DESIGN AND IN VITRO EVALUATION OF SUSTAINED RELEASE TABLETS OF RANOLAZINE

Sustained-release drug delivery system containing Ranolazine (an anti-anginal drug) with different ratios of pH dependent polymer, Eudragit L100-55 was designed by wet granulation method. The physicochemical compatibility of the drug and polymers were studied by FTIR spectrophotometer and found to be compatible. The in vitro release of Ranolazine SR tablets was studied in 900 ml of 0.1N HCl as dissolution medium using a USP dissolution paddle assembly at 50 rpm and 37±0.5°C. The promising formulation with concentration of Eudragit L100-55 polymer 12.5% showed better release of 99.78±0.99% after 24 hours. It showed Zero-order release with linearity (r=0.9447 to 0.9895). The similarity factor (f2 values) was used for the comparison of in vitro release study of the best formulation of SR tablets and marketed ER product of Ranolazine. The f2 values found to be 77.29.  Based on the similarity factor (f2 values), the F4 formulation of SR tablets can be considered as optimized formulation in comparison with marketed ER product’s drug release profile. To study the mechanism of drug release from the oral SR tablets of Ranolazine, the release data were fitted to the well-known exponential equation (Korsmeyer/ peppa’s equation) and ‘p’ values found to be 0.73-0.78. This indicates that the release of drug follows non – fickian transport. Hence the present study indicates that the formulation F4 of the oral sustained release tablets of Ranolazine provides a better option for development of oral SR tablets of Ranolazine for once-daily administration.