32%. The in-vitro drug release studies of opti-mized formulation show 96.44 ± 0.34 % drug release for 24 hours. Then, the optimized Niosome formulation (F2) was loaded into the transdermal patches. The in-vitro permeation studies of Nio-somal-loaded transdermal patch F1 (NLXTP) were performed, which showed a higher permeabil-ity than plain drug-loaded transdermal patch. F1 (NLXTP) followed Zero order release kinetic model, which shows a non-fickian controlled release diffusion mechanism. The ex-vivo drug re-lease studies of optimized formulation F1 (NLXTP) show 2.79 ± 0.76 (μg/ml) drug permeated for 8 hours with a flux value of 0.35 ± 0.55, and the percentage of drug retention was found to be 5.67%. The stability studies showed that patches were stable over 90 days in different atmospher-ic conditions. Conclusion: The Lornoxicam-loaded Niosomal transdermal patch was found to be a promising nano-drug-delivery alternative that showed better entrapment and release with a permeation pro-file for the daily management of osteoarthritis.