Studies on Formulation and Evaluation of Eudragit RS PO Based Nanoparticulate System of Aceclofenac for Ocular Delivery

Abstract

Abstract: Aim: Ocular drug delivery is the most challenging and interesting goal in front of the pharmaceutical scientist. Ocular inflammation is the most commonly affecting disease of the eye. The objectives of present investigation were to formulate and evaluate eudragit RS PO (ERS PO) based Aceclofenac (ACF) Nano suspension for ophthalmic application. Materials and Methods: The ACF Nano suspensions were prepared by Nano precipitation method and the optimized formulation was lyophilized and further characterized for, particle size, polydispersity index, zeta potential, drug entrapment efficiency, in-vitro drug release study, pH study, ex-vivo trans corneal study, corneal hydration (%) study, Fourier Transform Infrared spectroscopy (FTIR), Differential Scanning Colorimetry (DSC), X-ray Diffraction (XRD) and Scanning Electron Microscopy (SEM). Results: The optimized ACF Nano suspension was compared with standard ACF solution prepared according to USP. The Nano suspensions were prepared successfully by Nano precipitation method. The FTIR, DSC and XRD studies confirmed absence of drug-polymer interactions. DSC and XRD results reflected the amorphization of drug in formulation. The SEM images revealed that there will be no irritation cause after ocular administration due to spherical and smooth surface. The results of in vitro drug release study indicated that higher % entrapment efficiency of drug in Nano suspension delays the drug release and increase the corneal residence time. Conclusion: From ex vivo trans corneal study it was found that optimized formulation showed higher % permeation of drug as compared with 0.1 % Aceclofenac solution with no signs of corneal damage and eye friendly behavior. Key words: Aceclofenac, Nanosuspension, Occular, Eudragit, Permeation.