Effect of Sustained Release Polymers on Drug Release Profile of Aceclofenac Tablets Physicochemical Properties, Analysis of Kinetics and Fit Factor

Abstract

Aim: The sustained release tablets of Aceclofenac were prepared and evaluated for the sustained release drug profile with an aim to reduce dosing frequency and provide patient compliance. Materials and Method: The tablets were prepared by using different percentages of Kollidon SR, Carbopol 934P and Eudragit L100 and their combination thereof by wet granulation method. The tablets were analyzed for post compression studies including thickness, diameter, mechanical strength and uniformity of content. The in vitro dissolution studies were carried out in pH 1.2 for first 2 h and in pH 6.8 buffer for total of 12 h. Results: The tablets exhibited acceptable physicochemical characteristics as per USP limits. The formulation containing Eudragit L100 failed to give the desired sustained release effect where as a slow drug release was observed in formulations containing Carbopol 934P. Therefore, a combination of pH dependant polymer (Eudragit L100) and pH independent polymer (Carbopol 934P) combination was used. The formulations were also prepared by Carbopol 934P with plastic polymer (Kollidon SR). The desired sustained release effect was given by latter combination at 2:1 concentration. Conclusion: This formulation, U13, followed zero order kinetics with non Fickian drug release mechanism. When compared to the marketed brand by fit factor, U13 gave the ƒ2 value greater than 50 indicating closer proximity to the approved brand.