Abstract

DEVELOPMENT AND CHARACTERIZATION OF ORAL FAST DISSOLVING FILM CONTAINING NANOSUSPENSION OF CILNIDIPINE

*Dharmendrasinh V. Dabhi and Dasharath M. Patel

Abstract

This study was carried out to formulate and characterize oral fast dissolving film containing nanosuspension of Cilnidipine. Initially Cilnidipine nanosuspension was prepared by high pressure homogenization (HPH) and optimized for effect of No. of cycle and Stabilizer. Nanosuspension was optimized by two factor-three level full factorial design using Design expert 10.0.0. Two independent Variables, The HPH pressure and Concentration of Tween 80 were selected based on preliminary screening. The dependent variable measured as a response were particle size D(90), particle size D(50) and Zeta potential. The Optimized nanosuspension was further transformed in fast dissolving film by solvent casting method utilizing HPMC E15, Hydroxy ethyl Cellulose (HEC), PVP K-30 and HPMC E5 as a film forming polymers. The effect of plasticizers (PEG 400, Glycerol and Triethylcitrate) and their concentration were tested for physicomechanical properties of casted films. The optimized formulation selected from overlay plot containing HPMC E15 and Triethylcitrate showed greater drug dissolution (more than 85% within 30min). The stability study of optimized formulation for 3 month showed no appreciable change in drug content and in vitro drug release.

Keywords: Fast dissolving oral film, Nanosuspension, Solvent casting, Experimental design.