Abstract
Validation of methodology for assay, pharmaceutical equivalence, and comparative dissolution profile for tablets containing amlodipine besylate
Highlights
The amlodipine besylate is indicated as a drug of the first choice in the treatment of hypertension and angina pectoris due to myocardial ischemia
To perform pharmaceutical equivalence in vitro, it should be used official methods published in the Brazilian Pharmacopeia (Brasil, 2010b), or, if applicable, in other codes authorized by ANVISA (Brazil's National Health Surveillance Agency), or other applicable quality standards (Brasil, 2010a)
There is no monograph that describes a method for the quality control of tablets containing amlodipine besylate in the Brazilian Pharmacopeia
Summary
The amlodipine besylate is indicated as a drug of the first choice in the treatment of hypertension and angina pectoris due to myocardial ischemia. This drug relaxes the blood vessels, increasing the amount of blood and oxygen to the heart and reducing its workload. The high blood pressure makes the heart and the arteries a work overload that in the long term causes the heart and arteries to not function properly. This can cause damage to the blood vessels, resulting in brain-vascular diseases, heart attacks, and heart and renal failure. Differences in the results in vitro may lead to differences in bioavailability, impairing the bioequivalence between the products and, the effectiveness and safety of treatment when choosing a similar and generic drug product
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