In vitro quantitative and qualitative analysis of anti-hypertensive tablets and comparison between their generic versus branded formulations

Abstract

Background: While generic drugs and branded drugs are supposed to be bioequivalent, generic drugs have the additional benefit of being available at a lower cost which can be important in patients with chronic diseases such as hypertension. However, there are some concerns among clinicians that generic drugs may not be as effective as the branded counterparts. Hence, there is a need to generate comparative data between the branded and the generic drugs. Aims and Objectives: The objective of the study was to compare the pharmaceutical parameters and costs of four generic antihypertensive drugs with their branded counterparts. Materials and Methods: Four antihypertensive drugs, namely, Ramipril, atenolol, enalapril, and amlodipine were considered for evaluation for which their generic and branded samples were taken. All the drugs were in tablet form. The costs of these drugs were recorded, and various in vitro tests were conducted to assess and compare their characteristics, including disintegration, dissolution, hardness, weight variation, friability, thickness, diameter, and quantitative analysis using high-performance liquid chromatography and ultraviolet spectrophotometry. These tests were done in accordance with the specifications outlined in the Indian pharmacopoeia 2018. Results: All the branded drugs were more expensive than the generic counterparts. Quantitative assay of the generic sample of ramipril tablets showed a lower amount of the active ingredient than the stated value. Apart from the hardness values of the tablets, all the generic and branded samples fell within the specified normal range for most of the other important parameters. Conclusion: Generic antihypertensive tablets, were less costly than their branded counterparts and generally met the specified standards in in vitro testing. However, there were instances of subpar hardness results and a deficiency in the stated drug amount in the generic (less ramipril content in sample). These findings suggest the importance of rigorous quality control measures for generic medications particularly for those formulations liable for degradation.