Author: Rabia Bushra, Muhammad Harris Shoaib, Huma Ali, Yousra Shafiq, Farya Zafar, Shazia Alam and Nousheen Aslam
Publishing Date: 2017
E-ISSN: 1011-601X
Volume 30 Issue 6
ABSTRACT:
Aceclofenac is considered to be an effective drug that has been widely prescribed for multi- medical complaints globally. Owing to high demand many generic counterpart of aceclofenac tablets are now available in the commercial market. The aim of the present work is to evaluate and compare the quality attributes of various national/local brands of aceclofenac immediate release tablets (100mg) with the standard multi-national brand available in Pakistan. Physico-chemical evaluation was performed by determining the average tablet weight, thickness, hardness, disintegration time, percent dissolution and assay. Moreover, brands and reference formulation were exposed to multipoint dissolution. The in vitro drug release pattern was examined in various pH environment (1.2, 4.5 and 6.8) using USP dissolution apparatus 2 (paddle) at 50 rpm. The data was then analyzed by model dependent (Zero-order, first-order, Higuchi, Hixson-Crowell, Korsmeyer & Peppas, and Weibull model), pair wise procedure (f1 & f2) and one-way ANOVA methods. Results showed that the all aceclofenac brands and the reference tablets followed Weibull kinetics at pH 6.8. f1 & f2 were also found to be within the acceptable FDA limits. Furthermore, the values of One-way ANOVA also confirmed the absence of any significant difference among various aceclofenac brands.
Keywords: Aceclofenac, tablets, quality control, NSAID, dissolution studies.