Assessment of quality control parameters of aceclofenac sustained release tablets marketed in Nepal

Abstract

Introduction: Aceclofenac has low solubility and high permeability; its dissolution is rate-limiting step for its absorption. Different brand products of same drug require analysis for their biopharmaceutical equivalence to ensure their safety and efficacy.
Methods: It was a cross-sectional study. Eight brands of Aceclofenac SR tablets were collected from various retailerstoassess for their shape, size, weight and color and also were tested for their biopharmaceuticaland physicochemical equivalence. Descriptive statistics were calculated.
Results: The weight variation of all brands ranged within the maximum limit of ±5% except brand H.All of the brands had the recommended hardness (≥4Kg/cm2). The friability values of all products were within the recommended specification (≤1%). All tablets passed the test for assay as the amount of drug in each tablet was in the range of 85% - 115%. The % drug release of all brands were in the range of 50-80% except brand E and H at 8thhrs that showed 63.88% drug release. The brand A, B and H followed Pappes release model whereas brand C followed zero order model, brand D and G followed first order model and brand E & F followed Higuchi model.
Conclusions: All brands except one were interchangeable in terms of biopharmaceutical equivalence and sustained release formulation. Further, more in-vivo bioequivalent studies in human should be conducted to correlate the findings.