QUALITY PARAMETERS COMPARISON BETWEEN SIMILAR AND GENERIC ATENOLOL TABLETS AND THE REFERENCE PRODUCT

Abstract

Pharmaceutical equivalence between two medicinal products corresponds to the proof that both contain the same drug, i.e., the same active ingredient or salt, the same concentration, pharmaceutical form and route of administration, containing or not identical excipients. Tests conducted on comparative quality analysis include physico-chemical tests and when applicable, microbiological, and biological tests. This study evaluated the quality parameters of two brands of generic (called D and E) and two brands of similar (B and C) were evaluated in relation to the reference drug (A) of atenolol 50 mg. Tests of weight variation, friability, disintegration and assay were performed. In addition, microbiological control of the samples was performed by counting the total number of mesophilic microorganisms. The result was that there was no growth of colonies. All samples tested met the requirements of the tests performed according to the parameters described in the Brazilian Pharmacopeia 6th edition.