Quality control assessment and the possibility of interchangeability between multi-sourced clopidogrel tablets marketed in Nigeria

Background: The increasing availability of generic drug products has enhanced access to affordable medicines; however, concerns regarding their quality and interchangeability with innovator brands persist, particularly in developing countries. Clopidogrel, an antiplatelet agent, is widely used in cardiovascular therapy, making quality assurance of its multisource products essential.

Objectives: The study was aimed to assess the quality control parameters and explored the interchangeability between ten multi-sourced clopidogrel tablets marketed in Nigeria. 
Methods: Quality control parameters evaluated include colour, shape, weight variation, hardness, thickness, friability, disintegration, content of active ingredient and in-vitro dissolution profile according to the Pharmacopoeia’s standards.

Results: All the samples comply with the USP standard for thickness, weight uniformity and disintegration tests. Only samples A (4.35±0.34), C (5.00±0.00), I (4.80±0.92) and J (4.98 ±0.28%) passed the hardness (kg/m²) test. All the tested samples pass the friability test with exception of samples E (1.46%) and G (7.88%). Sample F (72.40 %) failed the USP test for content of active ingredient. Comparisons of dissolution profiles of the different brands were carried out by model-independent approach: the dissimilarity factor f1, similarity factor f2 and dissolution efficiency (DE). Statistical comparison of f 1, f2 and DE indicated that only sample J (Torrent-clopidogrel®) was found to be similar (p > 0.05) to sample A (Plavix®).

Conclusion: This study therefore concludes that only Torrent-clopidogrel® is similar with Plavix® and can be used interchangeably.