METHOD DEVELOPMENT AND FORMULATING REBAMIPIDE SUSTAINED RELEASE TABLETS AND ITS EVALUATION

摘要

Last few eras, the remarkable advancement in the drug delivery system has been done; the oral route remains the important and picks up the safest route of drug delivery. Regardless of outstanding advancements in the oral route medication, the current study focused on the formulation of rebamipide SR tablets by studying several blends and their characteristics, including drug-excipients compatibility studies. Ultimately, it was concluded that it is safe to use PEO N12K, Camphor (milled), and MCC in the formulation of the Rebamipide Sustained release tablet. Thus, rebamipide Sustained-release tablets are successfully prepared by using conventional wet granulation technique requires making a matrix type tablet and displaying drug-release through diffusion mechanism. This formulation will assuredly improve patient adherence, improve bioavailability, low side-effects, and sustained clinical activity over the required duration of time (24 h) after single-dose administration. For the determination of the drug content in formulation, a simple, rapid, accurate, robust, and specific UV-Spectroscopy method was developed for the assay of the rebamipide sustained release tablet. The detection was carried out at 325 nm. The linear concentration of standard solutions was approximately 5-60 μg/ml with a linear correlation coefficient of 0.998. The mean recoveries were 99.25%, substantiated the method was accurate. The method was validated concerning linearity, robustness, precision, accuracy, specificity & stability as per ICH guidelines. The proposed research could be successfully applied for the formulation of sustained-release tablets and the determination of rebamipide in SR tablets.