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Abstract

ABSTRACT:The availability of several brands of Simvastatin tablets in Libyan pharmacies today places health practitioners in a problem of generic substitution. The aim of the present study was the evaluation and comparison between four different Simvastatin brands, which are commercially available in the Libyan market produced by various pharmaceutical companies with different trade names. The physicochemical equivalence of four brands of Simvastatin tablets was investigated through the evaluation of both official and non-official standards according to the USP pharmacopoeia including uniformity of weight, thickness, hardness, disintegration time, drug content as well as dissolution rate. Acceptable external features as well as uniformity in diameter and thickness revealed for all the tablets. The entire brands complied with the official specifications for uniformity of weight where no tablet showed a deviation more than ±7.5%. Brand B had the highest crushing strength and highest disintegration time compared to the other brands. All the brands had values within the range specified for assay in the BP. The dissolution profiles showed that none of the brands had dissolution less than 75% within 30 minutes, dissolution efficiency at 30 minutes (DE30) more than 85%. All the four brands could be regarded as bioequivalent and therefore can be interchanged in the clinical practice. This sort of study is good indicator for the evaluation of the idealness of commercial products.