Abstract

DESIGN AND EVALUATION OF ACECLOFENAC SODIUM SUSTAINED RELEASE TABLETS USING SURFACE RESPONSE METHODOLOGY

Kamlesh J. Wadher*, Pallavi Kalambe and Milind J. Umekar

ABSTRACT

The aim of the study was to develop and evaluate colon targeted, compression coated matrix tablet of Aceclofenac sodium using prolonged release characteristics of HPMC K100 M with pH dependent solubility property of a Eudragit S 100. The pH dependent release was achieved by coating matrix tablet with Eudragit S100, soluble at pH 7. All the formulations of 32 factorial design were evaluated for the physicochemical parameters and subjected to in vitro drug release in 0.1 N HCl for two hour, three hour in pH 6.8 Phosphate buffer then in pH 7.4 phosphate buffer up to 12 hrs. Multiple regression analysis, two way ANOVA followed by Bonferroni Post Test were performed. Polynomial equations and response surface plots were generated for all dependent variables. It was observed that both the factors had significant effect on dependable variables (t2, t6 and t12). The presence of hydrophilic HPMCK100M sustains the drug release in colon due to formation of gel layer around the core tablet and EudragitS100 releases drug slowly over prolong period of time by pH dependent solubility.

Keywords: Aceclofenac sodium, colon target, sustained release, Response surface methodology, Mean dissolution time.