Formulation and Characterization of Novel Non-Ionic Surfactant Based Aceclofenac Gel as a Potential Drug Delivery System

Abstract

Background: Aceclofenac is considered to the first line drug in the symptomatic treatment of rheumatoid arthritis, osteoartheritis and ankylosing spondylitis. The successful treatment of arthritis depend on the maintenance of effective drug concentration level in the body, for which a constant and uniform supply of drug is desired. The short biological half-life (about 4 hrs) and dosing frequency more than once a day as well as (70-80%) of dose is excreted by renal transport make aceclofenac an ideal candidate for formulation of niosomal gel. Methodology: The niosomal gel of aceclofenac in order to sustain the release of aceclofenac topically, decreases the side effect of GI disturbance by maintaining the concentration of the drug in the blood and decrease the renal excretion as well as frequency of dosing. Niosomal gel was prepared by coacervation phase separation method. Preformulation studies, structural analysis, in-vitro drug release study, mechanism of drug release kinetic and data analysis (zero order, first order and higuchi’s model), percentage entrapment efficiency and stability study were performed (n=3). Anti-Inflammatory study was performed for final optimized formulation. Result and conclusion: It is revealed from preformulation studies that materials obtained for study did not show any incompatibility. Particle size was determined in the range of 9.46±1.055 to 12.91±3.587μm by using an optical microscope with calibrated eyepiece micrometer. Scanning Electron Microscopy of niosomes was performed to observe surface morphology and percentage entrapment efficiency of niosomes were reported in the range of 63.49±0.265% to 78.55±0.425%. From release kinetic modelling, it was analysed that the drug was released from niosomes by a diffusion-controlled mechanism. Lastly, stability study of all formulations was done in two different temperature and anti inflammatory activity of final optimised formulation was compared with marketed formulation (Voveran Emulgel). Results shows that the aceclofenac Niosomal gel showed fair anti-inflammatory activity but it was not as good as the commercial product.