Biopharmaceutical quality of 100 mg atenolol tablets

Abstract

Introduction: Atenolol is a cardio-selective β-blocker, which is widely used in the management of hypertension, angina pectoris, cardiac arrhythmias and acute myocardial infarction.

Objective: Determine the biopharmaceutical quality of multi-sources of oral administration containing 100 mg of atenolol.

Methods: Tablets of two national formulations were analyzed, one by wet way (A-VH) and one by dry way (A-CD), and two imported (B and C). The tests carried out were: evaluation of labels and prospectuses, description of the tablets, average weight, hardness, friability, disintegration, identity and content of atenolol, uniformity of dosing units, dilution test and dilution profiles. Simultaneously, the performance of the chromatographic method for the quantification of the analyte in the in vitro dilution test was verified. To evaluate the drug´s kinetics release, different mathematical models were applied, including, the calculation of the efficiency of the dilution and the area under the curve.

Results: According to the technological and chemical evaluation carried out, all the products met the established quality specifications. It was demonstrated that the chromatographic method met the criteria established for the intended purpose. The A-VH tablets were classified as fast dilution, while the rest of the formulations as very fast dilution. A-CD and C imported tablets showed equal dissolution efficiency values and areas under the curves.

Conclusions: The imported formulations of 100 mg atenolol and the new formulation by direct compression present better biopharmaceutical quality than the wet formulation.