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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 nonFickian 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. Key word: Aceclofenac, Fit factor, Kinetics, Carobopol, Kollidon, Eudragit L100. DOI: 10.5530/ijper.53.2s.49 Correspondence: Ms. Maryam Shabbir, Faculty of Pharmacy, University of Lahore, Lahore, PAKISTAN. Phone: +92 3454740763 E-mail: maryam.shabbir@ pharm.uol.edu.pk INTRODUCTION Aceclofenac is a Nonsteroidal Anti-inflammatory Drug (NSAID) which is considered as the first-line therapy in the symptomatic treatment of osteoarthritis and rheumatoid arthritis. Aceclofenac has short half-life of four hour and require frequent dosing. The successful treatment of arthritis depends in the maintenance of effective concentration of drug in the body by means of a sustained drug delivery system.1,2 Among the different approaches to achieve sustained drug delivery system, matrix tablets prepared by wet granulation method still appears as most efficient method in terms of process Submission Date: 12-06-2018; Revision Date: 24-10-2018; Accepted Date: 18-01-2019 development and economy.3 Various polymers have been used to retard the release of drug from matrix system. These polymers may include hydrophilic matrices, hydrophobic moieties and plastic matrix system. The hydrophilic polymer develops a highly viscous gel surface barrier when they are exposed to aqueous medium. This gelatinous barrier controls the liquid penetration into the center of the matrix system and in turn controls the drug release. The hydrophobic polymers are potentially erodible material and control the drug release by pore formation and erosion. On the other hand Uzair, et al.: Aceclofenec Sustained Release Tablet Indian Journal of Pharmaceutical Education and Research | Vol 53 | Issue 2 (Suppl) | Apr-Jun, 2019 S59 the plastic system forms insoluble matrices and liquid penetration into the matrix is the rate limiting step in such systems unless channeling agents are employed in the matrix system.4 The objective of the present study was to evaluate the efficiency of above mentioned polymers to sustain the release rate of aceclofenac and to reduce the dosing frequency to improve patient compliance. Carbopol 934P (hydrophilic polymer), Kollidon SR (plastic matrix) and Eudragit L100 (hydrophobic polymer) were evaluated for their physicochemical properties and potential sustain release effect at different concentration independently and in possible combination with each other. The formulations were also evaluated with the marketed product of aceclofenac sustained release product (hereby denoted as Brand-A) by means of model independent approach (fit factor) as approved by the FDA.5 MATERIALS AND METHOD

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